Federal and Massachusetts

Pharmacy Law Study Guide

For the Standardized Pharmacy Law Exam
2014 Version

Note: In this study guide, italics denotes language quoted verbatim from the law.
The source of the cited law has been provided when appropriate. A series of
dots (. . .) within an italicized quote signifies that language has been editorially
deleted because it is deemed not sufficiently relevant to the objectives of this
study guide. Because the language of the law as quoted in this study guide is
taken out of context, and has been edited for purposes of educational clarity, the
study guide should not be used as a reference by one who is seeking a complete
understanding of all laws. For specific legal advice, pharmacists and pharmacy
students should refer to the complete law at a library, or seek competent legal
counsel.
The materials provided in this study guide are updated annually. This study
guide utilizes various resources, including federal and state websites, which may
only update materials periodically. Changes in the law may occur prior to the next
updated version. Purchasers are advised to review the online federal and state
resources listed in the Study Guide for the most up-to-date changes. The laws
reviewed in this study guide are not a complete listing of all federal and state
laws and only provide a review. For a complete listing of all state laws, refer to
the website(s) provided in the state materials of this study guide. For a complete
listing of all federal laws, refer to the FDA website at
http://www.fda.gov/opacom/laws/, and to the DEA website at
http://www.deadiversion.usdoj.gov/21cfr/index.html.

Disclaimer: The materials in this document are intended for general information purposes only,
and are not intended to provide, and do not constitute, legal advice. Persons who need legal
advice should contact an attorney.

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All Rights Reserved.

Index

Chapter 1: The Food & Drug Administration................................4

Chapter 2: Federal Drug Control Law.........................................17
Chapter 3: Federal Controlled Substance Law.............................65
Chapter 4: The Drug Enforcement Administration....................104
Chapter 5: Massachusetts Statutes ............................................157
Chapter 6: Massachusetts Administrative Rules .......................188
Chapter 7: Sample Pharmacy Law Exam ..................................297

Federal Pharmacy Law Review

Chapter 1 : The Food and Drug Administration
The Federal Food and Drug Administration (FDA) is one of the most highly regarded federal agencies. The FDA is
an agency within the Department of Health and Human Services and consists of numerous centers, including:
1. Center for Biologics Evaluation and Research (CBER). CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal
Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products
are safe and effective and available to those who need them. CBER also provides the public with information to
promote the safe and appropriate use of biological products. CBER's mission is to protect and enhance the public
health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and
cellular and gene therapies.
2. Center for Devices and Radiological Health (CDRH). CDRH is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment,
microwave ovens and color televisions.
3. Center for Drug Evaluation and Research (CDER). CDER performs an essential public health task by making
sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. The Center is a
consumer watchdog in America's healthcare system. CDER's best-known job is to evaluate new drugs before they
can be sold. The Center's review of new drug applications not only prevents quackery, but it provides doctors and
patients with the information they need to use medicines wisely.
4. Center for Food Safety and Applied Nutrition (CFSAN). CFSAN, in conjunction with FDA field staff, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. CFSAN provides
services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency
administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to
food and cosmetics.
5. The Center for Tobacco Products (CTP). CTP oversees the implementation of the Family Smoking Prevention
and Tobacco Control Act. Some of the Agencys responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels,
and establishing and enforcing advertising and promotion restrictions.
6. The Center for Veterinary Medicine (CVM). CVM regulates the manufacture and distribution of food additives
and drugs that will be given to animals. These include animals from which human foods are derived, as well as
food additives and drugs for pet (or companion) animals. CVM is responsible for regulating drugs, devices, and
food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle,
swine, and minor animal species. (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.)
7. The National Center for Toxicological Research (NCTR). NCTR is the FDA's internationally recognized research center. NCTR, in partnership with researchers from elsewhere in the FDA, other government agencies, academia, and industry, provides innovative technology, methods development, vital scientific training, and technical
expertise. The unique scientific expertise of NCTR is critical in supporting FDA product centers and their regulatory roles.

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Federal Pharmacy Law Review

In addition to being trusted with safeguarding the safety, effectiveness and integrity of the nations drug supply, the
agency has had authority since 1948 to regulate the act of dispensing by a pharmacist. Although technically limited to the
regulation of interstate commerce, the courts have consistently held that the dispensing of a drug by a pharmacist to a patient, even though the act occurs entirely within a state, is an act that is in interstate commerce. Since the FDA has an important role in the regulation and implementation of federal laws, pharmacy practitioners should have a basic understanding of
the role of the FDA. The following provides information, including excerpts from FDA publications, describing the functioning of the agency. For additional information about the FDA, visit www.fda.gov.
A. CDER: The Consumer Watchdog for Safe and Effective Drugs
American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. CDER
ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.
This responsibility includes products that many consumers usually do not associate as drugs, such as fluoride toothpaste, dandruff shampoos and sunscreens. CDER carefully evaluates the benefits and risks of drugs and ensures that consumers have
access, as quickly as possible, to promising new treatments. The center oversees the research, development, manufacture and
marketing of drugs. CDER ensures truth in advertising for prescription drugs and monitors the use of marketed drugs for unexpected health risks. If unexpected risks are detected after approval, CDER takes action to inform the public, change a drug's
label, or--if necessary--remove a product from the market.
CDER has multiple Offices and Divisions, including: Office of New Drugs; Office of Nonprescription Products; Office of
Oncology Drug Products; Office of Pharmaceutical Science; Office of Biotechnology Products; Office of Generic Drugs; Office of New Drug Quality Assessment; Office of Testing and Research; Office of Surveillance and Epidemiology (formerly
Office of Drug Safety); and Division of Drug Information.
Prescription Drugs
Prescription medicines must be administered under a doctor's supervision or require a doctor's authorization for purchase.
There are several reasons that medicines are required to be sold by prescription. The disease or condition may be serious and
require a doctor's management. The same symptoms can be caused by different diseases that only a doctor can diagnose. The
different causes may require different medicines. Some medicines can be dangerous when used to treat the wrong diseases,
and some drugs are abused.
OTC Drugs
Over-the-counter (OTC) drugs play an increasingly vital role in America's health care system. OTC drug products are those
drugs that are available to consumers without a prescription. There are more than 80 therapeutic categories of OTC drugs,
ranging from acne drug products to weight control drug products. As with prescription drugs, CDER oversees OTC drugs to
ensure that they are properly labeled and that their benefits outweigh their risks. OTC drugs generally have these characteristics:

their benefits outweigh their risks

the potential for misuse and abuse is low

consumer can use them for self-diagnosed conditions

they can be adequately labeled

health practitioners are not needed for the safe and effective use of the product
Generic Drugs
A generic drug is a chemical clone of a drug sold under a brand name. There are generic versions of both prescription and
OTC medicines. For example, ibuprofen is the generic name of the anti-inflammatory drug sold under the brand names
Motrin or Advil. The biggest difference between a generic drug and a brand-name drug is usually price. A generic drug often
costs about 30 percent less than the brand-name drug. Widespread use of generics helps control medical costs and insurance
premiums.
The FDA works with pharmaceutical companies to assure that all drugs marketed in the United States meet specifications for
identity, strength, quality, purity, and potency. Before approving a generic drug product, CDER requires many rigorous tests
and procedures to assure that the generic drug can be substituted for the brand name drug. CDER bases evaluations of substi-

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Federal Pharmacy Law Review

tutability or "therapeutic equivalence" for generic drugs on scientific evaluations. By law, generic drug products must contain
the identical amounts of the same active drug ingredient as the brand name product. Drug products evaluated as
"therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product. FDA considers drug products to be substitutable if they meet the criteria of therapeutic equivalence, even though the generic drug may differ in certain other characteristics (e.g., shape, flavor, or preservatives).

B. The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective
The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug
is developed to treat a specific disease. An important use of a drug may also be discovered by accident. For example, Retrovir
(zidovudine, also known as AZT) was first studied as an anti-cancer drug in the 1960s with disappointing results. It wasn't
until the 1980s that researchers discovered the drug could treat AIDS, and the Food and Drug Administration approved the
drug, manufactured by GlaxoSmithKline, for that purpose in 1987. Most drugs that undergo preclinical (animal) testing never
even make it to human testing and review by the FDA. The drugs that do must undergo the agency's rigorous evaluation process, which scrutinizes everything about the drug--from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.
Investigational New Drug Application
In many ways, the investigational new drug (IND) application is the result of a successful preclinical development program.
The IND is also the vehicle through which a sponsor advances to the next stage of drug development known as clinical trials
(human trials). During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is
reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting
the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in
limited, early-stage clinical studies.
The IND is not an application for marketing approval. Rather, it is a request for an exemption from the Federal statute that
prohibits an unapproved drug from being shipped in interstate commerce. Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will
probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that
legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA; however, its main purpose is to detail the data that provide documentation that it is indeed reasonable to proceed with certain human trials with the drug.
Treatment Investigational New Drug
Treatment Investigational New Drugs are used to make promising new drugs available to desperately ill patients as early in
the drug development process as possible. FDA will permit an investigational drug to be used under a treatment IND if there
is preliminary evidence of drug efficacy and the drug is intended to treat a serious or life-threatening disease, or if there is no
comparable alternative drug or therapy available to treat that stage of the disease in the intended patient population. In addition, these patients are not eligible to be in the definitive clinical trials, which must be well underway, if not almost finished.
An immediately life-threatening disease means a stage of a disease in which there is a reasonable likelihood that death will
occur within a matter of months or in which premature death is likely without early treatment. For example, advanced cases
of AIDS, herpes simplex encephalitis, and subarachnoid hemorrhage are all considered to be immediately life-threatening diseases. Treatment INDs are made available to patients before general marketing begins, typically during Phase 3 studies.
Treatment INDs also allow FDA to obtain additional data on the drug's safety and effectiveness.

New Drug Application

This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United
States. A new drug application (NDA) includes all animal and human data and analyses of the data, as well as information

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Federal Pharmacy Law Review

about how the drug behaves in the body and how it is manufactured. When an NDA comes in, the FDA has 60 days to decide
whether to file it so that it can be reviewed. The FDA can refuse to file an application that is incomplete. For example, some
required studies may be missing. In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA's Center for
Drug Evaluation and Research (CDER) expects to review and act on at least 90 percent of NDAs for standard drugs no later
than 10 months after the applications are received. The review goal is six months for priority drugs. There is also continuous
interaction throughout the review process. For example, over roughly six years, the sponsor, Merck Research Laboratories of
West Point, Pa., and the FDA had several face-to-face meetings and about 28 teleconferences regarding the asthma drug Singulair (montelukast sodium).
Reviewing Applications
Though FDA reviewers are involved with a drug's development throughout the IND stage, the official review time is the
length of time it takes to review a new drug application and issue an action letter, an official statement informing a drug sponsor of the agency's decision. Once a new drug application is filed, an FDA review team--medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts--evaluates whether the studies the sponsor submitted show that the
drug is safe and effective for its proposed use. No drug is absolutely safe; all drugs have side effects. "Safe" in this sense
means that the benefits of the drug appear to outweigh the risks.
The review team analyzes study results and looks for possible issues with the application, such as weaknesses of the study
design or analyses. Reviewers determine whether they agree with the sponsor's results and conclusions, or whether they need
any additional information to make a decision.
Each reviewer prepares a written evaluation containing conclusions and recommendations about the application. These evaluations are then considered by team leaders, division directors, and office directors, depending on the type of application.
Reviewers receive training that fosters consistency in drug reviews, and good review practices remain a high priority for the
agency. Sometimes, the FDA calls on advisory committees made up of outside experts, who help the agency decide on drug
applications. Whether an advisory committee is needed depends on many things. Considerations would be if it's a drug that
has significant questions, if it's the first in its class, or the first for a given indication. Generally, the FDA takes the advice of
advisory committees, but not always.
FDA Process for Responding to Drug Applications
As of August, 2008, CDER no longer issued "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER now issues a "complete response" letter at the end of the review period to let a drug company know of
the agency's decision on the application. This approach will help the FDA adopt a more consistent and neutral way of conveying information to a company when the FDA cannot approve a drug application in its present form. Taking the place of
"approvable" and "not approvable" letters, a "complete response" letter will be issued to let a company know that the review
period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.
Drug Review Steps
Preclinical (animal) testing.
An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in
clinical trials.
Phase 1 studies (typically involve 20 to 80 people).
Phase 2 studies (typically involve a few dozen to about 300 people).
Phase 3 studies (typically involve several hundred to about 3,000 people).
The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug
sponsors to meet.
Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.

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Federal Pharmacy Law Review

The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
FDA reviewers will issue a response letter to let a drug company know the agencys decision on the application.
The Role of User Fees
Since the Prescription Drug User Fee Act (PDUFA) was passed in 1992, thousands of drugs and biologics have come to the
market, including new medicines to treat cancer, AIDS, cardiovascular disease, and life-threatening infections. PDUFA has
allowed the Food and Drug Administration to bring access to new drugs as fast or faster than anywhere in the world, all while
maintaining the same thorough review process. Under PDUFA, drug companies agree to pay fees that boost FDA resources,
and the FDA agrees to time goals for its review of new drug applications. Along with supporting increased staff, drug user
fees help the FDA upgrade resources in information technology. The agency has moved toward an electronic submission and
review environment, now accepting more electronic applications and archiving review documents electronically.
The goals set by PDUFA apply to the review of original new human drug and biological applications, resubmissions of original applications, and supplements to approved applications. The second phase of PDUFA, known as PDUFA II, was reauthorized in 1997 and extended the user fee program through September 2002. PDUFA III, which extended to Sept. 30, 2007, was
reauthorized in June 2002. PDUFA IV was reauthorized in September 2007 and extends an additional 5 years. PDUFA allows the FDA to spend some user fees to increase surveillance of the safety of medicines during their first two years on the
market, or three years for potentially dangerous medications. It is during this initial period, when new medicines enter into
wide use, that the agency is best able to identify and counter adverse side effects that did not appear during the clinical trials.
In addition to setting time frames for review of applications, PDUFA sets goals to improve communication and sets goals for
specific kinds of meetings between the FDA and drug sponsors. It also outlines how fast the FDA must respond to requests
from sponsors. Throughout a drug's development, the FDA advises sponsors on how to study certain classes of drugs, how to
submit data, what kind of data are needed, and how clinical trials should be designed.

C. Inside Clinical Trials: Testing Medical Products in People

What Is a Clinical Trial?
Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine,
blood product, or gene therapy. Potential treatments, however, must be studied in laboratory animals first to determine potential toxicity before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise
are then moved into clinical trials.
Although "new" may imply "better," it is not known whether the potential medical treatment offers benefit to patients until
clinical research on that treatment is complete. Clinical trials are an integral part of new product discovery and development
and are required by the Food and Drug Administration before a new product can be brought to the market.
The FDA is committed to protecting the participants of clinical trials, as well as providing reliable information to those interested in participating. Recently, unethical behavior on the part of some researchers has shaken the public trust and prompted
the federal government to establish regulations and guidelines for clinical research to protect participants from unreasonable
risks.
Although efforts are made to control risks to clinical trial participants, some risk may be unavoidable because of the uncertainty inherent in clinical research involving new medical products. It's important, therefore, that people make their decision
to participate in a clinical trial only after they have a full understanding of the entire process and the risks that may be involved.
Why Participate in a Clinical Trial?
People volunteer to participate in clinical trials for different reasons. Some volunteer because they want to help advance medical knowledge. Others have tried all available treatments for their condition without success. In a 2000 Harris Poll of cancer

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Federal Pharmacy Law Review

clinical trial participants, 76 percent of the respondents said they participated because they believed that the trial offered the
best quality of care for their disease. Helping other people and receiving more and better attention for their own specific disease were other reasons cited. People should not, however, be tempted to enroll in a clinical trial simply because a potential
treatment is being offered free during a study, or because of the promise of money. This could lead to people overlooking
known risks.
Who Can Participate?
It's important to test medical products in the people they are meant to help. In the past, most new drug testing had been done
on white men. Groups such as women, blacks, and Hispanics often were not adequately represented. It's important to test
medical products in a wide variety of people because drugs can work differently in people of various ages, races, ethnicity,
and gender. The FDA seeks to ensure that people from many different groups are included in clinical trials.
Trial guidelines, or eligibility requirements, are developed by the researchers and usually include criteria for age, sex, type
and stage of disease, previous treatment history, and other medical conditions. Some trials involve people with a particular
illness or condition to be studied, while others seek healthy volunteers. Inclusion or exclusion criteria--medical or social standards used to determine whether a person may or may not be allowed to enter a clinical trial--help identify appropriate participants and help to exclude those who may be put at risk by participating in a trial. Volunteering for a clinical trial is no
guarantee of acceptance. Similarly, there's no guarantee that an individual in a clinical trial will receive the drug or medical
product being studied.
What Happens in a Clinical Trial?
Every clinical trial is carefully designed to answer certain research questions. A trial plan called a protocol maps out what
study procedures will be done, by whom, and why. Products are often tested to see how they compare to standard treatments
or to no treatment. The FDA often provides extensive technical assistance to researchers conducting clinical trials, helping
them design better trials that can characterize effects of a new product more efficiently, while reducing risks to those participating in the trials. The clinical trial team includes doctors and nurses, as well as other health care professionals. This team
checks the health of the participant at the beginning of the trial and assesses whether that person is eligible to participate.
Those found to be eligible--and who agree to participate--are given specific instructions, and then monitored and carefully
assessed during the trial and after it is completed.
Done at hospitals and research centers around the country, clinical trials are conducted in phases. Phase 1 trials try to determine dosing, document how a drug is metabolized and excreted, and identify acute side effects. Usually, a small number of
healthy volunteers (between 20 and 80) are used in Phase 1 trials. Phase 2 trials include more participants (about 100-300)
who have the disease or condition that the product potentially could treat. In Phase 2 trials, researchers seek to gather further
safety data and preliminary evidence of the drug's beneficial effects (efficacy), and they develop and refine research methods
for future trials with this drug. If the Phase 2 trials indicate that the drug may be effective--and the risks are considered acceptable, given the observed efficacy and the severity of the disease--the drug moves to Phase 3. In Phase 3 trials, the drug is
studied in a larger number of people with the disease (approximately 1,000-3,000). This phase further tests the product's effectiveness, monitors side effects and, in some cases, compares the product's effects to a standard treatment, if one is already
available. As more and more participants are tested over longer periods of time, the less common side effects are more likely
to be revealed. Sometimes, Phase 4 trials are conducted after a product is already approved and on the market to find out
more about the treatment's long-term risks, benefits, and optimal use, or to test the product in different populations of people,
such as children. Phase 2 and Phase 3 clinical trials generally involve a "control" standard. In many studies, one group of volunteers will be given an experimental or "test" drug or treatment, while the control group is given either a standard treatment
for the illness or an inactive pill, liquid, or powder that has no treatment value (placebo). This control group provides a basis
for comparison for assessing effects of the test treatment. In some studies, the control group will receive a placebo instead of
an active drug or treatment. In other cases, it is considered unethical to use placebos, particularly if an effective treatment is
available. Withholding treatment (even for a short time) would subject research participants to unreasonable risks.
The treatment each trial participant receives is often decided by a process called randomization. This process can be compared to a coin toss that is done by computer. During clinical trials, no one likely knows which therapy is better, and randomization assures that treatment selection will be free of any preference a physician may have. Randomization increases the

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Federal Pharmacy Law Review

likelihood that the groups of people receiving the test drug or control are comparable at the start of the trial, enabling comparisons in health status between groups of patients who participated in the trial. In conjunction with randomization, a feature
known as blinding helps ensure that bias doesn't distort the conduct of a trial or the interpretation of its results. Single-blinding means the participant does not know whether he or she is receiving the experimental drug, an established treatment for
that disease, or a placebo. In a single-blinded trial, the research team does know what the participant is receiving. A doubleblinded trial means that neither the participant nor the research team knows during the trial which participants receive the experimental drug. The patient will usually find out what he or she received at a pre-specified time in the trial.
What Are the Risks?
Some treatments being studied can have unpleasant, or even serious, side effects. Often these are temporary and end when the
treatment is stopped. Others, however, can be permanent. Some side effects appear during treatment, and others may not
show up until after the study is over. The risks depend on the treatment being studied and the health of the people participating in the trial. All known risks must be fully explained by the researchers before the trial begins. If new risk information becomes available during the trial, participants must be informed.
How Are People Protected?
Most clinical trials are federally regulated with built-in safeguards to protect participants. Today, the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) leads the department's programs for the
protection of human research participants and oversees human protection in HHS-funded research. The FDA has authority
over clinical trials for drug, biologic, and medical device products regulated by the agency. This authority includes studies
that are HHS-funded (with joint oversight by the FDA and the OHRP), as well as studies that are solely funded by industry or
by private parties. Many clinical trials are not subject to FDA regulation but are monitored by the institution sponsoring the
trial, such as a hospital. To help protect the rights and welfare of volunteers and verify the quality and integrity of data submitted for review, the FDA performs inspections of clinical trial study sites and anyone involved in the research. The quality
of clinical trials has improved markedly since the agency started inspecting in 1977. Between the FDA, other government
agencies, the review by institutional review boards, the required monitoring of studies by industry or private sponsors, and
the required oversight and reporting by investigators and their staff, a lot of people are looking out for the research subject's
safety.
What Is Informed Consent?
The FDA requires that potential participants be given complete information about the study. This process is known as
"informed consent," and it must be in writing. The informed consent process provides an opportunity for the researcher and
patient to exchange information and ask questions. Patients invited to enter a trial are not obligated to join, but can consent to
participate if they find the potential risks and benefits acceptable. A consent form must be signed by the participant prior to
enrollment and before any study procedures can be performed. Participants also have the right to leave a study at any time. At
the same time, people need to know that circumstances may arise under which their participation may be terminated by the
researcher, without their consent. For example, sometimes it becomes evident early on that a trial is not working and researchers know they are not going to get enough meaningful information to make continuation worthwhile. In addition, if an
unexpected change occurs in the health status of a participant, such as toxic effects or sudden kidney problems that may have
developed, it would not be in the best interest of the patient to continue, and certainly not consistent with what the investigator is trying to study. In any case, the circumstances must be described in the consent document.
Where to Get Information on Clinical Trials
It is often difficult for patients to learn about opportunities to participate in clinical trials. Doctors and patient advocacy
groups can be valuable resources for patients in search of clinical trial information. Newspapers, particularly in large cities,
often carry clinical trial recruitment advertisements. A call to the relevant department at nearby university medical centers can
lead to information about clinical trials currently recruiting patients.
The web site ClinicalTrials.gov also provides patients, family members, health care professionals, and members of the public
easy access to information on clinical trials for a wide range of diseases and conditions. The National Institutes of Health
(NIH), through its National Library of Medicine, has developed this site in collaboration with all NIH institutes and the FDA.
The site contains information on thousands of clinical studies sponsored by the NIH, other federal agencies, and the pharma-

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ceutical industry in about 100,000 locations worldwide. Studies listed in the database are conducted primarily in the United
States and Canada, but include locations in about 90 countries. ClinicalTrials.gov gives information about a trial's purpose,
who may participate, locations, and phone numbers for more details. In addition, a glossary is available that will help people
become familiar with the most common clinical trial terms.
Information Required for Informed Consent
The FDA requires that people be told that the study involves research of an unproven drug, biologic(such as a vaccine, blood
product, or gene therapy), or medical device; the purpose of the research; how long the participant will be expected to participate in the study; what will happen in the study and which parts of the study are experimental; possible risks or discomforts to
the participant; possible benefits to the participant; other procedures or treatments that might be advantageous to the participant instead of the treatment being studied; that the FDA may look at study records, but the records will be kept confidential;
whether any compensation and medical treatments, if any, are available if the participant is injured, what those treatments are,
where they can be found, and who will pay for the treatment; the person to contact with questions about the study, participants' rights, or if the participant gets hurt; that participation is voluntary and that participants can quit the study at any time
without penalty or loss of benefits to which they are otherwise entitled.
Institutional Review Boards
Clinical trial procedures are reviewed by institutional review boards (IRBs). These boards are composed of at least five members that include scientists, doctors, and lay people, and they must approve every clinical trial taking place within their jurisdiction--usually a hospital. The purpose of an IRB review is to ensure that appropriate steps are taken to protect the rights and
welfare of participants as subjects of research. If the risks to participants are found to be too great, the IRB will not approve
the research, or it will specify changes that must be made before the research can be done.
IRBs also review participant inclusion and exclusion requirements to be sure that appropriate people have been identified as
eligible for the trial. They often look at how and where recruitment for clinical trials will occur. IRBs review the adequacy of
the informed consent document to ensure that it includes all the elements required by law, and that it is at an appropriate reading level and understandable to study participants.

D. Protecting Drug Quality

CDER also promotes public health by regulating the manufacture of drugs and by setting standards for drug quality. CDER
works closely with FDA field inspectors to make sure that manufacturers comply with current good manufacturing practices.
Before a drug is approved, investigators determine whether the manufacturing data in the application are accurate. Once a
drug is approved, another inspection is required to show the firm can consistently make a drug in large quantities. Periodic
inspections check a firm's overall operation.
Current Good Manufacturing Practices (cGMPs)
Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American. Consumers expect that
each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however,
are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. FDA inspects
pharmaceutical manufacturing facilities worldwide using scientifically and cGMP- trained individuals whose job it is to evaluate whether the company is following the cGMP regulations. FDA also relies upon reports of potentially defective drug
products from the public and the industry. FDA will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the cGMP regulations. If a company is not complying with cGMP regulations, any drug it makes is considered adulterated under the law. This kind of
adulteration means that the drug was not manufactured under conditions that comply with cGMP. It does not mean that there
is necessarily something wrong with the drug.
For consumers currently taking medicines from a company that was not following cGMPs, FDA usually advises these consumers not to interrupt their drug therapy, which could have serious implications for their health. Consumers should seek advice from their health care professionals before stopping or changing medications. Regulatory actions against companies with
poor cGMPs are taken as a preventive measure because the manufacturing processes do not meet FDAs regulatory standards.

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By focusing on the procedures and processes used to make these drugs, FDA is working to ensure that drugs meet their quality standards and are safe and effective. The impact of cGMP violations depends on the nature of those violations and on the
specific drugs involved. A drug manufactured in violation of cGMP may still meet its labeled specifications, and the risk that
the drug is unsafe or ineffective could be minimal. Thus, FDAs advice will be specific to the circumstances, and health care
professionals are best able to balance risks and benefits and make the right decision for their patients.
If the failure to meet cGMPs results in the distribution of a defective drug, the company may subsequently recall that product.
This protects the public by removing these drugs from the market. While FDA cannot force a company to recall a drug, companies will usually recall voluntarily or at FDAs request. If a company refuses to recall a drug, FDA can warn the public and
could seize the drugs that are on the market. Even if the drugs are not defective, FDA can bring a seizure or injunction case in
court to address cGMP violations. When FDA brings a seizure case, the agency asks the court for an order that allows federal
officials to take possession of adulterated drugs and destroy them. This enables FDA to immediately prevent a company
from distributing those drugs to consumers. When FDA brings an injunction case, FDA asks the court to order a company to
stop violating cGMPs. Both seizure and injunction cases often lead to court orders that require companies to take many steps
to correct cGMP violations, such as hiring outside experts, writing new procedures, and conducting extensive training of their
employees. FDA can also bring criminal cases because of cGMP violations, seeking fines and jail time.

E. Now Available Without a Prescription

Over-the-counter (OTC) drug products are those drugs that are available to consumers without a prescription. There are more
than 80 classes (therapeutic categories) of OTC drugs, ranging from acne drug products to weight control drug products. As
with prescription drugs, CDER oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh
their risks.
OTC drugs play an increasingly vital role in America's health care system by providing easy access to certain drugs that can
be used safely without the help of a health care practitioner. This enables consumers to take control of their own health care
in many situations. There are more than 100,000 OTC drug products marketed, encompassing about 800 significant active
ingredients. The FDA has given OTC approval to drugs with such household names as Children's Advil and Children's
Motrin (ibuprofen), Orudis KT and Actron (ketoprofen), and Aleve (naproxen sodium) for pain relief and fever reduction;
Femstat 3 (butoconazole nitrate) for vaginal yeast infection; Pepcid AC (famotidine), Tagamet HB (cimetidine), Zantac 75
(ranitidine hydrochloride), Axid AR (nizatidine), and Prilosec OTC (omeprazole magnesium) for heartburn; Rogaine
(minoxidil) for hair growth; and Claritin (loratadine), the first non-sedating antihistamine.
The FDA believes that there is an important trend toward consumer participation in their own health care. It's part of the
agency's mission to keep up with the consumers' wish to be more involved. Switches have a huge impact on the health care
economy. The greater availability of medicines over the counter saves approximately $20 billion each year, according to a
1997 study. The $20 billion takes into account prescription costs, doctor visits, lost time from work, insurance costs, and
travel.
The Switch Process
The original Federal Food, Drug, and Cosmetic Act of 1938 made no clear-cut distinction between prescription and OTC
drugs. The 1951 Durham-Humphrey amendment to the act set up specific standards for classification. The amendment requires that drugs that cannot be used safely without professional supervision be dispensed only by prescription. Such drugs
may be deemed unsafe for nonprescription use because they are habit-forming or toxic, have too great a potential for harmful
effects, or are for medical conditions that can't be readily self-diagnosed. All other drugs can be sold OTC. A drug must be
made available without a prescription if, by following the labeling, consumers can use it safely and effectively without professional guidance.
The process of reclassifying drugs from prescription to OTC status is referred to as an "Rx to OTC switch." Drugs are commonly switched one of two ways: under the "OTC drug review," or by a manufacturer's submission of additional information
to the original new drug application. The OTC drug review, which began in 1972, is an ongoing assessment of the safety and
effectiveness of all nonprescription drugs. In the first phase of the OTC drug review, panels of nongovernment experts review

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active ingredients in marketed OTC drug products to determine whether they can be classified as safe and effective. The panels also review prescription ingredients to determine whether some are appropriate for OTC marketing.
The second common path to OTC approval is under the new drug application process. Under this process, manufacturers submit data to the FDA showing the drug is appropriate for self-administration. Data are submitted in a new drug application or a
supplement to an already approved drug application. Often the submission includes studies showing that the product's labeling can be read, understood, and followed by the consumer without the guidance of a health care provider. The FDA reviews
the new data, along with any information known about the drug from its prescription use. Under the new drug application
process, some drugs are approved initially as OTC drugs, but most are first approved for prescription use and later switched
to OTC.
In almost every case for the first drug switched in a drug category, the agency has sought the recommendation of a joint advisory committee made up of members of the agency's Nonprescription Drugs Advisory Committee and another advisory committee with expertise in the type of drug being considered. For example, because Rogaine is for conditions of the hair and
scalp, representatives of the Dermatologic and Ophthalmic Drugs Advisory Committee participated. While not bound by the
advisory committee's counsel, the FDA almost always follows its recommendation.
Benefit-Risk Comparison
When considering an Rx-to-OTC switch, the key question for the FDA is whether patients alone can achieve the desired medical result without endangering their safety. No drug is absolutely safe. There are risks associated with every medication, so
the FDA does a benefit-to-risk comparison to determine whether it is appropriate for consumers to self-medicate with a drug
for a certain use. On the safety side, the agency looks at the drug's toxicity--its potential for poisonous effects--when the drug
is used according to its labeled directions, and also from foreseeable misuse of the drug.
The FDA weighs a drug's safety against its benefit to patients. The agency considers whether consumers will be able to understand and follow label directions, whether patients can diagnose the condition themselves--or at least recognize the symptoms they want to treat--and whether routine medical examinations or laboratory tests are required for continued safe use of a
drug. No easy risk-benefit formula exists. The FDA does a case-by-case review of each drug because each drug raises unique
issues. Concerns about side effects can sometimes be managed by approving OTC drugs at lower doses than their prescription counterparts. The drugs must still be effective for the short-term symptoms for which they're intended. The issue of
whether a condition can be self-diagnosed was a central one for the advisory committee reviewing Rogaine. Most OTC drugs
are intended for treatment of symptoms that can be easily recognized, like headache or upset stomach. Others, though, are
intended to treat diseases like asthma or vaginal fungal infections, which cannot be consumer-diagnosed.
Consumer-Friendly Labeling
Labeling is an influential element in the OTC risk-benefit comparison. The decision about a drug's safety for OTC use can't
be made in a vacuum, by looking only at the drug ingredients. Every drug, used improperly, can cause adverse reactions.
Even appropriate use can lead to side effects (antihistamine use may cause drowsiness, for example). And some drugs can be
dangerously unsafe or ineffective if taken while using certain other drugs. Labeling can alert consumers to such potential
problems. Labeling of all drugs must be clear and truthful. For OTC drugs, the intended uses, directions, and warnings have
to be written so consumers, including individuals with low reading comprehension, can understand them.
In March 1999, the FDA finalized regulations to increase the readability of OTC labels by making the language more consumer-friendly and standardizing the format, including where important information is placed. The FDA believes that, in
some cases, consumers can get more information in the OTC labeling than they would get from their doctors. An example of
the consumer-friendly OTC label, available from the FDA website, is shown below.

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A Popular Alternative
Under the law, OTC drugs may be advertised directly to consumers without the many restrictions placed on prescription
products. OTC status provides a greater opportunity for direct communication with the consumer, not only by advertising in
magazines and on television, but also with packaging, brochures, and retail displays. Today's emphasis on self-care fuels the
popularity of nonprescription drugs. But OTC products are intended to supplement the medical options of the consumer, not
substitute for a prescriber's medical knowledge. If a health problem persists or worsens while using an OTC drug, consult a
health care provider. People must be in a partnership with their health care providers for optimal health. Many situations
aren't appropriate for self-treatment, and others may require professional guidance for self-treatment.

F. Postmarketing Surveillance Programs

Despite CDER's vigilant premarket review, active postmarketing surveillance of drug adverse effects is also essential. Because all possible side effects of a drug can't be anticipated based on preapproval studies involving only several hundred to
several thousand patients, FDA maintains a system of postmarketing surveillance and risk assessment programs to identify
adverse events that did not appear during the drug approval process. FDA monitors adverse events such as adverse reactions
and poisonings. The Agency uses this information to update drug labeling, and, on rare occasions, to reevaluate the approval
or marketing decision.
The following describes how CDER works to assure the ongoing safety and effectiveness of drug products currently marketed in the United States.
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The ultimate goal of AERS is
to improve the public health by providing the best available tools for storing and analyzing safety reports. The reports in

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AERS are evaluated by a multidisciplinary staff safety evaluators, epidemiologists and other scientists in CDERs Office of
Surveillance and Epidemiology to detect safety signals and to monitor drug safety. As a result, the FDA may take regulatory
actions to improve product safety and protect the public health, such as updating a product's labeling information, sending out
a "Dear Health Care Professional" letter, or re-evaluating an approval decision.
The MedWatch program is for health professionals and the public to voluntarily report serious reactions and problems with
medical products, such as drugs and medical devices. It also ensures that new safety information is rapidly communicated to
the medical community thereby improving patient care. All data contained on the MedWatch form will be entered into the
AERS database. After the FDA evaluates reports, the result may be safety alerts, letters to health care professionals, labeling
changes, product withdrawals, or further postmarketing research. When the FDA receives a MedWatch report, it is entered
into a database that allows a safety evaluator to compare it to similar reports. As few as a handful of reports may trigger a
careful investigation by the FDA and a manufacturer. To report to MedWatch, log onto the MedWatch site at
www.fda.gov/medwatch/. Reports can be made online, by phone (1-800-FDA-1088), or by downloading a form to fax (1800-FDA-0178) or mail (MedWatch, FDA,5600 Fishers Lane, Rockville, MD 20852-9787).
Manufacturers of prescription medical products are required by regulation to submit adverse event reports to the FDA. The
MedWatch site provides information on mandatory reporting by manufacturers. In addition, drug manufacturers must submit
either error and accident reports or drug quality reports when deviation from current good manufacturing practice regulations
occur.

G. Strategies to Reduce Medication Errors: Working to Improve Medication Safety

FDA receives medication error reports on marketed human drugs (including prescription drugs, generic drugs, and over-thecounter drugs) and nonvaccine biological products and devices. The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such
events may be related to professional practice, health care products, procedures, and systems, including prescribing; order
communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use." CDER medication errors program staff review medication error reports sent to the Institute of
Safe Medication Practices (ISMP) and MedWatch, evaluate causality, and analyze the data to provide feedback to others at
FDA.
A Regulatory Approach
The public took notice in 1999 when the Institute of Medicine (IOM) released a report, "To Err is Human: Building a Safer
Health System." According to the report, between 44,000 and 98,000 deaths may result each year from medical errors in hospitals alone, with more than 7,000 deaths each year related to medications. In response to the IOM's report, all parts of the
U.S. health system put error reduction strategies into high gear by re-evaluating and strengthening checks and balances to
prevent errors.
The FDA enhanced its efforts to reduce medication errors by dedicating more resources to drug safety, which included forming a new division on medication errors at the agency in 2002. Some important ways the FDA has worked to reduce medication errors includes: issuing a bar code label rule; reviewing drug names to minimize confusion between look or sound alike
drug names; improving OTC and prescription labels; publishing information for consumers and health professionals regarding new drug warnings and other safety information; and launching several medication risk reduction projects.

H.
Direct-to-Consumer Advertising
When it comes to advertising prescription drugs on radio and television and in magazines, doctors say that, for the most part,
the ads have both positive and negative effects on their patients and practices. Results of a FDA survey, released in 2004, also
indicate that most physicians view direct-to-consumer (DTC) ads as one of many factors that affect their medical practices
and their interactions with patients.

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For decades, prescription drug makers promoted their products exclusively to health care professionals, who were expected to
interpret drug information for their patients. Beginning in the early 1990s, some drug manufacturers began targeting consumers due, in part, to the aging baby boomers and to an increase in the number of patients participating in their own health care
decisions. Since then, DTC advertising has become a popular promotional tool.
The FDA oversees the advertising of prescription drug products under the Federal Food, Drug, and Cosmetic Act and related
regulations. The FDAs Division of Drug Marketing, Advertising, and Communications (DDMAC) helps protect the public
health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished
through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers.
DDMAC reviewers have responsibility for reviewing prescription drug advertising and promotional labeling to ensure that
the information contained in these promotional materials is not false or misleading. They engage in a variety of tasks to perform this responsibility, including: providing written comments to pharmaceutical sponsors on proposed promotional materials to ensure clear and unambiguous communication of the laws and regulations relating to prescription drug promotion;
reviewing complaints about alleged promotional violations; initiating enforcement actions on promotional materials that are
false or misleading; comparing the product labeling and promotional materials of various closely related products to ensure
that the regulatory requirements are consistently and equitably applied; traveling to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities; and acting as a liaison between DDMAC and other divisions
within the FDA on promotional issues.
DDMAC also reminds all companies who are engaging in DTC advertising of prescription drugs that the requirements of section 906 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) went into effect on March 25, 2008. Section 906 of FDAAA mandates that published direct-to-consumer advertisements for prescription drugs include the following
statement printed in conspicuous text: "You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088."

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Chapter 2: Federal Drug Control Law
I.

The Federal Food, Drug & Cosmetic Act (FDCA)

Passed by the United States Congress in 1938, and amended many times since then, the FDCA serves as the basis for
drug regulation in the United States. The FDCA is both simple and complex at the same time. The simplicity is that it specifies only three basic illegal acts; adulteration, misbranding, and the placing into interstate commerce of an unapproved new
drug. The complexity is that many activities are included under the umbrella of these three basic illegal acts. If you are ever
challenged to explain why something you know to be illegal is illegal under the FDCA, a safe explanation would be to assert
that the activity is either adulteration, misbranding, or the placing into interstate commerce of an unapproved new drug.
The passage of the FDCA in 1938 had a catalyst: the sulfanilamide tragedy of 1937. This miracle anti-infective sulfa
drug was made into an elixir that contained diethylene glycol. With no toxicity tests completed, the elixir led to 107 deaths,
mostly children. Unfortunately, the Pure Food and Drug Act (which was passed in 1906 and active in 1937) did not allow the
FDA to ban unsafe drugs. Since 1938, there have been a number of amendments to the FDCA that are important to be familiar with. These include:
Durham-Humphrey Amendment of 1951. This amendment distinguished at the federal level those drugs requiring a prescription from nonprescription drugs. Prescription drugs were defined as drugs that could not be used safely without medical
supervision, and restricted the sale of such drugs to prescription by a licensed practitioner. In addition to requiring a prescription for specific drugs, the Durham Humphrey Amendment also provided statutory provisions for the receipt of oral
prescriptions as well as allowing for the refilling of prescriptions. Prescription drugs required the legend Caution: Federal law prohibits dispensing without a prescription.
Kefauver-Harris Amendment of 1962. This amendment, also known as the Drug Efficacy Amendment, was enacted due to
the worldwide Thalidomide disaster, and required drugs (RX and OTC) to be proven safe AND effective by the FDA.
The efficacy requirement was retroactive to 1938 (DESI Project).
Orphan Drug Act of 1983. This amendment provided for tax and exclusive licensing incentives for manufactures to develop
and market drugs that were too expensive to develop and market for diseases that affect fewer than 200,000 Americans.
Drug Price Competition and Patent-Term Restoration Act of 1984. Also known as the Waxman-Hatch Amendment, it
streamlined the generic drug approval process and made generic drugs more readily available to the public, while providing incentives for manufacturers to develop new drugs through possible extension of patent life.
Prescription Drug Marketing Act of 1987. This amendment, enacted in response to threats of public health by secondary distribution systems, restricted sales and established record keeping requirements for prescription samples. It also prohibited health care entities from reselling their purchases to other businesses, and required state licensing of drug wholesalers.
Dietary Supplement Health and Education Act (DSHEA) of 1994. This amendment permitted manufacturers to make certain
claims not allowed under the FDCA for dietary supplements. Under DSHEA, the FDA was to treat dietary supplements
more like foods than drugs.
Food and Drug Administration Modernization Act of 1997. This amendment streamlined the regulatory procedures to ensure
the expedited availability of safe and effective drugs and devices. In addition, it increased the FDAs public accountability, allowed for a fast tract approval process for drugs to treat serious/life threatening diseases, and established a databank
of information on clinical trials.
A.
Definitions
Important to a thorough understanding of the FDCA is a knowledge of how the FDCA defines the terms to which it frequently refers. Whether an activity falls outside or inside a definition under the act may well determine whether the activity is law-

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ful or unlawful. Some of the most important definitions follow. The language is quoted directly from the FDCA.
Numerations refer to subsections of Section 321, Title 21, of the United States Code.
(g) (1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other
animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food
or dietary supplement for which a claim is made... is not a drug solely because the label or the labeling contains such
a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is
made... is not a drug under clause (C) solely because the label or the labeling contains such a statement.
Note that the definition of drug is dependent on the intended use of the article, not on the actual use of it. And the relevant
intent is that of the provider of the article, not the user of the article. A single article may be a drug in one context, and not be
a drug in another context, because the intent of the provider changes between the two contexts. Note also that subsections
(B) and (C) differ significantly, because in (B) an article can be a drug due to its intended use in therapeutics, while in (C) an
article can be a drug merely due to its intended use in affecting the structure or function of the body.
(h) The term "device" . . . means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve
its primary intended purposes through chemical action within or on the body of man or other animals and which is
not dependent upon being metabolized for the achievement of its primary intended purposes.
Note that the principle distinction between drugs and devices is that drugs achieve their intended purpose through chemical
action while devices do not. Sometimes the distinction between drugs and devices is blurry, and it is important to ask in what
way the article achieves its intended purpose. The terms drug and device are mutually exclusive. A single article cannot
be both.
(i) The term "cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into,
or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or
altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term
shall not include soap.
The FDCA definition of cosmetic is relatively consistent with the lay usage of that term. The terms cosmetic and drug
are not mutually exclusive. A single article can be both.
(j) The term "official compendium" means the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them.
Official Compendia set standards with which those who are responsible for drug formulation and distribution must comply.
Many of the requirements for drugs are not explicitly stated within the FDCA because the act defers to an official compendium and merely requires compliance with compendial standards. This does not mean that there are no legally mandated standards; only that the standards are contained within a compendium that is adopted by reference within the act.
(k) The term "label" means a display of written, printed, or graphic matter upon the immediate container of any article.

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(m) The term "labeling" means all labels and other written, printed, or graphic matters (1) upon any article or any of
its containers or wrappers, or (2) accompanying such article.
Note that labeling includes the label. It is to the labeling that attention usually turns when decisions are made about the
intent of a provider of an article. It is the labeling that will frequently make the difference between an act being legal or illegal. Because the FDCA is oriented toward the product, rather than the prescibers and dispensers of the product, the labeling
is considered part of the product.
(p) The term "new drug" means-(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and
experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the condition prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be
deemed to be a "new drug" if at any time prior to the enactment of this Act [enacted June 25, 1938] it was subject to
the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or (2) Any drug (except a new animal drug or an animal feed bearing or
containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
Note that whether a drug is new or not new (most people who are familiar with pharmacy law use the phrase not new
drug rather than old drug), depends on its general recognition as safe and effective under the conditions suggested in the
labeling. As the labeling changes, perceptions of newness may change. Only new drugs must be shown to be safe and effective prior to their being placed into interstate commerce. Not new drugs must meet all other relevant requirements for
drugs (i.e., adulteration and misbranding provisions), but not those applicable to new drugs, because they are not new.
B.
Adulteration
A drug may be adulterated either because it is actually adulterated or because it is deemed to be adulterated due to some requirement for proper storage or handling not having been met. The FDCA adopts a take-no-chances approach. It also recognizes the practical difficulties of proving that an article actually is adulterated. Thus, the act creates circumstances under
which the assumption is made that an article must be adulterated. These assumptions are virtually impossible to rebut. Selected language of the act follows. Numerations refer to subsections of Section 351, Title 21, of the United States Code.
A drug or device shall be deemed to be adulterated-(a)(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it
may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls
used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in
conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as
to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is
represented to possess; . . .
(b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its
strength differs from, or its quality or purity falls below, the standard set forth in such compendium. . .
(c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or
quality falls below, that which it purports or is represented to possess.
(d) If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or
(2) substituted wholly or in part therefor.
Note that a drug may be adulterated either because it is actually adulterated in some way (contamination by a foreign substance, for example), or because it has been deemed to be adulterated due to the possibility of its being adulterated (by being
held under unsanitary conditions, for example).

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C.
Misbranding
The FDCA requires that any information a manufacturer places on the label of a drug be truthful and not misleading. In addition, the act imposes certain mandatory disclosure requirements. So a provider of drugs cannot get cute and omit information
that is mandated, else the provider will violate the disclosure requirement. And the provider cannot disclose in a misleading
way or the provider will violate the basic requirement of truth. This is essentially a Catch 22" situation, in which the only
way out is full and truthful (not misleading) disclosure. Selected language of the act follows. Numerations refer to subsections of Section 352, Title 21, of the United States Code.
A drug or device shall be deemed to be misbranded-(a) If its labeling is false or misleading in any particular...
(b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer,
packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or
numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and
exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
(c) If any word, statement, or other information required by or under authority of this Act to appear on the label or
labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.
(e)(1)(A) If it is a drug, unless its label bears... (i) the established name... of the drug, if there is such a name; ii) the
established name and quantity or... the proportion of each active ingredient, including the quantity, kind, and proportion of any alcohol,... (iii) the established name of each inactive ingredient listed in alphabetical order on the outside container of the retail package and, if determined to be appropriate... on the immediate container... except that
nothing in this subclause shall be deemed to require that any trade secret be divulged, and except that the requirements of this subclause with respect to alphabetical order shall apply only to nonprescription drugs that are not also
cosmetics and that this subclause shall not apply to nonprescription drugs not intended for human use. (B) For any
prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) shall be printed prominently and in type at least half as
large as that used thereon for any proprietary name or designation for such drug or ingredient, except that to the extent that compliance with the requirements of subclause (ii) or (iii) of clause (A) or this clause is impracticable, exemptions shall be established by regulations promulgated by the Secretary. (2) If it is a device and it has an
established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name...
prominently printed in type at least half as large as that used thereon for any proprietary name or designation for
such device, except that to the extent compliance with the requirements of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary. (3) As used in subparagraph (1), the
term "established name," with respect to a drug or ingredient thereof, means (A) the applicable official name designated... or (B) if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this
subparagraph applies, then the common or usual name...
(f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those
pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not
necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such
drug/device from such requirement.
(g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and
labeled as prescribed therein. . . .
(h) If it has been found ... to be a drug liable to deterioration, unless it is packaged in such form and manner, and its
label bears a statement of such precautions, ...as necessary for the protection of the public health. . . .
(i) If it is a drug and its container is so made, formed, or filled as to be misleading, or (2) if it is an imitation of another drug; or (3) if it is offered for sale under the name of another drug.

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(j) If it is dangerous to health when used in the dosage, or manner or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.
(m) If it is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive...
(n) In the case of any prescription drug distributed or offered for sale in any State, unless the manufacturer, packer,
or distributor thereof includes in all advertisements and other descriptive printed matter issued ... a true statement of
(1) the established name... printed prominently and in type at least half as large as that used for any trade or brand
name thereof, (2) the formula showing quantitatively each ingredient of such drug... and (3) such other information
in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations
which shall be issued by the Secretary...
(p) If it is a drug and its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3
or 4 of the Poison Prevention Packaging Act of 1970 [15 USCS 1472 or 1473].
Note that the general purpose of the misbranding provisions is to assure that accurate and complete information accompanies
every drug product, which applies to advertisements as well as to other product-related materials. Furthermore, a drug will be
considered misbranded if it does not comply with the Poison Prevention Packaging Act.
D.
New Drug Approval
One of the most controversial aspects of the FDCA is the restrictive provision regarding the approval of new drugs. The
Food and Drug Administration (FDA) is criticized by some because it is too lenient in its interpretation of the FDCA and permits new drugs to be marketed without adequate studies for safety and efficacy, while others criticize the agency for being
too strict and preventing the use of perfectly safe and effective remedies that are needed by people who are ill and near death.
In response to these criticisms, the agency has attempted to speed up approval of those new drugs that represent a significant
advance in therapy, while continuing to maintain a healthy skepticism regarding new drugs that are not as likely to advance
therapy and have the potential to cause significant harm. The language of the act follows. Numerations refer to subsections
of Section 355, Title 21, of the United States Code.
(a) No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval
of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
(b) (1) Any person may file with the Secretary an application with respect to any drug subject to the provisions of
subsection (a). Such person shall submit to the Secretary as a part of the application (A) full reports of investigations
which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; (B)
a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a
full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and
packing of such drug; (E) such samples of such drug and of the articles used as components thereof as the Secretary
may require; and (F) specimens of the labeling proposed to be used for such drug.
The information that must be included in an NDA is quite specific, and the brief list cited above is misleading in its simplicity. In fact, an NDA includes massive amounts of information beyond what is described here, because often FDA reviewers
require additional information to maintain a comfort zone regarding product safety and efficacy. In addition to safety and
efficacy information, product sponsors must include information about the patent status of the product they sponsor.

E.
Prescription Exemption
Some medications are so potentially hazardous to health that the law recognizes they are not capable of being labeled for safe
and effective use without medical supervision. For these drugs, a prescription is required before a pharmacist may dispense
them to a patient. These drugs must bear the federal legend on the label affixed to each stock bottle provided to pharmacists. When dispensed to patients, these drugs must be labeled with specific information required by the FDCA, but under
such circumstances the drug is exempt from most requirements of the misbranding provisions. Other drugs are of such a
character that they can be labeled for safe and effective use without medical supervision, thus they are available without a

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prescription. The FDCA specifies the conditions and characteristics that will cause a drug to be classified as Rx or OTC.
The language of the act follows. Numerations refer to subsections of Section 353, Title 21, of the United States Code.
(b)(1) A drug intended for use by man which-(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or
(B) is limited by an approved application under section 505 [21 USCS 355] to use under the professional supervision of a practitioner licensed by law to administer such drug, shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such
practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or
oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order
which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.
Note the two ways for a product to be classified as prescription-only: (1) lack of safety if used without medical supervision,
and (2) the sponsors request for prescription-only classification in the products NDA. Note also the three ways in which a
prescription may be authorized by a prescriber; (1) in writing, (2) verbal authorization, and (3) refilling a written or verbal
order. Finally, the dispensing of a prescription drug without a prescription is a misbranding violation, because the law says
so; regardless of the truthfulness and non-misleading nature of the drug labeling.
(2) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of section 502 [21 USCS 352], except paragraphs (a),
(i)(2) and (3), (k), and (l) [21 USCS 352(a), (i)(2), (3), (k), (l)], and the packaging requirements of paragraphs (g),
(h) and (p) [21 USCS 352(g), (h), (p)], if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the
prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in
such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of
dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this subsection.
Note the information that is required to appear on the label of a drug prescribed for a patient, when the drug is dispensed to
the patient. Some pieces of information are mandatory for every prescription, other pieces of information need be included
on the label only when they are contained in the prescription. The very important effect of this section is to exempt from
most important misbranding provisions those drugs that are dispensed pursuant to a prescription and are properly labeled.
This is the reason why requirements such as the adequate directions for use requirement need not be met by pharmacists
dispensing properly labeled drugs pursuant to a prescription; the drug is exempt from that requirement.
(3) The Secretary may by regulation remove drugs subject to section 505 [21 USCS 355] from the requirements
of paragraph (1) of this subsection when such requirements are not necessary for the protection of the public health.
(4) (A) A drug that is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing
the label of the drug fails to bear, at a minimum, the symbol "Rx only".
(B) A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing the label of the drug bears the symbol described in subparagraph (A).
Note that drugs may be switched from prescription to non-prescription status. They must contain the federal legend, which is
now Rx Only, but used to be Caution: Federal law prohibits dispensing without a prescription. If the label of a non-prescription drug contains this federal legend, then the drug is misbranded.
F.
Prohibited Acts
It would be nice to think that all parties involved in drug development, marketing, and distribution could be trusted to voluntarily comply with requirements of the FDCA, and that there would be no need to actually enforce the law through penalties.

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Actually, voluntary compliance with the act is quite prevalent, but occasionally there are those who test the waters by going
out on a limb and conducting themselves in ways that the law simply cannot allow. Very rarely there are others who simply
have no respect for the law or for the public health, and they conduct themselves in ways that cannot be tolerated. In either
event, the FDCA contains within it provisions to penalize those who fail to voluntarily comply with the law. These penalties
vary in severity, and can be used as necessary to protect the public health. The language of the act follows. Numerations refer to subsections of Section 331, Title 21, of the United States Code.
The following acts and the causing thereof are hereby prohibited:
(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that
is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and
the delivery or proffered delivery thereof for pay or otherwise.
(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 404 or
505 [21 USCS 344 or 355].
Note that the bad stuff that cannot be done relates primarily to adulteration, misbranding, and the placing into interstate commerce of an unapproved new drug. When these violations occur, the FDA may initiate injunction proceedings to
prevent further distribution of a drug, it may seize the drug, and it may criminally prosecute those responsible for the violation. The act also allows the FDA to issue a warning letter to alert violators of possible problems and to permit voluntary
compliance. The product recalls that are often publicized are theoretically voluntary, because there is no statutory authority
to require them (recent proposed amendments seek to change this). However, the FDA can enforce the statute strongly
against those who do not voluntarily withdraw their product when asked to do so. FDA does classify voluntary recalls. A
Class I recall applies when there is a reasonable probability that the product will cause serious adverse health consequences or
death. A Class II recall applies when the product may cause temporary or medically reversible adverse health consequences,
but the probability of serious adverse consequences is remote. A Class III recall applies when a product is not likely to cause
adverse health consequences.
II.

Application of the FDCA to Dispensing

Most of the provisions of the federal FDCA are applicable primarily to manufacturers of pharmaceuticals, although
they also have significant implications for dispensers. As a general rule, the FDCA applies only to interstate commerce, but
that phrase has been interpreted expansively within the rather narrow language of the FDCA. Pharmaceutical manufacturers
are frequently involved in transactions between states, while pharmacists usually are not (with the notable exception of pharmacists who work for pharmacies that deliver their products through the mail). Technically, the definition of interstate commerce is (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District
of Columbia or within any other Territory not organized with a legislative body. (21 U.S.C. 321). However, this definition
that would seem to encompass only transactions between states, has been held by case law to also incorporate transactions
within a state. In 1948, the Supreme Court of the United States held in United States v. Sullivan that the act of dispensing a
medication to a patient is an act that is within interstate commerce and to which the misbranding provisions of the FDCA apply. This means that pharmacists must concern themselves with possible violations of the FDCA when they dispense medications to patients.

III.

New Drugs
Any drug that is not generally recognized as safe (GRAS) or not generally recognized as effective (GRAE) is a new
drug. It is illegal to place a new drug into interstate commerce without first having a New Drug Application (NDA) approved
by the FDA. Many pharmacists assume that if a new drug is on the market then it must have been approved by the FDA or
the agency would swoop down unmercifully and punish those who have broken the law. Nothing could be farther from the
truth. The FDA cannot be in all places at all times. It is up to pharmacists to work with the agency to detect new drugs that
are being marketed without approval, and to report such violations to the agency.

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A.
The NDA Process
There are specific steps that must be followed by one who submits a NDA to the FDA, and by the FDA in reviewing the submission. These steps are explicitly outlined in the FDCA. The language of the act follows. Numerations refer to subsections
of Section 355, Title 21, of the United States Code.
(c)(1) Within one hundred and eighty days after the filing of an application under subsection (b), or such additional
period as may be agreed upon by the Secretary and the applicant, the Secretary shall either-(A) approve the application if he then finds that none of the grounds for denying approval specified in subsection
(d) applies, or
(B) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the
question whether such application is approvable.
Note that the statute indicates there will be a firm resolution to a request for approval under an NDA within 180 days; however, it takes much longer. If the FDA were held to the 180 day period, then there would be no approvals, because the level of
certainty required for approval is impossible in 180 days, under all but the most unusual circumstances. The grounds for refusing or approving the NDA application is located in 21 USC 355(d). Within this section, one of the seven criteria for NDA
evaluation involves substantial evidence, defined as evidence consisting of adequate and well-controlled investigations,
including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the
drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the
effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling
or proposed labeling thereof.
What the agency grants, the agency can also take away. Should new information surface following the approval of an NDA,
indicating that the original approval was based on incomplete or erroneous information, the agency can withdraw approval of
the new drug. When this withdrawal occurs, the distribution of the drug must cease. (See 21 USC 355(e)).
The FDA views all drugs that have not been approved specifically for use within the United States as unapproved new drugs
when they are brought into the United States. It is illegal to import drugs into the United States without approval from the
FDA. This position of the agency has caused consternation among those who wish to save money by purchasing drugs outside the United States for use within the United States. While there is no legal way to bring drugs into the United States without FDA approval, the agency does exercise its discretion and will allow the personal importation of drugs that are necessary
for patient care, as long as the amount brought into the country is limited to that necessary to treat the patient for 90 days.
This is a matter of discretion offered to patients and not to their health care providers. It is not permitted for a health care
provider to import drugs to use in the treatment of patients, under the discretionary policy. Excerpts from the policy reads as
follows:
BACKGROUND
Because the amount of merchandise imported into the United States in personal shipments is normally small, both in
size and value, comprehensive coverage of these imports is normally not justified. This guidance clarifies how FDA
may best protect consumers with a reasonable expenditure of resources.
There has always been a market in the United States for some foreign made products that are not available domestically. For example, individuals of differing ethnic backgrounds sometimes prefer products from their homeland or
products labeled in their native language to products available in the United States. Other individuals seek medical
treatments that are not available in this country. Drugs are sometimes mailed to this country in response to a prescription-like order to allow continuation of a therapy initiated abroad. With increasing international travel and
world trade, we can anticipate that more people will purchase products abroad that may not be approved, may be
health frauds or may be otherwise not legal for sale in the United States.
In addition, FDA must be alert to foreign and domestic businesses that promote or ship unapproved, fraudulent or
otherwise illegal medical treatments into the United States or who encourage persons to order these products. Such
treatments may be promoted to individuals who believe that treatments available abroad will be effective in the treatment of serious conditions such as AIDS or cancer. Because some countries do not regulate or restrict the exporta-

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tion of products, people who mail order from these businesses may not be afforded the protection of either foreign or
U.S. laws. In view of the potential scale of such operations, FDA has focused its enforcement resources more on
products that are shipped commercially, including small shipments solicited by mail-order promotions, and less on
those products that are personally carried, shipped by a personal non-commercial representative of a consignee, or
shipped from foreign medical facility where a person has undergone treatment.
PERSONAL BAGGAGE
FDA personnel are not to examine personal baggage. This responsibility rests with the U.S. Customs Service. It is
expected that a Customs officer will notify their local FDA district office when he or she has detected a shipment of
an FDA-regulated article intended for commercial distribution an article that FDA has specifically requested be detained, or an FDA regulated article that appears to represent a health fraud or an unknown risk to health.
MAIL SHIPMENTS
FDA personnel are responsible for monitoring mail importations. It is expected that a Customs officer from the Customs Mail Division will examine a parcel and will set it aside if it appears to contain a drug, biologic, or device, an
article that FDA has specifically requested be held, or an FDA-regulated article that appears to represent a health
fraud or unknown risk to health...
Importations detained in accordance with this guidance should be held by Customs until they are either released or
refused entry...
GENERAL GUIDANCE
FDA personnel may use their discretion to allow entry of shipments of violative FDA regulated products when the
quantity and purpose are clearly for personal use, and the product does not present an unreasonable risk to the user.
Even though all products that appear to be in violation of statutes administered by FDA are subject to refusal, FDA
personnel may use their discretion to examine the background, risk, and purpose of the product before making a final
decision. Although FDA may use discretion to allow admission of certain violative items, this should not be interpreted as a license to individuals to bring in such shipments.
Commercial or Promotional Shipments
Commercial and promotional shipments are not subject to this guidance. Whether or not a shipment is commercial or
promotional may be determined by a number of factors including, for example, the type of product, accompanying
literature, size, value, and/or destination of the shipment. FDA personnel may also consider whether an importation
of drugs or medical devices is a commercial shipment by evaluating whether the article appears to have been purchased for personal use or whether the quantity suggests commercial distribution (i.e., the supply exceeds what one
person might take in approximately three months). Commercial shipments generally include shipments other than
those products that are personally carried, shipped by a personal non-commercial representative of a consignee, or
shipped from a foreign medical facility where a person has undergone treatment.
Drugs, Biologics, and Devices
When personal shipments of drugs and devices that appear violative are brought to FDA's attention by Customs,
FDA personnel will use their discretion to decide on a case by case basis whether to detain, refuse, or allow entry of
the product. Generally, drugs and devices subject to Import Alerts are not amenable to this guidance. Devices to be
used by practitioners for treating patients should not be viewed as personal importations subject to this chapter.
Drugs subject to Drug Enforcement Agency (DEA) jurisdiction should be returned to Customs for handling.
In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel may consider a more permissive policy in the following situations:
1. when the intended use is appropriately identified, such use is not for treatment of a serious condition, and
the product is not known to represent a significant health risk; or
2. when a) the intended use is unapproved and for a serious condition for which effective treatment may not
be available domestically either through commercial or clinical means; b) there is no known commercializa-

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tion or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue;
c) the product is considered not to represent an unreasonable risk; and d) the individual seeking to import
the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply)and
provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the
product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country.
B.
The 505(b)(2) Approval (Formerly Paper NDA)
Under the FDCA, there is a mechanism for approval of a new drug that does not require extensive and expensive clinical trials, and is not the traditional generic approval route. Once known as a Paper NDA, but now known by the section number
that authorizes it, the 505(b)(2) approval permits the sponsor of a new drug to obtain approval if safety and efficacy can be
shown through published studies or other evidence not created by the sponsor. As a practical matter, of course, this route will
not be available for patented completely new molecular entities, because there will have been no reported studies of them due
to their newness. But for slight modifications of existing drugs (a different salt or ester, for example), this is an approval that
may be permitted. The language of the act follows. Numerations refer to subsections of Section 355, Title 21, of the United
States Code.
(2) An application submitted under paragraph (1) for a drug for which the investigations described in clause (A) of
such paragraph and relied upon by the applicant for approval of the application were not conducted by or for the
applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom
the investigations were conducted shall also include(A) a certification, in the opinion of the applicant and to the
best of his knowledge, with respect to each patent which claims the drug for which such investigations were conducted or which claims a use for such drug for which the applicant is seeking approval under this subsection and for
which information is required to be filed under paragraph (1) or subsection (c)(i) that such patent information has
not been filed, (ii) that such patent has expired, (iii) of the date on which such patent will expire, or (iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is
submitted; and (B) if with respect to the drug for which investigations described in paragraph (1)(A) were conducted
information was filed under paragraph (1) or subsection (c) for a method of use patent which does not claim a use
for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not
claim such a use.
.
C.
The IND Exemption
Before a drug can be shown to be safe and effective, it is necessary to study the drug in clinical trials. These trials occur
throughout the country, thus it is necessary to place the as yet unapproved new drug into interstate commerce so that the drug
can be provided to those who will use it for clinical trials. If there were no exemption from the FDCA provisions that prevent
the introduction into interstate commerce of an unapproved new drug, then clinical trials could not occur. Thus, an exemption has been provided through the IND (Investigational New Drug) provisions of the act. The language of the act follows.
Numerations refer to subsections of Section 355, Title 21, of the United States Code.
(i)(1) The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of
this section drugs intended solely for investigational use by experts qualified by scientific training and experience to
investigate the safety and effectiveness of drugs.
The basis for permitting an unapproved new drug to enter interstate commerce under an IND exemption is promising evidence of safety and efficacy from preclinical studies with animals, and a summary of the literature for a drug. To be approved a request for an IND exemption must also describe how the drug will be used in clinical trials. Note particularly that
an IND is an exemption and not an approval. Nothing is being approved. This is simply a very narrow exemption from the
requirement for approval.
D.
Postmarket Drug Safety
In accordance with Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA has a
website containing links to postmarket drug safety information to improve transparency and communication to patients and
healthcare providers (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/).

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Links available on this FDA site include: agency databases, including studies and clinical trials; latest safety information; regulation and guidance documents; information about FDAs Drug Safety Oversight Board; information on how to use medicines safely; consumer articles on drug safety; general health information; FDAs response to IOM reports; drug labeling
information; and Risk Evaluation and Mitigation Strategies (REMS).
In regards to REMS, the FDAAA created new section 5051 of the Federal Food, Drug, and Cosmetic Act . Section 505
1(a) of the act authorizes the FDA to require REMS:
Before approval: if FDA determines REMS is necessary to ensure that the benefits of the drug outweigh the risks
Post-approval: If FDA becomes aware of new safety information and determines REMS is necessary to ensure that
the benefits of the drug outweigh the risks
The goal of REMS is to ensure the safe use of medications that have risks if used improperly. These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use.
The original list of products requiring REMS included the multiple myeloma medication thalidomide (Thalomide), the antipsychotic medication clozapine (Clozaril), and the abortifacient drug mifepristone (Mifeprex). More recently, on February 6,
2009, the FDA sent letters to manufacturers of long-acting opioid drug products, indicating that these drugs will be required
to have a REMS to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioid drugs include
brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone.
To allow safe access to drugs with known serious risks, the FDA may require REMS for a drug and include such elements as
are necessary to assure safe use of the drug.
Elements to assure safe use include:
Clinician prescribers need specific training or experience or are specially certified.
Pharmacies, practitioners, or healthcare settings dispenses the drug are specially certified.
The drug is dispensed to patients only in certain healthcare settings, such as hospitals.
The drug is dispensed to patients with evidence or other documentation of safe use conditions, such as laboratory
test results.
Patients using the drug are subject to certain monitoring or are enrolled in a registry.
Examples of possible additional REMS elements could include Medication Guides (MedGuides) and/or Patient Package Inserts (PPIs), and a communication plan. Prior to REMS, and since 2005, these elements typically appeared in approved risk
minimization action plans (RiskMAPs) (see the guidance for industry entitled Development and Use of Risk Minimization
Action Plans (70 FR 15866, March 29, 2005)).
This influencing of actual drug usage is a change from the FDAs traditional role as that of monitor, or gatekeeper, for new
drugs and medical products. Until the REMS program, the FDA developed the labels that detail how drugs are meant to be
used, but it left the final prescribing decisions to doctors, who are not bound by federal guidelines and can prescribe medications for off-labeluses other than what is FDA approveduses. The language of the FDCA regarding REMS is found in
21 USC 355-1.
E.
Dietary Supplements
Public demand for access to products that are believed to be useful in the treatment of physical and emotional ailments, but
that do not fall within the traditional boundaries of scientific medicine, has led to changes in the law that permit the marketing
of dietary supplements even if the supplements do not meet the stringent requirements applicable to drugs. A dietary supplement, that meets the requirements of the FDCA is not a new drug, and thus it does not require premarketing approval.
The FDCA contains a very specific definition of dietary supplement. The following language is quoted directly from the
FDCA. Numerations refer to subsections of Section 321, Title 21, of the United States Code.

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ff) The term "dietary supplement"-(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the
following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in (A) through (E).
This is only part of the very complex definition of the phrase dietary supplement. Note that it is the source of the article
that determines to a large extent whether the article is classified as a dietary supplement, or instead is classified as a drug.
The labeling on dietary supplements may make structure/function claims, but may not make therapeutic claims. The following language is quoted directly from the FDCA. Numerations refer to subsections of Section 343, Title 21, of the United
States Code.
(6) For purposes of paragraph (r)(1)(B), a statement for a dietary supplement may be made if-(A) the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of
such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure
or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to
maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient,
(B) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and
(C) the statement contains, prominently displayed and in boldface type, the following: "This statement has not
been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.".
A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease
or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first
sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary
no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is
being made.
Note that when a manufacturer of a dietary supplement makes a structure or function claim and can substantiate that the claim
is truthful and not misleading, the dietary supplement is not a drug under the act, and therefore does not require premarket
approval.

IV.

Generic Drug Products

A new chemical entity that is developed by a sponsor and is approved as a new drug under an NDA is granted a period of exclusive marketing, and during that time no other manufacturer may market the chemical entity. Patent laws protect
the new drugs exclusivity for a period of time, and under some circumstances, the FDCA provides additional non-patent exclusivity. After all applicable periods of exclusivity have expired, it is possible for another manufacturer to formulate the
chemical entity into a product and market the product as a generic equivalent of the innovator product. The most frequent
way of getting to market as a generic equivalent is through an Abbreviated New Drug Application (ANDA). An ANDA relies on the safety and efficacy studies of the innovator products NDA. Through an ANDA, a sponsor of a generic equivalent
is required only to show bioequivalence with the innovator product. If such bioequivalence is shown, then the assumption is
made that the bioequivalent product must be as safe and effective as the innovator product.

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A.
Bioequivalence Standards
Approval as bioequivalent under and ANDA requires that there be data from bioequivalence studies showing that the innovator product and the generic product are essentially identical. Studies do not need to show that the two products are exactly
the same. Although the two products must contain the same amount of active ingredient, and be in the same dosage form,
variables in formulation may cause there to be differences in rate and extent of absorption. Different diluents, binders, lubricants and other excipients may cause disintegration and dissolution to differ between two apparently identical products. The
FDCA requires that studies be done to demonstrate that any differences between the innovator and generic products do not
produce significant differences in rate and extent of absorption. The language of the act describing this requirement can be
found in 21 USC 355(j), with standards for approval of a generically equivalent product under an ANDA requiring a showing
of generic equivalence (same chemical entity, same strength, same dosage form) and bioequivalence.
B.
The Orange Book
The FDCA mandates that the FDA publish an alphabetical list of approved drug products. The FDA does this by publishing
a book titled Approved Drug Products With Therapeutic Equivalence Evaluations. The cover of the book is the color orange, thus its unofficial name. Because the book is a public document, it is republished by commercial enterprises on a regular basis, and these reprintings may not retain the original orange cover color, thus leading to confusion as to why the odd
unofficial name is being used for a book that clearly does not warrant such a label. The Orange Book lists all products of a
drug, along with their sponsor and other information relating to the approval date and patent term. Most importantly for pharmacists, the Orange Book lists bioequivalence evaluations for drugs of which there is more than one product. A reference
standard is noted (usually the innovator product, but not always), and each generic product is compared with that reference
standard. Each product for which an evaluation has been made is given a two letter code, with the first letter of the two letters being either A or B. The second letter of the two letter code explains how the first letter came to be what it is. Only
the first letters are significant for making comparisons. If two products both have a code beginning with A, then the two
products are considered to be bioequivalent. No other combination has meaning. In other words, an A rated product cannot be compared with a B rated product, and two B rated products cannot be compared with each other. Simply because
products are not both A rated does not mean they are bad products, it means only that they are not shown to be equivalent.
Perhaps they really are equivalent, but just have not been shown to be. So, just to be perfectly clear, a B rated product is
not a bad product, it is a product with which no other product has been shown to be bioequivalent.

V.

Labeling
It is probably obvious by now that the FDCA is a law that is very much oriented toward drug products, rather than
drug use systems, and that the labeling of a product is part of the product from a regulatory perspective. Remember that the
label is what is affixed to the container of a drug, and labeling is that plus whatever else accompanies the drug. Labeling
must be written, printed, or graphic matter to meet the requisites of the statutory definition. Thus, the spoken word would not
qualify as labeling.
A.
The Package Insert
The official labeling for a product includes a package insert that must be approved by the FDA. There are many good sources of information about drugs, but the character of the package insert causes it to be only a fair source of information due to
its inclusiveness of some matters with little relevance and omission of some matters of great relevance. However, the package insert, as the official labeling of a pharmaceutical product, has tremendous significance beyond that of some drug information references that may be more useful but less official. The package insert is written in technical language, and is
intended for use by health care professionals. There is no rule that forbids the conveyance of a package insert to a patient
who requests it, or for whom a health care professional believes it would be beneficial information. However, it is prudent to
offer patients assistance in understanding the technical language of the package insert, else the inclusive nature of the insert
may cause patients to be more fearful of adverse effects than the facts would warrant. The package insert must be developed
in accord with specific FDA standards. The language of the current FDA regulation represents a new approach to official labeling, with a new sequence of sections and a more user-friendly approach to language. For the full text of the regulation,
refer to Title 21 of the Code of Federal Regulations, Section 201.57. The entire regulation is lengthy; therefore, only specific
points follow.

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The FDA regulation includes the following content and format requirements for labeling of prescription drugs:
Highlights of prescribing information. This section does not include full prescribing information, but a summary of
various important aspects of the package insert, including boxed warnings, recent major changes, indications and usage, dosage and administration, dosage forms and strengths, contraindications, warnings and precautions, adverse
reactions, drug interactions, and use in specific populations.
Full prescribing information. This information must be in a specific order and include specific information within
each subheading. Regarding order, boxed warning information is first, followed by information on indications and
usage, dosage and administration, dosage forms and strength, contraindications, warnings and precautions, adverse
reactions, drug interactions, use in specific populations, drug abuse and dependence, overdosage, description, clinical
pharmacology, nonclinical toxicology, clinical studies, references, how supplied/storage and handling, and finally
patient counseling information. Of note, under specific populations, the regulation requires all drugs to be categorized according to their risk in pregnancy, by being placed in one of five categories designated by the letters A, B, C,
D, and X, with the fetal risk increasing as the designation shifts from A to X. Regarding the patient counseling information section, information required here should be conveyed to patients regarding the drug prescribed and dispensed, and how the drug is used. Also, any FDA-approved patient labeling (such as Medication Guides) must be
referenced in the patient counseling information section, and the full text of it must be reprinted immediately following this section.
Specific format requirements including highlighted and bolded type for headings and subheadings, and a specific font
size for the print.
B.
Special Labeling
For some products, the FDA has determined that the general labeling requirements that apply to all drugs are inadequate. Under these circumstances, special labeling requirements are imposed to reflect the particular situation of risk presented by a
product. Several past examples of drugs (prescription and OTC) that were required to have specific warning requirements
include isoproterenol inhalation preparations, drugs with thyroid hormone activity for human use , and Ipecac syrup. Specific
labeling requirements for specific drug products can be found in Title 21 of the Code of Federal Regulations (CFR). The special labeling requirements for Ipecac and isoproterenol are provided below as an example.
Sec. 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale.
(a) It is estimated that each year about 500,000 accidental poisonings occur in the United States and result in approximately 1,500 deaths, of which over 400 are children. In the emergency treatment of these poisonings, ipecac
syrup is considered the emetic of choice. The immediate availability of this drug for use in such situations is critical,
since rapid treatment may be the difference between life and death. The restriction of this drug to prescription sale
limits its availability in emergencies. On the other hand, it is the consensus of informed medical opinion that ipecac
syrup should be used only under medical supervision in the emergency treatment of poisonings. In view of these facts,
the question of whether ipecac syrup labeled as an emergency treatment for use in poisonings should be available
over the counter has been controversial.
(b) In connection with its study of this problem, the Food and Drug Administration has obtained the views of medical
authorities. It is the unanimous recommendation of the American Academy of Pediatrics, the American Association
of Poison Control Centers, the American Medical Association, and the Medical Advisory Board of the Food and
Drug Administration that ipecac syrup in 1 fluid ounce containers be permitted to be sold without prescription so
that it will be readily available in the household for emergency treatment of poisonings, under medical supervision,
and that the drug be appropriately packaged and labeled for this purpose.
(c) In view of the above recommendations, the Commissioner of Food and Drugs has determined that it is in the interest of the public health for ipecac syrup to be available for sale without prescription, provided that it is packaged
in a quantity of 1 fluid ounce (30 milliliters), and its label bears, in addition to other required label information, the
following, in a prominent and conspicuous manner:
(1) A statement conspicuously boxed and in red letters, to the effect: "For emergency use to cause vomiting in poisoning. Before using, call physician, the Poison Control Center, or hospital emergency room immediately for advice."

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(2) A warning to the effect: "Warning--Keep out of reach of children. Do not use in unconscious persons. Ordinarily,
this drug should not be used if strychnine, corrosives such as alkalies (lye) and strong acids, or petroleum distillates
such as kerosine, gasoline, coal oil, fuel oil, paint thinner, or cleaning fluid have been ingested."
(3) Usual dosage: 1 tablespoon (15 milliliters) in persons over 1 year of age.
Sec. 201.305 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use;
warnings.
(a) Accumulating reports have been received by the Food and Drug Administration and have appeared in the medical literature of severe paradoxical bronchoconstriction associated with repeated, excessive use of isoproterenol inhalation preparations in the treatment of bronchial asthma and other chronic bronchopulmonary disorders. The
cause of this paradoxical reaction is unknown; it has been observed, however, that patients have not responded completely to other forms of therapy until use of the isoproterenol inhalation preparation was discontinued. In addition,
sudden unexpected deaths have been associated with the excessive use of isoproterenol inhalation preparations. The
mechanism of these deaths and their relationship, if any, to the cases of severe paradoxical bronchospasm are not
clear. Cardiac arrest was noted in several of these cases of sudden death.
(b) On the basis of the above information and after discussion with and concurrence of the Respiratory and Anesthetic Drugs Advisory Committee for Food and Drug Administration, the Commissioner of Food and Drugs concludes
that in order for the labeling of such drugs to bear adequate information for their safe use, as required by 201.100,
such labeling must include the following:
Warning: Occasional patients have been reported to develop severe paradoxical airway resistance with repeated,
excessive use of isoproterenol inhalation preparations. The cause of this refractory state is unknown. It is advisable
that in such instances the use of this preparation be discontinued immediately and alternative therapy instituted,
since in the reported cases the patients did not respond to other forms of therapy until the drug was withdrawn.
Deaths have been reported following excessive use of isoproterenol inhalation preparations and the exact cause is
unknown. Cardiac arrest was noted in several instances.
(c)(1) The Commissioner also concludes that in view of the manner in which these preparations are self-administered
for relief of attacks of bronchial asthma and other chronic bronchopulmonary disorders, it is necessary for the protection of users that warning information to patients be included as a part of the label and as part of any instructions
to patients included in the package dispensed to the patient as follows:
Warning: Do not exceed the dose prescribed by your physician. If difficulty in breathing persists, contact your physician immediately.
(2) The warning on the label may be accomplished (i) by including it on the immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the container prior to dispensing.
C.
Direct to Consumer Labeling
There is a complex but relatively brief history of FDA efforts to mandate prescription pharmaceutical labeling that would be
directed toward the consumer, rather than toward the health care provider. A program that would have mandated so-called
Patient Package Inserts for consumers was developed during the presidency of Jimmy Carter, but was not fully implemented during President Carters single term, and was repealed during the presidency of Ronald Reagan. At that time, the rational
in repealing the rule was that private interests could provide written information for patients more efficiently than a federal
program. More recently, the Medication Guide program was passed, and went into effect on June 1, 1999. Under this program, the word-for-word language of leaflets will not be developed by the FDA, as it would have been under the Patient
Package Insert program, but instead manufacturers are required to meet specific standards for labeling directed to patients.
Medication Guides are not required for all drugs. They are required only for specific drugs (and drug classes) that are determined by the FDA to be particularly in need of this sort of risk management labeling. The language of the FDA regulations
regarding Medication Guides can be found in Title 21 of the Code of Federal Regulations, Section 208. Limited subsections
are provided below.

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Sec. 208.1 Scope and purpose.
(a) This part sets forth requirements for patient labeling for human prescription drug products, including biological
products, that the Food and Drug Administration (FDA) determines pose a serious and significant public health concern requiring distribution of FDA-approved patient information. It applies primarily to human prescription drug
products used on an outpatient basis without direct supervision by a health professional. This part shall apply to new
prescriptions and refill prescriptions.
(b) The purpose of patient labeling for human prescription drug products required under this part is to provide information when the FDA determines in writing that it is necessary to patients' safe and effective use of drug products.
(c) Patient labeling will be required if the FDA determines that one or more of the following circumstances exists:
(1) The drug product is one for which patient labeling could help prevent serious adverse effects.
(2) The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients' decision to use, or to continue to use, the product.
(3) The drug product is important to health and patient adherence to directions for use is crucial to the drug's effectiveness.
From the language below, it is important to note that the manufacturer must receive approval from the FDA for the Medication Guide; that the manufacturer must supply the Medication Guides to the dispensers; and that the dispenser (e.g., pharmacist) must provide the Medication Guide to the patient for each fill.
Sec. 208.24 Distributing and dispensing a Medication Guide.
(a) The manufacturer of a drug product for which a Medication Guide is required under this part shall obtain FDA
approval of the Medication Guide before the Medication Guide may be distributed.
(b) Each manufacturer who ships a container of drug product for which a Medication Guide is required under this
part is responsible for ensuring that Medication Guides are available for distribution to patients by either:
(1) Providing Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit
the authorized dispenser to provide a Medication Guide to each patient receiving a prescription for the drug product; or
(2) Providing the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized
dispensers to permit the authorized dispenser to provide a Medication Guide to each patient receiving a prescription
for the drug product.
(c) Each distributor or packer that receives Medication Guides, or the means to produce Medication Guides, from a
manufacturer under paragraph (b) of this section shall provide those Medication Guides, or the means to produce
Medication Guides, to each authorized dispenser to whom it ships a container of drug product.
(d) The label of each container or package, where the container label is too small, of drug product for which a Medication Guide is required under this part shall instruct the authorized dispenser to provide a Medication Guide to
each patient to whom the drug product is dispensed, and shall state how the Medication Guide is provided. These
statements shall appear on the label in a prominent and conspicuous manner.
(e) Each authorized dispenser of a prescription drug product for which a Medication Guide is required under this
part shall, when the product is dispensed to a patient (or to a patient's agent), provide a Medication Guide directly to
each patient (or to the patient's agent) unless an exemption applies under 208.26.
In addition to the general Medication Guide program, a very few drugs continue to be subject to special requirements for patient package inserts. This is not a vestige of the repealed larger program on patient package inserts from the Carter-Reagan
years, but instead is a small scale effort to assure that patients receiving drugs that relate in some way to lifestyle choices have
sufficient scientific information upon which to make personal decisions. These patient package inserts are required for estrogen drugs and oral contraceptives. The language of the FDA regulation describing the requirement for estrogens follows.
Numerations refer to Sections of Title 21 of the Code of Federal Regulations.
310.515 Patient package inserts for estrogens.
(a) Requirement for a patient package insert. FDA concludes that the safe and effective use of drug products containing estrogens requires that patients be fully informed of the benefits and risks involved in the use of these drugs. Ac-

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cordingly, except as provided in paragraph (e) of this section, each estrogen drug product restricted to prescription
distribution, including products containing estrogens in fixed combinations with other drugs, shall be dispensed to
patients with a patient package insert containing information concerning the drug's benefits and risks. An estrogen
drug product that does not comply with the requirements of this section is misbranded under section 502(a) of the
Federal Food, Drug, and Cosmetic Act.
(b) Distribution requirements. (1) For estrogen drug products, the manufacturer and distributor shall provide a patient package insert in or with each package of the drug product that the manufacturer or distributor intends to be
dispensed to a patient.
(2) In the case of estrogen drug products in bulk packages intended for multiple dispensing, and in the case of injectables in multiple-dose vials, a sufficient number of patient labeling pieces shall be included in or with each package
to assure that one piece can be included with each package or dose dispensed or administered to every patient. Each
bulk package shall be labeled with instructions to the dispenser to include one patient labeling piece with each package dispensed or, in the case of injectables, with each dose administered to the patient. This section does not preclude the manufacturer or labeler from distributing additional patient labeling pieces to the dispenser.
(3) Patient package inserts for estrogens dispensed in acute-care hospitals or long-term care facilities will be considered to have been provided in accordance with this section if provided to the patient before administration of the first
estrogen and every 30 days thereafter, as long as the therapy continues.
(c) Patient package insert contents. A patient package insert for an estrogen drug product is required to contain the
following information:
(1) The name of the drug.
(2) The name and place of business of the manufacturer, packer, or distributor.
(3) A statement regarding the benefits and proper uses of estrogens.
(4) The contraindications to use, i.e., when estrogens should not be used.
(5) A description of the most serious risks associated with the use of estrogens.
(6) A brief summary of other side effects of estrogens.
(7) Instructions on how a patient may reduce the risks of estrogen use.
(8) The date, identified as such, of the most recent revision of the patient package insert.
(e) Exemptions. This section does not apply to estrogen-progestogen oral contraceptives. Labeling requirements for
these products are set forth in 310.501.
(f) Requirement to supplement approved application. Holders of approved applications for estrogen drug products
that are subject to the requirements of this section must submit supplements under 314.70(c) of this chapter to provide for the labeling required by paragraph (a) of this section. Such labeling may be put into use without advance
approval by the Food and Drug Administration.
Note that this is simply one more example of the special labeling required by FDA for specific drugs. This labeling is directed to patients, rather than to health care professionals.
D.
Imprinting on Solid Oral Dosage Forms
Avoidance of dispensing errors is a particularly important goal of pharmacy practice, and the identification of dosage units is
very helpful as a means to recognize and resolve errors. Pharmacist, pharmacy technicians and patients are able to visualize
dosage forms that bear unique identification marks, and recognize when an error has occurred. The FDA requires such identification as a means to avoid errors and to otherwise facilitate identification of drug products. The language of the FDA regulation describing the requirement can be found in Title 21 of the Code of Federal Regulations, Section 206.10. Although the
basic requirement is for solid oral dosage forms to be identified through an imprint, exceptions are recognized in the law,
when it would be impractical or unnecessary to use an imprint, due to the unique characteristics of a particular drug product.
E.
Side Effects Statement
In October, 2008, the FDA published a final rule implementing a provision of the Food and Drug Administration Amendments Act of 2007 (FDAAA) which requires medication labeling of prescription and non-prescription products to include a
toll-free number (1-800-FDA-1088) for the purpose of receiving reports of drug-related adverse events. For OTC drugs, the
requirements can be found in the Title 21 of the Code of Federal Regulations (CFR), section 201.66, and for drugs requiring

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Medication Guides, the requirement can be found in section 208.20. However, pharmacies are also required to distribute a
side effects statement (the toll-free number and the reporting statement) with new and refill medications. In the outpatient
setting, pharmacies can distribute the statement by: attaching a sticker to the unit package, vial, or container of the drug product; using a preprinted pharmacy prescription vial cap; using a separate sheet of paper; including the required statement on
consumer medication information (CMI); or delivering a Medication Guide that contains the statement. The requirement for
pharmacies to distribute the side effects statement can be found in Title 21 of the CFR, Section 209.

VI.

Non-Prescription Drugs
Those drugs that are capable of being labeled for safe and effective use without medical supervision may be sold
without a prescription. In fact, non-prescription sale is becoming far more prevalent now than in the past, because beliefs
about what is safe without medical supervision have expanded in recent years. Many products that were at one time viewed
to be safe only if available with a prescription are now freely available for self-supervised use. A process known as the OTC
Review resulted in many products being reformulated with more safe and effective ingredients, and it stimulated the switching of prescription-only products to OTC status.
A.
OTC Monographs
One way to bring to market a non-prescription drug is through an NDA, in the same way that a prescription drug would be
brought to the market. But a much less burdensome way, and the most common way, is through the OTC monographs. A
monograph covers a class of drugs (i.e., analgesics, sleep aids) and specifies the ingredients that may be included in a product
marketed OTC for such ailments. Not only does the monograph specify the ingredients, it specifies also the labeling that may
be used for such products. FDA has described the OTC monograph process, for further information refer to Title 21 of the
Code of Federal Regulations, Section 330.10.
B.
OTC Labeling
To promote consistency in labeling, and to prevent confusion by the public, the FDA has specified the content and format requirements for labeling of non-prescription drugs. The format uses standardized headings and subheadings and terms that are
more familiar to consumers. It also requires the information to appear in a standardized order, described below:
Drug Facts - title
Active ingredient(s) - including amount in each dosage unit
Purpose - pharmacologic class
Use(s) - indications
Warnings
Do not use - absolute contraindications, when the product should not be used under any circumstances
Ask a doctor before use if you have - warnings for persons with certain preexisting conditions and for persons experiencing
certain symptoms
Ask a doctor or pharmacist before use if you are - drug/drug and drug/food interactions
When using this product - side effects that could occur and substances or activities to avoid
Stop use and ask a doctor if - signs of toxicity and other serious reactions that would require consumers to stop using the
product immediately
Pregnancy/breast-feeding warning
Keep out of reach of children/Accidental overdose warnings
Direction - dosage and when, how, or how often to take
Other information
Inactive ingredients
Questions? (Optional) - followed by telephone number

The language of the FDA regulation detailing this information is provided below, and numerations refer to Sections of Title
21 of the Code of Federal Regulations.

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Sec. 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
(a)Scope. This section sets forth the content and format requirements for the labeling of all OTC drug products...
(c)Content requirements. The outside container or wrapper of the retail package, or the immediate container label if
there is no outside container or wrapper, shall contain the title, headings, subheadings, and information set forth in
paragraphs (c)(1) through (c)(8) of this section, and may contain the information under the heading in paragraph
(c)(9) of this section, in the order listed.
(1) (Title) "Drug Facts". If the drug facts labeling appears on more than one panel, the title "Drug Facts
(continued)" shall appear at the top of each subsequent panel containing such information.
(2) "Active ingredient" or "Active ingredients" "(in each [insert the dosage unit stated in the directions for use (e.g.,
tablet, 5 mL teaspoonful) or in each gram as stated in 333.110 and 333.120 of this chapter])", followed by the established name of each active ingredient and the quantity of each active ingredient per dosage unit. Unless otherwise
provided in an applicable OTC drug monograph or approved drug application, products marketed without discrete
dosage units (e.g., topicals) shall state the proportion (rather than the quantity) of each active ingredient.
(3) "Purpose" or "Purposes", followed by the general pharmacological category(ies) or the principal intended
action(s) of the drug or, where the drug consists of more than one ingredient, the general pharmacological categories or the principal intended actions of each active ingredient. When an OTC drug monograph contains a statement
of identity, the pharmacological action described in the statement of identity shall also be stated as the purpose of the
active ingredient.
(4) "Use" or "Uses", followed by the indication(s) for the specific drug product.
(5) "Warning" or "Warnings", followed by one or more of the following, if applicable:
(i) "For external use only" [in bold type] for topical drug products not intended for ingestion, or "For" (select one of
the following, as appropriate: "rectal" or "vaginal") "use only" [in bold type].
(ii) All applicable warnings listed in paragraphs (c)(5)(ii)(A) through (c)(5)(ii)(G) of this section with the appropriate subheadings highlighted in bold type:
(A) Reye's syndrome warning for drug products containing salicylates set forth in 201.314(h)(1). This warning shall
follow the subheading "Reye's syndrome:"
(B) Allergic reaction warnings set forth in any applicable OTC drug monograph or approved drug application for
any product that requires a separate allergy warning. This warning shall follow the subheading "Allergy alert:"
(C) Flammability warning, with appropriate flammability signal word(s) (e.g., 341.74(c)(5)(iii), 344.52(c),
358.150(c), and 358.550(c) of this chapter). This warning shall follow a subheading containing the appropriate flammability signal word(s) described in an applicable OTC drug monograph or approved drug application.
(D) Water soluble gums warning set forth in 201.319. This warning shall follow the subheading "Choking:"
(E) Alcohol warning set forth in 201.322. This warning shall follow the subheading "Alcohol warning:"
(F) Sore throat warning set forth in 201.315. This warning shall follow the subheading "Sore throat warning:"
(G) Warning for drug products containing sodium phosphates set forth in 201.307(b)(2)(i) or (b)(2)(ii). This warning
shall follow the subheading "Dosage warning:"
(H) Sexually transmitted diseases (STDs) warning for vaginal contraceptive and spermicide drug products containing nonoxynol 9 set forth in 201.325(b)(2). This warning shall follow the subheading "Sexually transmitted diseases
(STDs) alert:"
(iii) "Do not use" [in bold type], followed by all contraindications for use with the product. These contraindications
are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis
has been established by a doctor or for situations in which certain consumers should not use the product under any
circumstances regardless of whether a doctor or health professional is consulted.
(iv) "Ask a doctor before use if you have" [in bold type] or, for products labeled only for use in children under 12
years of age, "Ask a doctor before use if the child has" [in bold type], followed by all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The
warnings under this heading are those intended only for situations in which consumers should not use the product
until a doctor is consulted.
(v) "Ask a doctor or pharmacist before use if you are" [in bold type] or, for products labeled only for use in children
under 12 years of age, "Ask a doctor or pharmacist before use if the child is" [in bold type], followed by all drugdrug and drug-food interaction warnings.

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(vi) "When using this product" [in bold type], followed by the side effects that the consumer may experience, and the
substances (e.g., alcohol) or activities (e.g., operating machinery, driving a car, warnings set forth in 369.21 of this
chapter for drugs in dispensers pressurized by gaseous propellants) to avoid while using the product.
(vii) "Stop use and ask a doctor if" [in bold type], followed by any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product. For all OTC drug products under an approved drug application whose packaging does not include a toll-free number through which consumers can report complaints to the
manufacturer or distributor of the drug product, the following text shall immediately follow the subheading: "[Bullet]
side effects occur. You may report side effects to FDA at 1-800-FDA-1088." The telephone number must appear in a
minimum 6-point bold letter height or type size.
(viii) Any required warnings in an applicable OTC drug monograph, other OTC drug regulations, or approved drug
application that do not fit within one of the categories listed in paragraphs (c)(5)(i) through (c)(5)(vii), (c)(5)(ix),
and (c)(5)(x) of this section.
(ix) The pregnancy/breast-feeding warning set forth in 201.63(a); the third trimester warning set forth in 201.63(e)
for products containing aspirin or carbaspirin calcium; the third trimester warning set forth in approved drug applications for products containing ketoprofen, naproxen sodium, and ibuprofen (not intended exclusively for use in children).
(x) The "Keep out of reach of children" warning and the accidental overdose/ingestion warning set forth in 330.1(g)
of this chapter.
(6) "Directions", followed by the directions for use described in an applicable OTC drug monograph or approved
drug application.
(7) "Other information", followed by additional information that is not included under paragraphs (c)(2) through
(c)(6), (c)(8), and (c)(9) of this section, but which is required by or is made optional under an applicable OTC drug
monograph, other OTC drug regulation, or is included in the labeling of an approved drug application.
(i) Required information about certain ingredients in OTC drug products (e.g., sodium in 201.64(b), calcium in
201.70(b), magnesium in 201.71(b), and potassium in 201.72(b)) shall appear as follows: "each (insert appropriate
dosage unit) contains:" [in bold type (insert name(s) of ingredient(s) (in alphabetical order) and the quantity of each
ingredient). This information shall be the first statement under this heading.
(ii) The phenylalanine/aspartame content required by 201.21(b), if applicable, shall appear as the next item of information.
(iii) Additional information that is authorized to appear under this heading shall appear as the next item(s) of information. There is no required order for this subsequent information.
(8) "Inactive ingredients", followed by a listing of the established name of each inactive ingredient. If the product is
an OTC drug product that is not also a cosmetic product, then the inactive ingredients shall be listed in alphabetical
order. If the product is an OTC drug product that is also a cosmetic product, then the inactive ingredients shall be
listed as set forth in 701.3(a) or (f) of this chapter, the names of cosmetic ingredients shall be determined in accordance with 701.3(c) of this chapter, and the provisions in 701.3(e), (g), (h), (l), (m), (n), and (o) of this chapter and
720.8 of this chapter may also apply, as appropriate. If there is a difference in the labeling provisions in this 201.66
and 701.3 and 720.8 of this chapter, the labeling provisions in this 201.66 shall be used.
(9) "Questions?" or "Questions or comments?", followed by the telephone number of a source to answer questions
about the product. It is recommended that the days of the week and times of the day when a person is available to respond to questions also be included. A graphic of a telephone or telephone receiver may appear before the heading.
The telephone number must appear in a minimum 6-point bold type.
(d)Format requirements. The title, headings, subheadings, and information set forth in paragraphs (c)(1) through
(c)(9) of this section shall be presented on OTC drug products in accordance with the following specifications. In the
interest of uniformity of presentation, FDA strongly reccommends that the Drug Facts labeling be presented using
the graphic specifications set forth in appendix A to part 201.
(1) The title "Drug Facts" or "Drug Facts (continued)" shall use uppercase letters for the first letter of the words
"Drug" and "Facts." All headings and subheadings in paragraphs (c)(2) through (c)(9) of this section shall use an
uppercase letter for the first letter in the first word and lowercase letters for all other words. The title, headings, and
subheadings in paragraphs (c)(1), (c)(2), and (c)(4) through (c)(9) of this section shall be left justified.

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(2) The letter height or type size for the title "Drug Facts" shall appear in a type size larger than the largest type size
used in the Drug Facts labeling. The letter height or type size for the title "Drug Facts (continued)" shall be no
smaller than 8-point type. The letter height or type size for the headings in paragraphs (c)(2) through (c)(9) of this
section shall be the larger of either 8-point or greater type, or 2-point sizes greater than the point size of the text. The
letter height or type size for the subheadings and all other information described in paragraphs (c)(2) through (c)(9)
of this section shall be no smaller than 6-point type.
(3) The title, heading, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section shall be legible and clearly presented, shall have at least 0.5-point leading (i.e., space between two lines of text), and shall not
have letters that touch. The type style for the title, headings, subheadings, and all other required information described in paragraphs (c)(2) through (c)(9) of this section shall be any single, clear, easy-to-read type style, with no
more than 39 characters per inch. The title and headings shall be in bold italic, and the subheadings shall be in bold
type, except that the word "(continued)" in the title "Drug Facts (continued)" shall be regular type. The type shall be
all black or one color printed on a white or other contrasting background, except that the title and the headings may
be presented in a single, alternative, contrasting color unless otherwise provided in an approved drug application,
OTC drug monograph (e.g., current requirements for bold print in 341.76 and 341.80 of this chapter), or other OTC
drug regulation (e.g., the requirement for a box and red letters in 201.308(c)(1)).
(4) When there is more than one statement, each individual statement listed under the headings and subheadings in
paragraphs (c)(4) through (c)(7) of this section shall be preceded by a solid square or solid circle bullet of 5-point
type size. Bullets shall be presented in the same shape and color throughout the labeling. The first bulleted statement
on each horizontal line of text shall be either left justified or separated from an appropriate heading or subheading
by at least two square "ems" (i.e., two squares of the size of the letter "M"). If more than one bulleted statement is
placed on the same horizontal line, the end of one bulleted statement shall be separated from the beginning of the
next bulleted statement by at least two square "ems" and the complete additional bulleted statement(s) shall not continue to the next line of text. Additional bulleted statements appearing on each subsequent horizontal line of text under a heading or subheading shall be vertically aligned with the bulleted statements appearing on the previous line.
(5) The title, headings, subheadings, and information set forth in paragraphs (c)(1) through (c)(9) of this section may
appear on more than one panel on the outside container of the retail package, or the immediate container label if
there is no outside container or wrapper. The continuation of the required content and format onto multiple panels
must retain the required order and flow of headings, subheadings, and information. A visual graphic (e.g., an arrow)
shall be used to signal the continuation of the Drug Facts labeling to the next adjacent panel.
(6) The heading and information required under paragraph (c)(2) of this section shall appear immediately adjacent
and to the left of the heading and information required under paragraph (c)(3) of this section. The active ingredients
and purposes shall be aligned under the appropriate headings such that the heading and information required under
paragraph (c)(2) of this section shall be left justified and the heading and information required under paragraph
(c)(3) of this section shall be right justified. If the OTC drug product contains more than one active ingredient, the
active ingredients shall be listed in alphabetical order. If more than one active ingredient has the same purpose, the
purpose need not be repeated for each active ingredient, provided the information is presented in a manner that
readily associates each active ingredient with its purpose (i.e., through the use of brackets, dot leaders, or other
graphical features). The information described in paragraphs (c)(4) and (c)(6) through (c)(9) of this section may
start on the same line as the required headings. None of the information described in paragraph (c)(5) of this section
shall appear on the same line as the "Warning" or "Warnings" heading.
(7) Graphical images (e.g., the UPC symbol) and information not described in paragraphs (c)(1) through (c)(9) of
this section shall not appear in or in any way interrupt the required title, headings, subheadings, and information in
paragraphs (c)(1) through (c)(9) of this section. Hyphens shall not be used except to punctuate compound words.
(8) The information described in paragraphs (c)(1) through (c)(9) of this section shall be set off in a box or similar
enclosure by the use of a barline. A distinctive horizontal barline extending to each end of the "Drug Facts" box or
similar enclosure shall provide separation between each of the headings listed in paragraphs (c)(2) through (c)(9) of
this section. When a heading listed in paragraphs (c)(2) through (c)(9) of this section appears on a subsequent panel
immediately after the "Drug Facts (continued)" title, a horizontal hairline shall follow the title and immediately precede the heading. A horizontal hairline extending within two spaces on either side of the "Drug Facts" box or similar

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enclosure shall immediately follow the title and shall immediately precede each of the subheadings set forth in paragraph (c)(5) of this section, except the subheadings in paragraphs (c)(5)(ii)(A) through (c)(5)(ii)(G) of this section.
(9) The information set forth in paragraph (c)(6) of this section under the heading "Directions" shall appear in a table format when dosage directions are provided for three or more age groups or populations. The last line of the table may be the horizontal barline immediately preceding the heading of the next section of the labeling.
(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in
accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required
information for drug products, and, as appropriate, cosmetic products, other than information required to appear on
a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the
Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through
(d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the "Use(s)" heading, as set forth in paragraph (c)(4) of this
section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in
330.1(c)(2) of this chapter.
(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.
(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title "Drug Facts
(continued)" shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.
(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the
ascenders and descenders do not touch.
(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same
horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.
(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8)
of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

VII.

Drug Diversion
In the 1980s it became evident that the medications being dispensed by pharmacists were not always medications that
had been distributed through the normal channels of distribution. Some pharmaceutical products had been exported to foreign countries and then imported back into the United States. Others had been purchased at huge volume discounts by hospitals or nonprofit agencies, and then sold to for-profit businesses. Sample drugs had been diverted back into the for-sale
distribution chain. There were even more creative, and potentially harmful schemes to provide pharmacists with pharmaceuticals that had not necessarily benefited from the integrity of the traditional distribution system. The problem, of course, is
that when pharmaceuticals are diverted from the system, and then brought back into the system, there is no assurance that
they have been stored correctly or handled appropriately while outside the system. The Prescription Drug Marketing Act of
1987 sought to close the loopholes in drug distribution and assure the integrity of pharmaceutical products by preventing the
diversion of drugs from the normal stream of distribution. The language of the act follows. Numerations refer to subsections
of Section 353, Title 21, of the United States Code.

(c) Sales restrictions.

(1) No person may sell, purchase, or trade or offer to sell, purchase, or trade any drug sample. For purposes of this
paragraph and subsection (d), the term "drug sample" means a unit of a drug, subject to subsection (b), which is not
intended to be sold and is intended to promote the sale of the drug. Nothing in this paragraph shall subject an officer
or executive of a drug manufacturer or distributor to criminal liability solely because of a sale, purchase, trade, or
offer to sell, purchase, or trade in violation of this paragraph by other employees of the manufacturer or distributor.
(2) No person may sell, purchase, or trade, offer to sell, purchase, or trade, or counterfeit any coupon. For purposes of this paragraph, the term "coupon" means a form which may be redeemed, at no cost or at a reduced cost, for a
drug which is prescribed in accordance with subsection (b).

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(3) (A) No person may sell, purchase, or trade, or offer to sell, purchase, or trade, any drug-(i) which is subject to subsection (b), and
(ii) (I) which was purchased by a public or private hospital or other health care entity, or
(II) which was donated or supplied at a reduced price to a charitable organization described in section
501(c)(3) of the Internal Revenue Code of 1954 [26 USCS 501(c)(3)].
(B) Subparagraph (A) does not apply to-(i) the purchase or other acquisition by a hospital or other health care entity which is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or
health care entities which are members of such organization,
(ii) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by an organization described in subparagraph (A)(ii)(II) to a nonprofit affiliate of the organization to the extent otherwise permitted by
law,
(iii) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other
health care entities which are under common control,
(iv) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical
reasons, or
(v) a sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug
pursuant to a prescription executed in accordance with subsection (b).
For purposes of this paragraph, the term "entity" does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law and the term "emergency medical reasons" includes transfers of a drug between
health care entities or from a health care entity to a retail pharmacy undertaken to alleviate temporary shortages of
the drug arising from delays in or interruptions of regular distribution schedules.
Note the clear prohibition against the sale or other transfer of sample drugs for any purpose other than sampling. This prohibition keeps sample drugs from being diverted into the for-sale distribution chain. In addition, other drugs that have been
purchased by nonprofit entities may also not be diverted into the for-sale distribution chain.
(d) Distribution of drug samples.
(1) Except as provided in paragraphs (2) and (3), no person may distribute any drug sample. For purposes of this
subsection, the term "distribute" does not include the providing of a drug sample to a patient by a-(A) practitioner licensed to prescribe such drug,
(B) health care professional acting at the direction and under the supervision of such a practitioner, or
(C) pharmacy of a hospital or of another health care entity that is acting at the direction of such a practitioner
and that received such sample pursuant to paragraph (2) or (3).
(2) (A) The manufacturer or authorized distributor of record of a drug subject to subsection (b) may, in accordance
with this paragraph, distribute drug samples by mail or common carrier to practitioners licensed to prescribe such
drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. Such a distribution of drug samples may only be made-(i) in response to a written request for drug samples made on a form which meets the requirements of subparagraph (B), and
(ii) under a system which requires the recipient of the drug sample to execute a written receipt for the drug
sample upon its delivery and the return of the receipt to the manufacturer or authorized distributor of record.
(B) A written request for a drug sample required by subparagraph (A)(i) shall contain-(i) the name, address, professional designation, and signature of the practitioner making the request,
(ii) the identity of the drug sample requested and the quantity requested,
(iii) the name of the manufacturer of the drug sample requested, and
(iv) the date of the request.
(C) Each drug manufacturer or authorized distributor of record which makes distributions by mail or common
carrier under this paragraph shall maintain, for a period of 3 years, the request forms submitted for such distributions and the receipts submitted for such distributions and shall maintain a record of distributions of drug samples
which identifies the drugs distributed and the recipients of the distributions. Forms, receipts, and records required to

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Federal Pharmacy Law Review

be maintained under this subparagraph shall be made available by the drug manufacturer or authorized distributor
of record to Federal and State officials engaged in the regulation of drugs and in the enforcement of laws applicable
to drugs.
(3) The manufacturer or authorized distributor of record of a drug subject to subsection (b) may, by means other
than mail or common carrier, distribute drug samples only if the manufacturer or authorized distributor of record
makes the distributions in accordance with subparagraph (A) and carries out the activities described in subparagraphs (B) through (F) as follows:
(A) Drug samples may only be distributed-(i) to practitioners licensed to prescribe such drugs if they make a written request for the drug samples, or
(ii) at the written request of such a licensed practitioner, to pharmacies of hospitals or other health care entities.
A written request for drug samples shall be made on a form which contains the practitioner's name, address, and
professional designation, the identity of the drug sample requested, the quantity of drug samples requested, the name
of the manufacturer or authorized distributor of record of the drug sample, the date of the request and signature of
the practitioner making the request.
(B) Drug manufacturers or authorized distributors of record shall store drug samples under conditions that will
maintain their stability, integrity, and effectiveness and will assure that the drug samples will be free of contamination, deterioration, and adulteration.
(C) Drug manufacturers or authorized distributors of record shall conduct, at least annually, a complete and accurate inventory of all drug samples in the possession of representatives of the manufacturer or authorized distributor of record. Drug manufacturers or authorized distributors of record shall maintain lists of the names and address
of each of their representatives who distribute drug samples and of the sites where drug samples are stored. Drug
manufacturers or authorized distributors of record shall maintain records for at least 3 years of all drug samples distributed, destroyed, or returned to the manufacturer or authorized distributor of record, of all inventories maintained
under this subparagraph, of all thefts or significant losses of drug samples, and of all requests made under subparagraph (A) for drug samples. Records and lists maintained under this subparagraph shall be made available by the
drug manufacturer or authorized distributor of record to the Secretary upon request.
(D) Drug manufacturers or authorized distributors of record shall notify the Secretary of any significant loss of
drug samples and any known theft of drug samples.
(E) Drug manufacturers or authorized distributors of record shall report to the Secretary any conviction of their
representatives for violations of section 503(c)(1) [subsec. (c)(1) of this section] or a State law because of the sale,
purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample.
(F) Drug manufacturers or authorized distributors of record shall provide to the Secretary the name and telephone number of the individual responsible for responding to a request for information respecting drug samples.
Note that the net effect of this rule is to make it illegal for community pharmacies to possess pharmaceutical samples. The
result is that to even have samples in a community pharmacy is a violation of the law; regardless of what has been done or is
intended to be done with the samples.

VIII.

Compounding
Pharmacists have for centuries, in fact for millenia, extemporaneously compounded products to meet the specific
needs of individual patients. Because patients differ in their needs for medications, it is important not to limit patients to only
those strengths, dosage forms and combinations that are available from manufacturers. Manufacturers cannot know individual patients needs, because the need by an individual does not occur until long after a manufacturer has prepared a product
and placed it on the market. Pharmacists can know individual needs and respond to them in a timely fashion. Despite the
obvious value of contemporaneous compounding by pharmacists, questions have arisen about large-scale compounding that
begins to resemble manufacturing. Since compounding does not require FDA approval of an NDA, and since it need not necessarily meet many of the other requirements of the FDCA, some large scale distributors have attempted to use compounder
status to avoid the restrictiveness of laws that would apply to manufacturers. The FDA Modernization Act of 1997 clarifies

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the difference between compounding and manufacturing. The Act carved out a safe harbor for pharmacists who adhere to
the traditional compounding role, making it clear that such activity is outside the realm of regulation as manufacturing. However, the pharmacy compounding provisions of the Act were ruled unconstitutional by the Supreme Court of the United
States. Until a new law is passed by United States Congress, the following FDA compliance policy is in effect.
Generally, FDA will continue to defer to state authorities regarding less significant
violations of the Act related to pharmacy compounding of human drugs. FDA
anticipates that, in such cases, cooperative efforts between the states and the
Agency will result in coordinated investigations, referrals, and follow-up actions by
the states.
However, when the scope and nature of a pharmacy's activities raise the kinds of
concerns normally associated with a drug manufacturer and result in significant
violations of the new drug, adulteration, or misbranding provisions of the Act,
FDA has determined that it should seriously consider enforcement action. In
determining whether to initiate such an action, the Agency will consider whether
the pharmacy engages in any of the following acts:
1. Compounding of drugs in anticipation of receiving prescriptions, except in very
limited quantities in relation to the amounts of drugs compounded after receiving
valid prescriptions.
2. Compounding drugs that were withdrawn or removed from the market for
safety reasons.
3. Compounding finished drugs from bulk active ingredients that are not
components of FDA approved drugs without an FDA sanctioned investigational
new drug application (IND) in accordance with 21 U.S.C. 355(i) and 21 CFR
312.
4. Receiving, storing, or using drug substances without first obtaining written
assurance from the supplier that each lot of the drug substance has been made in
an FDA-registered facility.
5. Receiving, storing, or using drug components not guaranteed or otherwise
determined to meet official compendia requirements.
6. Using commercial scale manufacturing or testing equipment for compounding
drug products.
7. Compounding drugs for third parties who resell to individual patients or offering
compounded drug products at wholesale to other state licensed persons or
commercial entities for resale.
8. Compounding drug products that are commercially available in the marketplace
or that are essentially copies of commercially available FDA-approved drug
products. In certain circumstances, it may be appropriate for a pharmacist to
compound a small quantity of a drug that is only slightly different than an
FDA-approved drug that is commercially available. In these circumstances, FDA
will consider whether there is documentation of the medical need for the particular
variation of the compound for the particular patient.
9. Failing to operate in conformance with applicable state law regulating the
practice of pharmacy.
The foregoing list of factors is not intended to be exhaustive. Other factors may be
appropriate for consideration in a particular case.

IX.

Product Tampering
Widely publicized reports of deaths in 1982 due to tampering with Tylenol and other pharmaceutical products resulted in federal legislation designed to assure that pharmaceutical products purchased by consumers are either tamper-resistant

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or tamper-evident (but not tamper-proof). The FDA has promulgated regulations to implement this legislation. The language
of the FDA regulation follows. Numerations refer to Sections of Title 21 of the Code of Federal Regulations.
211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
(a) General.
The Food and Drug Administration has the authority under the Federal Food, Drug, and Cosmetic Act (the act) to
establish a uniform national requirement for tamper-evident packaging of OTC drug products that will improve the
security of OTC drug packaging and help assure the safety and effectiveness of OTC drug products. An OTC drug
product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale that is not packaged in a
tamper-evident package or that is not properly labeled under this section is adulterated under section 501 of the act
or misbranded under section 502 of the act, or both.
(b) Requirements for tamper-evident package.
(1) Each manufacturer and packer who packages an OTC drug product (except a dermatological, dentifrice, insulin,
or lozenge product) for retail sale shall package the product in a tamper-evident package, if this product is accessible to the public while held for sale. A tamper-evident package is one having one or more indicators or barriers to
entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of successful tampering and to increase the likelihood that consumers
will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of
one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered
trademark, logo, or picture). For purposes of this section, the term "distinctive by design" means the packaging cannot be duplicated with commonly available materials or through commonly available processes. A tamper-evident
package may involve an immediate-container and closure system or secondary-container or carton system or any
combination of systems intended to provide a visual indication of package integrity. The tamper-evident feature shall
be designed to and shall remain intact when handled in a reasonable manner during manufacture, distribution, and
retail display.
(2) In addition to the tamper-evident packaging feature described in paragraph (b)(1) of this section, any two-piece,
hard gelatin capsule covered by this section must be sealed using an acceptable tamper-evident technology.
(c) Labeling.
(1) In order to alert consumers to the specific tamper-evident feature(s) used, each retail package of an OTC drug
product covered by this section (except ammonia inhalant in crushable glass ampules, containers of compressed
medical oxygen, or aerosol products that depend upon the power of a liquefied or compressed gas to expel the contents from the container) is required to bear a statement that:
(i) Identifies all tamper-evident feature(s) and any capsule sealing technologies used to comply with paragraph (b) of
this section;
(ii) Is prominently placed on the package; and
(iii) Is so placed that it will be unaffected if the tamper-evident feature of the package is breached or missing.
(2) If the tamper-evident feature chosen to meet the requirements in paragraph (b) of this section uses an identifying
characteristic, that characteristic is required to be referred to in the labeling statement. For example, the labeling
statement on a bottle with a shrink band could say "For your protection, this bottle has an imprinted seal around the
neck."
X.

Poison Prevention Packaging

A law that is closely related to the FDCA is the Poison Prevention Packaging Act of 1970 (PPPA). Designed to protect children from accidental poisoning with a variety of toxic substances, the PPPA is currently enforced by the Consumer
Products Safety Commission (CPSC). Of the many significant provisions of the law, the one most relevant to pharmacy is
the requirement that child-resistant closures be used when dispensing medications pursuant to a prescription. From this general rule there are numerous exceptions. A physician may request that a prescribed medication not be dispensed in child-resistant closures, and this request will be honored as long as it is made for each prescription to which it applies (i.e., no
blanket requests). Patients may request that all dispensed drugs not be placed in child-resistant containers. Although this
request need not be made in writing under the law, it is a prudent move for pharmacists to request that there be a written document recording such a request. There are some drugs that need not ever be dispensed in child-resistant closures. The list of

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these drugs makes little sense. Select language of the CPSC regulation follows. Numerations refer to Sections of Title 16 of
the Code of Federal Regulations.
1700.14 Substances requiring special packaging.
*****
(10) Prescription drugs. Any drug for human use that is in a dosage form intended for oral administration and that is
required by Federal law to be dispensed only by or upon an oral or written prescription of a practitioner licensed by
law to administer such drug shall be packaged in accordance with the provisions of 1700.15 (a), (b), and (c), except
for the following:
(i) Sublingual dosage forms of nitroglycerin.
(ii) Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10 milligrams or less.
(iii) Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more
than 8 grams of the equivalent of erythromycin.
(iv) Cyclically administered oral contraceptives in manufacturers' mnemonic (memory-aid) dispenser packages that
rely solely upon the activity of one or more progestogen or estrogen substances.
(v) Anhydrous cholestyramine in powder form.
(vi) All unit dose forms of potassium supplements, including individually-wrapped effervescent tablets, unit dose vials
of liquid potassium, and powdered potassium in unit-dose packets, containing not more than 50 milliequivalents of
potassium per unit dose.
(vii) Sodium fluoride drug preparations including liquid and tablet forms, containing not more than 110 milligrams
of sodium fluoride (the equivalent of 50 mg of elemental fluoride) per package or not more than a concentration of
0.5 percent elemental fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for non-liquids
and containing no other substances subject to this 1700.14(a)(10).
(viii) Betamethasone tablets packaged in manufacturers' dispenser packages, containing no more than 12.6 milligrams betamethasone.
(ix) Pancrelipase preparations in tablet, capsule, or powder form and containing no other substances subject to this
1700.14(a)(10).
(x) Prednisone in tablet form, when dispensed in packages containing no more than 105 mg. of the drug, and containing no other substances subject to this 1700.14(a)(10).
(xi)(xii) [Reserved]
(xiii) Mebendazole in tablet form in packages containing not more than 600 mg. of the drug, and containing no other
substance subject to the provisions of this section.
(xiv) Methylprednisolone in tablet form in packages containing not more than 84 mg of the drug and containing no
other substance subject to the provisions of this section.
(xv) Colestipol in powder form in packages containing not more than 5 grams of the drug and containing no other
substance subject to the provisions of this section.
(xvi) Erythromycin ethylsuccinate tablets in packages containing no more than the equivalent of 16 grams erythromycin.
(xvii) Conjugated Estrogens Tablets, U.S.P., when dispensed in mnemonic packages containing not more than 32.0
mg of the drug and containing no other substances subject to this 1700.14(a)(10).
(xviii) Norethindrone Acetate Tablets, U.S.P., when dispensed in mnemonic packages containing not more than 50
mg of the drug and containing no other substances subject to this 1700.14(a)(10).
(xix) Medroxyprogesterone acetate tablets.
(xx) Sacrosidase (sucrase) preparations in a solution of glycerol and water.
(xxi) Hormone Replacement Therapy Products that rely solely upon the activity of one or more progestogen or estrogen substances.
Note the lack of similarity between the prescription drugs chosen for inclusion in this list. Since there is no rhyme or reason
for the drugs included, the best way to know the list is to simply memorize it.

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Poison Prevention Packaging: A Guide For Healthcare Professionals (revised 2005)
The CPSC provides guidance designed to educate pharmacists, physicians, and other healthcare professionals about their responsibilities under the PPPA. Available at http://www.cpsc.gov/cpscpub/pubs/384.pdf, the following is the language found
in the most current guide:
PART I
The History of Poison Prevention Background
"A child learns by doing. He gains experience by investigating the world around him. For his experiences to be constructive,
they must be conducted in an environment where hazards are kept to a minimum."1
Before the Poison Prevention Packaging Act (PPPA) was enacted in 1970, poisonings by common household substances, including medicines, had long been considered by pediatricians to be the leading cause of injuries among children under 5 years
of age. At one point, state death certificates reported about 500 fatalities a year in children under 5 due to poisoning caused
by unintentional ingestion of drugs and household products. As a result of the many injuries, individual poison control centers were established to provide specialized diagnoses and treatment for poisonings within their communities. The first poison
control center started in Chicago in 1953.
As these centers proliferated, the need for a coordinating body became apparent so that duplicative work could be avoided. In
1957, the National Clearinghouse for Poison Control Centers was established with the mandate to collect data from the centers and provide them with diagnostic and therapeutic information on the myriad of household products involved in childhood
poisonings.2 The Clearinghouse became the largest repository of poisoning case reports in the world. These reports became
the primary source of data to evaluate the incidence of childhood poisoning. The Clearinghouse data collection ended in
1984. Poisoning cases reported to poison control centers are currently documented in the Toxic Exposure Surveillance System (TESS) maintained by the American Association of Poison Control Centers. The National Electronic Injury Surveillance
System (NEISS) run by the U.S. Consumer Product Safety Commission (CPSC) is a source of national estimates of poisoning cases treated in hospital emergency rooms and it provides a follow-up mechanism when additional details about a particular drug or type of incident are needed.
A review of reports from poison control centers revealed a direct relationship between the stage of a child's development and
the type of substance being ingested.3 For example, youngsters still in the crawling stage were much more apt to get into
those products stored on the floor of the bathroom or the cabinet below the kitchen sink (soaps and detergents, drain, and
bowl cleaners). Toddlers were able to reach products left on low lying tables (uncapped bottles of furniture polish, for example). By the time youngsters were able to climb, they were reaching into the medicine cabinet.
Early Preventive Programs
The earliest attempts at controlling the problem of poisonings of young children surfaced after World War II, when there was
a proliferation of household chemicals. Working with the American Medical Association (AMA) and industry, the Food and
Drug Administration (FDA) drafted what in 1960 became the Hazardous Substances Labeling Act. This law stated that certain products, identified as hazardous substances within the meaning of the law, had to carry on their labels specific cautionary statements. Later, amendments to the law provided the authority to ban substances found too hazardous to be used
safely around the household - notwithstanding cautionary labeling.4
Another activity geared to the prevention and control of childhood poisonings was the passage of Public Law 87-319 which
requested the President to designate the third week in March each year as National Poison Prevention Week (NPPW), to
aid in encouraging the American people to learn of the dangers of unintentional poisoning and to take such preventive measures as are warranted by the seriousness of the danger.5 It was a pharmacist who was the driving force behind the Resolution. In 1950, Homer George, of Cape Girardeau, Missouri, convinced his mayor to proclaim a Poison Prevention Week in
his community. Mr. George then followed this up with the Governor of Missouri and subsequently prevailed on his congressman to introduce national legislation for a nationwide observance of poison prevention week.6

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The introduction of a poison prevention week on a nationwide scale provided community organizations an opportunity to initiate poison prevention programs or highlight ongoing ones. While NPPW was beneficial in developing and fostering community interest, child poisonings and deaths continued.
In 1966, to address his concern about the number of aspirin ingestions, Dr. James Goddard, Commissioner of the FDA, convened a conference of aspirin producers, representatives of poison control centers, and public health officials.7 One of the results of the conference was a voluntary agreement on the part of the manufacturers to restrict the number of childrens aspirin
tablets in a single container to 36, 1-grain tablets, generally accepted as a not highly toxic dose. Although this limitation
would do little to affect the frequency of ingestions, it was hoped it would have an effect on severity should a child gain access to the aspirin.
Creating A Barrier
Another decision of the conferees laid the groundwork for a far-reaching change in U.S. consumers experiences with the
packaging of household products. The Chairman of the FDA Industry Committee, Dr. Edward Press, appointed a subcommittee to look into the state of the art with respect to child-resistant packaging in 1966. One major manufacturer of childrens
aspirin was already using safety packaging for its product on a voluntary basis. The firm offered to make available whatever
data it had that might be useful to the Subcommittee.8 As part of this new approach to the prevention of poisonings, two independent studies were undertaken.
One of these took place in the State of Washington in the Fort Lewis-McChord Air Force Base area.9,10 Prescription drugs
were dispensed to the military population serviced by this area in packaging that utilized two dissimilar motions for opening
(pushing and turning). The study included a preliminary test program (May 1967 December 1970) which demonstrated that
the new package design was much more effective in preventing access by young children than the standard screw caps and
snap caps that were used on prescription vials. The effectiveness of this approach in controlling unintentional ingestions was
shown by a decrease in ingestions. There were 27 incidents reported instead of the 210 ingestions that would have been anticipated during this time period.11
The other study took place in Essex County in Ontario, Canada, where there had been a vigorous educational campaign in
effect for 10 years trying to reduce childhood unintentional ingestions. The campaign met with little success. A program to
use child-resistant packaging for all prescription tablets and capsules was initiated by area pediatricians and pharmacists. The
reduction in ingestions was as dramatic as that in the U.S.12
Backed by this and related information showing that childhood ingestions could be reduced through the use of child-resistant
packaging, Congress enacted legislation. In 1970, the Congress passed, and the President signed, Public Law 91-601, the Poison Prevention Packaging Act (PPPA).13 The legislation formed the basis for a new attack on the problem of unintentional
poisoning among young children. It was now possible to control the agents responsible for these toxic episodes by creating a
barrier between the harmful chemical and the child.
The FDA was responsible for enforcing the PPPA until 1973 when jurisdiction was transferred to the newly formed CPSC.14
The PPPA gives the CPSC the authority to require special packaging of household products and drugs to protect children
from serious injury or illness.
The PPPA defines special packaging as, packaging that is designed or constructed to be significantly difficult for children
under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time
and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time."15 Human performance tests were developed to measure child-resistance and adult-use effectiveness. Children aged 42 to 51 months were chosen as the test subjects. The test method was
developed to try to mimic the situation found at home. The test involved giving packages to pairs of children. The children
were given 5 minutes to try to open the package. If they did not open their package within that time period, the children were

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given a single visual demonstration and then given another 5 minutes to attempt to open the package. The package was considered to be child-resistant if not more than 20 percent of 200 children tested could open the package.
The packages also had to be opened and properly closed by adults. Adults aged 18 to 45 years were chosen as the test subjects. The adults had a 5-minute time period to open and properly close the package. If 90 percent of 100 adults tested could
open and close the childresistant package, it passed.
Improving the Packaging
The test methods and standards described above were adopted in the early 1970s. The CPSC enforced these standards to
make sure that special packaging on the market complied. Packaged products that did not meet the standards were recalled.
The CPSC staff continued to monitor ingestions. In 1986, the CPSC conducted an ingestion study with the AAPCC.16 The
results indicated that children were being poisoned by drugs that belonged to their grandparents. Many of these incidents occurred because special packaging was not being used properly; the closures were loose or left off. In other cases, the drugs
were not in special packaging at all.
The CPSC tested the packaging with adults over a wide range of ages up to 75 years. Many adults, especially seniors, could
not open special packaging. Children were being poisoned because adults could not use the packaging properly. The CPSC
worked with the industry to revise the adult test methods to increase the age of adults tested. In 1995, the CPSC issued new
requirements that amended the test procedures.17 Adults aged 50 to 70 years old are now tested to measure adult-use effectiveness for most packages. These changes became effective in January 1998.
Special packaging is improving. Packages are easier for adults to use properly while still maintaining child-resistance.
Success
Special packaging saves lives. CPSC analyzed child fatality data for unintentional ingestions of oral prescription medicines
during the 1964 through 1992 timeframe. The results of the analysis showed that the death rates for oral prescription medicines declined even after taking into account the changes in the consumption of the medications over time and the long-term
decline in the overall unintentional death rate of children from all causes.18
The CPSC study showed that special packaging reduced the oral prescription medicine-related death rate by up to 1.4 deaths
per million children under age 5. This represents a reduction in the rate of fatalities of up to 45 percent from levels that would
have been projected in the absence of special packaging requirements, and equates to about 24 fewer child deaths annually.19
A similar study of the effectiveness of special packaging of aspirin estimated that special packaging reduced the aspirin-related mortality rate by 34 percent. This equates to about 90 fewer child deaths from aspirin during the 1973-1990 study period.20
When combining the statistics for aspirin with those for prescription drugs, the staff of the CPSC estimates that special packaging saved the lives of more than 900 children since the requirements went into effect in the early 1970's.
This estimate relates to aspirin and oral prescription medicines only and does not include additional lives that may have been
saved by special packaging on other products.
PART II
Substances Covered by Regulation
Background
The PPPA gives the Commission the authority to require special packaging of hazardous household substances to protect
children. Section 3 of the PPPA details the findings that the Commission must make prior to promulgating a special packaging standard. The Commission may require special packaging of a household substance if it finds that:

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The degree or nature of the hazard to children in the availability of such substance, by reason of its packaging, is such that
special packaging is required to protect children from serious personal injury or serious illness resulting from handling, using,
or ingesting such substance; and
The special packaging to be required by such standard is technically feasible, practicable, and appropriate for such substance.
In establishing a standard the Commission also considers:
1. the reasonableness of such standard;
2. available scientific, medical, and engineering data concerning special packaging and concerning childhood unintentional
ingestions, illness, and injury caused by household substances;
3. the manufacturing practices of industries affected by the PPPA; and
4. the nature and use of the household substance.
The scope of products, which may potentially be subject to special packaging standards is quite broad and includes products
customarily produced for use in or around the household. Foods, drugs, cosmetics, as defined by the Federal Food, Drug and
Cosmetic Act, hazardous substances as defined by the Federal Hazardous Substances Act (FHSA), and pre-packaged fuels
are all within the jurisdiction of the legislation.
The responsibility for administration and enforcement of child-resistant packaging for pesticides (including cleaning products
that make antimicrobial claims) lies entirely with the Environmental Protection Agency (EPA) under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). It should be noted that the same test methods for determining whether a package is
child-resistant and senior friendly apply to pesticides because the FIFRA was amended to recognize packaging and labeling
violations under the PPPA.
In the years since enactment of the PPPA, many household chemicals or categories of household substances have been added
to the list of regulated substances.21 Those standards dealing with drug products, particularly prescription drug products, will
be discussed in somewhat greater detail. A list of substances that require special packaging as of 2005, is presented below.
Please refer to the PPPA regulations at 16 CFR 1700.14 for the most current list of regulated substances and for the specific
details of each regulation.
Substances Regulated At 16 CFR 1700.14
Aspirin: Any aspirin-containing preparation for human use in oral dosage form.
Furniture Polish: Low-viscosity, nonemulsion type liquid furniture polish containing 10 percent or more petroleum distillates, unless packaged in pressurized spray containers. (These products also require restricted flow so that not more than 2
milliliters is obtained when the package is inverted, squeezed or otherwise activated once.)
Methyl Salicylate (oil of wintergreen): Liquid preparations containing more than 5 percent by weight, unless packaged in
pressurized spray containers.
Controlled Drugs: Preparations intended for oral human use, which are subject to the Comprehensive Drug Abuse Prevention and Control Act of 1970.
Sodium and/or Potassium Hydroxide: Household substances in dry form (granules, powders, flakes, etc.) containing 10 percent or more by weight and all other household substances (aerosols, liquids, pastes) containing 2 percent or more by weight,
of chemically unneutralized sodium and/or potassium hydroxide.
Turpentine: Household substances in liquid form containing 10 percent or more by weight of turpentine.
Kindling and/or Illuminating Preparations: Prepackaged low viscosity substances (i.e., cigarette lighter fluids, charcoal
lighter fluids, camping equipment fuel, torch fuel, and fuel for decorative or functional lanterns) which contain 10 percent or
more by weight of petroleum distillates.
Methyl Alcohol (Methanol): Household substances in liquid form containing 4 percent or more by weight of methyl alcohol, unless packaged in a pressurized container.
Sulfuric Acid: Household substances containing 10 percent or more by weight of sulfuric acid, except in wet cell storage
batteries.
Prescription Drugs: Any drug for human use in oral dosage form and which is required by federal law to be dispensed only
by or upon an oral or written prescription of a practitioner licensed to administer such drug.

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Ethylene Glycol: Household substances in liquid form containing 10 percent or more by weight of ethylene glycol.
Iron-Containing Drugs: Non-injectable animal and human drugs providing iron for therapeutic or prophylactic purposes
which contain a total amount of elemental iron equivalent to 250 milligrams or more per package.
Iron-Containing Dietary Supplements: Most dietary supplements that contain an equivalent of 250 milligrams or more of
elemental iron per package.
Solvents for Paint or Similar Surface Coatings: Prepackaged low-viscosity liquid solvents for paints or other surface-coating
material that contain 10 percent or more by weight of benzene, toluene, xylene, petroleum distillates, or any combination
thereof.
Acetaminophen: Preparations for human use in oral dosage forms containing more than 1 gram of acetaminophen in a single
package.
Diphenhydramine: Preparations for human use in oral dosage forms containing more than the equivalent of 66 milligrams of
diphenhydramine base in a single package.
Glue removers containing acetonitrile: Household glue removers in a liquid form containing more than 500 milligrams of
acetonitrile in a single container.
Permanent wave neutralizers: Liquid home permanent wave neutralizers, containing more than 600 milligrams of sodium
bromate or more than 50 milligrams of potassium bromate in a single container.
Ibuprofen: Preparations for human use in oral dosage forms containing 1 gram or more of ibuprofen in a single package.
Loperamide: Preparations for human use in oral dosage forms containing more than 0.045 milligrams of loperamide in a
single package.
Mouthwash: Most mouthwash containing 3 grams or more of ethanol in a single package.
Lidocaine: Products containing more than 5 milligrams of lidocaine in a single package.
Dibucaine: Products containing more than 0.5 milligrams of dibucaine in a single package.
Naproxen: Preparations for human use in oral dosage forms containing 250 milligrams or more of naproxen in a single
package.
Ketoprofen: Preparations for human use in oral dosage forms containing more than 50 milligrams of ketoprofen in a single
package.
Fluoride: Products containing more than 50 milligrams of elemental fluoride and more than 0.5 percent fluoride in a single
package.
Minoxidil: Preparations for human use containing more than 14 milligrams of minoxidil in a single package.
Methacrylic Acid: Liquid products containing more than 5 percent (weight to volume) methacrylic acid in a single package.
Over-the-Counter Drug Products: Preparations in oral dosage forms that contain any active ingredient that was previously
available for oral administration only by prescription.
Hazardous substances containing lowviscosity hydrocarbons: Products containing 10 percent or more hydrocarbon by
weight with a viscosity of less than 100 SUS at 100F.
Drugs and cosmetics containing low viscosity hydrocarbons: Products containing 10 percent or more hydrocarbon by
weight with a viscosity of less than 100 SUS at 100F.
Review of the list of categories reveals a wide range of household products and chemicals. Healthcare professionals are more
directly involved with those regulations dealing with drug products than household chemical products.
Aspirin and Acetaminophen
Aspirin was the first substance to be regulated under the PPPA. Note that while acetaminophen is regulated at a level of more
than 1 gram per package, no level has been established for aspirin and aspirin-containing products. Thus a substance containing any amount of aspirin is required to be in special packaging. There are two exemptions to each of these regulations; each
based primarily upon physical characteristics of the dosage forms, which have been found to inhibit or limit unintentional ingestion of these products by children. These exemptions are:
1. Effervescent tablets or granules containing not more than 15 percent acetaminophen or aspirin, provided the dry tablet or
granules have an oral LD50 of 5 grams or more per kilogram of body weight.
2. Unflavored acetaminophen or aspirin containing preparations in powder form (other than those intended for pediatric use)
that are packaged in unit doses providing not more than 13 grains of acetaminophen or 15.4 grains of aspirin per unit dose.

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Methyl Salicylate
This regulation covers liquid preparations containing more than 5 percent by weight of the substance and specifically exempts pressurized spray containers. The cream and ointment preparations are not included.
Controlled Drugs
All controlled drugs intended for oral administration to humans are covered without exception, including over-the-counter
preparations.
Iron-Containing Drugs and Dietary Supplements
Iron-containing drugs and dietary supplements that contain 250 mg or more elemental iron have required special packaging
since 1978. Iron was responsible for many poisoning deaths. Consumers may be unaware of the toxicity of iron. It is important for Healthcare Professionals to educate their patients about the toxicity of iron.
Lidocaine, Dibucaine, and Minoxidil
All three of these drugs are available in topical formulations. The regulations for lidocaine and dibucaine, two topical local
anesthetic drugs, are noteworthy because they extend to all dosage forms including creams, sprays, and transdermal patches.
Minoxidil is available as an oral prescription drug used for hypertension; this formulation requires special packaging under
the prescription drug rule.
Minoxidil is also available in topical form for hair regrowth. The CPSC regulated minoxidil to require the topical forms to be
sold in special packaging. Many minoxidil preparations are sold with applicators (i.e., droppers or spray pumps) that are intended to replace the original closure on the package of minoxidil. The package is required to comply with the special packaging requirements of the PPPA for the life of the product. Thus the package must continue to meet the special packaging
requirements when the provided applicators are affixed to the package.22
Human Oral Prescription Drugs
The special packaging requirement for oral prescription drugs, which became effective on April 16, 1974, has had great impact on both pharmacists and drug manufacturers. As described previously, the PPPA requires that a number of findings be
made before a special packaging standard can be promulgated. The key finding is the establishment that the substance, because of the way it is packaged, has a significant potential for causing serious personal injury or illness in children. However,
some human oral prescription drugs may not have the potential to cause serious injury or illness to children. Why then did the
Federal government choose to require all human oral prescription drugs to be dispensed in special packaging?
The answer is twofold. First, it provides the best protection of children. Second, it eliminates the formidable task for dispensing pharmacists of having to maintain complete and accurate listings of regulated and non-regulated drugs. Since new drugs
and drug classes are being approved by the FDA at an increased rate, promulgation of separate regulations for drugs or classes of drugs known to be a potential hazard to young children upon unintentional ingestion would have been an extremely
onerous task. In addition, the burden upon individual pharmacists would have been great since they would have to check each
drug, dosage strength, and amount before dispensing.
These problems were resolved by regulating all human oral prescription drugs and then establishing a procedure for exempting products that do not pose a hazard to children (described below). This approach was possible with the support and cooperation of the various pharmaceutical, trade, and professional associations.
Oral investigational drugs for outpatient clinical trials require special packaging under the Human Oral Prescription Drug
Rule. Because of the special circumstances surrounding the use of investigational drugs, the CPSC staff has issued guidance
on the packaging of theseproducts.23
Oral prescription drug samples and starter kits dispensed by the prescribing practitioners require special packaging. However, the current CPSC position is that manufacturers are not responsible for the special packaging of these products since
they are distributed by a licensed medical practitioner who has the authority to specify non-complying packaging for his/her

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patients. This is not the case for oral prescription drugs, including samples, that are dispensed by pharmacists, since pharmacists do not have the authority to specify that prescriptions be dispensed in non-complying packaging.24
Drugs Switched from Rx to OTC Status
Diphenhydramine, ibuprofen, loperamide, naproxen, and ketoprofen are drugs that were originally available by prescription.
The FDA allowed the over-the-counter (OTC) sale of certain formulations of these drugs. When these drugs were granted
OTC status, they were no longer required to be packaged in special packaging under the oral prescription drug rule.
The CPSC had to initiate separate rulemaking activity in order to require special packaging of each drug. In 2001, the CPSC
issued a rule to require special packaging of oral prescription drugs that are granted over-the-counter (OTC) status by the
FDA. This will ensure that special packaging will continue to be required for these products when they are more readily
available to the public. Separate rulemakings such as those for diphenhydramine, ibuprofen, loperamide, naproxen, and ketoprofen will be unnecessary in the future for these types of drugs.
Exceptions and Exemptions
The section above describes the substances that must be in special packaging. However, there are several situations when special packaging is not required. Since the PPPA applies only to substances used in or around the household, the special packaging requirements do not extend to products used in institutional settings such as hospitals and traditional nursing homes.
However, if the patients are taking the drugs home, including assisted-living types of homes where patients are responsible
for taking their medication, the substances need to be in special packaging. Congress had concerns about the ability of elderly
or handicapped individuals to access products in special packaging. Therefore, the PPPA contains provisions to facilitate access of products by these special populations. Section 4(a) of the PPPA provides for the marketing of "non-complying" or
non-special packages of regulated substances other than prescription drugs in order to facilitate access to regulated products
by the elderly and handicapped.25
A manufacturer or packager may package any over-the-counter household substance (subject to a PPPA standard) in packaging of a single size that does not comply with such standard if:
1. The manufacturer (or packager) also supplies such substance in packages that comply with such standard; and
2. The packages of such substance that do not meet such standard bear conspicuous labeling stating: "This package for households without young children"; (or Package Not Child-Resistant for small packages).
As a result, manufacturers of over-the- counter household products regulated under the PPPA, have the option of marketing
one size in a conventional package as long as that same product is supplied in popular-sized complying packages. There is
one exception. Under the Federal Hazardous Substances Act, household products containing more than 10 percent
sodium/potassium hydroxide are banned unless marketed in special packaging.26 The effect of this is to essentially remove the
option of producing a single non-complying package of the substance.
Section 4(b) of the PPPA addresses the need for facilitating access to prescription drugs by elderly and handicapped individuals who have difficulty using special packaging.27
"In the case of a household substance which is subject to such a [PPPA] standard and which is dispensed pursuant to an order
of a physician, dentist, or other licensed medical practitioner authorized to prescribe, such substance may be dispensed in
noncomplying packages only when directed in such order or when requested by the purchaser.
The pharmacist's role in implementing this section is further discussed in Chapter III. In addition to the scenarios described
above, the regulations of the PPPA contain a procedure whereby exemptions from special packaging requirements may be
granted by the Commission. An exemption request, in the form of a formal petition, is generally initiated by the manufacturer
of a product. The majority of such requests are from manufacturers of human oral prescription drugs. Generally such requests
seek exemption for a specific package size of a drug, normally a package designed for direct dispensing to the consumer after
appropriate labeling by the pharmacist.

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The petitioner must submit various data relating to the toxicity of the product, and, generally must establish that the amount
of product contained within the requested exemption would not be harmful to a child under 5 years of age. Formal exemption
criteria exist to guide manufacturers in submitting petitions.28 The exemption procedure involves rulemaking by the Commission.
As of 2005, the following prescription drugs are exempt from the PPPA standards and may be dispensed in conventional
packaging, as long as they contain no other substance subject to 16 CFR 1700.14(a).29 The specific exemptions are in the
PPPA regulations at 16 CFR 1700 (a)(10).
1. Sublingual dosage forms of nitroglycerin,
2. Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10 milligrams or less.
3. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more than 8
grams or the equivalent of erythromycin.
4. Erythromycin ethylsuccinate tablets in packages containing no more than the equivalent of 16 grams erythromycin.
5. Anhydrous cholestyramine in powder form.
6. Potassium supplements in unit dose forms, including individually wrapped effervescent tablets, unit dose vials of liquid
potassium, and powdered potassium in unit dose packets, containing not more than 50 milliequivalents per unit dose.
7. Sodium fluoride drug preparations, including liquid and tablet forms, containing no more than 264 milligrams of sodium
fluoride per package.
8. Betamethasone tablets packaged in manufacturers' dispenser packages containing no more than 12.6 milligrams betamethasone.
9. Mebendazole in tablet form in packages containing not more than 600 milligrams of the drug.
10. Methylprednisolone in tablet form in packages containing not more than 84 milligrams of the drug.
11. Colestipol in powder form in packages containing not more than 5 grams of the drug.
12. Pancrelipase preparations in tablet, capsule, or powder form.
13. Cyclically administered oral contraceptives in mnemonic (memory-aid) dispenser packages which rely solely upon the
activity of one or more progestogen or estrogen substances.
14. Prednisone in tablet form when dispensed in packages containing no more than 105 milligrams of the drug.
15. Conjugated estrogen tablets when dispensed in mnemonic dispenser packages containing not more than 32.0 milligrams
of the drug.
16. Norethindrone acetate tablets in mnemonic dispenser packages containing not more than 50 milligrams of the drug.
17. Medroxyprogesterone acetate tablets.
18. Sacrosidase (sucrase) preparations in a solution of glycerol and water.
19. Hormone Replacement Therapy products that rely solely upon the activity of one or more progestogen or estrogen substances.

CHAPTER III
Responsibilities Under the Act Frequently Asked Questions
Prescribers/Dispensers of Medications
Q. What is the responsibility of the pharmacist under the PPPA?
A. The pharmacist must dispense oral prescription drugs in special packaging unless the drug is exempted or the patient or
prescribing practitioner requests nonspecial packaging.
Q. May an individual request that all of his/her prescriptions be filled in conventional (nonspecial) packaging?
A. Yes, the law does not preclude a pharmacist from relying upon a specific request from a patient to have all of his/her medications placed in non-special packaging. Many pharmacies choose to have this request in writing, i.e., a blanket waiver. However, a single request from a patient to dispense a specific prescription in non-special packaging is not a basis for the
pharmacist to infer the patient wants all subsequent prescriptions to be dispensed in non-special packaging. Such a request is
not a blanket waiver. A patient who previously requested blanket non-special packaging may later change his/her mind about

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the use of such packaging because of changing personal circumstances, but may not remember to inform the pharmacist of
the change in packaging preference. It is a prudent practice for the dispensing pharmacist to periodically check with all patients who have blanket waiver requests on file to ensure that noncomplying packaging continues to be the preferred packaging choice for the patients' prescription drugs.
Q. If the pharmacist is aware that one of his/her customers prefers conventional packaging for his/her prescriptions, can the
pharmacist make this decision without the customer's specific request?
A. No. The pharmacist may advise the customer that he/she has the option of having the prescription dispensed in noncomplying packaging, but the choice must be that of the customer.
Q. Must the customer make the choice for conventional packaging in writing?
A. Although many pharmacists do require a written waiver, the law and regulations do not require a written request. The CPSC staff recommends, however, that the pharmacist get a request in writing particularly when a blanket waiver is being requested. This will assist the pharmacist during inspections of the pharmacy by regulatory agencies.
Q. May a pharmacist dispense a prescription drug in a noncomplying package in response to a standing order from a physician that it be so dispensed?
A. This can be done only when it applies to refills of a prescription where the physician has prescribed noncomplying packaging for that prescription. However, a drug dispensed to the same person on a different prescription of the same or another
prescriber must be dispensed in special packaging, unless the prescription directs the use of noncomplying packaging or the
purchaser requests it.
Q. Can a physician simply check a box on a prescription blank to indicate to the pharmacist that a drug be dispensed in noncomplying packaging?
A. Yes. However, the CPSC staff discourages the use by physicians of prescription blanks having a box to check for noncomplying packaging, on the basis that the practice would tend to encourage excessive use of noncomplying packaging.
Q. Who is responsible for determining at the retail level whether a prescription drug must be packaged in accordance with
PPPA standards?
A. It is the responsibility of the dispensing pharmacist. Unless a prescription drug is expressly exempted from the regulations, or the customer or prescribing physician request noncomplying packaging, the drug must be dispensed in a special
package.
Q. How does a pharmacist or physician become aware of which drugs are exempted from PPPA standards?
A. This information listed in the PPPA regulations at 16 CFR 1700.14 and is available on the CPSC website,
http://www.cpsc.gov/businfo/notices.html. Announcements are published in the Federal Register, and in news releases issued
by CPSC (which may be published in the local press). In addition, the journals and newsletters of pharmaceutical and medical
groups, as well as the trade press, publicize these exemptions.
Q. In the case of an antibiotic drug provided by the manufacturer in a granular form to be reconstituted by the pharmacist,
who is responsible for providing the special package the pharmacist or the manufacturer?
A. If the product is in the same container intended to be given to the purchaser, the manufacturer and the pharmacist are both
responsible.
Q. Does the same rule apply to drugs dispensed in dropper bottles?
A. Yes.
Q. In the case of refills, can prescription bottles and vials be reused?
A. As a general rule, no. This prohibition is based on the wear associated with a plastic vial, which could compromise the
packages effectiveness. Since such wear or undetected damage with a glass container is negligible, the CPSC staff has indi-

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cated that it would have no objection to the reuse of a glass container, provided a new closure is used. This same consideration would be given to any other package type that is not prone to wear.
Q. Does the regulatory reference to dosage forms intended for oral administration include drugs intended for topical application to the teeth or mouth, or in a dosage form intended for inhalation?
A. No. The regulations intend oral administration to pertain to drugs that are taken by mouth for a systemic and not local
effect. Sublingual preparations are considered orally administered even though they are not swallowed. Their effect is systemic and not local to the mouth. Because of the need for quick access to the drug, sublingual nitroglycerin was excluded
from the oral prescription drug regulation when it was adopted in 1973.30
Q. When a prescription drug is dispensed in a special package, would the pharmacist be in violation of the regulations if he or
she included a separate non-complying closure with the package?
A. Although this practice is not prohibited, the CPSC staff discourages the practice in that it is likely to result in the use of
noncomplying packaging by those who are able to use special packaging without difficulty.
Q. Are Investigational New Drugs (INDs) subject to the PPPA standards?
A. Yes. Oral INDs are subject to the oral prescription drug regulation, if the IND is a drug that is for oral administration to
humans, can be dispensed only on or by an order of a licensed medical practitioner, and is to be dispensed directly to the patient. Such drugs must be packaged in a special package except as described at http://www.cpsc.gov/BUSINFO/trials.pdf. In
addition, if INDs contain any substances regulated under any of the other PPPA regulations, they would be required to be
packaged in special packaging if they are dispensed for household use.
Q. May a pharmacist legally use reversible or other types of dual-purpose packaging for dispensing prescription drugs?
A. Although this type of packaging is not prohibited, the CPSC staff discourages its use because it is likely to result in the use
of non-special packaging. The potential for children being poisoned thus increases.
Q. What should I advise a consumer who calls for information when there is a suspected poisoning or childhood ingestion
emergency?
A. If you are unable to provide the necessary emergency information for the caller or advise him or her as to the proper
course of action, refer the caller to the Poison Control Center or nearest hospital emergency room. The national Poison Control Center phone number is 1-800-222-1222. This number should be on or near your telephone, along with those of the fire
and police departments. It also would be prudent to suggest that the caller follow up with his/her physician.
Q. May I, as a hospital pharmacist, dispense a regulated drug in a conventional package for use by a patient in the hospital?
A. Yes, provided that the patient is confined in the hospital. Drugs dispensed for outpatient use must be packaged in accordance with the applicable regulations for special packaging.
Q. Our local hospital sometimes calls upon my pharmacy to provide drugs for patient use within the hospital. Must these
drugs be dispensed in special packaging?
A. No, provided they are to be used for institutionalized patients. The test is whether the package is likely to enter a home.
Q. My pharmacy provides drugs to a nursing home. Must these drugs be dispensed in special packaging?
A. No, traditional nursing homes where the nursing home staff administers doses to residents are considered to be institutions. This would not be true of senior citizen apartment complexes or assisted living facilities where residents store their
drugs in their households. The test is whether the package is likely to enter a home.
Q. I know of several physicians who dispense prescription drugs for a fee. Are they subject to the provisions of the PPPA?
A. Yes. Physicians who dispense drugs (including drug samples), are, and always have been, subject to the regulations under
the PPPA. It is important to note, however, that for the purpose of accommodating elderly and disabled consumers who have
difficulty using special packaging, Section 4(b) of the PPPA gives medical practitioners the authority to specify conventional
packaging for drugs they prescribe.

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Q. How can a pharmacist or pharmacy determine if the prescription packages they use meet the special packaging standards?
A. The pharmacy should request special packaging test data from the manufacturer or supplier of the prescription packages.
When ordering packaging, pharmacists should be aware that vials and closures from different manufacturers may not function properly when used together. Pharmacists are responsible for ensuring that the packages they use comply with the PPPA.
Manufacturers and Packagers
Q. What is the responsibility of manufacturers of prescription drugs subject to the PPPA?
A. If the manufacturer intends that the package of a particular oral prescription drug is to be dispensed directly to the patient
by the pharmacist, the CPSC interprets the PPPA to require the manufacturer to market that drug in special packaging.31 Such
packages are readily recognizable for the most part and often only require relabeling by the pharmacists prior to dispensing.
The pharmacist, however, bears the ultimate responsibility for repackaging the drug into special packaging if a manufacturer
has failed to comply.32
Q. May the manufacturer supply to the pharmacist one size of a regulated prescription drug in a conventional package under
Section 4 of the PPPA in the same manner as supplying a non-complying size for over-the-counter drugs?
A. There is no provision for a manufacturer or packager to market a single size of a prescription drug in noncomplying packaging as is the case for over-the-counter medications. Every unit of a prescription drug subject to the PPPA which is packaged by the manufacturer in a package intended to be dispensed to a consumer must be in special packaging. Regulated
prescription drugs may be dispensed in non-special packaging only when the prescribing physician directs its use, or the purchaser requests noncomplying packaging. In those cases, the pharmacist would have to repackage the drug with a conventional, non-special package.
Q. Can a supplier of special packaging include an equal number of noncomplying closures with each carton of complying
packaging shipped to pharmacies?
A. Yes.
Q. Does the drug manufacturer or packager have to test the packaging to determine if it complies with the PPPA standards?
A. The packages must meet the standards. Failure to meet the standards is a violation of federal law. Most packaging manufacturers will test their packaging to determine if it is complies.
Q. Is unit dose packaging considered to be child-resistant?
A. Any package that contains a substance regulated under the PPPA must meet the special packaging standards regardless of
the package type. This includes unit dose packaging such as blisters or pouches. Unit dose packaging is popular for many
drugs, especially OTC drugs. The package is evaluated using the same test methods; however, the definition of a package
failure is different than that of a bottle/closure package. If a child opens or gains access to a bottle/closure package, it is
counted as a failure for that package. However, a failure for unit dose packaging is defined as occurring when a child opens
or gains access to more than eight individual units or the number of units representing a toxic amount, whichever is less. The
level of child-resistance required of the unit packaging depends on the toxicity of the product in it. A unit package that is
compliant for one drug may not be able to be used to package another more toxic drug.
The Regulatory Agency
Q. What role does the U.S. Consumer Product Safety Commission play in informing and educating the public in the use of,
and need for, special packaging?
A. The Commission has issued news releases and other audio-visual material encouraging the use of special packaging. In
addition, the CPSC is the Secretary of the Poison Prevention Week Council and plays an important role in Poison Prevention
Week each year.
Q. What role does the Commission play in the professional education of health care personnel with respect to the special
packaging program?

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A. The CPSC staff interacts with the State Boards of Pharmacy. CPSC personnel participate in meetings with pharmaceutical,
medical, and packaging groups and prepare articles for publication in their journals. One of the areas where the CPSC staff
has been particularly active has been in encouraging pharmacists to demonstrate special package usage to their customers
who need help with the proper method of opening and closing a special package.
Q. Precisely what does the term "special packaging mean?
A. Congress defined the term special packaging in the PPPA. The term "special packaging" means packaging that is designed
or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the
substance within a reasonable time and not difficult for normal adults to use properly. However, "special packaging" does not
mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time. Normal
adults are regarded as those with no overt physical handicaps, which would preclude their manipulating the package. To meet
PPPA standards, all children need not be prevented from gaining access to the regulated product. This is why the packaging is
called child-resistant and not childproof. Further, all adults need not be able to gain entry into the package. The PPPA does
not allow the CPSC to mandate package designs. These stipulations were included in the legislation so that industrial ingenuity would not be stifled.
Q. What is the basis for determining which products will be covered by the PPPA?
A. The Commission must establish a relationship between a particular household substance (because of the way it is packaged) and the potential for serious injury or illness to young children as a result of ingesting, handling, or using that substance. Some substances do not lend themselves to this requirement. Ingestion of a product by children does not automatically
result in the need for special packaging. For example, many soaps and detergents are frequently ingested but do not cause serious injury or illness to children. Alternatively, it is not necessary to document serious injury to children for the Commission
to require special packaging of a toxic product.
Q. Suppose a pharmacist dispenses a prescription drug in a conventional package. What is the CPSCs position?
A. The law requires that the pharmacist dispense regulated drugs in special packaging. The only exceptions are those instances when the consumer or prescribing physician stipulates that a noncomplying package be used. Pharmacists who violate the
regulations may be criminally prosecuted. Individuals may be sentenced to 1 year imprisonment and fined up to $250,000.
Organizations may be fined up to $500,000. The Commission could also seek court orders enjoining violators or authorizing
seizure of noncomplying products supplied by manufacturers in consumer packages.
Q. What is the basis for selecting the noncomplying package, which the law permits for over-the-counter drugs, regulated under the PPPA?
A. The manufacturer may select one of its package sizes as its noncomplying package so long as it also supplies the product
in popular size packages, which comply with the PPPA standards. The Commission may require a manufacturer to use only
special packaging if the manufacturer has not supplied the product in popular size packages which comply with the standards
and the Commission finds, after the opportunity for a hearing, that the exclusive use of special packaging is necessary to accomplish the child protection intended by the PPPA.
Q. The FDA requires tamper-evident packaging for over-the-counter drugs. Does this replace the requirement for special
packaging?
A. No, the two systems are independent of one another. Although there are some special packages which are also tamperevident (blisters, unit-of-use), a tamperevident package is not necessarily childresistant. The FDA requires that evidence of tampering be visually determined on initial contact.33 Special packages must meet specific performance standards. These include
maintaining their childresistance for the number of openings and closings customary for the life of the product.
Q. What types of special packaging have been approved by the Commission for use with prescription drugs and other regulated household substances?
A. The Commission does not approve or certify special packaging. In fact, the PPPA itself specifically prohibits the Commission from prescribing specific package designs, product content, package quantity, and, with the exception of appropriate labeling for allowable single, noncomplying package sizes, labeling. The ultimate determination of whether a particular

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package complies with the standards is the responsibility of the manufacturer. The Commission assesses compliance on the
basis of human performance tests.
Q. What should a pharmacist or physician do if they know or suspect that PPPA regulations are being violated?
A. Contact CPSC Headquarters either by phone, letter, or e-mail. The CPSC operates a toll-free hotline at (800) 638-2772.
However, we recommend that you contact the Office of Compliance directly by phone at 301-504-7913, via fax at 301-5040359, or via e-mail at [email protected]. CPSC staff will review the complaint and take appropriate action as warranted.
Q. Can a State or other political subdivision establish packaging regulations that are more stringent than those promulgated
by the CPSC?
A. No. With certain narrow exceptions, they must be identical. However, a State may require child-resistant packaging of a
substance not regulated by CPSC.
Q. Can a State or other political subdivision establish packaging regulations that are less stringent than those promulgated by
the CPSC?
A. No.
Endnotes
1Eason,

L.A. The Evolutions and Interest Conflicts Involved in the Poison Prevention Packaging Act of
1970, Unpublished, Auburn University, Alabama, 8/25/72, p. 3.
2Verhulst, H.L. National Clearinghouse for Poison Control Centers, Military Medicine, 1(122): 321, 1958.
3Cann, Howard M., M.D. Iskrant, Albert, P., and Neyman, Dorthory, S. Epidemiological Aspects of
Poisoning Accidents, American Journal of Public Health, 50(12): December 1960, p. 1922.
4Federal Hazardous Substances Act, Public Law 86-613, 74 Stat. 372, July 12, 1960; 15 U.S.C. 12611276
5National Poison Prevention Week, Public Law 87-319, 75 Stat, 681, September 26,1961
6"The Legacy of Homer George, FDA Consumer. March 1973.
7Corrigan, J.J. "The Poison Prevention Packaging Act, FDA Papers, March 1973, p. 1.
8"Prevention of Accidental Ingestion of Salicylate Products By Children," FDA Papers, March 1967, p. 7
9Scherzo, RAG., Strainer, MAC., "We Can Prevent Accidental Poisonings By Using Child-Resistant
Containers," Unpublished paper presented at the Congress De Pediatria, Bogota, Columbia, July 25-30,
1970.
10Scherz, R.G., Stracener, M.C., "Prevention of Accidental Poisonings With Child-Resistant Closures.
Unpublished paper presented to the American Academy of Pediatrics, Military Section, and October 21,
1969.
11Scherz, Robert G. Performance Standards Development A Chronicle of Government-IndustryMedicine Joint Effort II, Safety Packaging in the 70s, Proceedings of a Conference Sponsored by the
Scientific Development Committee of the Proprietary Association, December 9, 1970.
12Breast, H.J., "Five Years With Five Million Child-Resistant Containers. Unpublished paper presented
at the 15th Annual Meeting, American Association of Poison Control Centers, October, 1972.
13Poison Prevention Packaging Act of 1970, (PPPA) Public Law 91-601, 84 Stat.1670, December 30,
1970, Sec. 3; 15 U.S.C. 1472
14Consumer Product Safety Act, Public Law 92-573; 86 Stat. 1207, October 27, 1972, Sec. 30; 15 U.S.C.
2079
15The Poison Prevention Packaging Act, 15 U.S.C.1471, Sec. 2(4).
16Jacobson, B., Rock, A., Cohn, M, and Litovitz, T. Accidental Ingestions of Oral Prescription Drugs: A
Multicenter Survey, American Journal of Public Health, 79:853-856, 1989.
1760 FR 37710, Requirements for the Special Packaging of Household Substances, Final Rule, July 21,
1995.
18
18Rodgers, G. The Safety Effects of Child-Resistant Packaging for Oral Prescription Drugs, Two
Decades of Experience, JAMA 275:1661-1665, 1996.
19Rodgers, G. Lets Welcome a New Generation of Child-Resistant Packaging, Contemporary
Pediatrics, 1997 p. 57-72.
20Rodgers, G., The Effectiveness of Child-Resistant Packaging for Aspirin, Arch Pediatr Adolesc Med

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Federal Pharmacy Law Review

156:929-933, 2002.
21Code of Federal Regulations, 16 CFR 1700.14.
2263 FR 63602
23Correspondence from Geri Niebauer, Office of Compliance, CPSC to Daphne Allen, Editor of
Pharmaceutical and Medical Packaging News, dated June 22, 2000. Text at:
http://www.cpsc.gov/BUSINFO/trials.pdf
2449 FR 8008.
25PPPA, op. cit., Sec. 4; 15 U.S.C. 1473.
26Code of Federal Regulations, 16 CFR 1500.17 (a)(4).
27PPPA, op. cit., Sec. 4; 15 U.S.C. 1473
2816 CFR 1702.
2916 CFR 1700.14(a)(10)(i)-(xx)
3038 FR 9431, April 16, 1973.
3116 CFR 1701.1(b)
3216 CFR 1701.1(d)
3321 CFR 211.132

XI.

Federal Laws Affecting Pharmacy Practice

Although federal law is primarily concerned with the distribution of drugs, it has an indirect effect on the practice of
pharmacy because pharmacists are the primary handlers of drugs. Federal laws directly affecting pharmacy are uncommon,
but they do exist. These laws are becoming more pervasive.
A. OBRA 90
One of the most important laws to ever affect the practice of pharmacy was passed without great fanfare or significant attention in late 1990. This law provides the framework for Drug Use Review, within which pharmacists play a critical role. Adopted as a condition of participation in the federally funded, but state administered, Medicaid program, OBRA 90 establishes
expanded standards of pharmacy practice that states must adopt to continue receiving funds under the prescription benefit
program of Medicaid. States have now adopted these expanded practice standards, although they differ in the way they have
fine-tuned the standards for their state. Although technically not a part of the FDCA, the OBRA 90 standards are a significant influence on drug therapy and pharmacy practice. Select language of the act follows. Numerations refer to subsections
of Section 1396r-8, Title 42, of the United States Code.
(g) Drug use review.
(1) In general.
(A) ... a State shall provide... for a drug use review program... for covered outpatient drugs in order to assure
that prescriptions (i) are appropriate, (ii) are medically necessary, and (iii) are not likely to result in adverse medical
results. The program shall be designed to educate physicians and pharmacists to identify and reduce the frequency of
patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care, among physicians, pharmacists, and patients, or associated with specific drugs or groups of drugs, as well as potential and actual severe adverse reactions to drugs including education on therapeutic appropriateness, overutilization and underutilization,
appropriate use of generic products, therapeutic duplication, drug-disease contraindications, drug-drug interactions,
incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse.
(2) Description of program. Each drug use review program shall meet the following requirements for covered outpatient drugs:
(A) Prospective drug review.
(i) The State plan shall provide for a review of drug therapy before each prescription is filled or delivered to an
individual receiving benefits under this title, typically at the point-of-sale or point of distribution. The review shall
include screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions (including serious interactions with nonprescription or over-the-counter drugs), incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse. Each State
shall use the compendia and literature referred to in paragraph (1)(B) as its source of standards for such review.

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(ii) As part of the State's prospective drug use review program under this subparagraph applicable State law
shall establish standards for counseling of individuals receiving benefits under this title by pharmacists which includes at least the following:
(I) The pharmacist must offer to discuss with each individual receiving benefits under this title or caregiver of
such individual (in person, whenever practicable, or through access to a telephone service which is toll-free for longdistance calls) who presents a prescription, matters which in the exercise of the pharmacist's professional judgment
(consistent with State law respecting the provision of such information), the pharmacist deems significant including
the following:
(aa) The name and description of the medication.
(bb) The route, dosage form, dosage, route of administration, and duration of drug therapy.
(cc) Special directions and precautions for preparation, administration and use by the patient.
(dd) Common severe side or adverse effects or interactions and therapeutic contraindications that may be
encountered, including their avoidance, and the action required if they occur.
(ee) Techniques for self-monitoring drug therapy.
(ff) Proper storage.
(gg) Prescription refill information.
(hh) Action to be taken in the event of a missed dose.
(II) A reasonable effort must be made by the pharmacist to obtain, record, and maintain at least the following
information regarding individuals receiving benefits under this title:
(aa) Name, address, telephone number, date of birth (or age) and gender.
(bb) Individual history where significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices.
(cc) Pharmacist comments relevant to the individuals [individual"s] drug therapy.
Nothing in this clause shall be construed as requiring a pharmacist to provide consultation when an individual
receiving benefits under this title or caregiver of such individual refuses such consultation.
Note that prospective drug use review (ProDUR) is forward-looking. It includes patient education and the detection of potential problems with medication use.
(B) Retrospective drug use review. The program shall provide, through its mechanized drug claims processing
and information retrieval systems or otherwise, for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care,
among physicians, pharmacists and individuals receiving benefits under this title, or associated with specific drugs
or groups of drugs.
(C) Application of standards. The program shall, on an ongoing basis, assess data on drug use against explicit
predetermined standards... including but not limited to monitoring for therapeutic appropriateness, overutilization
and underutilization, appropriate use of generic products, therapeutic duplication, drug-disease contraindications,
drug-drug interactions, incorrect drug dosage or duration of drug treatment, and clinical abuse/misuse and, as necessary, introduce remedial strategies, in order to improve the quality of care and to conserve program funds or personal expenditures.
Note that retrospective drug use review (RetroDUR) is backward-looking. It includes the application of data from a performance database (developed from claims submissions by pharmacies) to an ideal of practice represented by criteria and standards.
(D) Educational program. The program shall, through its State drug use review board established under paragraph (3), either directly or through contracts with accredited health care educational institutions, State medical societies or State pharmacists associations/societies or other organizations as specified by the State, and using data
provided by the State drug use review board on common drug therapy problems, provide for active and ongoing educational outreach programs... to educate practitioners on common drug therapy problems with the aim of improving
prescribing or dispensing practices.

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(3) State drug use review board.
(A) Establishment. Each State shall provide for the establishment of a drug use review board (hereinafter referred to as the "DUR Board") either directly or through a contract with a private organization.
(B) Membership. The membership of the DUR Board shall include health care professionals who have recognized
knowledge and expertise in one or more of the following:
(i) The clinically appropriate prescribing of covered outpatient drugs.
(ii) The clinically appropriate dispensing and monitoring of covered outpatient drugs.
(iii) Drug use review, evaluation, and intervention.
(iv) Medical quality assurance. The membership of the DUR Board shall be made up at least 1/3 but no more
than 51 percent licensed and actively practicing physicians and at least 1/3 licensed and actively practicing pharmacists.
(C) Activities. The activities of the DUR Board shall include but not be limited to the following:
(i) Retrospective DUR...
(ii) Application of standards...
(iii) Ongoing interventions for physicians and pharmacists, targeted toward therapy problems or individuals
identified in the course of retrospective drug use reviews performed under this subsection. Intervention programs
shall include, in appropriate instances, at least:
(I) information dissemination sufficient to ensure the ready availability to physicians and pharmacists in the
State of information concerning its duties, powers, and basis for its standards;
(II) written, oral, or electronic reminders containing patient-specific or drug-specific (or both) information
and suggested changes in prescribing or dispensing practices, communicated in a manner designed to ensure the privacy of patient-related information;
(III) use of face-to-face discussions between health care professionals who are experts in rational drug therapy and selected prescribers and pharmacists who have been targeted for educational intervention, including discussion of optimal prescribing, dispensing, or pharmacy care practices, and follow-up face-to-face discussions; and
(IV) intensified review or monitoring of selected prescribers or dispensers.
The Board shall re-evaluate interventions after an appropriate period of time to determine if the intervention
improved the quality of drug therapy, to evaluate the success of the interventions and make modifications as necessary.
Note that the state DUR Board, a truly multi-disciplinary committee, oversees educational programs designed to improve the
use of medications so that problems with drug therapy will decrease and criteria and standards will be more consistently met.

B.
HIPAA
The Health Insurance Portability and Accountability Act is a far-reaching piece of legislation that has an affect on virtually
every aspect of patient care. It is often viewed as being primarily a federal patient confidentiality requirement. This is unfortunate. In fact, HIPAA introduces very few new rules for confidentiality, beyond a massive requirement for paperwork that
threatens to convert confidentiality into a game rather than a fundamental principle of patient care. For decades the pharmacy
profession has recognized the importance of patient confidentiality, because this principle shows respect for patients as individuals, it provides evidence that pharmacy is a health care profession and not a retail business, and it encourages patients to
have their embarrassing prescriptions filled because they know the entire community will not be told of them. Now that
HIPAA has become federal law, every breach of confidentiality is viewed as a HIPAA violation rather than a violation of a
core principle to which the profession has adhered for decades. An in depth listing of HIPAA provisions is beyond the scope
of this text. The most salient points are listed below:
HIPAA applies to Protected Health Information (referred to as PHI) that is transmitted or maintained on electronic or
paper records or is orally communicated.
All health care providers that transmit PHI in any electronic form are covered under the act.
Patients must be given a notice of their privacy rights.

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Patients must provide informed consent before PHI may be disclosed by a covered health care provider, except under certain circumstances such as the reporting of product recalls, the reporting of adverse events, the conduct of post-marketing
surveillance, or other situations in which the law requires disclosure (such as public health agencies investigating communicable diseases or a report of child abuse).
Patients may request access to their own private medical record and PHI.
In communicating with other health care providers who have a responsibility for a patients care, it is important not to
disclose any more PHI than the minimum amount necessary. However, health care providers who communicate with
each other for treatment purposes are not constrained by the minimum amount necessary limit, and this limit also does
not apply to any communication to which the patient has given informed consent.
Specific excerpts from the federal medical privacy standards under HIPAA follow. These are lengthy and complex regulations. For further information about HIPAA, consult Article 45 of the Code of Federal Regulations, or visit the U.S. Department of Health and Human Services (HHS) website at http://www.hhs.gov/ocr/privacy/index.html.
164.104 Applicability.
(a) Except as otherwise provided, the standards, requirements, and implementation specifications adopted under this
part apply to the following entities:
(1) A health plan.
(2) A health care clearinghouse.
(3) A health care provider who transmits any health information in electronic form in connection with a transaction
covered by this subchapter.
164.502 Uses and disclosures of protected health information: general rules.
(a) Standard. A covered entity may not use or disclose protected health information, except as permitted...
(1) Permitted uses and disclosures. A covered entity is permitted to use or disclose protected health information as
follows:
(i) To the individual;
(ii) For treatment, payment, or health care operations...;
(iii) Incident to a use or disclosure otherwise permitted or required by this subpart, provided that the covered entity
has complied with the applicable requirements...
(2) Required disclosures. A covered entity is required to disclose protected health information:
(i) To an individual, when requested... ; and
(ii) When required by the Secretary... to investigate or determine the covered entity's compliance with this subpart.
(b) Standard: Minimum necessary. (1) Minimum necessary applies. When using or disclosing protected health information or when requesting protected health information from another covered entity, a covered entity must make
reasonable efforts to limit protected health information to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.
(2) Minimum necessary does not apply. This requirement does not apply to:
(i) Disclosures to or requests by a health care provider for treatment;
(ii) Uses or disclosures made to the individual...
(d) Standard: Uses and disclosures of de-identified protected health information.
(1) Uses and disclosures to create de-identified information. A covered entity may use protected health information
to create information that is not individually identifiable health information or disclose protected health information
only to a business associate for such purpose, whether or not the de-identified information is to be used by the covered entity.
164.506 Uses and disclosures to carry out treatment, payment, or health care operations.
(a) Standard: Permitted uses and disclosures. Except with respect to uses or disclosures that require an authorization under 164.508(a)(2) and (3), a covered entity may use or disclose protected health information for treatment,
payment, or health care operations as set forth in paragraph (c) of this section, provided that such use or disclosure
is consistent with other applicable requirements of this subpart.

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(b) Standard: Consent for uses and disclosures permitted. (1) A covered entity may obtain consent of the individual
to use or disclose protected health information to carry out treatment, payment, or health care operations...
(c) Implementation specifications: Treatment, payment, or health care operations.
(1) A covered entity may use or disclose protected health information for its own treatment, payment, or health care
operations.
(2) A covered entity may disclose protected health information for treatment activities of a health care provider.
(3) A covered entity may disclose protected health information to another covered entity or a health care provider for
the payment activities of the entity that receives the information.
(4) A covered entity may disclose protected health information to another covered entity for health care operations
activities of the entity that receives the information, if each entity either has or had a relationship with the individual
who is the subject of the protected health information being requested, the protected health information pertains to
such relationship, and the disclosure is:
(i) For a purpose listed in paragraph (1) or (2) of the definition of health care operations; or
(ii) For the purpose of health care fraud and abuse detection or compliance.
(5) A covered entity that participates in an organized health care arrangement may disclose protected health information about an individual to another covered entity that participates in the organized health care arrangement for
any health care operations activities of the organized health care arrangement.
In an effort to improve health information technology and protect health information, as the use of electronic information increases, the Health Information Technology and Economic and Clinical Health Act (HITECH) was passed in 2009 that expands the scope of HIPAA. The HITECH Act includes various new provisions, including the requirement to notify patients
and HHS of PHI security breaches without unreasonable delay. The act also expands the reach of HIPAA data privacy and
security requirements to include the business associates of covered entities (such as pharmacies). Examples of business associates are companies like accounting firms, billing agencies, law firms or others that provide services to the covered entities.
C.
Medicare Modernization Act (MMA)
On January 1, 2006, the MMA went into effect. This act offers senior citizens and persons with disabilities a voluntary prescription drug benefit. This is generally referred to as Part D of the Medicare program. It is a huge piece of legislation, but
the effect on pharmacy is felt primarily in the area of medication therapy management (MTM), federal electronic prescribing
standards and recordkeeping requirements. Refer to Title 42 of the Code of Federal Regulations for additional information
regarding Medicare Part D.
The MTM program is included within the provisions of the MMA related to quality assurance:
423.153 Drug utilization management, quality assurance, and medication therapy management programs
(MTMPs).
(a) General rule. Each Part D sponsor must have established, for covered Part D drugs furnished through a Part D
plan, a drug utilization management program, quality assurance measures and systems, and an MTMP as described
in paragraphs (b), (c), and (d) of this section.
(b) Drug utilization management. A Part D sponsor must have established a reasonable and appropriate drug utilization management program that -(1) Includes incentives to reduce costs when medically appropriate;
(2) Maintains policies and systems to assist in preventing over-utilization and under-utilization of prescribed medications; and
(3) Provides CMS with information concerning the procedures and performance of its drug utilization management
program, according to guidelines specified by CMS.
(c) Quality assurance. A Part D sponsor must have established quality assurance measures and systems to reduce
medication errors and adverse drug interactions and improve medication use that include all of the following -(1) Representation that network providers are required to comply with minimum standards for pharmacy practice as
established by the States.
(2) Concurrent drug utilization review systems, policies, and procedures designed to ensure that a review of the pre-

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scribed drug therapy is performed before each prescription is dispensed to an enrollee in a sponsor's Part D plan,
typically at the point-of-sale or point of distribution. The review must include, but not be limited to,
(i) Screening for potential drug therapy problems due to therapeutic duplication.
(ii) Age/gender-related contraindications.
(iii) Over-utilization and under-utilization.
(iv) Drug-drug interactions.
(v) Incorrect drug dosage or duration of drug therapy. (vi) Drug-allergy contraindications.
(vii) Clinical abuse/misuse.
(3) Retrospective drug utilization review systems, policies, and procedures designed to ensure ongoing periodic examination of claims data and other records, through computerized drug claims processing and information retrieval
systems, in order to identify patterns of inappropriate or medically unnecessary care among enrollees in a sponsor's
Part D plan, or associated with specific drugs or groups of drugs.
(4) Internal medication error identification and reduction systems.
(5) Provision of information to CMS regarding its quality assurance measures and systems, according to guidelines
specified by CMS.
(d) Medication therapy management program (MTMP).
(1) General rule. A Part D sponsor must have established a MTMP that -(i) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries described in paragraph
(d)(2) of this section are appropriately used to optimize therapeutic outcomes through improved medication use;
(ii) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries
described in paragraph (d)(2) of this section;
(iii) May be furnished by a pharmacist or other qualified provider; and
(iv) May distinguish between services in ambulatory and institutional settings.
(2) Targeted beneficiaries. Targeted beneficiaries for the MTMP described in paragraph (d)(1) of this section are
enrollees in the sponsor's Part D plan who -(i) Have multiple chronic diseases;
(ii) Are taking multiple Part D drugs; and
(iii) Are likely to incur annual costs for covered Part D drugs that exceed a predetermined level as specified by the
Secretary...
The provisions related to electronic prescribing establish foundation standards for the use of that technology, and they specify
that the federal standards preempt state standards to the extent that any state standard would make it impossible for a prescriber to electronically transmit prescriptions for a Medicare-eligible patient.
423.160 Standards for electronic prescribing.
(a) General rules. (1) Part D sponsors must establish and maintain an electronic prescription drug program that
complies with the applicable standards in paragraph (b) of this section when transmitting, directly or through an intermediary, prescriptions and prescription-related information using electronic media for covered Part D drugs for
Part D eligible individuals...
The provisions of the MMA also require that pharmacists retain all prescriptions for 10 years. Paper prescriptions need be
retained only for 3 years, while the remaining 7 years of prescriptions may be kept in some electronic format.
D.
Tamper-Resistant Prescriptions
Since 2008, in order for Medicaid outpatient drugs to be reimbursable by the federal government, all written, non-electronic
prescriptions must contain at least three tamper-resistant features, one from each of the three baseline characteristics outlined
in guidance issued by the Centers for Medicare & Medicaid Services (CMS). Although CMS has outlined three baseline
characteristics of tamper-resistant prescriptions, each State will define which features it will require to meet those characteristics in order to be considered tamper-resistant. The baseline characteristics must: (1) prevent unauthorized copying of a completed or blank prescription form; (2) prevent the erasure or modification of information written on the prescription by the
prescriber; or (3) prevent the use of counterfeit prescription forms. CMS has also provided situations where this requirements

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does not apply: when the prescription is communicated by the prescriber to the pharmacy electronically, verbally, or by fax;
a managed care entity pays for the prescription; or in most situations when drugs are provided in certain institutional and clinical facilities. Emergency fills are also allowed as long as a prescriber provides a verbal, faxed, electronic, or compliant written prescription within 72 hours. For detailed information on the requirements, please refer to the CMS website. The statute
language for tamper-resistant prescriptions is included below.
42 U.S.C. 1936b(i)
(23) with respect to amounts expended for medical assistance for covered outpatient drugs (as defined in section
1927(k)(2) [42 USCS 1396r-8(k)(2)]) for which the prescription was executed in written (and non-electronic) form
unless the prescription was executed on a tamper-resistant pad.

XII.

Patient Safety Quality Improvement Act of 2005

The Patient Safety and Quality Improvement Act of 2005 (Public Law 109-41) was signed into law on July 29, 2005.
It was enacted in response to growing concern about patient safety in the United States and the IOM 1999 report, To Err is
Human: Building a Safer Health System The goal of the Act is to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients. The Act creates Patient Safety Organizations (PSOs) to collect, aggregate, and analyze confidential information reported by health care providers. The Act also provides a federal legal
privilege for information that is assembled and reported by providers to PSOs. For further information about this law, visit
www.ahrq.gov/qual/psoact.htm.

XIII.

Medical Devices
Any article that is intended to achieve its therapeutic goal through mechanisms other than chemical mechanisms is a
medical device. Medical devices are classified by the FDA according to their relative danger to the public, and the need to
restrict them or require premarketing approval. The language of the act follows. Numerations refer to subsections of Section
360c, Title 21, of the United States Code.
(a) Classes of devices.
(1) There are established the following classes of devices intended for human use:
(A) Class I, general controls.
(i) A device for which the controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 [21
USCS 351, 352, 360, 360f, 360h, 360i, or 360j] or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device.
(ii) A device for which insufficient information exists to determine that the controls referred to in clause (i) are
sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls
to provide such assurance, but because it
(I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is
of substantial importance in preventing impairment of human health, and
(II) does not present a potential unreasonable risk of illness or injury, is to be regulated by the controls referred to in clause (i).
(B) Class II, special controls. A device which cannot be classified as a class I device because the general controls
by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for
which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance
with section 510(k) [21 USCS 360(k)]), recommendations, and other appropriate actions as the Secretary deems
necessary to provide such assurance. For a device that is purported or represented to be for a use in supporting or
sustaining human life, the Secretary shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.
(C) Class III, premarket approval. A device which because

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(i) it (I) cannot be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and (II) cannot be classified as a class II device because insufficient information exists to determine that the
special controls described in subparagraph (B) would provide reasonable assurance of its safety and effectiveness,
and
(ii) (I) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human health, or
(II) presents a potential unreasonable risk of illness or injury, is to be subject, in accordance with section
515 [21 USCS 360e], to premarket approval to provide reasonable assurance of its safety and effectiveness. If
there is not sufficient information to establish a performance standard for a device to provide reasonable assurance
of its safety and effectiveness, the Secretary may conduct such activities as may be necessary to develop or obtain
such information.

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Chapter 3:
Federal Controlled Substances Law
I.

The Federal Controlled Substances Act

A significant component of the federal Comprehensive Drug Abuse Prevention and Control Act of 1970 is the Controlled Substances Act (CSA). The CSA establishes rules that empower the Drug Enforcement Administration (DEA), the
federal agency that enforces the federal laws regarding controlled substances, to assure that drugs intended for medical use
are not diverted to nonmedical uses. Pharmacists, as custodians of the nations medicinal drug supply find themselves significantly involved in police activities in which they have little interest and no training. However, there is no escaping the reality that the law requires pharmacists to do their best to assure that the drugs pharmacists control do not end up in the wrong
hands. The basic structure of the CSA is to place all potentially abused drugs in one of five schedules. People and places that
are authorized to possess these drugs are then required to be registered with the DEA. Specific records must be kept so that
the whereabouts of any controlled substance can be followed from cradle to grave. Of particular interest to pharmacists are
rules relating to dispensing of controlled substances pursuant to a prescription. The failure to keep controlled substances
within authorized medical channels exposes to discipline the person or persons responsible for diversion outside authorized
medical channels.
A.
Definitions
The CSA uses specific words and phrases in ways that might not be anticipated from their ordinary day-to-day meaning. To
fully appreciate the functioning of the CSA, one must understand how the act uses these words and phrases. Select important
definitions follow. The language is quoted directly from the CSA. Numerations refer to subsections of Section 802, Title 21,
of the United States Code.
(1) The term "addict" means any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of selfcontrol with reference to his addiction.
Note that a patient who is using controlled substances to treat a medical condition, and who becomes habituated to the controlled substances, is not an addict under the CSA.
(2) The term "administer" refers to the direct application of a controlled substance to the body of a patient or research subject by-(A) a practitioner (or, in his presence, by his authorized agent), or
(B) the patient or research subject at the direction and in the presence of the practitioner,
whether such application be by injection, inhalation, ingestion, or any other means.
(3) The term "agent" means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or
employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier's or warehouseman's business.
(6) The term "controlled substance" means a drug or other substance, or immediate precursor, included in schedule
I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.
(8) The terms "deliver" or "delivery" mean the actual, constructive, or attempted transfer of a controlled substance
or a listed chemical, whether or not there exists an agency relationship.

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(10) The term "dispense" means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance
and the packaging, labeling or compounding necessary to prepare the substance for such delivery. The term
"dispenser" means a practitioner who so delivers a controlled substance to an ultimate user or research subject.
(11) The term "distribute" means to deliver (other than by administering or dispensing) a controlled substance or a
listed chemical. The term "distributor" means a person who so delivers a controlled substance or a listed chemical.
(21) The term "practitioner" means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or
other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.
(27) The term "ultimate user" means a person who has lawfully obtained, and who possesses, a controlled substance
for his own use or for the use of a member of his household or for an animal owned by him or by a member of his
household.
(29) The term "maintenance treatment" means the dispensing, for a period in excess of twenty-one days, of
a narcotic drug in the treatment of an individual for dependence upon heroin or other morphine-like drugs.
(30) The term "detoxification treatment" means the dispensing, for a period not in excess of one hundred and eighty
days, of a narcotic drug in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of
bringing the individual to a narcotic drug-free state within such period.
(55) The term "refilling prescriptions for controlled substances in schedule III, IV, or V" (A) means the dispensing of a controlled substance in schedule III, IV, or V in accordance with refill instructions
issued by a practitioner as part of a valid prescription that meets the requirements of subsections (b) and (c) of
section 829 of this title, as appropriate; and
(B) does not include the issuance of a new prescription to an individual for a controlled substance that individual
was previously prescribed.
(56) The term "filling new prescriptions for controlled substances in schedule III, IV, or V" means filling a prescription for an individual for a controlled substance in schedule III, IV, or V, if (A) the pharmacy dispensing that prescription has previously dispensed to the patient a controlled substance other than by means of the Internet and pursuant to the valid prescription of a practitioner that meets the applicable
requirements of subsections (b) and (c) of section 829 of this title (in this paragraph referred to as the "original
prescription");
(B) the pharmacy contacts the practitioner who issued the original prescription at the request of that individual
to determine whether the practitioner will authorize the issuance of a new prescription for that individual for the
controlled substance described in subparagraph (A); and
(C) the practitioner, acting in the usual course of professional practice, determines there is a legitimate medical
purpose for the issuance of the new prescription.

B.
Controlled Substance Schedules
Under the CSA, the DEA is given responsibility to schedule controlled substances in five categories knows as Schedules I
through V. The restrictions on controlled substances vary according the schedule in which the controlled substance has been
placed. Controlled substances in Schedule I are the most restrictively controlled, and controlled substances in Schedule V are

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the least restrictively controlled. Of course, there are many medicinal agents that are not controlled at all because they have
no abuse potential, and these drugs are the least restricted because they fall into no schedule. The language below is quoted
directly from the CSA. Numerations refer to subsections of Section 812, Title 21, of the United States Code.
a) Establishment. There are established five schedules of controlled substances, to be known as schedules I, II, III,
IV, and V. Such schedules shall initially consist of the substances listed in this section. The schedules shall be updated and republished on a semiannual basis during the two-year period beginning one year after the date of enactment of this title [enacted Oct. 27, 1970] and shall be updated and republished on an annual basis thereafter.
(b) Placement on schedules; findings required. Except where control is required by United States obligations under
an international treaty, convention, or protocol, in effect on the effective date of this part, and except in the case of
an immediate precursor, a drug or other substance may not be placed in any schedule unless the findings required
for such schedule are made with respect to such drug or other substance. The findings required for each of the schedules are as follows:
(1) SCHEDULE I.
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has no currently accepted medical use in treatment in the United States.
(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.
(2) SCHEDULE II.
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.
(C) Abuse of the drug or other substances may lead to severe psychological or physical dependence.
(3) SCHEDULE III.
(A)The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I
and II.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological
dependence.
(4) SCHEDULE IV.
(A)The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence
relative to the drugs or other substances in schedule III.
(5) SCHEDULE V.
(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence
relative to the drugs or other substances in schedule IV.
Note that the schedules of controlled substances are based on the potential for abuse, the recognition of a medical use, and the
possibility of physical or psychological dependence.
C.
Registration
Under the CSA, only certain parties are permitted to possess controlled substances legally. These parties must be registered
with the DEA, or they must be exempt from registration. For example, a pharmacist who meets the licensure requirements of
the state where the pharmacist is practicing, may dispense controlled substances to patients as long as the pharmacist practices in a pharmacy that is registered with the DEA. The pharmacist need not personally be registered with the DEA. The language below is quoted directly from the CSA. Numerations refer to subsections of Section 822, Title 21, of the United States
Code.

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(a) Annual registration.
(1) Every person who manufactures or distributes any controlled substance or list I chemical, or who proposes to
engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him.
(2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney
General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years.
(b) Authorized activities. Persons registered by the Attorney General under this title to manufacture, distribute, or
dispense controlled substances or list I chemicals are authorized to possess, manufacture, distribute, or dispense
such substances or chemicals (including any such activity in the conduct of research) to the extent authorized by their
registration and in conformity with the other provisions of this title.
(d) Waiver. The Attorney General may, by regulation, waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.
(e) Separate registration. A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or list I chemicals.
(f) Inspection. The Attorney General is authorized to inspect the establishment of a registrant or applicant for registration in accordance with the rules and regulations promulgated by him.
Note that the registration for dispensers is currently effective for a period of three years.
D.
Records
Every transaction in which controlled substances change hands must be recorded. This means generally that the receipt of
controlled substances must be recorded as must the dispersal of controlled substances. In addition, there are requirements for
the periodic inventory of controlled substances. Based on records kept of controlled substances, it should be possible to discern, for any registrant, what controlled substances are on hand, where they came from, and where controlled substances have
gone to. The language below is quoted directly from the CSA. Numerations refer to subsections of Section 827, Title 21, of
the United States Code.
(b) Availability of records. Every inventory or other record required under this section (1) shall be in accordance
with, and contain such relevant information as may be required by, regulations of the Attorney General, (2) shall (A)
be maintained separately from all other records of the registrant, or (B) alternatively, in the case of nonnarcotic controlled substances, be in such form that information required by the Attorney General is readily retrievable from the
ordinary business records of the registrant, and (3) shall be kept and be available, for at least two years, for inspection and copying by officers or employees of the United States authorized by the Attorney General.
E.
Prescriptions
The most frequent method through which controlled substances are dispersed by a pharmacy is through a prescription, issued
by a licensed prescriber and filled for a patient. Because this method of dispersion is so commonplace, specific rules have
been developed to guide appropriateness of it. These rules are intended to assure that all prescriptions filled by pharmacists
for controlled substances have been issued for a medical purpose, and will not result in diversion to nonmedical use. The
DEA issues regulations that expand on the CSA requirements, to assure that prescriptions are in such a form as to make it
likely that they have been issued for a medical purpose. The language below is quoted directly from the CSA. Numerations
refer to subsections of Section 829, Title 21, of the United States Code.
(a) Schedule II substances. Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate
user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food,
Drug, and Cosmetic Act [21 USCS 301 et seq.], may be dispensed without the written prescription of a practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act [21

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USCS 353(b)]. Prescriptions shall be retained in conformity with the requirements of section 307 of this title [21
USCS 827]. No prescription for a controlled substance in schedule II may be refilled.
Note that Schedule II prescriptions must be in writing, except in the case of particular narrowly circumscribed situations in
which oral prescriptions are permitted. Schedule II prescriptions may never be refilled. Never! End of story!!
(b) Schedule III and IV substances. Except when dispensed directly by a practitioner, other than a pharmacist, to an
ultimate user, no controlled substance in schedule III or IV, which is a prescription drug as determined under the
Federal Food, Drug, and Cosmetic Act [21 USCS 301 et seq.], may be dispensed without a written or oral prescription in conformity with section 503(b) of that Act [21 USCS 353(b)]. Such prescriptions may not be filled or
refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner.
This is the five times in six months rule under which Schedule III and IV prescriptions may be refilled if authorized by the
prescriber, during the six months following the issuance of the prescription.
(c) Schedule V substances. No controlled substance in schedule V which is a drug may be distributed or dispensed
other than for a medical purpose.
Note that for prescriptions issued for Schedule V controlled substances there is no hard and fast time limit on refills, but there
is the basic requirement of a medical purpose.
(e) Controlled substances dispensed by means of the Internet
(1) No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] may be delivered, distributed, or dispensed by means of the Internet without a
valid prescription.
(2) As used in this subsection:
(A) The term "valid prescription" means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by (i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or
(ii) a covering practitioner.
(B)(i) The term "in-person medical evaluation" means a medical evaluation that is conducted with the patient in
the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by
other health professionals.
(ii) Nothing in clause (i) shall be construed to imply that 1 in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.
(C) The term "covering practitioner" means, with respect to a patient, a practitioner who conducts a medical
evaluation (other than an in-person medical evaluation) at the request of a practitioner who (i) has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through
the practice of telemedicine, within the previous 24 months; and
(ii) is temporarily unavailable to conduct the evaluation of the patient.
(3) Nothing in this subsection shall apply to (A) the delivery, distribution, or dispensing of a controlled substance by a practitioner engaged in the practice of
telemedicine; or
(B) the dispensing or selling of a controlled substance pursuant to practices as determined by the Attorney General by regulation, which shall be consistent with effective controls against diversion.

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To help with concerns regarding dispensing and diversion of controlled substances over the Internet, this section addresses valid prescriptions and the importance of in-person medical evaluations.

II.

Application of the CSA to Dispensing

The federal government regulates controlled substances not as a health care matter but as a law enforcement matter.
The closed system of distribution for controlled substances aims to prevent inappropriate use of abusable drugs for purposes
other than medical use. Pharmacists are given the responsibility to assure that patients who need controlled substances get
them when a prescription has been appropriately generated, but also that people who do not need controlled substances are
prevented from acquiring them. All pharmacists would wish to be perfectly accurate in dispensing, and not dispense a drug
to a person who has no need for it, while at the same time always dispense a drug to a person who does have a need for it.
Unfortunately, such perfection is not possible. Sometimes a person who has no medical need for a drug mistakenly receives
it through a fraudulent prescription, and another person who does have a medical need is mistakenly denied it by an overly
suspicious pharmacist. The rules developed by the Drug Enforcement Administration (DEA) are intended to assure that pharmacists have available to them the documentation they need to make appropriate decisions about access to controlled substances. Checks and balances exist to preserve the integrity of the system.
III.

Classification of Controlled Substances

The first step in controlling drugs of abuse is to define which drugs are considered to be subject to abuse. The CSA
does this by enumerating five Schedules of drugs and describing the criteria for placing drugs into one of the five Schedules.
These criteria were listed earlier. It is important to note that there is a difference between a Scheduled drug and a legend
drug. This fundamental distinction is sometimes overlooked by pharmacists. A legend drug is one that may be distributed
only pursuant to a prescription. The opposite of legend drug is non-prescription drug. A Scheduled drug is one that is regulated under the CSA due to its potential for abuse. The opposite of Scheduled drug is non-Scheduled drug. Thus, there are
four possible combinations. A drug may be a Scheduled, legend drug. This would mean that it is has an abuse potential and
requires a prescription. Morphine and benzodiazepines are examples of Scheduled, legend drugs. Alternatively, a drug may
be a non-Scheduled, legend drug. This would mean that it does not have an abuse potential but it requires a prescription.
Oral antibiotics and antihypertensives are examples of non-Scheduled, legend drugs. A third possibility is that a drug could
be a non-Scheduled, non-legend drug. This would mean that the drug does not have an abuse potential and requires no prescription. Aspirin and ranitidine are examples of non-Scheduled, non-legend drugs. The fourth possibility is the most rarely
occurring and it sometimes takes some convincing before people believe there are really drugs of this kind; a drug that has
abuse potential and requires no prescription. Products that contain low strengths of opium to treat diarrhea and products that
contain low strengths of codeine to treat cough are examples of such drugs. These products are limited to dispensing by a
pharmacist under the CSA and they do not require a prescription under the FDCA, thus they occupy a very unusual category
of regulated drugs.
With five different Schedules, one might think that there would be five different sets of rules to learn. But the reality
for pharmacists is that three sets of rules will actually suffice. Since Schedule I controlled substances have no currently recognized medical use, they are generally not found in pharmacies. Only when such drugs are being used under clinical protocols would they be of concern to pharmacists, and that classification restricts them to research institutions. Schedule II
controlled substances are the most highly restricted of those drugs that are ordinarily found in pharmacies, so the rules applicable to them are numerous and somewhat burdensome. At the dispensing level, Schedule III and IV controlled substances
are handled in essentially the same way, so no distinction need be drawn between them. The rules for Schedule V controlled
substances are similar to those for Schedules III and IV, but there are differences that warrant considering them separately.
So as a general rule, it is possible to learn three sets of rules, those applicable to Schedule II drugs, those applicable to Schedules III and IV, and those applicable to Schedule V. The other rules of the CSA depend on this drug classification scheme.

IV.

Registration
Those individuals and institutions that are authorized to possess drugs classified as controlled substances are subject
to a registration requirement. In registering with the DEA, an individual or institution receives a DEA number. The number

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begins with a two-letter combination that is followed by seven numbers. The first of the two letters signifies the status of the
registrant. Practitioners and dispensers were at one time always given a DEA number beginning with the letter A, but the
DEA ran out of numbers and began giving such registrants numbers beginning with the letter B. When the letter B ran
out, the DEA began using the letter F. Mid-level practitioners receive DEA numbers beginning with the letter M, while
distributors receive DEA numbers beginning with either the letter P or the letter R. The second letter of the two-letter
initial sequence is usually the first letter of the last name of the registrant. Because rules change from time to time, it is important to not become overly concerned about a DEA number simply because it begins with letters that seem not to fit the
registrant. Careful questioning may disclose that there is a very good reason for an apparent mismatch, and that there is no
cause for concern.
The seven number sequence that follows the two initial letters should always match a formula that the DEA has established to evaluate legitimacy of a DEA number. To check whether the formula has been followed, do this: (1) Add the
first, third and fifth digits of the seven numbers that follow the first two letters; (2) Then add the second, fourth and sixth of
those seven numbers, double the result and add this figure to the first sum; (3) Compare the number in the ones column of
the result (the right-most digit) and determine whether this number matches the seventh and final number of the nine-figure
letter-and-number combination. If there is a match, then the DEA number looks valid. If there is no match, then it looks invalid. Of course, this is not so complicated a process that drug addicts and pushers are unable to figure it out. Simply because a DEA number looks valid does not mean that a prescription is guaranteed to be valid. Many other factors must be
considered in an evaluation of validity.
A.
Persons Required to Register
Every person who manufactures, distributes, or dispenses any controlled substance or who proposes to engage in the manufacture, distribution, or dispensing of any controlled substance must obtain a registration unless exempted by law. Law enforcement personnel, agents and employees of registrants, and certain military and other personnel are exempt from
registration. Only persons actually engaged in activities with controlled substances are required to register. For example, a
stockholder or parent corporation of a corporation dispensing controlled substances is not required to register.
B.
Separate Registration for Independent Activities
DEA registration is determined by what you are doing, not who you are. A pharmacist/pharmacy may be required to register
in several different categories, depending on what activities are being undertaken by the pharmacist. DEA regulations describe the independent activities that require separate registration (see 21 CFR 1301.13). In general, the business activities
that require separate registration include: manufacturing, distributing, reverse distributing, dispensing, research, narcotic
treatment program, importing, exporting, and chemical analysis. Any person registered to engage in the activities described
is also authrorized to engage in the coincident activities described without obtaining a separate registration, provided they
comply with all requirements and duties of the coincident activity. For example, one registered under the activity dispensing
or instructing (includes Practitioner, Hospital/Clinic, Retail Pharmacy, Online Pharmacy, Central fill pharmacy, Teaching Institution) would not have to separately register to conduct research and instructional activities with those substances for
which registration was granted. In addition, a pharmacist may manufacture an aqueous or oleaginous solution or solid dosage
form containing a narcotic controlled substance in Schedule IIV in a proportion not exceeding 20% of the complete solution,
compound or mixture without the need to register as a manufacturer.
Another important not for pharmacists is that they may distribute controlled substances to other registrants, as long as the total number of dosage units does not exceed 5 percent of the total units of controlled substances distributed and dispensed in
one year, without the need to register as a distributor. The DEA regulation follows. Numerations refer to sections of Title
21, Code of Federal Regulations.
1307.11 Distribution by dispenser to another practitioner or reverse distributor.
(a) A practitioner who is registered to dispense a controlled substance may distribute (without being registered to
distribute) a quantity of such substance to -(1) Another practitioner for the purpose of general dispensing by the practitioner to patients, provided that -(i) The practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that
controlled substance;

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(ii) The distribution is recorded by the distributing practitioner in accordance with 1304.22(c) of this chapter and
by the receiving practitioner in accordance with 1304.22(c) of this chapter;
(iii) If the substance is listed in Schedule I or II, an order form is used as required in part 1305 of this chapter; and
(iv) The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section and 1301.25 of this chapter during each calendar year in which the practitioner is registered to dispense does
not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the
practitioner during the same calendar year.
(2) A reverse distributor who is registered to receive such controlled substances.
(b) If, during any calendar year in which the practitioner is registered to dispense, the practitioner has reason to believe that the total number of dosage units of all controlled substances which will be distributed by him pursuant to
paragraph (a)(1) of this section and 1301.25 of this chapter will exceed 5 percent of this total number of dosage
units of all controlled substances distributed and dispensed by him during that calendar year, the practitioner shall
obtain a registration to distribute controlled substances.
(c) The distributions that a registered retail pharmacy makes to automated dispensing systems at long term care facilities for which the retail pharmacy also holds registrations do not count toward the 5 percent limit in paragraphs
(a)(1)(iv) and (b) of this section.
C.
Separate Registration for Separate Locations
For obvious reasons, a DEA registration is limited to a specific location. If this were not the case, then missing controlled
substances could always be claimed to be located at another place controlled by the registrant, and it would be impossible to
determine whether controlled substances had in fact been diverted from the chain of distribution. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
1301.12 Separate registrations for separate locations.
(a) A separate registration is required for each principal place of business or professional practice at one general
physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a
person.
(b) The following locations shall be deemed not to be places where controlled substances are manufactured, distributed, or dispensed:
(1) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registered locations other than the registered location
from which the substances were delivered or to persons not required to register... ;
(2) An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains such substances (other than substances for display purposes or lawful distribution as samples only) nor serves as a distribution point for filling sales orders; and
(3) An office used by a practitioner (who is registered at another location in the same State or jurisdiction of the
United States) where controlled substances are prescribed but neither administered nor otherwise dispensed as a
regular part of the professional practice of the practitioner at such office, and where no supplies of controlled
substances are maintained.
(4) A freight forwarding facility...
D.
Employee Responsibility
Within its registration rules, the DEA specifies security requirements that must be met by registrants. These requirements
will be well known to pharmacies at which pharmacists become employed. One specific section is worthy of note, because it
imposes a responsibility specifically on the employee rather than the employer. This section has to do with the reporting of
drug diversion by another employee. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
1301.91 Employee responsibility to report drug diversion.

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Reports of drug diversion by fellow employees is not only a necessary part of an overall employee security program
but also serves the public interest at large. It is, therefore, the position of DEA that an employee who has knowledge
of drug diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer. The employer shall treat such information as confidential and shall take all reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing information.
A failure to report information of drug diversion will be considered in determining the feasibility of continuing to allow an employee to work in a drug security area. The employer shall inform all employees concerning this policy.
V.

Labeling and Package Requirements

It is important for pharmacists and others who legally possess and distribute controlled substances to be able to distinguish controlled substances from other medications that do not fall into this category. It is also important to know what
Schedule a controlled substance falls into, because the manner in which controlled substances must be handled differs depending on the Schedule to which a controlled substance has been assigned. By requiring specific and obvious labeling of
controlled substances, the CSA assures that those legally possessing them know what they have and how it must be handled.
A.
Symbol requirement
Under DEA regulations, a standard symbol is required for identification of controlled substances. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
1302.03 Symbol required; exceptions.
(a) Each commercial container of a controlled substance (except for a controlled substance excepted by the Administrator pursuant to 1308.31 of this chapter) shall have printed on the label the symbol designating the Schedule in
which such controlled substance is listed. Each such commercial container, if it otherwise has no label, must bear a
label complying with the requirement of this part.
(b) Each manufacturer shall print upon the labeling of each controlled substance distributed by him the symbol designating the Schedule in which such controlled substance is listed.
(c) The following symbols shall designate the Schedule corresponding thereto:
Schedule
Symbol
Schedule I
CI or C-I.
Schedule II
CII or C-II.
Schedule III
CIII or C-III.
Schedule IV
CIV or C-IV.
Schedule V
CV or C-V.
The word "Schedule" need not be used. No distinction need be made between narcotic and nonnarcotic substances.
(d) The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily
legible through such carton or wrapper.
(e) The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if
the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an
ultimate user.
(f) The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance
being utilized in clinical research involving blind and double blind studies.
Note that the symbol requirement makes it easy to know into what Schedule a controlled substance has been classified. One
need only look at the label of the stock bottle to learn this information. In practice there is no need to memorize lists of drugs
and their Schedule. However, standardized exams usually require those taking the exam to know the schedule of all drugs.
Those who are preparing to take a standardized exam should study the schedule of controlled substances at the DEA website.
A complete list of all controlled substances and their schedule is beyond the scope of this text.
B.
Location and Size of Symbol
DEA regulations not only specify what the symbol must be, they state where the symbol must be and how large is must be.
The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.

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1302.04 Location and size of symbol on label and labeling.
The symbol shall be prominently located on the label or the labeling of the commercial container and/or the panel of
the commercial container normally displayed to dispensers of any controlled substance. The symbol on labels shall
be clear and large enough to afford easy identification of the Schedule of the controlled substance upon inspection
without removal from the dispenser's shelf. The symbol on all other labeling shall be clear and large enough to afford prompt identification of the controlled substance upon inspection of the labeling.
VI.

Records
One of the basic principles of controlled substance law is the ability to know at all times where controlled substances
are and how they got there. Extensive recordkeeping requirements are used to meet this goal. As a rule of thumb, every registrant should bear in mind that it is important to be able to provide information to an outside observer regarding what controlled substances are on hand, what controlled substances were received, and what controlled substances were dispersed. If a
registrant is unable to produce an inventory, records of receipt and records of dispersal, then the registrant is simply asking
for trouble. Faced with this reality, the observer will have to conclude that controlled substances are missing and must have
been diverted to nonmedical uses. Because it would be overly burdensome to require that registrants maintain constantly upto-date inventories, records of receipt and records of dispersal, the law does not impose this requirement. Rather, the law requires that registrants have the ability to create these records quickly, based on information readily at hand. Unfortunately, at
times pharmacists become victimized by theft, and there is also the possibility that controlled substances will be lost. In the
event of theft of loss of controlled substances, DEA requires that a report be made to the nearest DEA office and to the local
police. The theft or significant loss must then be reported on DEA form 106. DEA has clarified what a significant loss is
interpreted to be within a section related to security matters. The DEA regulation addressing this follows. Numerations refer
to sections of Title 21, Code of Federal Regulations.
1301.76 Other security controls for practitioners.
(a) The registrant shall not employ, as an agent or employee who has access to controlled substances, any person
who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application
for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for
cause. For purposes of this subsection, the term "for cause" means a surrender in lieu of, or as a consequence of, any
federal or state administrative, civil or criminal action resulting from an investigation of the individual's handling of
controlled substances.
(b) The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or
significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant
shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft.
When determining whether a loss is significant, a registrant should consider, among others, the following factors:
(1) The actual quantity of controlled substances lost in relation to the type of business;
(2) The specific controlled substances lost;
(3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts
taken to resolve the losses; and, if known,
(5) Whether the specific controlled substances are likely candidates for diversion;
(6) Local trends and other indicators of the diversion potential of the missing controlled substance.
(c) Whenever the registrant distributes a controlled substance (without being registered as a distributor, as permitted
in Sec. 1301.13(e)(1) and/or Secs. 1307.11-1307.12) he/she shall comply with the requirements imposed on nonpractitioners in Sec. 1301.74 (a), (b), and (e).
(d) Central fill pharmacies must comply with 1301.74(e) when selecting private, common or contract carriers to
transport filled prescriptions to a retail pharmacy for delivery to the ultimate user. When central fill pharmacies contract with private, common or contract carriers to transport filled prescriptions to a retail pharmacy, the central fill
pharmacy is responsible for reporting in-transit losses upon discovery of such loss by use of a DEA Form 106. Retail
pharmacies must comply with 1301.74(e) when selecting private, common or contract carriers to retrieve filled

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prescriptions from a central fill pharmacy. When retail pharmacies contract with private, common or contract carriers to retrieve filled prescriptions from a central fill pharmacy, the retail pharmacy is responsible for reporting intransit losses upon discovery of such loss by use of a DEA Form 106.
A.
General Recordkeeping Rules
Under DEA rules, dispensers of controlled substances are required to maintain records of them, but prescribers are not required to keep records if they simply prescribe or administer drugs in the course of their practice, and do not dispense them.
The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
1304.03 Persons required to keep records and file reports.
(a) Each registrant shall maintain the records and inventories and shall file the reports required by this part, except
as exempted by this section...
(b) A registered individual practitioner is required to keep records, as described in Sec. 1304.04, of controlled substances in Schedules II, III, IV, and V which are dispensed, other than by prescribing or administering in the lawful
course of professional practice.
(c) Except as provided in Sec. 1304.06, a registered individual practitioner is not required to keep records of controlled substances in Schedules II, III, IV, and V that are prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxification treatment of an individual.
(d) A registered individual practitioner is not required to keep records of controlled substances listed in Schedules II,
III, IV and V which are administered in the lawful course of professional practice unless the practitioner regularly
engages in the dispensing or administering of controlled substances and charges patients, either separately or together with charges for other professional services, for substances so dispensed or administered. Records are required to be kept for controlled substances administered in the course of maintenance or detoxification treatment of
an individual.
(e) Each registered mid-level practitioner shall maintain in a readily retrievable manner those documents required
by the state in which he/she practices which describe the conditions and extent of his/her authorization to dispense
controlled substances and shall make such documents available for inspection and copying by authorized employees
of the Administration. Examples of such documentation include protocols, practice guidelines or practice agreements.
Under DEA rules, it is permissible to maintain records centrally, offsite. However, specific conditions must be met if this
option is chosen. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
1304.04 Maintenance of records and inventories.
(a) Except as provided in paragraphs (a)(1) and (a)(2) of this section, every inventory and other records required to
be kept under this part must be kept by the registrant and be available, for at least 2 years from the date of such inventory or records, for inspection and copying by authorized employees of the Administration.
(1)Financial and shipping records (such as invoices and packing slips but not executed order forms subject to
1305.17 and 1305.27 of this chapter) may be kept at a central location, rather than at the registered location,
if the registrant has notified the Administration of his intention to keep central records. Written notification must
be submitted by registered or certified mail, return receipt requested, in triplicate, to the Special Agent in Charge
of the Administration in the area in which the registrant is located. Unless the registrant is informed by the Special Agent in Charge that permission to keep central records is denied, the registrant may maintain central records commencing 14 days after receipt of his notification by the Special Agent in Charge. All notifications must
include the following:
i) The nature of the records to be kept centrally.
(ii) The exact location where the records will be kept.
(iii) The name, address, DEA registration number and type of DEA registration of the registrant whose records
are being maintained centrally.

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(iv) Whether central records will be maintained in a manual, or computer readable, form.
(2)A registered retail pharmacy that possesses additional registrations for automated dispensing systems at long
term care facilities may keep all records required by this part for those additional registered sites at the retail
pharmacy or other approved central location.
(b) All registrants that are authorized to maintain a central recordkeeping system under paragraph (a) of this section
shall be subject to the following conditions:
(1) The records to be maintained at the central record location shall not include executed order forms and inventories, which shall be maintained at each registered location.
(2) If the records are kept on microfilm, computer media or in any form requiring special equipment to render
the records easily readable, the registrant shall provide access to such equipment with the records. If any code
system is used (other than pricing information), a key to the code shall be provided to make the records understandable.
(3) The registrant agrees to deliver all or any part of such records to the registered location within two business
days upon receipt of a written request from the Administration for such records, and if the Administration chooses to do so in lieu of requiring delivery of such records to the registered location, to allow authorized employees
of the Administration to inspect such records at the central location upon request by such employees without a
warrant of any kind.
(4) In the event that a registrant fails to comply with these conditions, the Special Agent in Charge may cancel
such central recordkeeping authorization, and all other central recordkeeping authorizations held by the registrant without a hearing or other procedures. In the event of a cancellation of central recordkeeping authorizations under this paragraph the registrant shall, within the time specified by the Special Agent in Charge, comply
with the requirements of this section that all records be kept at the registered location.
(c) Registrants need not notify the Special Agent in Charge or obtain central recordkeeping approval in order to
maintain records on an in-house computer system.
(d) ARCOS participants who desire authorization to report from other than their registered locations must obtain a
separate central reporting identifier. Request for central reporting identifiers will be submitted to the ARCOS Unit.
See the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current mailing address.
(e) All central recordkeeping permits previously issued by the Administration expired September 30, 1980.
(f) Each registered manufacturer, distributor, importer, exporter, narcotic treatment program and compounder for
narcotic treatment program shall maintain inventories and records of controlled substances as follows:
(1) Inventories and records of controlled substances listed in Schedules I and II shall be maintained separately
from all of the records of the registrant; and
(2) Inventories and records of controlled substances listed in Schedules III, IV, and V shall be maintained either
separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.
(g) Each registered individual practitioner required to keep records and institutional practitioner shall maintain inventories and records of controlled substances in the manner prescribed in paragraph (f) of this section.
DEA requires that records of controlled substances be maintained so as to be distinct from records of drugs that are not controlled substances, and that Schedule I and II controlled substance records be maintained separately.
(h) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:
(1) Inventories and records of all controlled substances listed in Schedule I and II shall be maintained separately
from all other records of the pharmacy.

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(2) Paper prescriptions for Schedule II controlled substances shall be maintained at the registered location in a
separate prescription file.
(3) Inventories and records of Schedules III, IV, and V controlled substances shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable
from ordinary business records of the pharmacy.
(4) Paper prescriptions for Schedules III, IV, and V controlled substances shall be maintained at the registered
location either in a separate prescription file for Schedules III, IV, and V controlled substances only or in such
form that they are readily retrievable from the other prescription records of the pharmacy. Prescriptions will be
deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink
in the lower right corner with the letter "C" no less than 1 inch high and filed either in the prescription file for
controlled substances listed in Schedules I and II or in the usual consecutively numbered prescription file for
noncontrolled substances. However, if a pharmacy employs a computer application for prescriptions that permits
identification by prescription number and retrieval of original documents by prescriber name, patient's name,
drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is
waived.
(5) Records of electronic prescriptions for controlled substances shall be maintained in an application that meets
the requirements of part 1311 of this chapter. The computers on which the records are maintained may be located at another location, but the records must be readily retrievable at the registered location if requested by the
Administration or other law enforcement agent. The electronic application must be capable of printing out or
transferring the records in a format that is readily understandable to an Administration or other law enforcement
agent at the registered location. Electronic copies of prescription records must be sortable by prescriber name,
patient name, drug dispensed, and date filled.
Note that the requirement of a red C in the bottom right corner of a prescription for a controlled substance in Schedules III,
IV and V is waived if the pharmacy uses a computerized recordkeeping system and it is possible to generate a list of those
drugs from a computer file. In addition, note that executed order forms, inventories, and prescriptions cannot be kept at a
central location.
B.
Inventories
To form the basis of a determination of what controlled substances should be on hand at a registrants location, there must be
an inventory performed at a specific time. It is then possible to add to the inventory those controlled substances reflected in
records of receipt and deduct from the inventory those controlled substances reflected in records of dispersal. The result
should be an accurate reflection of what is on hand. If fewer controlled substances are on hand than the result of this calculation would indicate should be, then the conclusion may be reached that controlled substances have been diverted. It all starts
with the inventory. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
1304.11 Inventory requirements.
(a) General requirements. Each inventory shall contain a complete and accurate record of all controlled substances
on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location. An inventory taken by use of an oral recording device must be promptly transcribed. Controlled substances shall be deemed to be "on hand" if they are in the possession of or under the control of the registrant,
including substances returned by a customer, ordered by a customer but not yet invoiced, stored in a warehouse on
behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution
as complimentary samples. A separate inventory shall be made for each registered location and each independent
activity registered, except as provided in paragraph (e)(4) of this section. In the event controlled substances in the
possession or under the control of the registrant are stored at a location for which he/she is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which
the person possessing the substance is responsible. The inventory may be taken either as of opening of business or as
of the close of business on the inventory date and it shall be indicated on the inventory.

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(b) Initial inventory date. Every person required to keep records shall take an inventory of all stocks of controlled
substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with paragraph (e) of this section as applicable. In the event a person commences business
with no controlled substances on hand, he/she shall record this fact as the initial inventory.
(c) Biennial inventory date. After the initial inventory is taken, the registrant shall take a new inventory of all stocks
of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is
within two years of the previous biennial inventory date.
(d) Inventory date for newly controlled substances. On the effective date of a rule by the Administrator pursuant to
1308.45, 1308.46, or 1308.47 of this chapter adding a substance to any Schedule of controlled substances, which
substance was, immediately prior to that date, not listed on any such Schedule, every registrant required to keep records who possesses that substance shall take an inventory of all stocks of the substance on hand. Thereafter, such
substance shall be included in each inventory made by the registrant pursuant to paragraph (c) of this section.
(e) Inventories of manufacturers, distributors, dispensers, researchers, importers, exporters and chemical analysts.
Each person registered or authorized (by 1301.13 or 1307.11-1307.13 of this chapter) to manufacture, distribute, dispense, import, export, conduct research or chemical analysis with controlled substances and required to keep
records pursuant to 1304.03 shall include in the inventory the information listed below.
(1) Inventories of manufacturers. Each person registered or authorized to manufacture controlled substances shall
include the following information in the inventory:
(iii) For each controlled substance in finished form the inventory shall include:
(A) The name of the substance;
(B) Each finished form of the substance (e.g., 10 milligram tablet or 10 milligram concentration per fluid ounce or
milliliter);
(C) The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3
milliliter vial); and
(D) The number of commercial containers of each such finished form (e.g. four 100 tablet bottles or six 3 milliliter
vials).
(iv) For each controlled substance not included in paragraphs (e)(1) (i), (ii) or (iii) of this section (e.g., damaged,
defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compoundings) the inventories shall include:
(A) The name of the substance;
(B) The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form;
and
(C) The reason for the substance being maintained by the registrant and whether such substance is capable of use in
the manufacture of any controlled substance in finished form.
(3) Inventories of dispensers and researchers. Each person registered or authorized to dispense or conduct research
with controlled substances shall include in the inventory the same information required of manufacturers pursuant to
paragraphs (e)(1) (iii) and (iv) of this section. In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows:
(i) If the substance is listed in Schedule I or II, make an exact count or measure of the contents, or
(ii) If the substance is listed in Schedule III, IV or V, make an estimated count or measure of the contents, unless the
container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents.
Note that the requirements for dispensers incorporate by reference two sections of the requirements for manufacturers. These
two sections, and only these, are included above.
C.
Records of Receipt and Dispersal
A record must be made of any controlled substances received or dispersed. The DEA regulation follows. Numerations refer
to sections of Title 21, Code of Federal Regulations.
1304.22 Records for manufacturers, distributors, dispensers, researchers, importers and exporters.

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Each person registered or authorized ... to manufacture, distribute, dispense, import, export or conduct research with
controlled substances shall maintain records with the information listed below.
(a) Records for manufacturers. Each person registered or authorized to manufacture controlled substances shall
maintain records with the following information:
(2) For each controlled substance in finished form,
(i) The name of the substance;
(ii) Each finished form (e.g., 10 milligram tablet or 10 milligram concentration per fluid ounce or milliliter) and the
number of units or volume of finished form in each commercial container (e.g., 100 tablet bottle or 3 milliliter vial);
(iv) The number of units of finished forms and/or commercial containers acquired from other persons, including the
date of and number of units and/or commercial containers in each acquisition to inventory and the name, address,
and registration number of the person from whom the units were acquired;
(vii) The number of commercial containers distributed to other persons, including the date of and number of containers in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed;
(ix) The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and
the quantity in finished form distributed or disposed.
(c) Records for dispensers and researchers. Each person registered or authorized to dispense or conduct research
with controlled substances shall maintain records with the same information required of manufacturers pursuant to
paragraph (a)(2) (i), (ii), (iv), (vii), and (ix) of this section. In addition, records shall be maintained of the number of
units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser.
Note that the requirements for dispensers incorporate by reference sections of the requirements for manufacturers. These sections, and only these, are included above.
D.
Special Order Forms
To order controlled substances in Schedules III through V, no special order form is required. However, to order controlled
substances in Schedules I or II, a special order form (DEA Form 222) must be used. Specific procedures surrounding the use
of the DEA Form 222 are located in DEA regulations, a number of which follow below. Numerations refer to sections of Title 21, Code of Federal Regulations.
Section 1305.05 Power of attorney.
(a) A registrant may authorize one or more individuals, whether or not located at his or her registered location, to
issue orders for Schedule I and II controlled substances on the registrant's behalf by executing a power of attorney
for each such individual, if the power of attorney is retained in the files, with executed Forms 222 where applicable,
for the same period as any order bearing the signature of the attorney. The power of attorney must be available for
inspection together with other order records.
Section 1305.11 Procedure for obtaining DEA Forms 222.
(a) DEA Forms 222 are issued in mailing envelopes containing either seven or fourteen forms, each form containing
an original, duplicate, and triplicate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit, which is based on the
business activity of the registrant, will be imposed on the number of DEA Forms 222, which will be furnished on any
requisition unless additional forms are specifically requested and a reasonable need for such additional forms is
shown.
(b) Any person applying for a registration that would entitle him or her to obtain a DEA Form 222 may requisition
the forms by so indicating on the application form; a DEA Form 222 will be supplied upon the registration of the ap-

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plicant. Any person holding a registration entitling him or her to obtain a DEA Form 222 may requisition the forms
for the first time by contacting any Division Office or the Registration Section of the Administration. Any person already holding a DEA Form 222 may requisition additional forms on DEA Form 222a, which is mailed to a registrant
approximately 30 days after each shipment of DEA Forms 222 to that registrant, or by contacting any Division Office or the Registration Section of the Administration. All requisition forms (DEA Form 222a) must be submitted to
the DEA Registration Section.
(c) Each requisition must show the name, address, and registration number of the registrant and the number of books
of DEA Forms 222 desired. Each requisition must be signed and dated by the same person who signed the most recent application for registration or for reregistration, or by any person authorized to obtain and execute DEA Forms
222 by a power of attorney under 1305.05.
(d) DEA Forms 222 will be serially numbered and issued with the name, address, and registration number of the registrant, the authorized activity, and schedules of the registrant. This information cannot be altered or changed by the
registrant; any errors must be corrected by the Registration Section of the Administration by returning the forms with
notification of the error.
Section 1305.12 Procedure for executing DEA Forms 222.
(a) A purchaser must prepare and execute a DEA Form 222 simultaneously in triplicate by means of interleaved carbon sheets that are part of the DEA Form 222. DEA Form 222 must be prepared by use of a typewriter, pen, or indelible pencil.
(b) Only one item may be entered on each numbered line. An item must consist of one or more commercial or bulk
containers of the same finished or bulk form and quantity of the same substance. The number of lines completed must
be noted on that form at the bottom of the form, in the space provided. DEA Forms 222 for carfentanil, etorphine hydrochloride, and diprenorphine must contain only these substances.
(c) The name and address of the supplier from whom the controlled substances are being ordered must be entered on
the form. Only one supplier may be listed on any form.
(d) Each DEA Form 222 must be signed and dated by a person authorized to sign an application for registration or a
person granted power of attorney to sign a Form 222 under 1305.05. The name of the purchaser, if different from
the individual signing the DEA Form 222, must also be inserted in the signature space.
(e) Unexecuted DEA Forms 222 may be kept and may be executed at a location other than the registered location
printed on the form, provided that all unexecuted forms are delivered promptly to the registered location upon an
inspection of the location by any officer authorized to make inspections, or to enforce, any Federal, State, or local
law regarding controlled substances.
When executing a DEA Form 222, the purchaser (such as a pharmacy) must follow the above procedures exactly, or the Form
will be returned by the supplier.
Section 1305.13 Procedure for filling DEA Forms 222.
(a) A purchaser must submit Copy 1 and Copy 2 of the DEA Form 222 to the supplier and retain Copy 3 in the purchaser's files.
(b) A supplier may fill the order, if possible and if the supplier desires to do so, and must record on Copies 1 and 2
the number of commercial or bulk containers furnished on each item and the date on which the containers are
shipped to the purchaser. If an order cannot be filled in its entirety, it may be filled in part and the balance supplied
by additional shipments within 60 days following the date of the DEA Form 222. No DEA Form 222 is valid more
than 60 days after its execution by the purchaser, except as specified in paragraph (f) of this section.
(c) The controlled substances must be shipped only to the purchaser and the location printed by the Administration
on the DEA Form 222, except as specified in paragraph (f) of this section.
(d) The supplier must retain Copy 1 of the DEA Form 222 for his or her files and forward Copy 2 to the Special
Agent in Charge of the Drug Enforcement Administration in the area in which the supplier is located. Copy 2 must be
forwarded at the close of the month during which the order is filled. If an order is filled by partial shipments, Copy 2

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must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period
expires.
(e) The purchaser must record on Copy 3 of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser.
(f) DEA Forms 222 submitted by registered procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed services establishments within the United States may be shipped to locations other
than the location printed on the DEA Form 222, and in partial shipments at different times not to exceed six months
from the date of the order, as designated by the procurement officer when submitting the order.
Note that the submission of DEA form 222 is not the only requirement for ordering controlled substances in Schedules I and
II. In addition, when these controlled substances are received, they must be logged in on DEA form 222. The failure to log
in Schedule II controlled substance on DEA form 222 upon their receipt has caused problems for pharmacists with the DEA.
Section 1305.06 Persons entitled to fill orders for Schedule I and II controlled substances.
(c) A person registered to dispense Schedule II substances may distribute the substances to another dispenser with
either a DEA Form 222 or an electronic order only in the circumstances described in 1307.11 of this chapter.
Note that in transferring Schedule II controlled substances from one registrant to another, it is necessary to use DEA form
222. For example, if one pharmacy is temporarily out of a Schedule II controlled substance, and another pharmacy agrees to
transfer to that pharmacy one bottle of 100 tablets to help out in a pinch, the receiving pharmacy must send its DEA form
222 to the dispersing pharmacy. When the time comes to return the favor, the same process is followed. The restriction referred to above is that of the 5 percent rule described earlier.
Another important note is that the DEA permits, but does not require, Schedule I and Schedule II drugs to be ordered from a
supplier electronically. Do not confuse the concept of ordering Schedule I and II drugs from a supplier with the concept of a
prescriber ordering drugs for dispensing to patients electronically, which is discussed later. The Controlled Substance Ordering System (CSOSPronounced like sea sauce) allows ordering Schedule I and II drugs electronically from the supplier as
long as specific criteria have been met. For these criteria, refer to 21 CFR 1305.21.
VII.

Prescriptions
Pharmacists fulfill many significant roles in health care, and there are enormous possibilities for expanded practice in
the future. However, the traditional role of the pharmacist has been in processing prescription orders. In the near future, it is
likely that robotics will replace this role and that pharmacists will find themselves primarily doing very important systems
organization activities related to order processing. Under both the traditional and expanded roles, pharmacists find themselves responsible for the integrity of the dispensing they do, and they must assure adherence to DEA regulations regarding
prescriptions.
A.
Persons Entitled to Issue Prescriptions
The DEA regulations specify who may issue a prescription. The DEA regulation follows. Numerations refer to sections of
Title 21, Code of Federal Regulations.
1306.03 Persons entitled to issue prescriptions.
(a) A prescription for a controlled substance may be issued only by an individual practitioner who is:
(1) authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession
and
(2) either registered or exempted from registration pursuant to 1301.22(c) and 1301.23 of this chapter.
(b) A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or
agent of the individual practitioner.

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Note that it is state law that determines who may issue a prescription. However, one need not be authorized by law to issue a
prescription in order to merely transmit the prescription to a pharmacy. An authorized prescribers agent may communicate
with the pharmacy and inform the pharmacy of the prescribers prescription. Of course, the pharmacy has a responsibility to
assure that the agent is really functioning on behalf of the prescriber.
B.
Purpose of Issuance of a Prescription
One of the most challenging regulations with which pharmacists must comply is the so-called corresponding responsibility
rule that requires of pharmacists a careful review of each controlled substance prescription to assure its validity. The DEA
regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
1306.04 Purpose of issue of prescription.
(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the
usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law
relating to controlled substances.
(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.
(c) A prescription may not be issued for "detoxification treatment" or "maintenance treatment," unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use
in maintenance or detoxification treatment and the practitioner is in compliance with requirements in 1301.28 of
this chapter.
Note that the most significant word in this section is knowingly. A pharmacist who knowingly fills a purported prescription has violated the law. In this sense, knowingly refers both to what a pharmacist actually knows and to what a pharmacist ought to know, given the relevant circumstances. The distinction a pharmacist is required to make is between medicine
and non-medicine, not between good medicine and bad medicine. Simply because a prescription for a controlled substance
may be a bit out of the ordinary does not trigger the responsibility to refuse filling. A pharmacists duty to refuse filling under this rule arises when the pharmacist knows the prescribed drug will be diverted to a non-medical use. A pharmacist may
fill a prescription for detoxification or maintenance only if the requirements for such a program have been met, as specified in
DEA regulations, and described later.
C.
Manner of Issuance of Prescriptions
It is not only important that the purpose of a prescription be valid, the prescription must also meet specific format requirements. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
Section 1306.05 Manner of issuance of prescriptions.
(a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall
bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions
for use, and the name, address and registration number of the practitioner.
(b) A prescription for a Schedule III, IV, or V narcotic drug approved by FDA specifically for "detoxification treatment" or "maintenance treatment" must include the identification number issued by the Administrator under Sec.
1301.28(d) of this chapter or a written notice stating that the practitioner is acting under the good faith exception of
Sec. 1301.28(e) of this chapter.
(c) Where a prescription is for gamma-hydroxybutyric acid, the practitioner shall note on the face of the prescription
the medical need of the patient for the prescription.

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(d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document
(e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, paper prescriptions shall be written with
ink or indelible pencil, typewriter, or printed on a computer printer and shall be manually signed by the practitioner.
A computer-generated prescription that is printed out or faxed by the practitioner must be manually signed.
(e) Electronic prescriptions shall be created and signed using an application that meets the requirements of part
1311 of this chapter.
(f) A prescription may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing
practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations.
(g) An individual practitioner exempted from registration under Sec. 1301.22(c) of this chapter shall include on all
prescriptions issued by him the registration number of the hospital or other institution and the special internal code
number assigned to him by the hospital or other institution as provided in Sec. 1301.22(c) of this chapter, in lieu of
the registration number of the practitioner required by this section. Each paper prescription shall have the name of
the practitioner stamped, typed, or handprinted on it, as well as the signature of the practitioner.
(h) An official exempted from registration under Sec. 1301.23(a) of this chapter must include on all prescriptions issued by him his branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and his service identification number, in lieu of the registration number of the practitioner required by this section. The service identification
number for a Public Health Service employee is his Social Security identification number. Each paper prescription
shall have the name of the officer stamped, typed, or handprinted on it, as well as the signature of the officer.
Note that the section above does not specify when the prescription must come to bear all of the listed information. Therefore,
it is generally considered acceptable for a pharmacist to fill in missing but required information, if the pharmacist is able to
do so. Obviously, the prescribers signature is not possible for a pharmacist to provide. However, if the pharmacist knows
the prescribers DEA number, for example, and it has not been provided by the prescriber, the pharmacist may place that information on the prescription, along with any other missing and required information, prior to filling the prescription. Note
also the requirements for community based prescribing of drugs approved for detoxification and maintenance.
Also note that interns and some other physicians, who are licensed to prescribe by the state in which they practice, may not
have their own individual DEA number. If this is the case, then they may use the DEA number of the hospital, along with a
special code they have been assigned by the hospital. These prescriptions are completely legitimate.
D.
Persons Entitled to Fill Prescriptions
To fill a prescription for a controlled substance, a pharmacist must either be registered with the DEA, or employed by a registered pharmacy. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
1306.06 Persons entitled to fill prescriptions.
A prescription for controlled substances may only be filled by a pharmacist acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy or registered institutional
practitioner.
Note once again that pharmacists need not be individually registered with the DEA as long as they are practicing in a pharmacy that is registered with the DEA.
E.
Automated Dispensing Units in Nursing Homes
It is permitted by the DEA for a pharmacist to fill an order through the use of automated dispensing unit in a nursing home.
The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
1301.27 Separate registration by retail pharmacies for installation and operation of automated dispensing systems
at long term care facilities.
(a) A retail pharmacy may install and operate automated dispensing systems, as defined in 1300.01 of this chapter,
at long term care facilities, under the requirements of 1301.17. No person other than a registered retail pharmacy

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may install and operate an automated dispensing system at a long term care facility.
(b) Retail pharmacies installing and operating automated dispensing systems at long term care facilities must maintain a separate registration at the location of each long term care facility at which automated dispensing systems are
located. If more than one registered retail pharmacy operates automated dispensing systems at the same long term
care facility, each retail pharmacy must maintain a registration at the long term care facility.
(c) A registered retail pharmacy applying for a separate registration to operate an automated dispensing system for
the dispensing of controlled substances at a long term care facility is exempt from application fees for any such additional registrations.
VIII.

Rules for Schedule II Controlled Substances

Because they are the most highly regulated of the controlled substances that are available in most pharmacies, Schedule II controlled substances are subject to very tight security. The requirements applicable to them must be followed very
carefully. Most problems pharmacists have with legal authorities, related to controlled substances, are due to the failure to
follow rules for Schedule II controlled substances.
A.
Requirement of a Written Prescription
Most prescriptions may be authorized either in writing or verbally. Such is not the case with Schedule II prescriptions, which
must be in writing. Keep in mind that in 2010 the DEA authorized electronic prescriptions of controlled substances, including Schedule II. The DEA regulation for a Schedule II prescription follows. Numerations refer to sections of Title 21, Code
of Federal Regulations.
Section 1306.11 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance listed in Schedule II that is a prescription drug as determined under section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. A paper prescription
for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original manually signed prescription is presented to the pharmacist for
review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this
section. The original prescription shall be maintained in accordance with 1304.04(h) of this chapter.
(b) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule II in the
course of his professional practice without a prescription, subject to 1306.07.
(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed
in Schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order
for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user.
(d) In the case of an emergency situation, as defined by the Secretary in 290.10 of this title, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that:
(1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a paper or electronic prescription
signed by the prescribing individual practitioner);
(2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information
required in 1306.05, except for the signature of the prescribing individual practitioner;
(3) If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to
determine that the oral authorization came from a registered individual practitioner, which may include a call-

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back to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or
other good faith efforts to insure his identity; and
(4) Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall
cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist.
In addition to conforming to the requirements of 1306.05, the prescription shall have written on its face
Authorization for Emergency Dispensing, and the date of the oral order. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7-day period. Upon receipt, the dispensing pharmacist must attach this paper prescription to the oral emergency
prescription that had earlier been reduced to writing. For electronic prescriptions, the pharmacist must annotate
the record of the electronic prescription with the original authorization and date of the oral order. The pharmacist must notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a
written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.
(5) Central fill pharmacies shall not be authorized under this paragraph to prepare prescriptions for a controlled
substance listed in Schedule II upon receiving an oral authorization from a retail pharmacist or an individual
practitioner.
(e) A prescription prepared in accordance with 1306.05 written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or
intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (e) and it shall be
maintained in accordance with 1304.04(h) of this chapter.
(f) A prescription prepared in accordance with 1306.05 written for Schedule II substance for a resident of a Long
Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by
facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (f) and it shall be
maintained in accordance with 1304.04(h).
(g) A prescription prepared in accordance with 1306.05 written for a Schedule II narcotic substance for a patient
enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program
which is licensed by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing
pharmacy by facsimile. The practitioner or the practitioner's agent will note on the prescription that the patient is a
hospice patient. The facsimile serves as the original written prescription for purposes of this paragraph (g) and it
shall be maintained in accordance with 1304.04(h).
Note that in general a facsimile will not serve as an original prescription. There are important exceptions to when a facsimile
may serve as the original of a Schedule II prescription, and may be filled by a pharmacist, under the three situations described
above. Of course, state law must also permit such a prescription to be filled. Also note that in an emergency situation, when
specific requirements are met, a pharmacist may dispense a Schedule II drug upon oral authorization.
B.
No Refills Permitted
The message here is brief. No Schedule II prescription may be refilled. Never! End of story!! However, the DEA does permit the issuance of multiple prescriptions on the same day, all dated on the date of issuance, with instructions to the pharmacist to dispense the medications at a future time. The DEA regulation follows. Numerations refer to sections of Title 21,
Code of Federal Regulations.

1306.12Refilling Prescriptions; Issuance of Multiple Prescriptions

(a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.

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(b)(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a
90-day supply of a Schedule II controlled substance provided the following conditions are met:
(i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the
usual course of professional practice;
(ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if
the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on
which a pharmacy may fill each prescription;
(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does
not create an undue risk of diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws;
and
(v) The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.
(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue
multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often
to see their patients when doing so.
C.
Partial Filling
Although refilling of a Schedule II prescription is forbidden, partial filling is permitted subject to specific conditions. Refilling and partial filling are different. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal
Regulations.
Section 1306.13 Partial filling of prescriptions.
(a) The partial filling of a prescription for a controlled substance listed in Schedule II is permissible if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription, written record of the emergency oral
prescription, or in the electronic prescription record. The remaining portion of the prescription may be filled within
72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall notify the prescribing individual practitioner. No further quantity may be supplied beyond
72 hours without a new prescription.
(b) A prescription for a Schedule II controlled substance written for a patient in a Long Term Care Facility (LTCF)
or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include
individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the
pharmacist must contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally
ill patient. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall
be deemed to have been filled in violation of the Act. For each partial filling, the dispensing pharmacist shall record
on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the
date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of
the dispensing pharmacist. The total quantity of Schedule II controlled substances dispensed in all partial fillings
must not exceed the total quantity prescribed. Schedule II prescriptions for patients in a LTCF or patients with a
medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue
date unless sooner terminated by the discontinuance of medication.
(c) Information pertaining to current Schedule II prescriptions for patients in a LTCF or for patients with a medical
diagnosis documenting a terminal illness may be maintained in a computerized system if this system has the capability to permit:

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(1) Output (display or printout) of the original prescription number, date of issue, identification of prescribing
individual practitioner, identification of patient, address of the LTCF or address of the hospital or residence of
the patient, identification of medication authorized (to include dosage, form, strength and quantity), listing of the
partial fillings that have been dispensed under each prescription and the information required in Sec.
1306.13(b).
(2) Immediate (real time) updating of the prescription record each time a partial filling of the prescription is
conducted.
(3) Retrieval of partially filled Schedule II prescription information is the same as required by Sec. 1306.22(b)(4)
and (5) for Schedule III and IV prescription refill information.
Note that partial filling of a Schedule II prescription, beyond the 72 hour limit for most prescriptions, is extended to 60 days
for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness.
D.
Labeling and Filing Prescriptions
Special rules for labeling and filing of Schedule II prescriptions have been promulgated. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
1306.14 Labeling of substances and filing of prescriptions.
(a) The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II
shall affix to the package a label showing date of filling, the pharmacy name and address, the serial number of the
prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary
statements, if any, contained in such prescription or required by law.
(b) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule II
is prescribed for administration to an ultimate user who is institutionalized: Provided, That:
(1) Not more than 7-day supply of the controlled substance listed in Schedule II is dispensed at one time;
(2) The controlled substance listed in Schedule II is not in the possession of the ultimate user prior to the administration;
(3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II; and
(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product,
and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription
or required by law.
(c) All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with
requirements of 1304.04(h) of this chapter.
(d) All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with
requirements of Sec. 1304.04(h) of this chapter.
(e) Where a prescription that has been prepared in accordance with section 1306.12(b) contains instructions from
the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may
fill the prescription before that date.
Note that this rule gives a huge break to hospitals when dispensing small quantities of Schedule II controlled substances to
inpatients. Otherwise, these small quantities would have to bear labels that would hardly fit on their small packages.
E.
Changing a C-II Prescription
The matter of whether a pharmacist could change information on a C-II prescription has been very confusing. Until a few
years ago, the DEA provided the following guidance as to what information could be changed on a C-II prescription:
The majority of changes can be made only after the pharmacist contacts the prescribing practitioner. After consultation with the prescribing practitioner, the pharmacist is permitted to change the patients address, drug strength,
drug quantity, and directions for use. The pharmacist is permitted to make information additions that may be provid-

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ed by the patient or bearer such as the patients address, and such additions should be verified. The pharmacist may
also add the dosage form to the prescription order after verification with the prescribing practitioner.
The pharmacist is never permitted to make changes to the patients name, controlled substances prescribed (except
for generic substitution permitted by State Law), or the prescribers signature. These types of changes challenge the
necessity of the original prescription and would require a new prescription from the prescribing practitioner. In
those cases where a prescriber either omits the strength, quantity, or directions, or where the pharmacist doing prospective drug utilization review discovers an error in any of these required elements, this policy allows the problem
to be dealt with by a telephone call rather than a trip back to the prescribers office. The pharmacist should always
document the time and date that the prescriber was contacted about the correction, and should always ask the prescriber to document the change in the patients chart so that both the prescriber and the pharmacist have a record of
the conversation. Please contact the local DEA office or the State Board of Pharmacy if you have any questions
about this policy.
However, this guidance was then later changed to the following statement:
On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple
Prescriptions for Schedule II Controlled Substances (72 FR 64921). In the preamble to that Rule, DEA stated that
"the essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed)may not be modified orally."
The instructions contained in the Rule's preamble are in opposition to DEA's previous policy which permitted the
same changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral consultation
with the prescriber. DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter
through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.
Then, due to this confusion, in August, 2011, the DEA provided additional written information for pharmacists on this matter.
The DEA recognized that pharmacists are sometimes presented with prescriptions for for Schedule II controlled substances
that are missing information required by law. The DEA reminded pharmacists of their corresponding responsibility to ensure
that controlled substance prescriptions are in compliance with federal law and regulations, and specifically that they must be
dated as of and signed on the day when issued and must include the full name and address of the patient, the drug name,
strength, dosage form, quantity prescribed, directions for use, and the name, address, and registration number of the practitioner. The DEA then advised that whether a pharmacist could make changes to a CII prescription, such as adding a
practitioners DEA number, or correcting the patients name or address, varies case by case based on the facts present. The
DEA provided that it expects that when information is missing from or needs to be changed on a schedule II controlled substance prescription, pharmacists use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.

IX.

Rules for Schedule III, IV and V Controlled Substances

Although less highly regulated than Schedule II controlled substances, drugs classified in Schedules III through V
nevertheless are subject to far more strict control than are drugs that do not fall into the category of controlled substances.
A.
Requirement of a Prescription
Controlled substances in Schedules III through V may be dispensed pursuant to a verbal prescription. The DEA regulation
follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
Section 1306.21 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V that is a prescription
drug as determined under section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) only pursuant to either a paper prescription signed by a practitioner, a facsimile of a signed paper prescription transmitted

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by the practitioner or the practitioner's agent to the pharmacy, an electronic prescription that meets the requirements
of this part and part 1311 of this chapter, or an oral prescription made by an individual practitioner and promptly
reduced to writing by the pharmacist containing all information required in Sec. 1306.05, except for the signature of
the practitioner.
(b) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule III, IV, or
V in the course of his/her professional practice without a prescription, subject to Sec. 1306.07.
(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed
in Schedule III, IV, or V only pursuant to a paper prescription signed by an individual practitioner, a facsimile of a
paper prescription or order for medication transmitted by the practitioner or the practitioner's agent to the institutional practitioner-pharmacist, an electronic prescription that meets the requirements of this part and part 1311 of
this chapter, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in Sec. 1306.05 except for the signature of the individual practitioner), or
pursuant to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user, subject to Sec. 1306.07.
Note the distinction that is made between a prescription and an order for medication which is dispensed for immediate administration to an ultimate user in an institution. The law imposes strict requirements for the former, but not for the latter.
B.
Refills Permitted
Unlike prescriptions for controlled substances in Schedule II, prescriptions for controlled substances in Schedule III and IV
may be refilled, however specific limits apply. The DEA regulation follows. Numerations refer to sections of Title 21, Code
of Federal Regulations.
Section 1306.22 Refilling of prescriptions.
(a) No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six
months after the date on which such prescription was issued. No prescription for a controlled substance listed in
Schedule III or IV authorized to be refilled may be refilled more than five times.
(b) Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document or electronic prescription record. If entered on another document, such as a medication record, or electronic
prescription record, the document or record must be uniformly maintained and readily retrievable.
(c) The following information must be retrievable by the prescription number:
(1) The name and dosage form of the controlled substance.
(2) The date filled or refilled.
(3) The quantity dispensed.
(4) The initials of the dispensing pharmacist for each refill.
(5) The total number of refills for that prescription.
(d) If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription
record, it shall be deemed that the full face amount of the prescription has been dispensed.
(e) The prescribing practitioner may authorize additional refills of Schedule III or IV controlled substances on the
original prescription through an oral refill authorization transmitted to the pharmacist provided the following conditions are met:
(1) The total quantity authorized, including the amount of the original prescription, does not exceed five refills
nor extend beyond six months from the date of issue of the original prescription.

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(2) The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or
annotates the electronic prescription record with the date, quantity of refill, number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received
the authorization from the prescribing practitioner who issued the original prescription.
(3) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial
filling of the original prescription.
(4) The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five-refill, six-month limitation.
(f) As an alternative to the procedures provided by paragraphs (a) through (e) of this section, a computer application
may be used for the storage and retrieval of refill information for original paper prescription orders for controlled
substances in Schedule III and IV, subject to the following conditions:
(1) Any such proposed computerized application must provide online retrieval (via computer monitor or hardcopy printout) of original prescription order information for those prescription orders that are currently authorized for refilling. This shall include, but is not limited to, data such as the original prescription number; date of
issuance of the original prescription order by the practitioner; full name and address of the patient; name, address, and DEA registration number of the practitioner; and the name, strength, dosage form, quantity of the
controlled substance prescribed (and quantity dispensed if different from the quantity prescribed), and the total
number of refills authorized by the prescribing practitioner.
(2) Any such proposed computerized application must also provide online retrieval (via computer monitor or
hard-copy printout) of the current refill history for Schedule III or IV controlled substance prescription orders
(those authorized for refill during the past six months). This refill history shall include, but is not limited to, the
name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or
initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.
(3) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills
an original paper, fax, or oral prescription order for a Schedule III or IV controlled substance is correct must be
provided by the individual pharmacist who makes use of such an application. If such an application provides a
hard-copy printout of each day's controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist must verify that the data indicated are correct and then sign this document in the same manner as he
would sign a check or legal document ( e.g., J.H. Smith, or John H. Smith). This document shall be maintained in
a separate file at that pharmacy for a period of two years from the dispensing date. This printout of the day's
controlled substance prescription order refill data must be provided to each pharmacy using such a computerized application within 72 hours of the date on which the refill was dispensed. It must be verified and signed by
each pharmacist who is involved with such dispensing. In lieu of such a printout, the pharmacy shall maintain a
bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a
statement (in the manner previously described) each day, attesting to the fact that the refill information entered
into the computer that day has been reviewed by him and is correct as shown. Such a book or file must be maintained at the pharmacy employing such an application for a period of two years after the date of dispensing the
appropriately authorized refill.
(4) Any such computerized application shall have the capability of producing a printout of any refill data that the
user pharmacy is responsible for maintaining under the Act and its implementing regulations. For example, this
would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance
(by either brand or generic name or both). Such a printout must include name of the prescribing practitioner,
name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name or
identification code of the dispensing pharmacist, and the number of the original prescription order. In any computerized application employed by a user pharmacy the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours, and if a DEA Special Agent or Diversion Investigator requests

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a copy of such printout from the user pharmacy, it must, if requested to do so by the Agent or Investigator, verify
the printout transmittal capability of its application by documentation ( e.g., postmark).
(5) In the event that a pharmacy which employs such a computerized application experiences system down-time,
the pharmacy must have an auxiliary procedure which will be used for documentation of refills of Schedule III
and IV controlled substance prescription orders. This auxiliary procedure must ensure that refills are authorized
by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the
appropriate data are retained for online data entry as soon as the computer system is available for use again.
(g) When filing refill information for original paper, fax, or oral prescription orders for Schedule III or IV controlled
substances, a pharmacy may use only one of the two applications described in paragraphs (a) through (e) or (f) of
this section.
(h) When filing refill information for electronic prescriptions, a pharmacy must use an application that meets the requirements of part 1311 of this chapter.
Note that computerized information for controlled substances is subject to a daily signoff by a pharmacist who verifies the
authenticity of the information contained in the printout for the day. Care must be taken by this pharmacist to assure that
what is being signed is in fact an accurate accounting of the daily activity.
C.
Partial Filling
The partial filling of prescriptions for controlled substances in Schedules III through V is permitted, subject to conditions far
less restrictive than those applicable to prescriptions for controlled substances in Schedule II. The DEA regulation follows.
Numerations refer to sections of Title 21, Code of Federal Regulations.
1306.23 Partial filling of prescriptions.
The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided
that:
(a) Each partial filling is recorded in the same manner as a refilling,
(b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and
(c) No dispensing occurs after 6 months after the date on which the prescription was issued.
D.
Labeling and Filing
The labeling and filing requirements applicable to prescriptions for controlled substances in Schedules III through V are virtually the same as those applicable to prescriptions for controlled substances in Schedule II. The DEA regulation follows.
Numerations refer to sections of Title 21, Code of Federal Regulations.
1306.24 Labeling of substances and filing of prescriptions.
(a) The pharmacist filling a prescription for a controlled substance listed in Schedule III, IV, or V shall affix to the
package a label showing the pharmacy name and address, the serial number and date of initial filling, the name of
the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statements, if
any, contained in such prescription as required by law.
(b) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule III,
IV, or V is prescribed for administration to an ultimate user who is institutionalized: Provided, That:
(1) Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in Schedule III, IV, or V is dispensed at one time;
(2) The controlled substance listed in Schedule III, IV, or V is not in the possession of the ultimate user prior to administration;
(3) The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and
storage of the controlled substance listed in Schedule III, IV, or V; and

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(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product
and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription
or required by law.
(c) All prescriptions for controlled substances listed in Schedules III, IV, and V shall be kept in accordance with
1304.04(h) of this chapter.
E.
Transfer of Prescriptions
In our mobile society, it is quite possible that a patient will need to have a prescription initially dispensed at a particular location, but require that refills be dispensed at a different location. This may be due to a prescribers office being far away from
the patients home, or it may be due to a vacation or other reason to be out of town. To prevent inconvenience to patients, the
DEA permits the transfer of prescriptions for controlled substances in Schedules III to V from one pharmacy to another. The
DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
Section 1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled
substances for refill purposes.
(a) The transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the
purpose of refill dispensing is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber's authorization.
(b) Transfers are subject to the following requirements:
(1) The transfer must be communicated directly between two licensed pharmacists.
(2) The transferring pharmacist must do the following:
(i) Write the word VOID on the face of the invalidated prescription; for electronic prescriptions, information
that the prescription has been transferred must be added to the prescription record.
(ii) Record on the reverse of the invalidated prescription the name, address, and DEA registration number of the
pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information; for
electronic prescriptions, such information must be added to the prescription record.
(iii) Record the date of the transfer and the name of the pharmacist transferring the information.
(3) For paper prescriptions and prescriptions received orally and reduced to writing by the pharmacist pursuant
to 1306.21(a), the pharmacist receiving the transferred prescription information must write the word transfer
on the face of the transferred prescription and reduce to writing all information required to be on a prescription
pursuant to 1306.05 and include:
(i) Date of issuance of original prescription.
(ii) Original number of refills authorized on original prescription.
(iii) Date of original dispensing.
(iv) Number of valid refills remaining and date(s) and locations of previous refill(s).
(v) Pharmacy's name, address, DEA registration number, and prescription number from which the prescription
information was transferred.
(vi) Name of pharmacist who transferred the prescription.
(vii) Pharmacy's name, address, DEA registration number, and prescription number from which the prescription
was originally filled.
(4) For electronic prescriptions being transferred electronically, the transferring pharmacist must provide the
receiving pharmacist with the following information in addition to the original electronic prescription data:
(i) The date of the original dispensing.

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(ii) The number of refills remaining and the date(s) and locations of previous refills.
(iii) The transferring pharmacy's name, address, DEA registration number, and prescription number for each
dispensing.
(iv) The name of the pharmacist transferring the prescription.
(v) The name, address, DEA registration number, and prescription number from the pharmacy that originally
filled the prescription, if different.
(5) The pharmacist receiving a transferred electronic prescription must create an electronic record for the prescription that includes the receiving pharmacist's name and all of the information transferred with the prescription under paragraph (b)(4) of this section.
(c) The original and transferred prescription(s) must be maintained for a period of two years from the date of last
refill.
(d) Pharmacies electronically accessing the same prescription record must satisfy all information requirements of a
manual mode for prescription transferal.
(e) The procedure allowing the transfer of prescription information for refill purposes is permissible only if allowable under existing State or other applicable law.
X.

Nonprescription Dispensing
The crossover between the CSA and the FDCA was noted above. Due to this crossover, there is the possibility that
some drugs will be classified as controlled substances but not as legend drugs. As a practical matter, this possibility is restricted to those controlled substances in Schedule V, however, the DEA regulations reflect the theoretical possibility that any
available controlled substance may be a non-legend drug. Rules have been developed for non-prescription sales of controlled
substances. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
1306.26 Dispensing without prescription.
A controlled substance listed in Schedules II, III, IV, or V which is not a prescription drug as determined under the
Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at
retail, provided that:
(a) Such dispensing is made only by a pharmacist (as defined in part 1300 of this chapter), and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be
completed by a nonpharmacist);
(b) Not more than 240 cc. (8 ounces) of any such controlled substance containing opium, nor more than 120 cc. (4
ounces) of any other such controlled substance nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage units of any other such controlled substance may be dispensed at retail to
the same purchaser in any given 48-hour period;
(c) The purchaser is at least 18 years of age;
(d) The pharmacist requires every purchaser of a controlled substance under this section not known to him to furnish
suitable identification (including proof of age where appropriate);
(e) A bound record book for dispensing of controlled substances under this section is maintained by the pharmacist,
which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser (the book shall be maintained in accordance with the recordkeeping requirement of 1304.04 of this
chapter); and
(f) A prescription is not required for distribution or dispensing of the substance pursuant to any other Federal, State
or local law.
XI.

Medical Treatment of Narcotic Addiction

The controversy over how to respond to the problem of drug abuse is widespread in American society. On the one
hand, there is an argument to continue strenuous efforts to criminalize narcotic possession and sale, penalizing those who are

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involved with drug abuse. On the other hand, there is an argument that it is the criminalization of drug abuse that is the problem, and not drug abuse itself; and that narcotic use should be legalized rather than continue to lose battles in the war against
drugs. The government has taken one small step to strike a balance between these two views, by permitting the establishment of programs that treat narcotic addiction as a medical problem. But these programs are limited in scope and they must
be approved by both the appropriate state authorities and the FDA. Patients who are addicted to narcotic drugs must be treated within the parameters of the rules for narcotic addiction treatment programs. Sections of the pertinent regulations follow.
Numerations refer to sections of Title 42, Code of Federal Regulations.
8.12 Federal opioid treatment standards.
(a) General. OTPs must provide treatment in accordance with the standards in this section and must comply with
these standards as a condition of certification...
(d) Staff credentials. Each person engaged in the treatment of opioid addiction must have sufficient education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions...
(e) Patient admission criteria. -- (1) Maintenance treatment. An OTP shall maintain current procedures designed to
ensure that patients are admitted to maintenance treatment by qualified personnel who have determined, using accepted medical criteria such as those listed in the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV),
that the person is currently addicted to an opioid drug, and that the person became addicted at least 1 year before
admission for treatment. In addition, a program physician shall ensure that each patient voluntarily chooses maintenance treatment and that all relevant facts concerning the use of the opioid drug are clearly and adequately explained to the patient, and that each patient provides informed written consent to treatment.
(2) Maintenance treatment for persons under age 18. A person under 18 years of age is required to have had two
documented unsuccessful attempts at short-term detoxification or drug-free treatment within a 12-month period to
be eligible for maintenance treatment. No person under 18 years of age may be admitted to maintenance treatment
unless a parent, legal guardian, or responsible adult designated by the relevant State authority consents in writing to
such treatment.
(3) Maintenance treatment admission exceptions. If clinically appropriate, the program physician may waive the requirement of a 1-year history of addiction under paragraph (e)(1) of this section, for patients released from penal
institutions (within 6 months after release), for pregnant patients (program physician must certify pregnancy), and
for previously treated patients (up to 2 years after discharge).
(4) Detoxification treatment. An OTP shall maintain current procedures designed to ensure that patients are admitted to short- or long-term detoxification treatment by qualified personnel, such as a program physician, who determines that such treatment is appropriate for the specific patient by applying established diagnostic criteria. Patients
with two or more unsuccessful detoxification episodes within a 12-month period must be assessed by the OTP physician for other forms of treatment. A program shall not admit a patient for more than two detoxification treatment episodes in one year.
(f) Required services. -- (1) General. OTPs shall provide adequate medical, counseling, vocational, educational, and
other assessment and treatment services...
(g) Recordkeeping and patient confidentiality. (1) OTPs shall establish and maintain a recordkeeping system that is
adequate to document and monitor patient care. This system is required to comply with all Federal and State reporting requirements relevant to opioid drugs approved for use in treatment of opioid addiction. All records are required
to be kept confidential in accordance with all applicable Federal and State requirements... (2) ...A patient enrolled
in an OTP shall not be permitted to obtain treatment in any other OTP except in exceptional circumstances...
(h) Medication administration, dispensing, and use. (1) OTPs must ensure that opioid agonist treatment medications
are administered or dispensed only by a practitioner licensed under the appropriate State law and registered under
the appropriate State and Federal laws to administer or dispense opioid drugs, or by an agent of such a practitioner,
supervised by and under the order of the licensed practitioner. This agent is required to be a pharmacist, registered
nurse, or licensed practical nurse, or any other healthcare professional authorized by Federal and State law to administer or dispense opioid drugs.
(2) OTPs shall use only those opioid agonist treatment medications that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in the treatment of
opioid addiction. In addition, OTPs who are fully compliant with the protocol of an investigational use of a drug and

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other conditions set forth in the application may administer a drug that has been authorized by the Food and Drug
Administration under an investigational new drug application under section 505(i) of the Federal Food, Drug, and
Cosmetic Act for investigational use in the treatment of opioid addiction. Currently the following opioid agonist
treatment medications will be considered to be approved by the Food and Drug Administration for use in the treatment of opioid addiction:
(i) Methadone; and
(ii) Levomethadyl acetate (LAAM).
(3) OTPs shall maintain current procedures that are adequate to ensure that the following dosage form and initial
dosing requirements are met:
(i) Methadone shall be administered or dispensed only in oral form and shall be formulated in such a way as to reduce its potential for parenteral abuse.
(ii) For each new patient enrolled in a program, the initial dose of methadone shall not exceed 30 milligrams and
the total dose for the first day shall not exceed 40 milligrams, unless the program physician documents in the patient's record that 40 milligrams did not suppress opiate abstinence symptoms.
(4) OTPs shall maintain current procedures adequate to ensure that each opioid agonist treatment medication used
by the program is administered and dispensed in accordance with its approved product labeling... any significant
deviations from the approved labeling, including deviations with regard to dose, frequency, or the conditions of use
described in the approved labeling, are specifically documented in the patient's record.
(i) Unsupervised or "take-home" use. To limit the potential for diversion of opioid agonist treatment medications to
the illicit market, opioid agonist treatment medications dispensed to patients for unsupervised use shall be subject to
the following requirements.
(1) Any patient in comprehensive maintenance treatment may receive a single take-home dose for a day that the clinic is closed for business, including Sundays and State and Federal holidays.
(2) Treatment program decisions on dispensing opioid treatment medications to patients for unsupervised use beyond that set forth in paragraph (i)(1) of this section, shall be determined by the medical director...
(3) Such determinations and the basis for such determinations consistent with the criteria outlined in paragraph
(i)(2) of this section shall be documented in the patient's medical record. If it is determined that a patient is responsible in handling opioid drugs, the following restrictions apply:
(i) During the first 90 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is
limited to a single dose each week and the patient shall ingest all other doses under appropriate supervision as provided for under the regulations in this subpart.
(ii) In the second 90 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is two
doses per week.
(iii) In the third 90 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is three
doses per week.
(iv) In the remaining months of the first year, a patient may be given a maximum 6-day supply of take-home medication.
(v) After 1 year of continuous treatment, a patient may be given a maximum 2-week supply of take-home medication.
(vi) After 2 years of continuous treatment, a patient may be given a maximum one-month supply of take-home medication, but must make monthly visits.
(4) No medications shall be dispensed to patients in short-term detoxification treatment or interim maintenance
treatment for unsupervised or take-home use.
(5) OTPs must maintain current procedures adequate to identify the theft or diversion of take-home medications, including labeling containers with the OTP's name, address, and telephone number. Programs also must ensure that
take-home supplies are packaged in a manner that is designed to reduce the risk of accidental ingestion, including
child-proof containers.
(j) Interim maintenance treatment. (1) The program sponsor of a public or nonprofit private OTP may place an individual, who is eligible for admission to comprehensive maintenance treatment, in interim maintenance treatment if
the individual cannot be placed in a public or nonprofit private comprehensive program within a reasonable geographic area and within 14 days of the individual's application for admission to comprehensive maintenance treatment. An initial and at least two other urine screens shall be taken from interim patients during the maximum of 120

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days permitted for such treatment. A program shall establish and follow reasonable criteria for establishing priorities for transferring patients from interim maintenance to comprehensive maintenance treatment...
(2) The program shall notify the State health officer when a patient begins interim maintenance treatment, when a
patient leaves interim maintenance treatment, and before the date of mandatory transfer to a comprehensive program, and shall document such notifications.
Under a relatively new program, the DEA has promulgated regulations that permit the prescribing of Schedule III, IV and V
controlled substances for the treatment of the disease of addiction, as long as the prescribed drug has been approved for that
purpose by the FDA. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
Section 1301.28 - Exemption from separate registration for practitioners dispensing or prescribing Schedule III, IV,
or V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or
detoxification treatment.
(a) An individual practitioner may dispense or prescribe Schedule III, IV, or V narcotic controlled drugs or combinations of narcotic controlled drugs which have been approved by the Food and Drug Administration (FDA) specifically for use in maintenance or detoxification treatment without obtaining the separate registration required by
Section1301.13(e) if all of the following conditions are met:
(1) The individual practitioner meets the conditions specified in paragraph (b) of this section.
(2) The narcotic drugs or combination of narcotic drugs meet the conditions specified in paragraph (c) of this section.
(3) The individual practitioner is in compliance with either paragraph (d) or paragraph (e) of this section.
(b)(1) The individual practitioner must submit notification to the Secretary of Health and Human Services stating the
individual practitioner's intent to dispense or prescribe narcotic drugs under paragraph (a) of this section. The notice must contain all of the following certifications:
(i) The individual practitioner is registered under Section1301.13 as an individual practitioner and is a "qualifying
physician'' as defined in section 303(g)(2)(G) of the Act (21 U.S.C. 823(g)(2)(G)).
(ii) The individual practitioner has the capacity to refer the patients to whom the individual practitioner will provide
narcotic drugs or combinations of narcotic drugs for appropriate counseling and other appropriate ancillary services.
(iii)The total number of patients to whom the individual practitioner will provide narcotic drugs or combinations of
narcotic drugs under this section will not exceed 30 at any one time unless, not sooner than 1 year after the date on
which the practitioner submitted the initial notification to the Secretary of Health and Human Services, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients.
A second notification under this subparagraph shall contain the certifications required by subparagraphs (i) and (ii)
of this paragraph. The Secretary of Health and Human Services may promulgate regulations to change the total
number of patients.
(2) If an individual practitioner wishes to prescribe or dispense narcotic drugs pursuant to paragraph (e) of this section, the individual practitioner must provide the Secretary of Health and Human Services the following:
(i) Notification as required under paragraph (b)(1) of this section in writing, stating the individual practitioner's
name and DEA registration number issued under Section1301.13.
(ii) If the individual practitioner is a member of a group practice, the names of the other individual practitioners in
the group and the DEA registration numbers issued to the other individual practitioners under Section1301.13.
(c) The narcotic drugs or combination of narcotic drugs to be dispensed or prescribed under this section must meet
all of the following conditions:
(1) The drugs or combination of drugs have been approved for use in "maintenance treatment'' or "detoxification
treatment'' under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act.
(2) The drugs or combination of drugs have not been the subject of an adverse determination by the Secretary of
Health and Human Services, after consultation with the Attorney General, that the use of the drugs or combination of
drugs requires additional standards respecting the qualifications of practitioners or the quantities of the drugs that
may be provided for unsupervised use.
(d)(1) After receiving the notification submitted under paragraph (b) of this section, the Secretary of Health and Human Services will forward a copy of the notification to the Administrator. The Secretary of Health and Human Ser-

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vices will have 45 days from the date of receipt of the notification to make a determination of whether the individual
practitioner involved meets all requirements for a waiver under section 303(g)(2)(B) of the Act (21 U.S.C.
823(g)(2)(B)). Health and Human Services will notify DEA of its determination regarding the individual practitioner.
If the individual practitioner has the appropriate registration under Section1301.13, then the Administrator will issue
the practitioner an identification number as soon as one of the following conditions occurs:
(i) The Administrator receives a positive determination from the Secretary of Health and Human Services before the
conclusion of the 45- day review period, or
(ii) The 45-day review period has concluded and no determination by the Secretary of Health and Human Services
has been made.
(2) If the Secretary denies certification to an individual practitioner or withdraws such certification once it is issued,
then DEA will not issue the individual practitioner an identification number, or will withdraw the identification number if one has been issued.
(3) The individual practitioner must include the identification number on all records when dispensing and on all prescriptions when prescribing narcotic drugs under this section.
(e) An individual practitioner may begin to prescribe or dispense narcotic drugs to a specific individual patient under this section before receiving an identification number from the Administrator if the following conditions are met:
(1) The individual practitioner has submitted a written notification under paragraph (b) of this section in good faith
to the Secretary of Health and Human Services.
(2) The individual practitioner reasonably believes that the conditions specified in paragraphs (b) and (c) of this section have been met.
(3) The individual practitioner reasonably believes that the treatment of an individual patient would be facilitated if
narcotic drugs are prescribed or dispensed under this section before the sooner of: (i) Receipt of an identification
number from the Administrator, or
(ii) Expiration of the 45-day period.
(4) The individual practitioner has notified both the Secretary of Health and Human Services and the Administrator
of his or her intent to begin prescribing or dispensing the narcotic drugs before expiration of the 45-day period.
(5) The Secretary has not notified the registrant that he/she is not qualified under paragraph (d) of this section.
(6) The individual practitioner has the appropriate registration under Section1301.13.
(f) If an individual practitioner dispenses or prescribes Schedule III, IV, or V narcotic drugs approved by the Food
and Drug Administration specifically for maintenance or detoxification treatment in violation of any of the conditions
specified in paragraphs (b), (c) or (e) of this section, the Administrator may revoke the individual practitioner's registration in accordance with Section1301.36.
XII.

Methamphetamine Control

In order to restrict access to pharmaceuticals that can be used as precursors in the illegal manufacture of methamphetamine, the federal law requires pharmacists to be vigilant to the possibility that large purchases of pseudoephedrine may be
intended for illicit purposes. In December 2005, the federal government passed the Combat Methamphetamine Epidemic Act
of 2005 (Title VII of Public Law 109-177), the first step in enacting a nationwide measure to require drugs containing ephedrine, pseudoepedrine, and phenylpropanolamine. The law has requirements for product placement, logbook provisions and
sales limits. Regarding product placement, products are to be kept behind pharmacy counters or in a locked cabinet that is
located in an area of the facility to which customers do have direct access. Sellers must deliver the product directly to the
purchaser. In addition, sellers must maintain a written or electronic logbook of the sales for two years after the date of entry.
The logbook must identify the products sold, quantity sold, names and addresses of purchasers, and the date and time of the
sales. The product must not be sold unless the purchaser presents an acceptable photographic identification card and signs
the logbook. Sale limits include no more than 3.6 grams per day and 9 grams per 30-day period (7.5 grams of product per
customer during a 30-day period for mail order or mobile retail vendors). For additional information about methamphetamine control, visit the DEA website.
XIII.

Internet Controlled Substance Prescriptions

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The unlawful use of pharmaceutical controlled substances has reached alarming levels in the United States in recent
years, causing a substantial detrimental effect on the public health and safety. One of the main factors contributing to the nationwide increase in the diversion of pharmaceutical controlled substances has been the rise in the number of Internet sites
that sell or facilitate the sale of these drugs for other than legitimate medical purposes. While in-person prescription mills
(practitioners' offices that readily supply drug seekers with prescriptions for controlled substances without establishing a legitimate medical basis for doing so) have always been, and remain, a significant source of diversion, the advent of rogue Web
sites that cater to those who abuse pharmaceutical controlled substances has allowed the criminal operators of these sites to
exploit the anonymity of the Internet to generate illicit sales of controlled substances (and/or prescriptions therefor) that far
exceed those of any in-person prescription mill.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Pub. L. 110-425) was enacted on October 15,
2008. This Act amended the Controlled Substances Act (CSA) and Controlled Substances Import and Export Act (CSIEA) by
adding various provisions to prevent the illegal distribution and dispensing of controlled substances by means of the Internet.
The law became effective April 13, 2009. Thus, it is illegal under federal law to deliver, distribute, or dispense a controlled
substance by means of the Internet, except as authorized by [the CSA] or to aid or abet such activity. 21 U.S.C. 841(h)(1).
The Act applies to all controlled substances in all schedules.
Congress passed the Ryan Haight Act precisely because of the increasing use of prescription controlled substances
by adolescents and others for nonmedical purposes, which has been exacerbated by drug trafficking on the Internet. The
person for whom the Act was named, Ryan Haight, was a California high school honors student and athlete who died in 2001
from an overdose of controlled substances that he had purchased from a rogue online pharmacy. According to the Senate Report accompanying the legislation, Ease of access to the Internet, combined with lack of medical supervision, has led to tragic consequences in the online purchase of prescription controlled substances.
The following is a brief recitation of two of the most important new statutory requirements: the in-person medical
evaluation requirement for prescribing practitioners and the modified registration requirement for online pharmacies. A. Inperson medical evaluation requirement--One of the primary ways in which the Ryan Haight Act combats the use of the Internet to facilitate illegal sales of pharmaceutical controlled substances is by mandating, with limited exceptions, that the dispensing of controlled substances by means of the Internet be predicated on a valid prescription involving at least one
in-person medical evaluation. While the lack of an in-person medical evaluation has always been viewed as a red flag indicating that diversion might be occurring, the Ryan Haight Act makes it unambiguous that it is a per se violation of the CSA
for a practitioner to issue a prescription for a controlled substance by means of the Internet without having conducted at least
one in-person medical evaluation, except in certain specified circumstances. At the same time, it is crucial to bear in mind
that, as Congress expressly stated under the Act, the mere fact that the prescribing practitioner conducted one in-person medical evaluation does not demonstrate that the prescription was issued for a legitimate medical purpose within the usual course
of professional practice. Even where the prescribing practitioner has complied with the requirement of at least one in-person
medical evaluation, a prescription for a controlled substance must still satisfy the additional, fundamental prerequisite that has
been legally mandated for more than 90 years: it must be issued for a legitimate medical purpose by a practitioner acting in
the usual course of professional practice. B. Requirement of modified registration for online pharmacies-- Another of the
core provisions of the Act is the requirement that any person who operates a Web site that fits within the definition of an
online pharmacy must obtain from DEA a modification of its DEA pharmacy registration that expressly authorizes such
online activity. Only DEA-registered pharmacies are eligible under the Act to obtain such a modification of registration. One
of the ramifications of this requirement is that those who are not DEA-registered pharmacies (for example, those nonregistrants who have heretofore facilitated unlawful Internet controlled substance sales by enlisting the services of unscrupulous
pharmacies and/or prescribing practitioners) are prohibited from operating online pharmacies. The Act's definition of online
pharmacy encompasses more than merely legitimate pharmacies that may obtain a modification of their DEA registrations
allowing them to dispense controlled substances by means of the Internet. As explained below, the definition of online pharmacy includes, among others, those persons who operate the types of rogue Web sites that the Act was designed to eliminate. Consistent with the longstanding structure of the CSA (since it was enacted in 1970), the Ryan Haight Act prohibits all
controlled substance activities by online pharmacies except those expressly authorized by the Act. Again, only DEA-registered pharmacies may obtain a modification of their registration authorizing them to operate as online pharmacies. In addition, a pharmacy that has obtained such a modification of its registration may not operate as an online pharmacy unless it has
notified DEA of its intent to do so and its Web site contains certain declarations designed to provide clear assurance that it is
operating legitimately and in conformity with the Act.

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The Act adds several new definitions to the CSA. The following are two of the key definitions in the Act, which are
set forth in 21 U.S.C. 802: (51) The term deliver, distribute, or dispense by means of the Internet refers, respectively, to any
delivery, distribution, or dispensing of a controlled substance that is caused or facilitated by means of the Internet. This definition is plainly broad in scope, encompassing any activity utilizing the Internet that causes or facilitates the delivery, distribution, or dispensing of a controlled substance. This definition is incorporated into the Act's definition of an online
pharmacy. The term online pharmacy means [with certain exceptions] a person, entity, or Internet site, whether in the
United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver,
distribute, or dispense, a controlled substance by means of the Internet.
The Act adds two new criminal offenses to the CSA. The first new offense is set forth in 21 U.S.C. 841(h)(1), which
states: It shall be unlawful for any person to knowingly or intentionally- (A) Deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized by [the CSA]; or (B) Aid or abet (as such terms are used in section 2 of
title 18, United States Code) any activity described in subparagraph (A) that is not authorized by [the CSA].
XIV.

Electronic Prescriptions for Controlled Substances

The DEA states that an electronic prescription means a prescription that is generated on an electronic application and
transmitted as an electronic data file. In March, 2010, the DEA published a rule Electronic Prescriptions for Controlled Substances which became effective June 1, 2010. The rule revised DEA regulations to provide practitioners with the option of
writing prescriptions for controlled substances electronically. The regulations also permit pharmacies to receive, dispense,
and archive these electronic prescriptions. These regulations are in addition to, not a replacement of, the existing rules. The
regulations provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances. Under federal requirements,
prescriptions for Schedule II, III, IV, and V medications that are transmitted electronically and in compliance with the DEA
rule may be filled; however, one should recall that state law must also allow the activity.
The DEA has available on their website numerous resources regarding the implementation of the rule. Sections of
information from the DEA are provided below, as well as numerous DEA regulations specific to electronic prescribing.
Please note that a number of DEA regulations already provided within this text have within them requirements for electronic
prescriptions.
The DEA regulations do not mandate that practitioners prescribe controlled substances using only electronic prescriptions. Nor do they require pharmacies to accept electronic prescriptions for controlled substances for dispensing. Whether a
practitioner or pharmacy uses electronic prescriptions for controlled substances is voluntary from DEAs perspective. Prescribing practitioners are still able to write, and manually sign, prescriptions for schedule II, III, IV, and V controlled substances and pharmacies are still able to dispense controlled substances based on those written prescriptions. Oral prescriptions
remain valid for schedule III, IV, and V controlled substances.
A practitioner will be able to issue electronic controlled substance prescriptions only when the electronic prescription
or electronic health record (EHR) application the practitioner is using complies with the requirements in the rule. A pharmacy
will be able to process electronic controlled substance prescriptions only when the pharmacy application the pharmacy is using complies with the requirements in the interim final rule. A number of DEA regulation specific to electronic prescribing
follow. Numerations refer to sections of Title 21, Code of Federal Regulations.
1304.06 Records and reports for electronic prescriptions.
(a) As required by 1311.120 of this chapter, a practitioner who issues electronic prescriptions for controlled substances
must use an electronic prescription application that retains the following information:
(1) The digitally signed record of the information specified in part 1306 of this chapter.
(2) The internal audit trail and any auditable event identified by the internal audit as required by 1311.150 of this
chapter.
(b) An institutional practitioner must retain a record of identity proofing and issuance of the two-factor authentication credential, where applicable, as required by 1311.110 of this chapter.
(c) As required by 1311.205 of this chapter, a pharmacy that processes electronic prescriptions for controlled substances
must use an application that retains the following:

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(1) All of the information required under 1304.22(c) and part 1306 of this chapter.
(2) The digitally signed record of the prescription as received as required by 1311.210 of this chapter.
(3) The internal audit trail and any auditable event identified by the internal audit as required by 1311.215 of this
chapter.
(d) A registrant and application service provider must retain a copy of any security incident report filed with the Administration pursuant to 1311.150 and 1311.215 of this chapter.
(e) An electronic prescription or pharmacy application provider must retain third party audit or certification reports as required by 1311.300 of this chapter.
(f) An application provider must retain a copy of any notification to the Administration regarding an adverse audit or certification report filed with the Administration on problems identified by the third-party audit or certification as required by
1311.300 of this chapter.
(g) Unless otherwise specified, records and reports must be retained for two years.
Note that electronic records and reports must be retained for two years by the practitioner and pharmacy.
1311.100 General.
(a) This subpart addresses the requirements that must be met to issue and process Schedule II, III, IV, and V controlled substance prescriptions electronically.
(b) A practitioner may issue a prescription for a Schedule II, III, IV, or V controlled substance electronically if all of the following conditions are met:
(1) The practitioner is registered as an individual practitioner or exempt from the requirement of registration under
part 1301 of this chapter and is authorized under the registration or exemption to dispense the controlled substance;
(2) The practitioner uses an electronic prescription application that meets all of the applicable requirements of this
subpart; and
(3) The prescription is otherwise in conformity with the requirements of the Act and this chapter.
(c) An electronic prescription for a Schedule II, III, IV, or V controlled substance created using an electronic prescription
application that does not meet the requirements of this subpart is not a valid prescription, as that term is defined in 1300.03
of this chapter.
(d) A controlled substance prescription created using an electronic prescription application that meets the requirements of
this subpart is not a valid prescription if any of the functions required under this subpart were disabled when the prescription
was indicated as ready for signature and signed.
(e) A registered pharmacy may process electronic prescriptions for controlled substances only if all of the following conditions are met:
(1) The pharmacy uses a pharmacy application that meets all of the applicable requirements of this subpart; and
(2) The prescription is otherwise in conformity with the requirements of the Act and this chapter.
(f) Nothing in this part alters the responsibilities of the practitioner and pharmacy, specified in part 1306 of this chapter, to
ensure the validity of a controlled substance prescription.
1311.200 Pharmacy responsibilities.
(a) Before initially using a pharmacy application to process controlled substance prescriptions, the pharmacy must determine
that the third-party auditor or certification organization has found that the pharmacy application does the following accurately and consistently:
(1) Import, store, and display the information required for prescriptions under 1306.05(a) of this chapter.
(2) Import, store, and display the indication of signing as required by 1311.120(b)(17).

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(3) Import, store, and display the number of refills as required by 1306.22 of this chapter.
(4) Import, store, and verify the practitioner's digital signature, as provided in 1311.210(c), where applicable.
(b) If the third-party auditor or certification organization has found that a pharmacy application does not accurately and
consistently import, store, and display other information required for prescriptions under this chapter, the pharmacy must
not process electronic prescriptions for controlled substances that are subject to the additional information requirements.
(c) If a pharmacy application provider notifies a pharmacy that a third-party audit or certification report indicates that the
application or the application provider no longer meets the requirements of this part or notifies it that the application provider has identified an issue that makes the application non-compliant, the pharmacy must immediately cease to process controlled substance prescriptions using the application.
(d) A pharmacy that receives a notification that the pharmacy application is not in compliance with the requirements of this
part must not use the application to process controlled substance prescriptions until it is notified that the application is again
compliant and all relevant updates to the application have been installed.
(e) The pharmacy must determine which employees are authorized to enter information regarding the dispensing of controlled substance prescriptions and annotate or alter records of these prescriptions (to the extent such alterations are permitted under this chapter). The pharmacy must ensure that logical access controls in the pharmacy application are set so that
only such employees are granted access to perform these functions.
(f) When a pharmacist fills a prescription in a manner that would require, under part 1306 of this chapter, the pharmacist to
make a notation on the prescription if the prescription were a paper prescription, the pharmacist must make the same notation electronically when filling an electronic prescription and retain the annotation electronically in the prescription record
or in linked files. When a prescription is received electronically, the prescription and all required annotations must be retained electronically.
(g) When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically to
the pharmacy, the pharmacist must check its records to ensure that the electronic version was not received and the prescription dispensed. If both prescriptions were received, the pharmacist must mark one as void.
(h) When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically to
another pharmacy, the pharmacist must check with that pharmacy to determine whether the prescription was received and
dispensed. If the pharmacy that received the original electronic prescription had not dispensed the prescription, that pharmacy must mark the electronic version as void or canceled. If the pharmacy that received the original electronic prescription
dispensed the prescription, the pharmacy with the paper version must not dispense the paper prescription and must mark the
prescription as void.
(i) Nothing in this part relieves a pharmacy and pharmacist of the responsibility to dispense controlled substances only pursuant to a prescription issued for a legitimate medical purpose by a practitioner acting in the usual course of professional
practice.
1311.205 Pharmacy application requirements.
(a) The pharmacy may only use a pharmacy application that meets the requirements in paragraph (b) of this section to process electronic controlled substance prescriptions.
(b) The pharmacy application must meet the following requirements:
(1) The pharmacy application must be capable of setting logical access controls to limit access for the following
functions:
(i) Annotation, alteration, or deletion of prescription information.
(ii) Setting and changing the logical access controls.
(2) Logical access controls must be set by individual user name or role.
(3) The pharmacy application must digitally sign and archive a prescription on receipt or be capable of receiving
and archiving a digitally signed record.
(4) For pharmacy applications that digitally sign prescription records upon receipt, the digital signature functionality must meet the following requirements:

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(i) The cryptographic module used to digitally sign the data elements required by part 1306 of this chapter must be at
least FIPS 1402 Security Level 1 validated. FIPS 1402 is incorporated by reference in 1311.08.
(ii) The digital signature application and hash function must comply with FIPS 1863 and FIPS 1803, as incorporated by reference in 1311.08.
(iii) The pharmacy application's private key must be stored encrypted on a FIPS 1402 Security Level 1 or higher
validated cryptographic module using a FIPS-approved encryption algorithm. FIPS 1402 is incorporated by reference in 1311.08.
(iv) For software implementations, when the signing module is deactivated, the pharmacy application must clear the
plain text password from the application memory to prevent the unauthorized access to, or use of, the private key.
(v) The pharmacy application must have a time application that is within five minutes of the official National Institute
of Standards and Technology time source.
(5) The pharmacy application must verify a practitioner's digital signature (if the pharmacy application accepts prescriptions that were digitally signed with an individual practitioner's private key and transmitted with the digital signature).
(6) If the prescription received by the pharmacy application has not been digitally signed by the practitioner and
transmitted with the digital signature, the pharmacy application must either:
(i) Verify that the practitioner signed the prescription by checking the data field that indicates the prescription was
signed; or
(ii) Display the field for the pharmacist's verification.
(7) The pharmacy application must read and retain the full DEA number including the specific internal code number
assigned to individual practitioners authorized to prescribe controlled substances by the hospital or other institution
as provided in 1301.22(c) of this chapter.
(8) The pharmacy application must read and store, and be capable of displaying, all information required by part
1306 of this chapter.
(9) The pharmacy application must read and store in full the information required under 1306.05(a) of this chapter.
The pharmacy application must either verify that such information is present or must display the information for the
pharmacist's verification.
(10) The pharmacy application must provide for the following information to be added or linked to each electronic
controlled substance prescription record for each dispensing:
(i) Number of units or volume of drug dispensed.
(ii) Date dispensed.
(iii) Name or initials of the person who dispensed the prescription.
(11) The pharmacy application must be capable of retrieving controlled substance prescriptions by practitioner
name, patient name, drug name, and date dispensed.
(12) The pharmacy application must allow downloading of prescription data into a database or spreadsheet that is
readable and sortable.
(13) The pharmacy application must maintain an audit trail of all actions related to the following:
(i) The receipt, annotation, alteration, or deletion of a controlled substance prescription.
(ii) Any setting or changing of logical access control permissions related to the dispensing of controlled substance
prescriptions.
(iii) Auditable events as specified in 1311.215.
(14) The pharmacy application must record within each audit record the following information:

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(i) The date and time of the event.
(ii) The type of event.
(iii) The identity of the person taking the action, where applicable.
(iv) The outcome of the event (success or failure).
(15) The pharmacy application must conduct internal audits and generate reports on any of the events specified in
1311.215 in a format that is readable by the pharmacist. Such an internal audit may be automated and need not require human intervention to be conducted.
(16) The pharmacy application must protect the stored audit records from unauthorized deletion. The pharmacy application shall prevent modifications to the audit records.
(17) The pharmacy application must back up the controlled substance prescription records daily.
(18) The pharmacy application must retain all archived records electronically for at least two years from the date of
their receipt or creation and comply with all other requirements of 1311.305.
Additional information from the DEA regarding electronic prescriptions is available on the DEA website at
www.deadiversion.usdoj.gov. Selected DEA guidance is also available in the next chapter of this guide/text.

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Chapter 4: The Drug Enforcement Administration
The Drug Enforcement Administration (DEA) is the primary agency within the Federal Government responsible for
the enforcement of the Controlled Substances Act (CSA). In cooperation with state authorities and other federal agencies,
DEA is tasked with preventing the diversion of controlled substances for illicit purposes. In carrying out its mission, DEA
complies with international treaty obligations, works closely with foreign as well as domestic state and local governments,
private industry, and other organizations concerned with drug abuse and diversion.
To promote voluntary compliance with laws applicable to controlled substances, the DEA has published several
handbooks and pamphlets on their website (www.deadiversion.usdoj.gov), and these are quite useful. One example includes
the Pharmacists Manual, an informational outline of the CSA. The Pharmacistss Manual was recently updated in 2010.
In addition to various publications the DEA has available on their website, one can also find frequently asked questions and answers about topics related to controlled substances. In this chapter you will find (reproduced below) select information from the Pharmacists Manual as well questions and answers that the agency has published to clarify their
understanding of the statutes and regulations they enforce.
I. 2010 Pharmacists Manual
The 2010 Pharmacits Manaul was prepared by the Drug Enforcement Administration, Office of Diversion Control, as
a guide to assist pharmacists in their understanding of the Federal Controlled Substances Act and its implementing regulations as they pertain to the pharmacy profession. The 2010 edition replaces all previous editions of the Pharmacists Manual
issued by the Drug Enforcement Administration, both hard copy and electronic. The entire document, in electronic format, is
available on the DEA website, and printed copies can be obtained from the U.S. Government Printing Office. Pertinent sections of the manual are provided below.
Preface
The Drug Enforcement Administration (DEA) was established in 1973 to serve as the primary agency responsible for
the enforcement of federal drug laws. The Controlled Substances Act (CSA) and its implementing regulations establish federal requirements regarding both illicit and licit controlled substances. With respect to pharmaceutical controlled substances, DEAs responsibility is twofold: to prevent diversion and abuse of these substances while
ensuring an adequate and uninterrupted supply is available to meet the countrys legitimate medical, scientific, and
research needs. In carrying out this mission, DEA works closely with state and local authorities and other federal
agencies.
Under the framework of the CSA, all controlled substance transactions take place within a closed system of distribution established by Congress. Within this closed system all legitimate handlers of controlled substances manufacturers, distributors, physicians, pharmacies, and others, must be registered with DEA (unless exempt) and maintain
strict accounting for all controlled substance transactions.
To carry out this mission effectively, DEA seeks to educate its registrants regarding their legal obligations. It is
DEAs goal to maintain a positive working relationship with all of its registrants, including pharmacies. DEA understands that it can best serve the public interest by working with the pharmacy community to prevent the diversion of
pharmaceutical controlled substances and scheduled listed chemical products (SLCPs) into the illicit market.
Federal controlled substance laws are designed to function in tandem with state controlled substance laws. DEA
works in cooperation with state professional licensing boards and state and local law enforcement officials to make
certain that pharmaceutical controlled substances are prescribed, administered, and dispensed for a legitimate medical
purpose in the usual course of professional practice. Within this framework, the majority of investigations into possible violations of controlled substance laws are carried out by state authorities. DEA focuses its investigations on cases involving violators of the highest level or most significant impact.
In the event a state board revokes the license of a pharmacy, DEA will request a voluntary surrender of the
pharmacys DEA registration. If the pharmacy refuses to surrender its registration, DEA will seek administrative action to revoke its DEA registration based on lack of state authorization. Additional administrative remedies that may
be utilized to correct a lack of compliance include a letter of admonition or an administrative hearing. DEA may also

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pursue civil or criminal sanctions if there is sufficient evidence to justify a prosecution. All such actions are designed
to protect the public health and safety.
In addition to the diversion of controlled substances, DEA is concerned with the diversion of certain chemicals used
in the clandestine manufacture of controlled substances. Chemicals such as ephedrine and pseudoephedrine contained
in over the counter and prescription substances are immediate precursors used in the illicit manufacture of methamphetamine and amphetamine. These products may be purchased or stolen from retail outlets, including pharmacies,
for use in clandestine laboratories.
Pharmacies that sell over the counter products containing ephedrine and pseudoephedrine must be self-certified as
required by the Combat Methamphetamine Epidemic Act of 2005 (CMEA). The CMEA created a new category of
products designated as SLCPs. SLCPs are products containing ephedrine, pseudoephedrine, or phenylpropanolamine
that may be marketed or distributed lawfully in the United States as a non-prescription drug under the Food, Drug,
and Cosmetic Act. The retail provisions of the CMEA went into effect on September 30, 2006 and require, among
other things, employee training, self certification, placement of SLCPs out of customer reach, required identification,
sales logbooks, sales and purchase limits, and others.
DEA and the pharmacy profession have strong common interests in the appropriate use of controlled substances and
SLCPs. An effective working relationship to ensure compliance with CSA requirements will continue to produce
lasting benefits on a national scale.
SECTION II SCHEDULES OF CONTROLLED SUBSTANCES
The drugs and other substances that are considered controlled substances under the CSA are divided into five schedules. A listing of the substances and their schedules is found in the DEA regulations, 21 C.F.R. Sections 1308.11
through 1308.15. A controlled substance is placed in its respective schedule based on whether it has a currently accepted medical use in treatment in the United States and its relative abuse potential and likelihood of causing dependence. Some examples of controlled substances in each schedule are outlined below.
NOTE: Drugs listed in schedule I have no currently accepted medical use in treatment in the United States and,
therefore, may not be prescribed, administered, or dispensed for medical use. In contrast, drugs listed in schedules
II-V have some accepted medical use and may be prescribed, administered, or dispensed for medical use.
Schedule I Controlled Substances
Substances in this schedule have a high potential for abuse, have no currently accepted medical use in treatment in
the United States, and there is a lack of accepted safety for use of the drug or other substance under medical supervision.
Some examples of substances listed in schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana
(cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine (ecstasy).
Schedule II Controlled Substances
Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence.
Examples of single entity schedule II narcotics include morphine and opium. Other schedule II narcotic substances
and their common name brand products include: hydromorphone (Dilaudid), methadone (Dolophine), meperidine
(Demerol), oxycodone (OxyContin), and fentanyl (Sublimaze or Duragesic).
Examples of schedule II stimulants include: amphetamine (Dexedrine, Adderall), methamphetamine (Desoxyn),
and methylphenidate (Ritalin). Other schedule II substances include: cocaine, amobarbital, glutethimide, and pentobarbital.

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Schedule III Controlled Substances
Substances in this schedule have a potential for abuse less than substances in schedules I or II and abuse may lead to
moderate or low physical dependence or high psychological dependence.
Examples of schedule III narcotics include combination products containing less than 15 milligrams of hydrocodone
per dosage unit (Vicodin) and products containing not more than 90 milligrams of codeine per dosage unit (Tylenol
with codeine). Also included are buprenorphine products (Suboxone and Subutex) used to treat opioid addiction.
Examples of schedule III non-narcotics include benzphetamine (Didrex), phendimetrazine, ketamine, and anabolic
steroids such as oxandrolone (Oxandrin).
Schedule IV Controlled Substances
Substances in this schedule have a low potential for abuse relative to substances in schedule III.
An example of a schedule IV narcotic is propoxyphene (Darvon and Darvocet-N 100).
Other schedule IV substances include: alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Tranxene),
diazepam (Valium), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), and triazolam
(Halcion).
Schedule V Controlled Substances
Substances in this schedule have a low potential for abuse relative to substances listed in schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. These are generally used for antitussive, antidiarrheal, and analgesic purposes.
Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per
100 grams (Robitussin AC and Phenergan with Codeine).
Scheduled Listed Chemical Product (SLCP)
An SLCP is defined as a product that contains ephedrine, pseudoephedrine, or phenylpropanolamine and may be
marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act as a nonprescription drug.
SECTION III REGISTRATION REQUIREMENTS
New Pharmacy Registration
Every pharmacy that dispenses a controlled substance must be registered with the DEA. First, a state license must be
obtained.
To register as a new pharmacy, the DEA Form 224 must be completed. The cost of the application fee is indicated on
the application form. The certificate of registration must be maintained at the registered location and kept available
for official inspection. If a person owns and operates more than one pharmacy, each place of business must be registered.
The DEA Form 224 should be completed online (www.DEAdiversion.usdoj.gov).
A paper version of the DEA Form 224 may be requested by writing to:
Drug Enforcement Administration
Attn: Registration Section/ODR
P.O. Box 2639
Springfield, Virginia 22152-2639

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If a pharmacy needs a duplicate Certificate of Registration (DEA Form 223), a copy may be requested online via
DEAs Diversion website, www.DEAdiversion.usdoj.gov, or contact DEA Headquarters at 1-800-882-9539 or via
e-mail at [email protected].
Renewal of Pharmacy Registration
A pharmacy registration must be renewed every three years utilizing DEA Form 224a, Renewal Application for DEA
Registration. The cost of the application fee is indicated on the application form.
To renew a registration, the most current information from the pharmacys existing registration must be utilized. A
registrant can renew online no more than 60 days prior to the current expiration date. The DEA Form 224a should be
completed online and can be found at www.DEAdiversion.usdoj.gov.
If the registrant has not renewed online approximately 50 days before the registration expiration date, a renewal application is sent to the registrant at the mailing address listed on the current registration. If the renewal form is not
received by the 30th day before the expiration date of the current registration, the pharmacy should contact the local
DEA Registration Specialist (Appendix J) or DEA Headquarters at 1-800-882-9539 and request a renewal registration form.
NOTE: Once the expiration date has passed and no renewal has been received by DEA, the pharmacy has no authority to handle controlled substances.
Affidavit for Renewal of Retail Chain Pharmacy Registration
Corporations that own or operate a chain of pharmacies may submit a single DEA Form 224b, Retail Pharmacy Registration Affidavit for Chain Renewal. This affidavit, along with a list of the corporation's registrations, is provided in
lieu of a separate registration application for each pharmacy registration. No registration may be issued unless the
completed affidavit is received by DEA. The corporation should retain a copy of this affidavit with their readily retrievable records for the duration of the registrations covered by the affidavit. A responsible individual must answer
the questions listed on the affidavit on behalf of the corporation as they pertain to each registrant.
The original affidavit along with the registration application fee and the list of registrations should be mailed to:
Registration Chain Renewal
Drug Enforcement Administration
Attn: Registration Section/ODR
P.O. Box 2639
Springfield, Virginia 22152-2639
Change of Business Address
A pharmacy that moves to a new physical location must request a modification of registration. Modifications are handled in the same manner as applications and must be approved by DEA.
A modification of registration can be requested online at www.DEAdiversion.usdoj.gov or in writing to the local
DEA Registration Specialist (Appendix J) responsible for the area in which the pharmacy is located. If the change of
address involves a change in state, the proper state issued license and, if applicable, controlled substances registration
must be obtained prior to the approval of modification of the federal registration. If the modification is approved,
DEA will issue a new certificate of registration and, if requested, new schedule II order forms (DEA Form 222). The
registrant should maintain the new certificate with the old certificate until expiration. A Renewal Application for
Registration (DEA Form 224a) will only be sent to the mailing address on file with DEA. It will not be forwarded.

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Termination of Registration
A pharmacy that discontinues business activities either completely or only regarding controlled substances must return its DEA registration certificate and unused official order forms (DEA Form 222) to the local DEA Registration
Specialist (Appendix J). In addition, DEA may ask for the location of where inventories, prescriptions, and other required controlled substance records will be stored during the requisite two-year retention period.
Unwanted controlled substances in the pharmacys possession must be disposed of in accordance with DEA regulations (see Section IV, Transfer or Disposal of Controlled Substances).
Transfer of Business
A pharmacy registrant that transfers its business operations to another pharmacy registrant must submit in person or
by registered or certified mail, return receipt requested, to the Special Agent in Charge in his/her area, at least 14 days
in advance of the date of the proposed transfer (unless the Special Agent in Charge waives this time limitation in individual instances), the following information:
The name, address, registration number, and authorized business activity of the registrant discontinuing the business
(registrant-transferor);
The name, address, registration number, and authorized business activity of the person acquiring the business
(registrant-transferee);
Whether the business activities will be continued at the location registered by the person discontinuing business, or
moved to another location (if the latter, the address of the new location should be listed); and
The date on which the transfer of controlled substances will occur.
On the day the controlled substances are transferred, a complete inventory must be taken and a copy of the inventory
must be included in the records of both the person transferring the business and the person acquiring the business.
This inventory will serve as the final inventory for the registrant going out of business and transferring the controlled
substances. It will also serve as the initial inventory for the registrant acquiring the controlled substances. It is not
necessary to send a copy of the inventory to the DEA unless requested by the Special Agent in Charge.
To transfer schedule II controlled substances, the receiving registrant must issue an official order form (DEA Form
222) or an electronic equivalent to the registrant transferring the drugs. The transfer of schedules III-V controlled
substances must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred. The document must include the names, addresses, and DEA registration numbers of the parties involved in the
transfer of the controlled substances.
All controlled substance records required to be kept by the registrant-transferor shall be transferred to the registranttransferee. Responsibility for the accuracy of records prior to the date of transfer remains with the transferor, but responsibility for custody and maintenance shall be upon the transferee.
If the registrant acquiring the pharmacy owns at least one other pharmacy licensed in the same state as the pharmacy
being transferred, the registrant may apply for a new DEA registration prior to the date of transfer. DEA will issue a
registration which will authorize the registrant to obtain controlled substances at the time of transfer, but the registrant may not dispense controlled substances until the pharmacy has been issued a valid state pharmacy license.
A DEA registration application to transfer ownership of an existing pharmacy can be facilitated if the applicant includes an affidavit verifying that the pharmacy has been registered by the state licensing agency. The affidavit verifying the existence of the state license should be attached to the initial application for registration.

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Denial, Suspension, or Revocation of Registration
Under the CSA (21 U.S.C. 824 (a)), DEA has the authority to deny, suspend, or revoke a DEA registration upon a
finding that the registrant:
Has materially falsified the application;
Has been convicted of a felony relating to a controlled substance or a List I chemical;
Had a State license or registration suspended, revoked, or denied by a competent State authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances or List I
chemicals or has had the suspension, revocation, or denial of a registration recommended by competent State authority;
Has committed an act which would render the DEA registration inconsistent with the public interest; or
Has been excluded (or directed to be excluded) from participation in a program pursuant to Title 42 U.S.C. 1320a7(a), that is, a Medicaid or Medicare program.
Denial of Registration in the Public Interest
In determining the public interest, the CSA states the following factors are to be considered (21 U.S.C. 823 (f)):
The recommendation of the appropriate State licensing board or professional disciplinary authority.
The applicants experience in dispensing or conducting research with respect to controlled substances.
The applicants conviction record under federal or state laws relating to the manufacture, distribution, or dispensing
of controlled substances.
Compliance with applicable State, Federal, or local laws relating to controlled substances.
Such other conduct which may threaten the public health and safety.
Chemical Registration Requirements
Registration is not required for regulated sellers of SLCPs. However, a regulated seller must self-certify with DEA
pursuant to federal law (see Section XIV, Self-Certification). A regulated seller is defined as a grocery store, general
merchandise store, drug store, or other entity engaged in over-the-counter sales of ephedrine (both single-entity and
combination products), pseudoephedrine, or phenylpropanolamine products, directly to walk-in customers or in faceto-face transactions by direct sales. A mobile retail vendor is defined as a person or entity that makes sales at retail
from a stand that is intended to be temporary or is capable of being moved from one location to another.
Federal law requires any person who is engaged in the wholesale distribution of an SLCP to obtain a registration as a
chemical distributor. A distributor who does not meet all the requirements for a regulated seller of SLCPs, or who
does not meet the requirements for distributors required to submit mail-order reports, is a wholesale distributor.
Note: this would include those pharmacies that sell quantities of SLCPs to institutions, including long term care facilities, jails, and other institutional-type settings for non-patient specific use. Such pharmacies are often referred to as
closed door pharmacies.
Retail pharmacies that are registered to handle controlled substances need not obtain a separate DEA chemical registration for retail distribution of SLCPs. If a pharmacy desires to engage in the wholesale distribution of bulk quantities of SLCPs, the pharmacy is required to register with DEA as a chemical distributor because these activities fall
outside the definition of a regulated seller. Therefore, the pharmacy would be subject to the registration requirements
that apply to wholesale distributors for those distribution activities, and subject to the pharmacy requirements for its
pharmacy activities. To obtain a DEA chemical distributor registration, a pharmacy may complete the DEA Form
510 online at www.DEAdiversion.usdoj.gov. A paper version may be requested by writing to:

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Drug Enforcement Administration
Attn: Registration Section/ODR
P.O. Box 2639
Springfield, Virginia 22152-2639
SECTION IV TRANSFER OR DISPOSAL OF CONTROLLED SUBSTANCES
Transfer of Controlled Substances
A pharmacy may hire an outside firm to inventory, package, and arrange for the transfer of its controlled substances
to another pharmacy, the original supplier, or the original manufacturer. The pharmacy is responsible for the actual
transfer of the controlled substances and for the accuracy of the inventory and records. The records involving the
transfer of controlled substances must be kept readily available by the pharmacy for two years for inspection by the
DEA.
To transfer schedule II substances, the receiving registrant must issue an official order form (DEA Form 222) or an
electronic equivalent to the registrant transferring the drugs. The transfer of schedules III-V controlled substances
must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred. The
document must include the names, addresses, and DEA registration numbers of the parties involved in the transfer of
the controlled substances.
Transfer to a Pharmacy
If a pharmacy goes out of business or is acquired by a new pharmacy, it may transfer the controlled substances to another pharmacy. On the day the controlled substances are transferred, a complete inventory must be taken which documents the drug name, dosage form, strength, quantity, and date transferred. In addition, DEA Form 222 or the
electronic equivalent must be prepared to document the transfer of schedule II controlled substances. This inventory
will serve as the final inventory for the registrant going out of business and transferring the controlled substances. It
will also serve as the initial inventory for the registrant acquiring the controlled substances. A copy of the inventory
must be included in the records of each pharmacy. It is not necessary to send a copy of the inventory to the DEA. The
pharmacy acquiring the controlled substances must maintain all records involved in the transfer of the controlled substances for two years.
Transfer to the Original Supplier or Original Manufacturer
Any pharmacy may transfer controlled substances to the original supplier or the original manufacturer that is appropriately registered with the DEA. The pharmacist must maintain a written record showing:
The date of the transaction.
The name, strength, dosage form, and quantity of the controlled substance.
The supplier or manufacturers name, address, and registration number.
The DEA Form 222 or the electronic equivalent will be the official record for the transfer of schedule II controlled
substances.
Disposal of Controlled Substances
A pharmacy may transfer controlled substances to a DEA registered reverse distributor who handles the disposal of
controlled substances. The pharmacy should contact the local DEA Diversion Field Office (Appendix K) for an updated list of DEA registered reverse distributors. In no case should drugs be forwarded to the DEA unless the registrant has received prior approval from the DEA. The DEA procedures established for the disposal of controlled

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substances must not be construed as altering in any way the state laws or regulations for the disposal of controlled
substances.
Reverse Distributors Authorized to Dispose Controlled Substances
A pharmacy may forward controlled substances to a DEA registered reverse distributor who handles the disposal of
controlled substances. When a pharmacy transfers schedule II controlled substances to a reverse distributor for destruction, the reverse distributor must issue an official order form (DEA Form 222) or the electronic equivalent to the
pharmacy. When schedules III-V controlled substances are transferred to a reverse distributor for destruction, the
pharmacy must maintain a record of distribution that lists the drug name, dosage form, strength, quantity, and date
transferred. The DEA registered reverse distributor who will destroy the controlled substances is responsible for submitting a DEA Form 41 (Registrants Inventory of Drugs Surrendered) to the DEA when the controlled substances
have been destroyed. A DEA Form 41 should not be used to record the transfer of controlled substances between the
pharmacy and the reverse distributor disposing of the drugs.
A paper version of the DEA Form 41 may be requested by writing to:
Drug Enforcement Administration
Attn: Registration Section/ODR
P.O. Box 2639
Springfield, Virginia 22152-2639
Disposal of Controlled Substances by Persons Not Registered with DEA
On January 21, 2009, DEA published in the Federal Register an Advance Notice of Proposed Rulemaking
(ANPRM), Disposal of Controlled Substances by Persons Not Registered with the Drug Enforcement Administration.
This ANPRM sought comments on how to address the issue of disposal of dispensed controlled substances held by
DEA nonregistrants (i.e., ultimate users, long term care facilities). DEA was interested in the possible options that
would enable nonregistrants to dispose of unwanted controlled substances, while also protecting public health and
public safety, and minimizing the possibility of diversion. The public comment period for this ANPRM ended on
March 23, 2009.
SECTION V SECURITY REQUIREMENTS
Requests for Employment Waivers for Certain Pharmacy Employees
Under 21 C.F.R. 1301.76(a), a registrant must not employ in a position which allows access to controlled substances any person who has been convicted of a felony relating to controlled substances, or who, at any time, has had an
application for DEA registration denied, revoked, or surrendered for cause. "For cause" means surrendering a registration in lieu of, or as a consequence of, any federal or state administrative, civil, or criminal action resulting from an
investigation of the individuals handling of controlled substances.
However, 21 C.F.R. 1307.03 does permit registrants desiring to employ an individual who meets this definition to
request an exception to this requirement. The employer must have a waiver approved before allowing such an employee or prospective employee to have access to controlled substances. A waiver request should be sent by the employer to the following address:
Drug Enforcement Administration
Attn: Regulatory Section/ODG
8701 Morrissette Drive
Springfield, Virginia 22152

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A registrant that applies for such a waiver should understand that the following factors will be considered by the
DEA in the approval process and should provide details relevant to each factor as part of the waiver request submitted, since a waiver will not be considered unless there are valid reasons to believe that diversion is unlikely to occur:
A detailed description of the nature and extent of the individuals past controlled substances violations, including all
pertinent documentation;
Current status of the individuals state licensure;
Extent of individuals proposed access to controlled substances. Access is not limited to only physical access to
controlled substances, but includes any influence over the handling of controlled substances;
Registrants proposed physical and professional safeguards to prevent diversion by the individual;
Status of employing registrant regarding handling of controlled substances;
Other pertinent information uncovered by DEA in its investigation of the individuals or registrants handling of controlled substances; and
All other relevant factors or materials.
Controlled Substance Theft or Significant Loss
Should a theft or significant loss of any controlled substance occur at a pharmacy, the following procedures must be
implemented within one business day of the discovery of the theft or loss.
A. Notify DEA and Local Police
The theft of controlled substances from a registrant is a criminal act and a source of diversion that requires notification to DEA. A pharmacy must notify in writing the local DEA Diversion Field Office (Appendix K) within one business day of discovery of a theft or significant loss of a controlled substance. Although not specifically required by
federal law or regulations, the registrant should also notify local law enforcement and state regulatory agencies.
Prompt notification to enforcement agencies will allow them to investigate the incident and prosecute those responsible for the diversion. If there is a question as to whether a theft has occurred or a loss is significant, a registrant
should err on the side of caution and report it to DEA and local law enforcement authorities.
DEA must be notified directly. This requirement is not satisfied by reporting the theft or significant loss in any other
manner. For example, a corporation which owns or operates multiple registered sites and wishes to channel all notifications through corporate management or any other internal department responsible for security, must still provide
notice directly to DEA in writing within one business day upon discovery and keep a copy of that notice for its records. The notice must be signed by an authorized individual of the registrant.
B. Complete DEA Form 106
A pharmacy must also complete a DEA Form 106 (Report of Theft or Loss of Controlled Substances) which can be
found online at www.DEAdiversion.usdoj.gov under the Quick Links section. The DEA Form 106 is used to document the actual circumstances of the theft or significant loss and the quantities of controlled substances involved. A
paper version of the form can be obtained by writing to:
Drug Enforcement Administration
Attn: Registration Section/ODR
8701 Morrissette Drive
Springfield, Virginia 22152
If completing the paper version, the pharmacy should send the original DEA Form 106 to the local DEA Diversion
Field Office (Appendix K) and keep a copy for its records. Please see the Guidelines for Completing the DEA Form
106 (Appendix I) for additional guidance.
The DEA Form 106 must include the following information:
Name and address of the firm (pharmacy),

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DEA registration number,
Date of theft or loss (or when discovered if not known),
Name and telephone number of local police department (if notified),
Type of theft (e.g., night break-in, armed robbery),
List of identifying marks, symbols, or price codes (if any) used by the pharmacy on the labels of the containers, and
A listing of controlled substances missing, including the strength, dosage form, and size of container (in milliliters if
liquid form) or corresponding National Drug Code numbers.
C. If Investigation Finds No Theft or Loss
If, after the initial notification to DEA, the investigation of the theft or loss determines no such theft or loss of controlled substances occurred, a DEA Form 106 does not need to be filed. However, the registrant must notify DEA in
writing of this fact in order to resolve the initial report and explain why no DEA Form 106 was filed regarding the
incident.
D. Registrants Responsibility for Identifying "Significant Loss"
Although the CSA regulations do not define the term "significant loss," it is the responsibility of the registrant to use
his/her best judgment to take appropriate action. Whether a significant loss has occurred depends, in large part, on
the business of the pharmacy and the likelihood of a rational explanation for a particular occurrence. What would
constitute a significant loss for a pharmacy may be viewed as comparatively insignificant for a hospital or manufacturer.
Further, the loss of a small quantity of controlled substances, repeated over a period of time, may indicate a significant problem for a registrant, which must be reported. The burden of responsibility is on the registrant to identify
what is a significant loss and make the required report to DEA.
When determining whether a loss is significant, a registrant should consider, among others, the following factors:
The actual quantity of controlled substances lost in relation to the type of business;
The specific controlled substances;
Whether the loss of the controlled substances can be associated with access to those controlled substances by specific
individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known
Whether the specific controlled substances are likely candidates for diversion; and
Local trends and other indicators of the diversion potential of the missing controlled substances.
If it is determined that the loss is not significant, the registrant should place a record of the occurrence in a theft and
loss file for future reference. Miscounts or adjustments to inventory involving clerical errors on the part of the pharmacy should not be reported on a DEA Form 106, but rather should be noted in a separate log at the pharmacy
managements discretion.
In-Transit Loss
When all or part of an in-transit shipment of controlled substances fails to reach its intended destination, the supplier
is responsible for reporting the in-transit loss of controlled substances to DEA. The purchaser is responsible for reporting any loss of controlled substances after he/she has signed for or taken custody of a shipment. If it is discovered
after that point that an in-transit loss or theft has occurred; the purchaser must then submit a DEA Form 106. If the
purchaser does not take custody of the shipment and instead returns it to the supplier, it is the suppliers responsibility
for reporting any loss of controlled substances in the original shipment.

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In-Transit Loss from Central Fill Pharmacy
Central fill pharmacies must comply with 21 C.F.R. 1301.74(e) when selecting private, common or contract carriers
to transport filled prescriptions to a retail pharmacy for delivery to an ultimate user. Pursuant to 21 C.F.R.
1301.76(d), when a central fill pharmacy contracts with private, common or contract carriers to transport filled prescriptions to a retail pharmacy, the central fill pharmacy is responsible for reporting the in-transit loss upon discovery
of such loss by use of a DEA Form 106. In addition, when a retail pharmacy contracts with private, common or contract carriers to retrieve filled prescriptions from a central fill pharmacy, the retail pharmacy is responsible for reporting in-transit losses upon discovery using a DEA Form 106.
Breakage and Spillage
The breakage or spillage of controlled substances does not constitute a "loss" of controlled substances. When there is
breakage, damage, or spillage or some other form of destruction, any recoverable controlled substances must be disposed of according to DEA requirements. When this disposal occurs, it must be reported to DEA on a DEA Form 41
(Registrants Inventory of Drugs Surrendered). Damaged goods may also be disposed of through shipment to a reverse distributor or by a DEA approved process as defined in Section IV, Transfer or Disposal of Controlled Substances.
A paper version of the DEA Form 41 may be requested by writing to:
Drug Enforcement Administration
Attn: Registration Section/ODR
8701 Morrissette Drive
Springfield, Virginia 22152
Robberies and Burglaries Involving Controlled Substances
The Controlled Substance Registrant Protection Act of 1984 (CSRPA) was enacted to protect DEA registrants against
certain crimes (see Title 18 U.S.C. 2118 for a complete text of CSRPA). The CSRPA provides for the federal investigation of controlled substances thefts and robberies if any of the following conditions are met:
The replacement cost of the controlled substances taken is $500 or more.
Interstate or foreign commerce was involved in the execution of the crime.
A person was killed or suffered significant bodily injury as a result of the crime.
Penalties Upon Conviction - The perpetrator(s) convicted of violating CSRPAs provisions may be subject to the following penalties:
Burglary or robbery - a maximum $25,000 fine and/or 20 years imprisonment.
If a dangerous weapon was used to carry out the crime - a maximum $35,000 fine and/or 25 years imprisonment.
If death resulted from the crime - a maximum $50,000 fine and/or life imprisonment.
SECTION VI RECORDKEEPING REQUIREMENTS
Every pharmacy must maintain complete and accurate records on a current basis for each controlled substance purchased, received, stored, distributed, dispensed, or otherwise disposed of. These records are required to provide accountability of all controlled substances from the manufacturing process through the dispensing pharmacy and to the
ultimate user. The closed system reduces the potential for diversion of controlled substances.
All required records concerning controlled substances must be maintained for at least two years for inspection and
copying by duly authorized DEA officials. Records and inventories of schedule II controlled substances must be

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maintained separately from all other records of the registrant. All records and inventories of schedules III, IV, and V
controlled substances must be maintained either separately from all other records or in such a form that the information required is readily retrievable from the ordinary business records. Recordkeeping requirements for prescriptions
are detailed in Section VI, Prescription Records.
Readily retrievable is defined as:
Records kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such
a manner that they can be separated out from all other records in a reasonable time, and/or
Records kept in such a manner that certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.
Required Records
The records which must be maintained by a pharmacy are:
Executed and unexecuted official order forms (DEA Form 222) or the electronic equivalent
Power of Attorney authorization to sign order forms
Receipts and/or invoices for schedules III, IV, and V controlled substances
All inventory records of controlled substances, including the initial and biennial inventories, dated as of beginning or
close of business
Records of controlled substances distributed (i.e., sales to other registrants, returns to vendors, distributions to reverse
distributors)
Records of controlled substances dispensed (i.e., prescriptions, schedule V logbook)
Reports of Theft or Significant Loss (DEA Form 106), if applicable
Inventory of Drugs Surrendered for Disposal (DEA Form 41), if applicable
Records of transfers of controlled substances between pharmacies
DEA registration certificate
Self-certification certificate and logbook (or electronic equivalent) as required under the Combat Methamphetamine
Epidemic Act of 2005
Central Recordkeeping
A registrant desiring to maintain shipping and financial records (but not executed official order forms) at a central
location rather than the registered location must submit written notification of his/her intention by registered or certified mail, return receipt requested, in triplicate, to the Special Agent in Charge of the local DEA Diversion Field Office in which the registrant is located (Appendix K). Unless the registrant is informed by the DEA that the permission
to keep central records is denied, the registrant may begin maintaining central records 14 days after DEA receives
this notification. Central recordkeeping requirements are described in 21 C.F.R. 1304.04. Central recordkeeping
permits are no longer issued by the DEA.
Prescription Records
Pharmacies have two options for filing prescription records under the C.F.R. If there is a conflict between federal and
state requirements for filing prescriptions, DEA recognizes that the pharmacy must choose a filing system that would
comply with both federal and state law. All prescription records must be readily retrievable for DEA inspection.
Controlled substance prescriptions must be filed in one of the following ways:
Option 1 (Three separate files):
1. A file for schedule II controlled substances dispensed.

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2. A file for schedules III, IV and V controlled substances dispensed.
3. A file for all noncontrolled drugs dispensed.
Option 2 (Two separate files):
1. A file for all schedule II controlled substances dispensed.
2. A file for all other drugs dispensed (noncontrolled and those in schedules III, IV and V). If this method is used, a
prescription for a schedule III, IV or V drug must be made readily retrievable by use of a red "C" stamp not less than
one inch high. If a pharmacy has an electronic recordkeeping system for prescriptions which permits identification by
prescription number and retrieval of original documents by prescribers name, patients name, drug dispensed, and
date filled, the requirement to mark the hard copy with a red C is waived.
Electronic Prescription Records
1. If a prescription is created, signed, transmitted, and received electronically, all records related to that prescription
must be retained electronically.
2. Electronic records must be maintained electronically for two years from the date of their creation or receipt. However, this record retention requirement shall not pre-empt any longer period of retention which may be required now
or in the future, by any other Federal or State law or regulation, applicable to pharmacists or pharmacies.
3. Records regarding controlled substances must be readily retrievable from all other records. Electronic records must
be easily readable or easily rendered into a format that a person can read.
Records of electronic prescriptions for controlled substances shall be maintained in an application that meets the requirements of 21 C.F.R. 1311. The computers on which the records are maintained may be located at another location, but the records must be readily retrievable at the registered location if requested by the DEA or other law
enforcement agent. The electronic application must be capable of printing out or transferring the records in a format
that is readily understandable to an Administration or other law enforcement agent at the registered location. Electronic copies of prescription records must be sortable by prescriber name, patient name, drug dispensed, and date
filled.
SECTION VII INVENTORY REQUIREMENTS
An inventory is a complete and accurate list of all stocks and forms of controlled substances in the possession of
the registrant as determined by an actual physical count for schedule II controlled substances and an estimated count
or measure of the contents of a schedule III, IV, or V controlled substance (unless the container holds more than
1,000 tablets or capsules in which case an exact count of the contents must be made). The CSA also requires that all
inventory records be maintained at the registered location in a readily retrievable manner for at least two years for
copying and inspection. In addition, the inventory records of schedule II controlled substances must be kept separate
from all other controlled substances.
Initial Inventory
When issued a DEA registration, a registrant must take an initial inventory, which is an actual physical count of all
controlled substances in their possession. If there are no stocks of controlled substances on hand, the registrant should
make a record showing a zero inventory. There is no requirement to submit a copy of the inventory to the DEA. The
C.F.R. requires that the inventory include:
The date of the inventory,
Whether the inventory was taken at the beginning or close of business,
The name of each controlled substance inventoried,
The finished form of each of the substances (e.g., 10 milligram tablet),

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The number of dosage units of each finished form in the commercial container
(e.g., 100 tablet bottle),
The number of commercial containers of each finished form (e.g., four 100
tablet bottles), and
A count of the substance - if the substance is listed in schedule II, an exact count or measure of the contents or if the
substance is listed in schedules III, IV, or V, an estimated count or measure of the contents, unless the container holds
more than 1,000 tablets or capsules in which case, an exact count of the contents is required.
DEA recommends, but does not require, an inventory record include the name, address, and DEA registration number
of the registrant, and the signature of the person or persons responsible for taking the inventory.
Biennial Inventory
Following the initial inventory, the registrant is required to take a biennial inventory (every two years), which requires the same information as the initial inventory (see list above) of all controlled substances on hand. The biennial
inventory may be taken on any date which is within two years of the previous inventory date. There is no requirement
to submit a copy of the inventory to DEA.
Newly Scheduled Controlled Substance Inventory
When a drug not previously listed as a controlled substance is scheduled or a drug is rescheduled, the drug must be
inventoried as of the effective date of scheduling or change in scheduling.
SECTION VIII ORDERING CONTROLLED SUBSTANCES
Ordering Schedule II Controlled Substances
Only schedules I and II controlled substances are ordered with an official order form, DEA Form 222, or the electronic equivalent (see below, Controlled Substance Ordering System (CSOS) Electronic Order Forms). A DEA
Form 222 is required for each distribution, purchase, or transfer of a schedule II controlled substance.
When a controlled substance has been moved by DEA from schedule II to another schedule at the federal level, in
many states it may remain a schedule II controlled substance pending any legislative or administrative action that
may result from the federal action. Many states require transactions that involve substances they classify as schedule
II be made via official order forms (DEA Form 222) or the electronic equivalent. When federal law or regulations
differ from state law or regulations, a pharmacy is required to abide by the more stringent aspects of both the federal
and state requirements. When the use of DEA Form 222 or the electronic equivalent for the transfer of a controlled
substance is not required under federal law, its use as mandated by these states does not violate federal law and is
therefore permitted.
Requesting Official Order Forms
The unexecuted DEA Form 222 can be requested initially by checking "block 3" on the application for a new registration (DEA Form 224). The DEA Form 224 can be found online at www.DEAdiversion.usdoj.gov.
Once a registrant has received a DEA registration number, additional DEA Forms 222 may be ordered online at
www.DEAdiversion.usdoj.gov. When requesting additional DEA Forms 222 online, a valid DEA registration number, business name, and contact telephone number are required. The registrant may also request DEA Forms 222 by
calling the DEA Headquarters Registration Section at 1-800-882-9539 or by contacting the local DEA Registration
Specialist (Appendix J).

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Each book of DEA Form 222 consists of seven sets of forms. Each pharmacy is provided a maximum of six books at
one time unless its needs exceed this limit. In such a case, the pharmacy should contact the local DEA Registration
Specialist (Appendix J) to request additional books.
Completing Official Order Forms
When ordering schedule II controlled substances, the purchaser is responsible for filling in the number of packages,
the size of the package, and the name of the item. Each DEA Form 222 must be signed and dated by a person authorized to sign a registration application or a person granted power of attorney (see below, Power of Attorney to Sign an
Official Order Form). When the items are received, the pharmacist must document on the purchasers copy (copy
three) the actual number of packages received and the date received.
The executed DEA Form 222 must be maintained separately from the pharmacys other business records. However,
this does not preclude a registrant from attaching a copy of the supplier's invoice to the related DEA Form 222.
Title 21 C.F.R. 1305.15(a)(1) requires that, for orders using the DEA Form 222, an order must not be filled if the
order is not complete, legible, or properly prepared, executed, or endorsed, or if the order shows any alteration, erasure, or change of any description. For a discussion of the circumstances in which an electronic order must not be
filled see below, Controlled Substance Ordering System (CSOS) Electronic Order Forms.
A supplier may refuse to accept an order for any reason as set forth under 21 C.F.R. 1305.15(c). If a supplier refuses to accept an order, a statement that the order is not accepted is sufficient. If an order is refused, the supplier must
return copies one and two of the DEA Form 222 to the purchaser with a statement explaining the reason the order
was refused. For electronic orders, the supplier must notify the purchaser and provide a statement as to the reason
(see below, Controlled Substance Ordering System (CSOS) Electronic Order Forms).
DEA policy does not preclude the substitution of identical products differing in packaging size from those initially
ordered, provided that the actual quantity received does not exceed the amount initially ordered and that the National
Drug Code number reflected is that of the actual product shipped. For example, a distributor may substitute five bottles of 100, 2 milligram tablets for one bottle of 500, 2 milligram tablets or any variation thereof.
Cancellation and Voiding an Official Order Form
A purchaser may cancel an order (or partial order) on a DEA Form 222 by notifying the supplier in writing. The supplier must indicate the cancellation on Copies 1 and 2 of the DEA Form 222 by drawing a line through the cancelled
item(s) and printing cancelled in the space provided for the number of items shipped.
A supplier may void part or all of an order on a DEA Form 222 by notifying the purchaser in writing. The supplier
must indicate the voiding in Copies 1 and 2 of the DEA Form 222 by drawing a line through the cancelled item(s)
and printing void in the space provided for the number of items shipped. For information regarding cancelled electronic orders, see below, Controlled Substance Ordering System (CSOS) Electronic Order Forms.
Power of Attorney to Sign an Official Order Form
Any registrant (pharmacy) may authorize one or more individuals, whether or not they are located at the registered
location, to obtain and execute DEA Forms 222 by granting a power of attorney to each such individual. The power
of attorney must be signed by the same person who signed the most recent application for registration or renewal registration, as well as the individual being authorized to obtain and execute the DEA Forms 222.
The power of attorney may be revoked at any time by the person who granted and signed the power of attorney. Only
if the renewal application is signed by a different person is it necessary to
grant a new power of attorney when the pharmacy completes a renewal registration. The power of attorney should be
filed with executed DEA Forms 222 as a readily retrievable record. The power of attorney is not submitted to DEA.
Suggested formats for granting and revoking a power of attorney follow:

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Power of Attorney for DEA Forms 222 and Electronic Orders
_________________________ (Name of registrant)
_________________________(Address of registrant)
_________________________(DEA registration number)
I, _______________________________________________(name of person granting power), the undersigned, who
is authorized to sign the current application for registration of the above named registrant under the Controlled Substances Act or Controlled Substances Import and Export Act, have made, constituted, and appointed, and by these
presents, do make, constitute, and appoint _________________________________(name of attorney-in-fact), my
true and lawful attorney for me in my name, place, and stead, to execute applications for books of official order forms
and to sign such order forms in requisition for schedule I and II controlled substances, in accordance with Section
308 of the Controlled Substances Act (21 U.S.C. 828) and part 1305 of Title 21 of the Code of Federal Regulations. I
hereby ratify and confirm all that said attorney shall lawfully do or cause to be done by virtue hereof.
_____________________________
(Signature of person granting power)
I, _______________________(name of attorney-in-fact), hereby affirm that I am the person named herein as attorney-in-fact and that the signature affixed hereto is my signature.
_______________________
(Signature of attorney-in-fact)
Witnesses:
1. _______________________
2. _______________________
Signed and dated on the ___ day of ____________in the year____ at
Notice of Revocation
The foregoing power of attorney is hereby revoked by the undersigned, who is authorized to sign the current application for registration of the above-named registrant under the Controlled Substances Act. Written notice of this revocation has been given to the attorney-in-fact ____________________________ this same day.
_____________________________
(Signature of person revoking power)
Witnesses:
1. ______________________
2. ______________________
Signed and dated on the ___ day of ____________in the year____ at
Lost or Stolen Order Forms
When a pharmacist has not received an expected shipment of controlled substances, he/she should first contact the
supplier to determine whether the original DEA Form 222 was received. If the original order form has been lost or
stolen, the pharmacist must complete a second order form so the supplier can fill the original order. The pharmacist
must also prepare a statement which includes the first order forms serial number and date, and verify that the drugs
ordered were never received. The pharmacy must attach a copy of the statement to the second order form that is sent
to the supplier. In addition, the pharmacist must keep a copy of the statement with copy three from the first and second order forms.
A pharmacy, upon discovery of the loss or theft of used or unused order forms, must immediately report the loss to
the local DEA Diversion Field Office (Appendix K) and provide the serial numbers of each lost or stolen order form.
If an entire book or multiple books of order forms are lost or stolen, and the serial numbers of the missing forms cannot be identified, the pharmacist must report the approximate date of issuance (in lieu of the serial numbers) to the

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DEA. If an unused order form reported stolen or lost is later recovered or found, the pharmacy must immediately notify the local DEA Diversion Field Office.
Controlled Substance Ordering System (CSOS) Electronic Order Forms
Any registrant permitted to order schedule II controlled substances may do so electronically via the DEA Controlled
Substance Ordering System (CSOS) and maintain the records of these orders electronically for two years. The use of
electronic orders is optional; registrants may continue to issue orders on a paper DEA Form 222. CSOS allows for
secure electronic transmission of controlled substance orders without the supporting paper DEA Form 222. The adoption of the CSOS standards is the only allowance for the electronic transmission of schedule II controlled substance
orders between controlled substance manufacturers, distributors, pharmacies, and other DEA authorized entities.
CSOS uses Public Key Infrastructure (PKI) technology, which requires CSOS users to obtain a CSOS digital certificate for electronic ordering. The electronic orders must be signed using a digital signature issued by a Certification
Authority (CA) run by the DEA.
Digital certificates can be obtained only by registrants and individuals granted power of attorney by registrants to
sign orders. A registrant must appoint a CSOS coordinator who will serve as that registrant's recognized agent regarding issues pertaining to issuance of, revocation of, and changes to, digital certificates issued under that registrant's
DEA registration. A CSOS digital certificate will be valid until the DEA registration under which it is issued expires
or until the CSOS CA is notified that the certificate should be revoked. Certificates will be revoked if the certificate
holder is no longer authorized to sign schedule II orders for the registrant, if the information on which the certificate
is based changes, or if the digital certificate used to sign electronic orders has been compromised, stolen, or lost.
A Questions and Answers page about the CSOS certificate is available on the DEA E-Commerce Program website
at www.DEAecom.gov. Applicants can download the Diversion PKI CSOS Enrollment document and the CSOS
Subscribers Manual for assistance on the enrollment process. DEA maintains a support line to assist applicants and
subscribers with issues pertaining to certificate enrollment, issuance, revocation, and renewal. Staff is available from
8:00 a.m. to 6:00 p.m. (Eastern Time), Monday through Friday at 1-877-332-3266 if further assistance is needed.
Unaccepted and Defective Electronic Orders
An electronic order for controlled substances may not be filled if any of the following occurs:
1. The required data fields have not been completed.
2. The order is not signed using a digital certificate issued by DEA.
3. The digital certificate used has expired or been revoked prior to signature.
4. The purchasers public key will not validate the digital certificate.
5. The validation of the order shows that the order is invalid for any reason.
If an order cannot be filled, the supplier must notify the purchaser and provide a statement as to the reason (e.g., improperly prepared or altered). A supplier may, for any reason, refuse to accept any order. If a supplier refuses, a statement that the order is not accepted is sufficient.
When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must electronically link
the statement of nonacceptance to the original order. The original statement must be retained for two years. Neither a
purchaser nor a supplier may correct a defective order. The purchaser must issue a new order for the order to be
filled.
Cancellation and Voiding of Electronic Orders
A supplier may void all (or part) of an electronic order by notifying the purchaser of the voiding. If the entire order is
voided, the supplier must make an electronic copy of the order and indicate Void on the copy and return it to the
purchaser. The supplier is not required to retain a record of orders that are not filled. The purchaser must retain an

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electronic copy of the voided order. Should a supplier partially void an order, the supplier must indicate in the linked
record that nothing was shipped for each item voided.
Lost Electronic Orders
If a purchaser determines that an unfilled electronic order has been lost before or after receipt, the purchaser must
provide, to the supplier, a signed statement. This statement must include the unique tracking number and date of the
lost order and state that the goods covered by the first order were not received through loss of that order. If the purchaser executes a new order to replace the lost order, the purchaser must electronically link an electronic record of the
second order and a copy of the statement with the record of the first order and retain them both. If the supplier to
whom the order was directed subsequently receives the first order, the supplier must indicate that it is not accepted
and return it to the purchaser. The purchaser must link the returned order to the record of that order and the statement.
Ordering Schedules III-V Controlled Substances
The registrant must keep a receipt (invoice or packing slip) on which it records the date the drugs were received and
confirm that the order is accurate. These receipts must also contain the name of each controlled substance, the finished form, the number of dosage units of finished form in each commercial container, and the number of commercial containers ordered and received. In addition, these receipts must be maintained in a readily retrievable manner
for inspection by the DEA.
SECTION IX VALID PRESCRIPTION REQUIREMENTS
To dispense controlled substances, a pharmacist must know the requirements for a valid prescription which are described in this section. A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is not an order for medication which is dispensed for immediate administration to the ultimate user (i.e., an
order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription).
A prescription for a controlled substance must be dated and signed on the date when issued. The prescription must
include the patients full name and address, and the practitioners full name, address, and DEA registration number.
The prescription must also include:
Drug name
Strength
Dosage form
Quantity prescribed
Directions for use
Number of refills authorized (if any)
A prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner on the date when issued. An individual (i.e., secretary or nurse) may be designated by the practitioner to prepare
prescriptions for the practitioners signature. The practitioner is responsible for ensuring the prescription conforms to
all requirements of the law and regulations, both federal and state.
Who May Issue
A prescription for a controlled substance may only be issued by a physician, dentist, podiatrist, veterinarian, mid-level practitioner, or other registered practitioner who is:
Authorized to prescribe controlled substances by the jurisdiction in which the practitioner is licensed to practice, and
Registered with DEA or exempted from registration (e.g., Public Health Service, Federal Bureau of Prisons, military
practitioners), or

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An agent or employee of a hospital or other institution acting in the normal course of business or employment under
the registration of the hospital or other institution which is registered in lieu of the individual practitioner being registered, provided that additional requirements as set forth in the C.F.R. are met.
Purpose of Issue
To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and
dispensing of controlled substances.
A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying
the individual practitioner for the purpose of general dispensing to patients.
Corresponding Responsibility
A pharmacist also needs to know there is a corresponding responsibility for the pharmacist who fills the prescription.
An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and
authorized research is an invalid prescription within the meaning and intent of the CSA (21 U.S.C. 829). The person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties
provided for violations of the provisions of law relating to controlled substances.
A pharmacist is required to exercise sound professional judgment when making a determination about the legitimacy
of a controlled substance prescription. Such a determination is made before the prescription is dispensed. The law
does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin. To the contrary, the pharmacist who deliberately ignores a questionable prescription when there is reason to believe it was not
issued for a legitimate medical purpose may be prosecuted along with the issuing practitioner, for knowingly and intentionally distributing controlled substances. Such action is a felony offense, which may result in the loss of ones
business or professional license (see United States v. Kershman, 555 F.2d 198 [United States Court Of Appeals,
Eighth Circuit, 1977]).
Electronic Prescriptions
On March 31, 2010 the DEA published in the Federal Register an interim final rule Electronic Prescriptions for Controlled Substances which became effective June 1, 2010. The rule revises DEA regulations to provide practitioners
with the option of writing prescriptions for controlled substances electronically. The regulations also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These regulations are an addition to, not a replacement of, the existing rules.
Persons who wish to dispense controlled substances using electronic prescriptions must select software that meets the
requirements of this rule. As of June 1, 2010, only those electronic pharmacy applications that comply with all of
DEAs requirements as set forth in 21 C.F.R. 1311 may be used by DEA-registered pharmacies to electronically receive and archive controlled substances prescriptions and dispense controlled substances based on those prescriptions.
A registered pharmacy may process electronic prescriptions for controlled substances only if the following conditions
are met:
The pharmacy uses a pharmacy application that meets all of the applicable requirements of 21 C.F.R. 1311, and
The prescription is otherwise in conformity with the requirements of the CSA and 21 C.F.R. 1311.
A pharmacy cannot process electronic prescriptions for controlled substances until its pharmacy application provider
obtains a third party audit or certification review that determines that the application complies with DEAs requirements and the application provider provides the audit/certification report to the pharmacy. The audit report the pharmacy will receive from the pharmacy application provider will indicate if the application is capable of importing,
displaying, and storing DEA-required prescription information accurately and consistently. If the third-party auditor
or certification organization finds that a pharmacy application does not accurately and consistently import, store, and
display the information related to the name, address, and registration number of the practitioner, patient name and

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address, and prescription information (drug name, strength, quantity, directions for use), the indication of signing,
and the number of refills, the pharmacy must not accept electronic prescriptions for the controlled substance.
If the third-party auditor or certification organization finds that a pharmacy application does not accurately and consistently import, store, and display other information required for prescriptions, the pharmacy must not accept electronic prescriptions for controlled substances that are subject to the additional information requirements. For
example, until the audit or certification report indicates that the pharmacy application can import, display, and store
both a hospital DEA number and the individual practitioners extension number, the pharmacy must not accept electronic prescriptions that include only a hospital DEA registration number. The pharmacy may, however, use the application to process other controlled substance prescriptions if the audit or certification report has found that the
pharmacy application meets all other requirements.
The pharmacy must determine which employees are authorized to enter information regarding the dispensing of controlled substance prescriptions and annotate or alter records of these prescriptions (to the extent such alterations are
permitted under DEA regulations). The pharmacy must ensure that logical access controls in the pharmacy application are set so that only such employees are granted access to perform these functions.
When a pharmacist fills a prescription in a manner that would require, under 21 C.F.R. 1306, the pharmacist to
make notation on the prescription if the prescription were a paper prescription, the pharmacist must make the same
notation electronically when filling an electronic prescription and retain the annotation electronically in the prescription record or linked files. When a prescription is received electronically, the prescription and all required annotations must be stored electronically.
When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically
to the pharmacy, the pharmacist must check the pharmacys records to ensure that the electronic version was not received and the prescription dispensed. If both prescriptions were received, the pharmacist must mark one as void.
When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically
to another pharmacy, the pharmacist must check with that pharmacy to determine whether the prescription was received and dispensed. If the pharmacy that received the original electronic prescription had not dispensed the prescription, that pharmacy must mark the electronic version as void or cancelled. If the pharmacy that received the
original electronic prescription dispensed the prescription, the pharmacy with the paper version must not dispense the
paper prescription and must mark the prescription as void.
Verification of Practitioner Registration
A pharmacist has a responsibility to ensure that a prescription has been issued by an appropriately registered or exempt practitioner (see above, Who May Issue). As such, it is helpful to be familiar with how a DEA registration number is constructed and to whom such registrations are issued.
Construction of Valid DEA Registration Number for Practitioners
Knowing how a DEA registration number is constructed can be a useful tool for recognizing a forged prescription
(see Appendix D, Pharmacists Guide to Prescription Fraud). Prior to October 1, 1985, DEA registration numbers
for physicians, dentists, veterinarians, and other practitioners started with the letter A. New registration numbers issued to practitioners after that date begin with the letter B or F. Registration numbers issued to mid-level practitioners
begin with the letter M. The first letter of the registration number is almost always followed by the first letter of the
registrants last name (e.g., J for Jones or S for Smith) and then a computer generated sequence of seven numbers
(such as MJ3614511).
Practitioners Use of a Hospitals DEA Registration Number
Practitioners (e.g., intern, resident, staff physician, mid-level practitioner) who are agents or employees of a hospital
or other institution, may, when acting in the usual course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the
hospital or other institution in which he or she is employed, in lieu of individual registration, provided that:
The dispensing, administering, or prescribing is in the usual course of professional practice.

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The practitioner is authorized to do so by the state in which they practice.
The hospital or institution has verified that the practitioner is permitted to administer, dispense, or prescribe controlled substances within the state.
The practitioner acts only within the scope of employment in the hospital or institution.
The hospital or institution authorizes the practitioner to administer, dispense, or prescribe under its registration and
assigns a specific internal code number for each practitioner.
An example of a specific internal code number is depicted below:

A current list of internal codes and the corresponding individual practitioners is to be maintained by the hospital or
other institution. This list is to be available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner. Pharmacists should contact
the hospital or other institution for verification if they have any doubts in filling such a prescription.
Exemption of Federal Government Practitioners from Registration
The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast
Guard, Public Health Service, or Bureau of Prisons, who is authorized to administer, dispense, or prescribe, but not to
procure or purchase controlled substances in the course of his or her official duties. Such officials must follow procedures set forth in 21 C.F.R. part 1306 regarding prescriptions, but must also state the branch of service or agency
(e.g., "U.S. Army" or "Public Health Service") and the service identification number of the issuing official in lieu of
the registration number required on prescription forms. The service identification number for a Public Health Service
employee is his or her Social Security identification number.
If federal government practitioners wish to maintain a DEA registration for a private practice, which would include
prescribing for private patients, these practitioners must be fully licensed to handle controlled substances by the state
in which they are located.
Registration Requirements for Mid-Level Practitioners
Mid-level practitioners (MLPs) are registered and authorized by the DEA and the state in which they practice to dispense, administer, and prescribe controlled substances in the course of professional practice (see Appendix B, Definitions). Examples of MLPs include, but are not limited to, nurse practitioners, nurse midwives, nurse anesthetists,
clinical nurse specialists, physician assistants, optometrists, ambulance services, animal shelters, euthanasia technicians, nursing homes, and homeopathic physicians.
MLPs may apply for an individual DEA registration granting controlled substance privileges. However, such registration is contingent upon the authority granted by the state in which they are licensed. The DEA may register MLPs
whose states clearly authorize them to prescribe, dispense, and administer controlled substances in one or more
schedules.
It is incumbent upon the pharmacist who fills the prescription to ensure that the MLP is prescribing within the parameters established by the state in which he/she practices. MLP authority to prescribe controlled substances varies greatly by state. Pharmacists should check with the state licensing or controlled substances authority to determine which
MLP disciplines are authorized to prescribe controlled substances in the state. Pharmacists may also visit the DEA
Diversion website at www.DEAdiversion.usdoj.gov for a chart indicating the prescribing authority of MLPs by state
(click on Registration Support and scroll down to Mid-Level Practitioners Authorization by State).

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For electronic prescriptions written by mid-level practitioners, if required by State law, a supervisors name and DEA
number may be listed on the prescription, provided the prescription clearly indicates who is the supervisor and who is
the prescribing practitioner.
Schedule II Controlled Substances
Schedule II controlled substances require a written prescription which must be manually signed by the practitioner or
an electronic prescription that meets all DEA requirements for electronic prescriptions for controlled substances.
There is no federal time limit within which a schedule II prescription must be filled after being signed by the practitioner. However, the pharmacist must determine that the prescription is still needed by the patient. While some states
and many insurance carriers limit the quantity of controlled substances dispensed to a 30-day supply, there are no express federal limits with respect to the quantities of drugs dispensed via a prescription. However, the amount dispensed must be consistent with the requirement that a prescription for a controlled substance be issued only for a
legitimate medical purpose by a practitioner acting in the usual course of professional practice. For a schedule II controlled substance, an oral order is only permitted in an emergency situation (see Section X, Emergency Dispensing).
Refills
The refilling of a prescription for a controlled substance listed in schedule II is prohibited
(21 U.S.C. 829(a)).
Issuance of Multiple Prescriptions for Schedule II Controlled Substances
The DEA has revised its regulations regarding the issuance of multiple prescriptions for schedule II controlled substances. Under the new regulation, which became effective December 19, 2007, an individual practitioner may issue
multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled
substance provided the following conditions are met:
Each prescription must be issued on a separate prescription blank.
Each separate prescription must be issued for a legitimate medical purpose by an individual practitioner acting in the
usual course of professional practice.
The individual practitioner must provide written instructions on each prescription (other than the first prescription, if
the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which
a pharmacy may fill each prescription.
The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not
create an undue risk of diversion or abuse.
The issuance of multiple prescriptions is permissible under applicable state laws.
The individual practitioner complies fully with all other applicable requirements under the CSA and C.F.R., as well
as any additional requirements under state law.
It should be noted that the implementation of this change in the regulation should not be construed as encouraging
individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound
medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple
prescriptions and how often to see their patients when doing so.

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Facsimile Prescriptions for Schedule II Controlled Substances
In order to expedite the filling of a prescription, a prescriber may transmit a schedule II prescription to the pharmacy
by facsimile. The original schedule II prescription must be presented to the pharmacist and verified against the facsimile at the time the controlled substance is actually dispensed. The pharmacist must make sure the original document is properly annotated and filed with the records that are required to be kept.
Exceptions for Schedule II Facsimile Prescriptions
DEA has granted three exceptions to the facsimile prescription requirements for schedule II controlled substances.
The facsimile of a schedule II prescription may serve as the original prescription as follows:
A practitioner prescribing a schedule II narcotic controlled substance to be compounded for the direct administration
to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may transmit the prescription by facsimile. The pharmacy will consider the facsimile prescription a written prescription and no further documentation is required. All normal requirements of a legal prescription must be followed.
Practitioners prescribing schedule II controlled substances for residents of Long Term Care Facilities may transmit a
prescription by facsimile to the dispensing pharmacy. The facsimile prescription serves as the original written prescription for the pharmacy. No further documentation is required.
A practitioner prescribing a schedule II narcotic controlled substance for a patient enrolled in a hospice care program
certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state, may
transmit a prescription to the dispensing pharmacy by facsimile. The practitioner will note on the prescription that it
is for a hospice patient. The facsimile serves as the original written prescription. No further documentation is required.
Schedules III-V Controlled Substances
A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V only pursuant to either a
paper prescription signed by a practitioner, a facsimile of a signed paper prescription transmitted by the practitioner
or the practitioner's agent to the pharmacy, an electronic prescription that meets DEAs requirements for such prescriptions, or a call-in as indicated below (see Telephone Authorization for Schedules III-V Controlled Substances).
Refills
Schedules III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to five times within six months after the date of issue. After five refills or after six
months, whichever occurs first, a new prescription is required.
When a prescription for any controlled substance in schedules III or IV is refilled, the following information must be
entered on the back of the prescription: the dispensing pharmacists initials, the date the prescription was refilled, and
the amount of drug dispensed on the refill. If the pharmacist only initials and dates the back of the prescription, the
pharmacist will be deemed to have dispensed a refill for the full face amount of the prescription.
Electronic Recordkeeping of Schedules III-IV Prescription Information
A pharmacy is permitted to use an electronic recordkeeping system as an alternative to the manual method for the
storage and retrieval of original paper prescription orders for schedules III and IV controlled substances.
The electronic system must provide online retrieval of original prescription information for those prescriptions which
are currently authorized for refill. The information must include, but is not limited to: the original prescription number; date of issuance; full name and address of the patient; the prescribers name, address, and DEA registration num-

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ber; the name, strength, dosage form and quantity of the controlled substance prescribed (and quantity dispensed if
different from the quantity prescribed); and the total number of refills authorized by the prescriber.
In addition, the electronic system must provide online retrieval of the current refill history for schedules III or IV
controlled substance prescriptions. This information must include, but is not limited to: the name of the controlled
substance, the date of refill, the quantity dispensed, the dispensing pharmacists identification code or name/initials
for each refill, and the total number of refills dispensed to date for that prescription.
The pharmacist must verify and document that the refill data entered into the system is correct. All computer generated prescription/refill documentation must be stored in a separate file at the pharmacy and must be maintained for a
period of two years from the dispensing date. To meet the C.F.R. recordkeeping requirements, the pharmacys electronic system must comply with the following guidelines:
If the system provides a hard copy printout of each days controlled substance prescription refills, each pharmacist
who refilled those prescriptions must verify his/her accuracy by signing and dating the printout as he/she would sign
a check or legal document.
The printout must be provided to each pharmacy that uses the computer system within 72 hours of the date on which
the refill was dispensed. The printout must be verified and signed by each pharmacist who dispensed the refills.
In lieu of such a printout, the pharmacy must maintain a bound logbook or a separate file in which each pharmacist
involved in the days dispensing signs a statement, verifying that the refill information entered into the computer that
day has been reviewed by him/her and is correct as shown.
A pharmacys electronic system must have the capability of printing out any refill data which the pharmacy must
maintain under the CSA. For example, this would include a refill-by-refill audit trail for any specified strength and
dosage form of any controlled substance, by either brand or generic name or both, dispensed by the pharmacy. Such a
printout must include:

Prescribing practitioners name

Patients name and address

Quantity and date dispensed on each refill

Name or identification code of the dispensing pharmacist

Original prescription number

In any electronic system employed by a user pharmacy, the central recordkeeping location must be capable of providing a printout to a requesting pharmacy of the above information within 48 hours.
In case a pharmacy's electronic system experiences downtime, the pharmacy must have a back-up procedure to document in writing refills of schedules III or IV controlled substances. This procedure must ensure that refills are authorized by the original prescription, that the maximum number of refills has not been exceeded, and that all required
data is retained for online entry as soon as possible.
A pharmacy may use only one of the two systems described (i.e., manual or electronic) for storage and retrieval of
prescription order refill information of schedules III or IV controlled substances.
Facsimile Prescriptions for Schedules III-V Controlled Substances
Prescriptions for schedules III-V controlled substances may be transmitted by facsimile from the practitioner or the
practitioners agent to the dispensing pharmacy. The facsimile is considered to be equivalent to an original prescription as long as the practitioner has manually signed the prescription.

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Telephone Authorization for Schedules III-V Prescriptions
A pharmacist may dispense a controlled substance listed in schedules III, IV, or V pursuant to an oral prescription
made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required for a valid prescription except for the signature of the practitioner (see Appendix D, Pharmacists Guide to
Prescription Fraud).
Transfer of Schedules III-V Prescription Information
A DEA registered pharmacy may transfer original prescription information for schedules III, IV, and V controlled
substances to another DEA registered pharmacy for the purpose of refill dispensing between pharmacies, on a one
time basis only. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescribers authorization.
Transfers are subject to the following requirements:
1. Write the word VOID on the face of the invalidated prescription; for electronic prescriptions, information that
the prescription has been transferred must be added to the prescription record.
2. Record on the reverse of the invalidated prescription the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information; for electronic
prescriptions, such information must be added to the prescription record.
3. Record the date of the transfer and the name of the pharmacist transferring the information.
For paper prescriptions and prescriptions received orally and reduced to writing by the pharmacist, the pharmacist
receiving the transferred prescription information must write the word transfer on the face of the transferred prescription and reduce to writing all information required to be on a prescription and include:
1. Date of issuance of original prescription.
2. Original number of refills authorized on original prescription.
3. Date of original dispensing
4. Number of valid refills remaining and date(s) and locations of previous refill(s).
5. Pharmacys name, address, DEA registration number, and prescription number from which the prescription information was transferred.
6. Name of pharmacist who transferred the prescription.
7. Pharmacys name, address, DEA registration number, and prescription number from which the prescription was
originally filled.
For electronic prescriptions being transferred electronically, the transferring pharmacist must provide the receiving
pharmacist with the following information in addition to the original electronic prescription data:
1. The date of the original dispensing
2. The number of refills remaining and the date(s) and locations of previous refills
3. The transferring pharmacys name, address, DEA registration number, and prescription number for each dispensing.
4. The name of the pharmacist transferring the prescription.
5. The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the
prescription, if different.

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The pharmacist receiving a transferred electronic prescription must create an electronic record for the prescription
that includes the receiving pharmacists name and all of the information transferred with the prescription (listed
above).
The original and transferred prescription(s) must be maintained for a period of two years from the date of last refill.
Pharmacies electronically accessing the same prescription record must satisfy all information requirements of a manual mode for prescription transferal.
The procedure allowing the transfer of prescription information for refill purposes is permissible only if allowable
under existing State or other applicable law.
Pharmacies electronically sharing a real time, online database may transfer up to the maximum refills permitted by
law and the prescribers authorization.
Prescription Monitoring Programs
A prescription monitoring program is a state-administered data collection system used to gather prescription information. This information may be made available to state and federal investigators on a need-to-know basis.
Many states have established an electronic prescription drug monitoring program because it has proven to be an effective tool for detecting pharmaceutical diversion and for developing pharmacist and physician medical education
programs. These programs heighten awareness about diversion, prescription drug abuse, drug trends, and are useful
for tracking prescription medication dispensed within a state. In some states, the data can be used by pharmacists to
identify potential "doctor shoppers" and those who attempt to obtain controlled substances by fraud, forgery, or deceit.
In the states that have adopted these programs, a large part of their success has been attributed to the pharmacists
participation. The DEA strongly endorses prescription monitoring programs.
SECTION X DISPENSING REQUIREMENTS
Required Information for Prescription Labels
The pharmacist dispensing a prescription for a controlled substance listed in schedules II, III, IV, or V must affix to
the package a label showing date of filling, the pharmacy name and address, the serial (prescription) number, the
name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any,
contained in such prescription or required by law. If a prescription is filled at a central fill pharmacy, the central fill
pharmacy must affix to the package a label showing the retail pharmacy name and address and a unique identifier
(i.e., the central fill pharmacy's DEA registration number) indicating that the prescription was filled at the central fill
pharmacy.
Federal Food and Drug Administration regulations require that the label of any drug listed as a "controlled substance"
in schedules II, III, or IV of the CSA must, when dispensed to or for a patient, contain the following warning: CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed. In addition, a pharmacist who receives a prescription for a controlled substance must dispense that
prescription to the patient or a member of the patients household. To provide the controlled substance to anyone other than the patient or a member of the patients household is distribution, not dispensing.
Schedule II Controlled Substance Prescriptions
A pharmacist may dispense a schedule II controlled substance, which is a prescription drug as determined under the
Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the practitioner, except in an
emergency situation as described below.

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Emergency Dispensing
An emergency prescription in this context, is defined to mean that the immediate administration of the drug is necessary for proper treatment of the intended ultimate user, that no alternative treatment is available (including a drug
which is not a schedule II controlled substance), and it is not possible for the prescribing practitioner to provide a
written prescription for the drug at that time. In a bona fide emergency, a practitioner may telephone a schedule II
prescription to the pharmacist who may then dispense the prescription. The prescribing practitioner must provide a
written and signed prescription to the pharmacy within seven days and meet the below requirements:
1. The drug prescribed and dispensed must be limited to the amount needed to treat the patient during the emergency
period. Prescribing or dispensing beyond the emergency period must be pursuant to a written prescription order.
2. The prescription order must be immediately reduced to writing by the pharmacist and must contain all information,
except for the prescribing practitioners signature.
3. If the prescribing individual practitioner is not known to the pharmacist, he/she must make a reasonable effort to
determine that the oral authorization came from a registered individual practitioner, which may include a call back to
the prescribing individual practitioner using his or her telephone number as listed in the telephone directory and/or
other good faith efforts to insure his or her identity.
4. Within seven days after authorizing an emergency telephone prescription, the prescribing practitioner must furnish
the pharmacist a written, signed prescription for the controlled substance prescribed. The prescription must have written on its face Authorization for Emergency Dispensing and the date of the oral order. The written prescription may
be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the seven
day period. Upon receipt, the dispensing pharmacist must attach this written prescription to the oral emergency prescription which had earlier been reduced to writing by the pharmacist. By regulation, the pharmacist must notify the
local DEA Diversion Field Office (Appendix K) if the prescriber fails to provide a written prescription within seven
days. Failure of the pharmacist to do so will void the authority conferred on the pharmacy to dispense the controlled
substance without a written prescription of a prescribing practitioner.
5. For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription with the original
authorization and date of the oral order.
Partial Dispensing
A prescription for a schedule II controlled substance may be partially dispensed if the pharmacist is unable to supply
the full quantity of a written or emergency oral (telephone) prescription, provided the pharmacist notes the quantity
supplied on the front of the written prescription, on a written record of the emergency oral prescription, or in the electronic prescription record. The remaining portion may be dispensed within 72 hours of the first partial dispensing.
However, if the remaining portion is not or cannot be filled within the 72 hour period, the pharmacist must notify the
prescribing practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.
Partial Filling of Schedule II Prescriptions for Terminally Ill or Long Term Care Facility Patients
A prescription for a schedule II controlled substance written for a patient in a Long Term Care Facility (LTCF) or for
a patient with a medical diagnosis documenting a terminal illness, may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing
practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient.
The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" must be deemed
to have been filled in violation of the CSA. For each partial filling, the dispensing pharmacist must record on the
back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of

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the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. The total quantity of schedule II controlled substances dispensed in all partial fillings must not
exceed the total quantity prescribed. Schedule II prescriptions for patients in an LTCF or terminally ill patients are
valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication.
Schedules III-V Controlled Substance Prescriptions
A pharmacist may dispense a controlled substance in schedules III, IV, or V having received either a paper prescription signed by a practitioner, a facsimile of that prescription transmitted by the practitioner or their agent to the pharmacy, an electronic prescription that meets DEAs requirements for such prescriptions, or an oral prescription made
by an individual practitioner. The pharmacist must promptly reduce the oral prescription to writing, including all required information except the signature of the prescribing practitioner.
Partial Dispensing
A pharmacist may partially dispense a prescription for schedules III-V controlled substances provided that each partial filling is recorded in the same manner as a refilling, the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs beyond six months from the date on which the
prescription was issued.
Dispensing Without a Prescription
Dispensing a controlled substance without a prescription is outlined in 21 C.F.R. 1306.26.
The regulation states that a controlled substance listed in schedules II, III, IV, or V which is not a prescription drug as
determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that:
Such dispensing is made only by a pharmacist and not by a non-pharmacist employee even if under the supervision
of a pharmacist (although after the pharmacist has fulfilled his or her professional and legal responsibilities, the actual cash, credit transaction, or delivery, may be completed by a non-pharmacist);
Not more than 240 cc. (8 ounces) of any such controlled substance containing opium, nor more than 120 cc. (4 ounces) of any other such controlled substance, nor more than 48 dosage units of any such controlled substance containing
opium, nor more than 24 dosage units of any other such controlled substance, may be dispensed at retail to the same
purchaser in any given 48-hour period;
The purchaser is at least 18 years of age and the pharmacist requires every purchaser of a controlled substance under
this section not known to him or her to furnish suitable identification (including proof of age where appropriate);
A bound record book (which must be maintained in accordance with the recordkeeping requirement of 21 C.F.R.
1304.04) for dispensing of controlled substances is maintained by the pharmacist, which contains the name and address of the purchaser, the name and quantity of the controlled substance purchased, the date of each purchase, and
the name or initials of the pharmacist who dispensed the substance to the purchaser;
The prescription is not required for distribution or dispensing of the substance pursuant to any other Federal, State or
local law; and
Central fill pharmacies may not dispense controlled substances at the retail level to a purchaser.
Delivery of a Controlled Substance to Persons in Other Countries
Controlled substances that are dispensed pursuant to a legitimate prescription may not be delivered or shipped to individuals in other countries without proper authorization. Any such delivery or shipment is an export under the CSA
and cannot be conducted unless the person sending the controlled substances:

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Has registered with DEA as an "exporter" (see 21 C.F.R. 1301 and 1309).
Has obtained the necessary permit(s), or submitted the necessary declaration(s) for export (21 C.F.R. 1312 or
1313).
SECTION XI Ryan Haight Online Pharmacy Consumer Protection Act of 2008
Summary of the Acts Major Provisions
On October 15, 2008, the President signed into law the Ryan Haight Online Pharmacy Consumer Protection Act of
2008, often referred to as the Ryan Haight Act. This law amends the CSA by adding a series of new regulatory requirements and criminal provisions designed to combat the proliferation of so-called rogue Internet sites that unlawfully dispense controlled substances by means of the Internet. The Ryan Haight Act applies to all controlled
substances in all schedules.
This law became effective April 13, 2009. As of that date, it is illegal under federal law to deliver, distribute, or dispense a controlled substance by means of the Internet unless the online pharmacy holds a modification of DEA registration authorizing it to operate as an online pharmacy. Thus, any person who knowingly or intentionally dispenses a
controlled substance by means of the Internet that does not have a modification of DEA registration allowing such
activity is in violation of 21 U.S.C. 841(h)(1) and subject to potential criminal prosecution and (in the case of DEA
registrants) loss of DEA registration.
Note: The information contained in this section is meant to summarize the Ryan Haight Act but should not be
relied upon as setting forth all the requirements. As is always the case, pharmacies are responsible for complying with the actual text of the CSA and DEA regulations.
Definition of an Online Pharmacy
An online pharmacy is a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet. Examples of an online pharmacy include (but are not limited to) the following:

Any website that sells, or offers to sell, any controlled substance or a prescription therefor to a person in the
United States.

Any person who operates such a website.

Any person who pays a practitioner to write prescriptions for controlled substances for customers of such a website.

Any person who pays a pharmacy to fill prescriptions for controlled substances that were issued to customers of
such a website.

Any pharmacy that knowingly or intentionally fills prescriptions for controlled substances that were issued to
customers of such a website.

Any person who sends an e-mail that:

offers to sell a controlled substance or a prescription for a controlled substance in a manner not authorized by the Act;
directs buyers to a website operating in violation of the Act;
or otherwise causes or facilitates the delivery, distribution, or dispensing of a controlled substance in a manner not
authorized by the Act.
Online Pharmacy Registration Exemptions
The following are exempt from the Ryan Haight Act's definition of an online pharmacy so long as their activities
are limited solely to the exemptions provided:

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Manufacturers or distributors registered under 21 U.S.C. 823(a), (b), (d), or (e) who do not dispense controlled
substances to nonregistrants.

Nonpharmacy practitioners who are registered under 21 U.S.C. 823(f) and whose activities are authorized by
that registration, provided that any website operated by such nonpharmacy practitioners complies with 21 C.F.R.
1304.50, which requires the website to post in a visible and clear manner on its homepage, or on a page directly
linked thereto in which the hyperlink is also visible and clear on the homepage, a list of the DEA-registered nonpharmacy practitioners who are affiliated with the website.

Any hospital or other medical facility registered under 21 U.S.C. 823(f) that is operated by an agency of the
United States (including the Armed Forces).

A health care facility owned or operated by an Indian tribe or tribal organization carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act.

Any agent or employee of any hospital or facility that is operated by an agency of the United States, and any
agent or employee of any hospital or facility owned or operated by an Indian tribe or tribal organization carrying out
a contract or compact under the Indian Self-Determination and Education Assistance Act, provided such agent or employee is lawfully acting in the usual course of business or employment, and within the scope of the official duties of
such agent or employee, with such hospital or facility, and, with respect to agents or employees of such health care
facilities only to the extent such individuals are furnishing services pursuant to those contracts or compacts.

Mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance.

A person, entity, or Internet site that is not in the United States and does not facilitate the delivery, distribution,
or dispensing of a controlled substance by means of the Internet to any person in the United States.

A pharmacy registered under 21 U.S.C. 823(f) whose dispensing of controlled substances via the Internet consists solely of "refilling prescriptions for controlled substances in schedule III, IV, or V," as that term is defined in
21 C.F.R. 1300.04(k). (This definition is set forth at the end of this section.)

A pharmacy registered under 21 U.S.C. 823(f) whose dispensing of controlled substances via the Internet consists solely of "filling new prescriptions for controlled substances in schedule III, IV, or V," as that term is defined
in 21 C.F.R. 1300.04(d). (This definition is set forth at the end of this section.)

Any registered pharmacy whose delivery, distribution, or dispensing of controlled substances by means of the
Internet consists solely of filling prescriptions that were electronically prescribed in a manner authorized by the CSA.

Any registered pharmacy whose delivery, distribution, or dispensing of controlled substances by means of the
Internet consists solely of the transmission of prescription information between a pharmacy and an automated dispensing system located in a Long Term Care Facility when the registration of the automated dispensing system is
held by that pharmacy as described in 21 C.F.R 1301.17 and 1301.27 and the pharmacy is otherwise complying
with the DEA regulations.
Notification Requirements
Thirty days prior to offering a controlled substance for sale, delivery, distribution, or dispensing by means of the Internet, the online pharmacy shall notify DEA and the State boards of pharmacy in any States in which the online
pharmacy offers to sell, deliver, distribute, or dispense controlled substances. Completion of the Application for Modification of Registration for Online Pharmacies serves as the notification requirement to DEA.
The online pharmacy must make a separate thirty-day advance notice to the State boards of pharmacy in each State in
which it intends to offer to sell, deliver, distribute, or dispense controlled substances. Online pharmacies that apply
for the modification of registration are required to certify that the applicable State boards of pharmacy have been notified.
How to Register as an Online Pharmacy
To operate legally as an online pharmacy, the online pharmacy must first be registered with DEA as a pharmacy.
Once registered with DEA as a pharmacy, the pharmacy may apply for a modification of registration to operate as an

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online pharmacy. To apply for a modification of registration, complete the Application for Modification of Registration for Online Pharmacies online at www.DEAdiversion.usdoj.gov. There is no fee to apply to modify a DEA registration to an online pharmacy.
If the modification of registration is approved, the pharmacy will be issued a modified DEA Certificate of Registration with the new business activity listed as online pharmacy. The registrant will keep the same DEA registration
number. A pharmacy may perform the activities of a retail pharmacy and an online pharmacy at the same time.
State Licensure Requirements
An online pharmacy must comply with the requirements of all applicable State laws concerning the licensure of pharmacies in each State from which it, and in each State to which it, delivers, distributes, or dispenses, or offers to deliver, distribute, or dispense, controlled substances by means of the Internet. In addition, online pharmacies must certify
they are in compliance with these requirements when completing the Application for Modification of Registration for
Online Pharmacies.
The requirement that an online pharmacy list the States in which it is licensed to dispense controlled substances is
designed to ensure that an online pharmacy only dispenses controlled substances to patients in States in which it is
authorized to practice pharmacy. Dispensing beyond the scope of State licensure is one of the recurring transgressions of some rogue online pharmacies and generally violates State law. Under this Act, a State may bring civil action
in federal court to enjoin any violation of the Ryan Haight Act not merely those violations of State law and to obtain other appropriate legal or equitable relief. 21 U.S.C. 882(c).
Online Pharmacy Website Requirements
When a pharmacy applies for a modification of registration to become an online pharmacy, it must display on its
homepage a declaration that it has done so. This declaration must state the following:
In accordance with the Controlled Substances Act and the DEA regulations, this online pharmacy has made the notifications to the DEA Administrator required by 21 U.S.C. 831 and 21 C.F.R. 1304.40.
Once approved to operate as an online pharmacy, the online pharmacy must display at all times on the homepage of
its Internet site a declaration of compliance with the requirements of 21 U.S.C. 831 with respect to the delivery or
sale or offer for sale of controlled substances. This statement must include the name of the pharmacy as it appears on
the DEA Certificate of Registration.
An online pharmacy is required to post Internet Pharmacy Site Disclosure Information on the homepage of each Internet site it operates. It must be posted in a visible and clear manner and contain the following information:
The name and address of the pharmacy as it appears on the pharmacys DEA Certificate of Registration.
The pharmacys telephone number and e-mail address.
Name of pharmacist-in-charge, professional degree, States of licensure, and telephone number.
List of State(s) in which the pharmacy is licensed to dispense controlled substances.
Certification that the pharmacy is registered to deliver, distribute, or dispense controlled substances by means of the
Internet.
The name, address, telephone number, professional degree, and States of licensure of any practitioner who has a contractual relationship to provide medical evaluations or issue prescriptions for controlled substances, through referrals
from the website or at the request of the owner or operator of the website, or any employee or agent thereof.
The following statement must be visible on the website:
This online pharmacy is obligated to comply fully with the Controlled Substances Act and DEA regulations. As part
of this obligation, this online pharmacy has obtained a modified DEA registration authorizing it to operate as an online pharmacy. In addition, this online pharmacy will only dispense a controlled substance to a person who has a
valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing
practitioner. This includes at least one prior in-person medical evaluation in accordance with section 309 of the

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Controlled Substances Act (21 U.S.C. 829), or a medical evaluation via telemedicine in accordance with section
102(54) of the Controlled Substances Act (21 U.S.C. 802(54)).
If at any time an online pharmacy should change its Internet site web address, the online pharmacy must notify DEA
at least thirty days in advance of this change.
Reporting Requirements
Each online pharmacy must submit a monthly report to DEA of the total quantity of each controlled substance that
the online pharmacy has dispensed the previous calendar month. The report is required for every month in which the
total amount of dispensing of controlled substances by the pharmacy is either (i) over 100 prescriptions filled or (ii)
5,000 or more dosage units dispensed of all controlled substances combined. Should an online pharmacys total quantity of dispensed controlled substances fall below both of the thresholds listed above, a report is still required that indicates a negative response for that given month.
The report must include the total amount of such dispensing by any means including all controlled substances dispensed via Internet transactions, mail-order transactions, face-to-face transactions, or any other means. It is not required that the online pharmacy identify the means of the dispensing in its report. Reporting will be by National Drug
Code (NDC) numbers. Report the total number of dosage units dispensed for each NDC number.
This report is due on or before the 15th day of the following month. For example, an online pharmacy would submit
its report for the month of January no later than February 15th. Reports must be submitted electronically via online
reporting, electronic upload, or other means as approved by DEA. All reports must be kept for at least two years and
be readily retrievable for inspection.
Should an online pharmacy revert back to a retail pharmacy, the pharmacy is still required to report the monthly sales
for the month in which it changes back to a retail pharmacy.
Prescription Requirements
In order for a prescription to be valid, it must be issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least one in-person medical evaluation of the patient or by a
covering practitioner. An in-person medical evaluation is a medical evaluation that is conducted with the patient in
the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other
health professionals.
Definition of Prescription Terms
A pharmacy website is exempted from the Ryan Haight Act's definition of an "online pharmacy" if its Internet-facilitated activity relating to controlled substances is limited to filling new and/or refilling prescriptions for controlled
substances in schedules III, IV, or V. If the pharmacy is so exempted from the definition of an "online pharmacy," it
is not required under the Act to obtain a modification of its DEA registration authorizing it to operate as an online
pharmacy. Thus, it is important to understand precisely the definitions of the following terms.
Filling New Prescriptions for Controlled Substances in Schedules III-V
As stated in 21 C.F.R. 1300.04 (d), the term "filling new prescriptions for controlled substances in schedule III,
IV, or V" means filling a prescription for an individual for a controlled substance in schedule III, IV, or V, if:
The pharmacy dispensing that prescription has previously dispensed to the patient a
controlled substance other than by means of the Internet and pursuant to the valid
prescription of a practitioner that meets the applicable requirements of [21 U.S.C. 829(b) and (c)] and [21 C.F.R.
1306.21 and 1306.22] (for purposes of this definition, such a prescription shall be referred to as the original prescription);
The pharmacy contacts the practitioner who issued the original prescription at the request of that individual to determine
whether the practitioner will authorize the issuance of a new prescription for that individual for the controlled substance described in [paragraph (1) of this definition] (i.e., the same controlled substance as described in [paragraph
(1)]); and

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The practitioner, acting in the usual course of professional practice, determines there is a legitimate medical purpose for
the issuance of the new prescription.
Refilling Prescriptions for Controlled Substances in Schedules III-V
As stated in 21 C.F.R. 1300.04(k), the term "refilling prescriptions for controlled substances in schedule III,
IV, or V:
Means the dispensing of a controlled substance in schedule III, IV, or V in accordance with refill instructions issued by a
practitioner as part of a valid prescription that meets the requirements of [21 U.S.C. 829(b) and (c)] and [21 C.F.R.
1306.21 and 1306.22], as appropriate; and
Does not include the issuance of a new prescription to an individual for a controlled
substance that individual was previously prescribed.
SECTION XII OTHER PHARMACY OPERATIONS
Central Fill Pharmacy
A "central fill pharmacy (see Appendix B, Definitions) fills prescriptions for controlled substances on behalf of retail pharmacies with which it has a contractual agreement to provide such services or with pharmacies who share a
common owner. When one retail pharmacy receives a prescription and a second pharmacy prepares and subsequently
delivers the controlled substance medication to the first retail pharmacy for dispensing to the patient, the second pharmacy is engaging in a "central fill activity. Records must be maintained by both the central fill pharmacy and the
retail pharmacy that completely reflect the disposition of all controlled substance prescriptions dispensed. Central fill
pharmacies are required to comply with the same security requirements applicable to retail pharmacies including the
general requirement to maintain effective controls and procedures to guard against theft and diversion of controlled
substances. Retail pharmacies that also perform central fill activities are allowed to do so without a separate DEA
registration, separate inventories, or separate records.
Central fill pharmacies are permitted to prepare both initial and refill prescriptions, subject to all applicable state and
federal regulations. Only a licensed pharmacist may fill the prescription. Both the retail and central fill pharmacists
have a corresponding responsibility to ensure that the prescription was issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of professional practice and otherwise in the manner specified by
DEA regulations.
Prescription information may be provided to an authorized central fill pharmacy by a retail pharmacy for dispensing
purposes. Prescriptions for controlled substances listed in schedules II, III, IV, or V may be transmitted electronically
from a retail pharmacy to a central fill pharmacy including via facsimile. The retail pharmacy transmitting the prescription information must:
Write the word "CENTRAL FILL'' on the face of the original prescription and record the name, address, and DEA
registration number of the central fill pharmacy to which the prescription has been transmitted and the name of the
retail pharmacy pharmacist transmitting the prescription, and the date of transmittal;
Ensure that all information required to be on a prescription is transmitted to the central fill pharmacy (either on the
face of the prescription or in the electronic transmission of information);
Maintain the original prescription for a period of two years from the date the prescription was last refilled;
Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common, or contract carrier) and the name of the retail pharmacy employee accepting delivery;
For schedules III-V prescriptions, indicate in the information transmitted the number of refills already dispensed and
the number of refills remaining (refills for schedule II prescriptions are not permitted).
The central fill pharmacy receiving the transmitted prescription must:

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Keep a copy of the prescription (if sent via facsimile) or an electronic record of all the information transmitted by the
retail pharmacy, including the name, address, and the DEA registration number of the retail pharmacy transmitting
the prescription;
Keep a record of the date of receipt of the transmitted prescription, the name of the licensed pharmacist filling the
prescription, and dates of filling or refilling of the prescription; and
Keep a record of the date the filled prescription was delivered to the retail pharmacy and the method of delivery (i.e.
private, common, or contract carrier).
Central fill pharmacies must affix to the package a label showing the retail pharmacy name and address and a unique
identifier (i.e. the central fill pharmacy's DEA registration number) indicating that the prescription was filled at the
central fill pharmacy. Central fill pharmacies must comply with the provisions of the C.F.R. when selecting private,
common, or contract carriers to transport filled prescriptions to a retail pharmacy (and likewise for retail pharmacies
retrieving filled prescriptions from a central fill pharmacy) for delivery to the ultimate user.
For electronic prescriptions, the name, address, and DEA registration number of the central fill pharmacy to which
the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and
the date of transmittal must be added to the electronic prescription record.
Long Term Care Facilities
A Long Term Care Facility (LTCF) is defined in the C.F.R. as a nursing home, retirement care, mental care, or other
facility or institution, which provides extended health care to resident patients. In most cases, these facilities are not
registered with DEA, yet these health care facilities routinely maintain controlled substances issued via prescription
to their residents. These controlled substances are already outside the CSAs closed drug distribution system since
they have been dispensed to the ultimate user.
LTCFs frequently need to dispose of unused medications due to a change in the residents medication or the
residents death. Accordingly, LTCFs should contact the local DEA Diversion Field Office (Appendix K) for drug
disposal instructions. The DEA is aware of issues currently facing LTCFs concerning the dispensing and handling of
controlled substances, which are affected by a variety of state laws and circumstances. Pharmacists should check with
their state agency for guidelines concerning controlled substances at LTCFs.
Regulations concerning LTCFs can also be found under:

Section IX, Exceptions for Schedule II Facsimile Prescriptions

Section X, Partial Filling of Schedule II Prescriptions for Terminally Ill or Long Term Care Facility Patients

Use of Automated Dispensing Systems by Retail Pharmacies at Long Term Care Facilities
If state law or regulations permit, the DEA will allow a retail pharmacy to register at the site of the LTCF and store
controlled substances in an Automated Dispensing System (ADS) as outlined in 21 C.F.R. 1301.27. In an ADS, a
pharmacy stores bulk drugs in the machine in separate bins or containers. The pharmacy programs and controls the
ADS remotely. Only authorized LTCF staff are allowed access to its contents, which are dispensed on a single-dose
basis at the time of administration pursuant to a valid prescription. The ADS electronically records each dispensing,
thus maintaining dispensing records for the pharmacy. Because the drugs are not considered dispensed until the system provides them, drugs in the ADS are counted as pharmacy stock. A registered retail pharmacy that possesses additional registrations for ADS machines at LTCFs may keep all records required for those additional registered sites
at the retail pharmacy or other approved central location.
DEA registered pharmacies wishing to operate an ADS at an LTCF must contact the DEA Office of Diversion Control, Registration Section, at 1-800-882-9539 for registration instructions. Additional requirements for maintaining an
ADS can be found online at www.DEAdiversion.usdoj.gov.

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Emergency Kits for Long Term Care Facilities
The DEA has issued a policy statement which provides individual state licensing and regulatory boards with general
guidelines for establishing specific rules concerning controlled substances used in emergency kits at Long Term Care
Facilities (see Appendix H, Guidelines for Emergency Kits in Long Term Care Facilities).
Opioid (Narcotic) Addiction Treatment Programs
The Narcotic Addiction Treatment Act of 1974 and the Drug Addiction Treatment Act (DATA) of 2000 amended the
CSA with respect to the use of controlled substances in the medical treatment of opioid addiction. These laws established the procedures for approving and licensing practitioners involved in the treatment of opioid addiction as well
as improving the quality and delivery of that treatment to the segment of society in need.
Practitioners wishing to prescribe and dispense FDA approved schedule II controlled substances (i.e., methadone) for
maintenance and detoxification treatment must obtain a separate DEA registration as a Narcotic Treatment Program
via a DEA Form 363 which may be completed online at www.DEAdiversion.usdoj.gov. In addition to obtaining this
separate DEA registration, this type of activity also requires the approval and certification by the Center for Substance Abuse Treatment (CSAT) within the Substance Abuse and Mental Health Services Administration
(SAMHSA) of the U.S. Department of Health and Human Services as well as the applicable state methadone authority.
If a practitioner wishes to prescribe or dispense schedules III, IV, or V controlled substances approved by the FDA
for addiction treatment (i.e., Suboxone or Subutex drug products), the practitioner must request a waiver from
CSAT which will then notify DEA of all waiver requests. These practitioners are referred to as DATA waived practitioners.
DATA waived practitioners may treat 30 or 100 patients at any one time, dependent on individual authorization from
CSAT. Upon authorization by CSAT, DEA will issue a new DEA certificate of registration bearing (1) the DEA registration number, (2) a unique identification number, and (3) the corresponding business activity to identify whether
the physician is authorized to treat 30 or 100 patients. Pursuant to 21 C.F.R. 1301.28(d), the practitioner is required
to include the identification number on all records when dispensing and on all prescriptions when prescribing Schedules III, IV, or V narcotic controlled drugs for use in maintenance or detoxification treatment. The listing of the identification number on a prescription is in addition to all other information required on a valid prescription to include
the practitioners DEA registration number (see Section IX, Valid Prescription Requirements).
Dispensing Controlled Substances for the Treatment of Pain
On September 6, 2006, the DEA published in the Federal Register a Policy Statement, Dispensing Controlled Substances for the Treatment of Pain. The purpose of the Policy Statement was to make clear the longstanding requirement under the law that physicians may prescribe controlled substances only for a legitimate medical purpose in the
usual course of professional practice. In no way should this interfere with the legitimate practice of medicine or cause
any physician to be reluctant to provide legitimate pain treatment. The second purpose of the Policy Statement was
for the DEA to dispel the mistaken notion among a small number of medical professionals that the agency has embarked on a campaign to target physicians who prescribe controlled substances for the treatment of pain or that
physicians must curb their legitimate prescribing of pain medications to avoid legal liability.
To achieve these aims, the document summarized the relevant legal principles and provided an explanation of DEAs
role with respect to the regulation of controlled substances. The document also addressed specific issues and questions that have been raised on a recurring basis by physicians who seek guidance on the subject of dispensing controlled substances for the treatment of pain.
To review the Policy Statement, it may be accessed at www.DEAdiversion.usdoj.gov. Click on Info & Legal Resources, then Federal Register Notices, then Notices 2006, then Policy Statement: Dispensing Controlled Substances

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for the Treatment of Pain, September 6, 2006. For additional guidance on the responsibilities of the pharmacist where
it pertains to the treatment of pain, see Section IX, Corresponding Responsibility.
SECTION XIII - OTHER CONTROLLED SUBSTANCE REGULATIONS
Controlled Substance Distribution by a Pharmacy Five Percent Rule
A pharmacy registered to dispense controlled substances may distribute such substances (without being registered as
a distributor) to another pharmacy or to a registered practitioner for the purpose of general dispensing by the practitioner to patients, provided that the following conditions are met:
The pharmacy or practitioner that will receive the controlled substances is registered under the CSA to dispense controlled substances;
The distribution is recorded by the distributing practitioner in accordance with 21 C.F.R. 1304.22(c) and the receipt
is recorded by the receiving practitioner in accordance with 21 C.F.R. 1304.22(c);
If the pharmacy distributes a schedule II controlled substance, it must document the transfer on an official order form
(DEA Form 222) or the electronic equivalent. For instructions on completing this form, see Section VIII, Ordering
Controlled Substances.
Five Percent Rule - total number of dosage units of all controlled substances distributed by a pharmacy may not
exceed five percent of all controlled substances dispensed by the pharmacy during a calendar year. If at any time the
controlled substances distributed exceed five percent, the pharmacy is required to register as a distributor.
United States Postal Service Mailing Requirements for Controlled Substances
United States Postal Services regulations permit the mailing of controlled substances by drug manufacturers or their
agents, pharmacies, or other authorized handlers when distribution is lawful under DEA regulations and if the mailer
or the addressee meets one of the following conditions:
The mailer or the addressee is registered with DEA.
The mailer or the addressee is exempt from DEA registration as permissible by law.
United States Postal Service regulations permit mailing of any controlled substance, provided it is not outwardly dangerous and will not cause injury to a persons life or health, and if the following preparation and packaging standards
are met:
The inner container of any parcel containing controlled substances is marked and sealed as required by the provisions
of the CSA and its implementing regulations, and is placed in a plain outer container or securely wrapped in plain
paper.
If the controlled substance consists of prescription medicines, the inner container is also labeled to show the name
and address of the pharmacy, practitioner, or other person dispensing the prescription.
The outside wrapper or container is free of markings that would indicate the nature of the contents.
SECTION XIV COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005
Summary of the Acts Major Provisions
In March 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005 (CMEA). As a result of the
new law, the DEA issued an Interim Final Rule in the Federal Register on September 26, 2006, which outlined the
retail provisions of the CMEA.
Under the CMEA, regulated sellers must follow new requirements for retail sales of over-the-counter products containing the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine (PPA), which can be used to

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manufacture methamphetamine illegally. The CMEA defined "regulated seller" to mean a retail distributor (including
a pharmacy and mobile retail vendors) and "at retail" to mean sale or purchase for personal use.
Scheduled Listed Chemical Products
The CMEA created a new category of products called scheduled listed chemical product (SLCP). It includes any
product that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act as a nonprescription drug that contains ephedrine, pseudoephedrine, or PPA (includes salts, optical isomers,
and salts of optical isomers) (21 U.S.C. 802(45)). This applies to nonprescription drug products only, not prescription drug products. Retail sales of SLCPs are excluded from the definition of a regulated transaction and from the
registration requirement under 21 U.S.C. 823, but are subject to a separate system of retail sales controls under 21
U.S.C. 830.
Other requirements of the law include:

Requirement of regulated sellers to place the products behind the counter or in locked cabinets.

Requirement of regulated sellers to check the identity of purchasers and maintain a log of each sale that includes
the purchaser's name and address, signature of the purchaser, product sold, quantity sold, date, and time.

Requirement of regulated sellers to maintain the logbook for at least two years.

Requirement of regulated sellers to train employees in the requirements of the law and certify to DEA that the
training has occurred.

Places a quantity limit of each of the chemicals that may be sold to an individual in a day to 3.6 grams of the
chemical (base) without regard to the number of transactions.

For nonliquids, product packaging is limited to blister packs containing no more than 2 dosage units per blister.
Where blister packs are not technically feasible, the product must be packaged in unit dose packets or pouches.

For individuals, purchases in a 30-day period are limited to 9 grams, of which not more than 7.5 grams may be
imported by means of a common or contract carrier or the U.S. Postal Service.
While many states have enacted their own legislation regarding the regulation of these products, the federal law also
requires regulated sellers to complete a self-certification process with the DEA that includes training their employees
on the new regulations and procedures. The self-certification process must be completed online at
www.DEAdiversion.usdoj.gov. If state law differs from federal law regarding the regulation of these products, retail
outlets are to adhere to the stricter provisions of both.
Copies of the Interim Final Rule are available at www.DEAdiversion.usdoj.gov (click on the Combat Meth Act of
2005, then Interim Final Rule Retail Sales of Scheduled Listed Chemical Products). Details on specific provisions
of the CMEA that may impact a pharmacy that engages in retail sales of SLCPs are outlined below.
Recordkeeping Requirements
Regulated sellers are required to maintain a written (bound logbook) or electronic list of sales that identifies the transactions with the following information:
The name of the purchaser
The address of the purchaser
The date and time of the sale
The amount of product sold
The logbook requirement does not apply to any purchase by an individual of a single sales package that contains not
more than 60 milligrams of pseudoephedrine.
Concurrently, purchasers are required to:

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Present a photo identification issued by a State or the Federal Government (see Proof of Identity Requirements below
for a complete list of acceptable forms of identification).
Sign a logbook and enter his or her name, address, date, and time of sale.
Once identification of the purchaser is presented to the seller, the seller is required to:
Determine that the name in the logbook corresponds to the name on the identification and that the date and time are
correct.
Enter into the logbook the name of the product and the quantity sold.
The logbook must include a notice to purchasers that entering false statements or misrepresentations in the logbook
may subject purchasers to criminal penalties under 18 U.S.C. 1001. Sellers must maintain each entry in the logbook
for not fewer than two years after the date on which the entry is made.
Loss or Theft of SLCPs
A report should be made orally to the local DEA Diversion Field Office (Appendix K) in the area where the pharmacy is located. Per 21 C.F.R. 1314.15(c), a written report of losses must be filed within 15 days after the pharmacist
becomes aware of the loss or theft. A written report should include the DEA registration number (if applicable),
name, business address, date of loss, type of loss, and a description of the circumstances of the loss (e.g., in-transit,
theft from premises).
Proof of Identity Requirements
The CMEA requires an individual to present an identification card that includes a photograph and is issued by a State
or the Federal Government or a document considered acceptable under 8 C.F.R. 274a.2(b)(1)(v)(A) and (B). Those
documents currently include the following:

United States passport;

Alien Registration Receipt Card or Permanent Resident Card, Form I-551;

An unexpired foreign passport that contains a temporary I-551 stamp, or temporary I551 printed notation on a
machine-readable immigrant visa;

An Employment Authorization Document which contains a photograph (Form I766);

In the case of a nonimmigrant alien authorized to work for a specific employer incident to status, a foreign passport with form I-94 or Form I-94A bearing the same name as the passport and containing an endorsement of the
alien's nonimmigrant status, as long as the period of endorsement has not yet expired and the proposed employment
is not in conflict with any restrictions or limitations identified on the Form;

A passport from the Federated States of Micronesia (FSM) or the Republic of the Marshall Islands (RMI) with
Form I94 or Form I94A indicating nonimmigrant admission under the Compact of Free Association Between the
United States and the FSM or RMI;

In the case of an individual lawfully enlisted for military service in the Armed Forces under 10 U.S.C. 504, a
military identification card issued to such individual may be accepted only by the Armed Forces.
For individuals 16 years of age or older:

A driver's license or identification card containing a photograph, issued by a state or an outlying possession of
the United States. If the driver's license or identification card does not contain a photograph, identifying information
shall be included such as: name, date of birth, sex, height, color of eyes, and address;

School identification card with a photograph;

Voter's registration card;

U.S. military card or draft record;

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Identification card issued by federal, state, or local government agencies or entities. If the identification card
does not contain a photograph, identifying information shall be included such as: name, date of birth, sex, height, color of eyes, and address;

Military dependent's identification card;

Native American tribal documents;

United States Coast Guard Merchant Mariner Card;

Driver's license issued by a Canadian government authority.

For individuals under age 18 who are unable to produce a document from the list above, the following documents are
acceptable to establish identity only:

School record or report card;

Clinic doctor or hospital record;

Daycare or nursery school record.

NOTE: The list of acceptable forms of identification, as cited in the CMEA, may change ("in effect on or after the
date of enactment''). The DEA has no discretion to alter the list.
Product Placement
SLCPs must be stored behind the counter or, if in an area where the public has access, in a locked cabinet. Although
DEA is not including cabinet specifications in the rule, a locked cabinet should be substantial enough that it cannot
be easily picked up and removed. In a store setting, the cabinet should be similar to those used to store items, such as
cigarettes, that can be accessed only by sales staff.
Self-Certification
As part of the requirements of CMEA, an annual self-certification is required for all regulated sellers of SLCPs. A
regulated seller must not sell SLCPs unless it has self-certified with DEA. In self-certifying, the regulated seller is
confirming:

The employees who will be engaged in the sale of SLCPs have undergone training regarding provisions of
CMEA.

Records of the training are maintained.

Sales to individuals do not exceed 3.6 grams of ephedrine, pseudoephedrine, or phenylpropanolamine per day.

Nonliquid forms are packaged as required.

SLCPs are stored behind the counter or in a locked cabinet.

A written or electronic logbook containing the required information on sales of these products is properly maintained.

The logbook information will be disclosed only to Federal, State, or local law enforcement and only to ensure
compliance with Title 21 of the United States Code or to facilitate a product recall.
The only way to self-certify is through DEAs Diversion website at www.DEAdiversion.usdoj.gov. Self-certification
can be accomplished on any computer (e.g., at the store, at home, at the library, or at any other location).
A certificate will be generated by DEA upon receipt of the self-certification application. The regulated seller may
print this certificate, or if the regulated seller is unable to print it, DEA will print and mail the certificate to the regulated seller. Chain stores wishing to file self-certifications for more than 10 locations must print or copy the form
electronically and submit the information to DEA by mail. DEA will work with these persons to facilitate this process. Persons interested in this self-certification option should contact DEA for assistance at 1-800-882-9539. For
current DEA registrants, the system will pre-populate the form with basic information if the registrant enters his DEA
registration number in the field provided.

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The regulated seller must self-certify to DEA as described above on an annual basis. It is the responsibility of the
regulated seller to ensure that all employees have been trained prior to self-certifying each time.
It is the regulated sellers responsibility to annually renew before the certificate expires if the regulated seller
intends to continue selling SLCPs at retail. The certificate contains a self-certification number in the upper right
corner. The expiration date of the certificate is listed under the self-certification number. Regulated sellers may verify
the expiration date of their certificate at www.DEAdiversion.usdoj.gov.
The self-certification requirement is subject to the provisions of 18 U.S.C. 1001. A regulated seller who knowingly
or willfully certifies to facts that are not true is subject to fines and imprisonment.
Required Training
Training materials designed by DEA must be used, although a regulated seller may include information in addition to
that provided by DEA. DEA training materials may be found at www.DEAdiversion.usdoj.gov.
Training Records
Each employee of a regulated seller who is responsible for delivering SL
.CPs to purchasers or who deals directly with purchasers by obtaining payment for the SLCPs must undergo training
and must sign an acknowledgement of training received prior to selling SLCPs. This record must be kept in the employee's personnel file.
Self-Certification Fee
On December 29, 2008, the DEA published a Final Rule in the Federal Register entitled Combat Methamphetamine
Epidemic Act of 2005: Fee for Self-Certification for Regulated Sellers of Scheduled Listed Chemical Products. The
rule established a self-certification fee for regulated sellers of SLCPs that are not DEA pharmacy registrants.
Appendix D
Pharmacists Guide to Prescription Fraud
The purpose of this guide is to ensure that controlled substances continue to be available for legitimate medical and scientific
purposes while preventing diversion into the illicit market. It is not the intent of this publication to discourage or prohibit the
use of controlled substances where medically indicated. However, nothing in this guide should be construed as authorizing or
permitting any person to conduct any act that is not authorized or permitted under federal or state laws.
Pharmacists Responsibilities
The abuse of prescription drugsespecially controlled substancesis a serious social and health problem in the
United States today. As a healthcare professional, pharmacists share responsibility for preventing prescription drug
abuse and diversion.

Pharmacists have a personal responsibility to protect their practice from becoming an easy target for drug diversion. They need to know of the potential situations where drug diversion can occur, and establish safeguards to prevent drug diversion.

The dispensing pharmacist must maintain a constant vigilance against forged or altered prescriptions. The CSA
holds the pharmacist responsible for knowingly dispensing a prescription that was not issued in the usual course of
professional treatment.
Types of Fraudulent Prescriptions
Pharmacists should be aware of the various kinds of forged prescriptions that may be presented for dispensing. Some
patients, in an effort to obtain additional amounts of legitimately prescribed drugs, alter the practitioners prescription. They may have prescription pads printed using a legitimate doctors name, but with a different call back number
that is answered by an accomplice to verify the prescription. Drug seeking individuals may also call in their own prescriptions and give their own telephone number as a call-back for confirmation. Drug abusers sometimes steal legiti-

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mate prescription pads from practitioners offices and/or hospitals and prescriptions are written using fictitious
patient names and addresses.
In addition, individuals may go to emergency rooms complaining of pain in the hopes of receiving a controlled substance prescription. The prescription can then be altered or copied to be used again. Computers are often used to create prescriptions for nonexistent doctors or to copy legitimate doctors prescriptions. The quantity of drugs prescribed
and frequency of prescriptions filled are not lone indications of fraud or improper prescribing, especially if a patient
is being treated with opioids for pain management. Pharmacists should also recognize that drug tolerance and physical dependence may develop as a consequence of a patients sustained use of opioid analgesics for the legitimate
treatment of chronic pain.
The following criteria may indicate that a prescription was not issued for a legitimate medical purpose:

The prescriber writes significantly more prescriptions (or in larger quantities) compared to other practitioners in
the area.

The patient appears to be returning too frequently. A prescription which should last for a month in legitimate
use is being refilled on a biweekly, weekly or even a daily basis.

The prescriber writes prescriptions for antagonistic drugs, such as depressants and stimulants, at the same time.
Drug abusers often request prescriptions for "uppers and downers" at the same time.

The patient presents prescriptions written in the names of other people.

A number of people appear simultaneously, or within a short time, all bearing similar prescriptions from the
same physician.

People who are not regular patrons or residents of the community, show up with prescriptions from the same
physician.
The following criteria may indicate a forged prescription:

Prescription looks "too good". The prescribers handwriting is too legible.

Quantities, directions, or dosages differ from usual medical usage.

Prescription does not comply with the acceptable standard abbreviations or appears to be textbook presentations.

Prescription appears to be photocopied.

Directions are written in full with no abbreviations.

Prescription is written in different color inks or written in different handwriting.

Prevention Techniques

Know the prescriber and his/her signature.

Know the prescribers DEA registration number.

Know the patient.

Check the date on the prescription order to determine if it has been presented in a reasonable length of time since
being issued by the prescriber.
When there is a question about any aspect of the prescription order, the pharmacist should contact the prescriber for
verification or clarification.
If at any time a pharmacist is in doubt, he /she should require proper identification. Although this procedure is not
foolproof (identification papers can also be stolen/forged), it does increase the drug abusers risk. If a pharmacist believes the prescription is forged or altered, he/she should not dispense it and call the local police. If a pharmacist believes he/she has discovered a pattern of prescription abuse, he/she should contact the state Board of Pharmacy or the
local DEA Diversion Field Office (Appendix K). Both DEA and state authorities consider retail-level diversion a priority issue.

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Proper Controls
Dispensing procedures without control and professional caution are an invitation to the drug abuser. Proper controls
can be accomplished by following common sense, sound professional practice, and proper dispensing procedures. In
addition, pharmacy staff should have knowledge of these safeguards, as it will help prevent and protect the pharmacy
from becoming a source of diversion.
Most drug abusers seek out areas where communication and cooperation between health care professionals are minimal because it makes the drug abusers work easier. Thus, a pharmacist should encourage other local pharmacists and
physicians to develop a working relationship which will promote teamwork and camaraderie. In addition, the pharmacist should become familiar with those controlled substances that are popular for abuse and resale on the streets in
the area and should discuss those findings with other pharmacists and practitioners in the community.
Appendix H
Guidelines for Emergency Kits in Long Term Care Facilities
A pharmacy may place an emergency kit with controlled substances in a non-DEA registered Long Term Care Facility
(LTCF), if the appropriate state agency or regulatory authority specifically approves the placement and promulgates procedures that delineate:
The source from which the LTCF may obtain controlled substances for emergency kits and that the source of supply is a
DEA-registered hospital/clinic, pharmacy, or practitioner.
The security safeguards for each emergency kit stored at the LTCF, including who may have access to the emergency kit,
and specific limitation of the type and quantity of controlled substances permitted in the kit.
The responsibility for proper control and accountability of the emergency kit within the LTCF, including the requirement
that the LTCF and the supplying registrant maintain complete and accurate records of the controlled substances
placed in the emergency kit, the disposition of the controlled substances, and the requirement to take and maintain
periodic physical inventories.
The emergency medical conditions under which the controlled substances may be administered to LTCF patients, including the requirement that controlled substances be administered by authorized personnel only as expressly authorized
by an individual practitioner and in compliance with the provisions of 21 C.F.R. 1306.11 and 1306.21.
The prohibited activities that if violated could result in state revocation, denial, or suspension of the privilege to supply or
possess emergency kits containing controlled substances.
The requirements for emergency kits in LTCFs were published in a Federal Register notice on April 9, 1980 (45 FR 24128).
Pharmacies and LTCFs may wish to consult the notice to ensure compliance with the requirements.

II. DEA Frequently Asked Questions

Prescriptions
Question: What is a prescription?
Answer: A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is not an order
for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to an
inpatient for immediate administration in a hospital is not a prescription). To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a registered practitioner acting in the usual course of sound professional practice.
Question: What information is required on a prescription for a controlled substance?
Answer: A prescription for a controlled substance must include the following information:

Date of issue;

Patients name and address;

Practitioners name, address, and DEA registration number;

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Drug name;

Drug strength;

Dosage form;

Quantity prescribed;

Directions for use;

Number of refills (if any) authorized; and

Manual signature of prescriber.

A prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner. An
individual may be designated by the practitioner to prepare the prescriptions for his/her signature. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation.
Prescriptions for schedule II controlled substances must be written and be signed by the practitioner. In emergency situations,
a prescription for a schedule II controlled substance may be telephoned to the pharmacy and the prescriber must follow up
with a written prescription being sent to the pharmacy within seven days. Prescriptions for schedules III through V controlled
substances may by written, oral or transmitted by fax.
Question: Can controlled substance prescriptions be refilled?
Answer: Prescriptions for schedule II controlled substances cannot be refilled. A new prescription must be issued. Prescriptions for schedules III and IV controlled substances may be refilled up to five times in six months. Prescriptions for schedule
V controlled substances may be refilled as authorized by the practitioner.
Question: Can controlled substance prescriptions for hospice patients be faxed to a pharmacy?
Answer: A prescription written for a schedule II narcotic substance for a patient enrolled in a hospice care program certified
and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the
practitioner or the practitioners agent to the dispensing pharmacy by facsimile.
A pharmacist may dispense directly a controlled substance listed in schedules III, IV, or V pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the
practitioners agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist.
Question: Is it appropriate to provide a DEA registration number on prescriptions written for medications other than
controlled substances?
Answer: DEA strongly opposes the use of a DEA registration number for any purpose other than the one for which it was
intended, to provide certification of DEA registration in transactions involving controlled substances. The use of DEA registration numbers as an identification number is not an appropriate use and could lead to a weakening of the registration system. Although DEA has repeatedly made its position known to industries such as insurance providers and pharmacy benefit
managers, there is currently no legal basis for DEA to prevent or preclude companies from requiring or requesting a
practitioners DEA registration number.
The Centers for Medicare and Medicaid Services has developed a National Provider Identification (NPI) number unique to
each healthcare provider. The Final Rule for establishment of the NPI system was published in the Federal Register (FR
3434, Vol. 69, No. 15) by the Department of Health and Human Services on January 23, 2004. The effective date of this Final
Rule was May 23, 2005; all covered entities were to begin using the NPI in standard transactions by May 23, 2007. A contingency extension was provided to covered entities unable to meet the 2007 deadline. Contingency plans were to not extend
beyond May 23, 2008.
Question: Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in a
greater number of dispensations than the number of refills indicated on the prescription?
Answer: Yes. Partial refills of schedules III and IV controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount
dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total
quantity prescribed, and no dispensing occurs after six months past the date of issue.

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Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedule II?
Answer: On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances (72 FR 64921). In the preamble to that Rule, DEA stated that "the
essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance,
strength, dosage form, and quantity prescribed)may not be modified orally."
The instructions contained in the Rule's preamble are in opposition to DEA's previous policy which permitted the same
changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral consultation with the prescriber. DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a
pharmacist may make to a schedule II prescription after oral consultation with the prescriber.
Therefore, when information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA
expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.
Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedules IIIV?
Answer: The pharmacist may add or change the patients address upon verification. The pharmacist may add or change the
dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the
prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these
changes to controlled substance prescriptions.
The pharmacist is never permitted to make changes to the patients name, controlled substance prescribed (except for generic
substitution permitted by state law) or the prescribers signature.
Question: Can a practitioner prescribe methadone for the treatment of pain?
Answer: Federal law and regulations do not restrict the prescribing, dispensing, or administering of any schedule II, III, IV,
or V narcotic medication, including methadone, for the treatment of pain, if such treatment is deemed medically necessary by
a registered practitioner acting in the usual course of professional practice.
Confusion often arises due to regulatory restrictions concerning the use of methadone for the maintenance or detoxification of
opioid addicted individuals, in which case the practitioner is required to be registered with the DEA as a Narcotic Treatment
Program (NTP).
Question: Can an individual return his/her controlled substance prescription medication to a pharmacy?
Answer: No. An individual patient may not return his/her unused controlled substance prescription medication to the pharmacy. Federal laws and regulations make no provisions for an individual to return the controlled substance prescription medication to a pharmacy for further dispensing or for disposal. There are no provisions in the Controlled Substances Act or Code
of Federal Regulations (CFR) for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e., individual patient).
The CFR does have a provision for an individual to return his/her unused controlled substance medication to the pharmacy in
the event of the controlled substance being recalled or a dispensing error has occurred.
An individual may dispose of his/her own controlled substance medication without approval from DEA. Medications should
be disposed of in such a manner that does not allow for the controlled substances to be easily retrieved. In situations where an
individual has expired, a caregiver or hospice staff member may assist the family with the proper disposal of any unused controlled substance medications.

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Long Term Care Facility (LTCF)
Question: Can controlled substance prescriptions for a resident of an LTCF be faxed to a pharmacy?
Answer: Yes. Schedules II-V controlled substance prescriptions may be transmitted by the practitioner or the practitioners
agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription.
Question: Can an LTCF store controlled substances in an emergency kit without being registered with DEA?
Answer: DEA published the following Statement of Policy in the April 9, 1980 Federal Register regarding the placement of
controlled substances in an emergency kit located in an LTCF.
STATEMENT OF POLICY
The placement of emergency kits containing controlled substances in non-federally registered Long Term Care Facilities (LTCF) shall be deemed to be in compliance with the Comprehensive Drug Abuse Prevention and Control
Act of 1970, if the appropriate state agency or regulatory authority specifically approves such placement and promulgates procedures which delineate:
A. The source from which an LTCF may obtain controlled substances for emergency kits. The source of supply must
be a DEA registered hospital/clinic, pharmacy, or practitioner.
B. Security safeguards for each emergency kit stored in the LTCF which include the designation of individuals who
may have access to the emergency kits and a specific limitation of the type and quantity of controlled substances permitted to be placed in each emergency kit.
C. Responsibility for proper control and accountability of such emergency kits within the LTCF to include the requirement that the LTCF and the providing DEA registered hospital/clinic, pharmacy, or practitioner maintain complete and accurate records of the controlled substances placed in the emergency kit, the disposition of these controlled
substances plus the requirement to take periodic physical inventories.
D. The emergency medical conditions under which the controlled substances may be administered to patients in the
LTCF to include the requirement that medication be administered by authorized personnel only as expressly authorized by an individual practitioner and in compliance with the provisions of 21 CFR 1306.11 and 21 CFR 1306.21.
E. Prohibited activities which can result in the state revocation, denial, or suspension of the privilege of having or
placing emergency kits, containing controlled substances, in an LTCF.
Question: Can an LTCF return a residents unused controlled substance medication to a pharmacy?
Answer: No. There are no provisions in the Controlled Substances Act for a DEA registrant (i.e., retail pharmacy) to acquire
controlled substances from a non-registrant (i.e., resident of an LTCF). Most LTFCs are not licensed by their respective state
to handle controlled substances and, therefore, are not registered with DEA. LTCFs act in a custodial capacity, holding controlled substances that, pursuant to a prescription, have been dispensed to and belong to the resident of the LTCF. Federal
laws and regulations make no provisions for controlled substances that have already been dispensed to patients, regardless of
the packaging method, to be returned to a pharmacy for further dispensing or disposal.
Question: Can a patient in an LTCF receive methadone for maintenance purposes?
Answer: If the LTCF is registered with DEA as a hospital/clinic, it need not be separately registered as a Narcotic Treatment
Program (NTP) to administer or dispense methadone as an adjunct to medical treatment of conditions other than addiction.
[21 CFR 1306.07(c)]
If an LTCF that is not registered with DEA has a patient who is also currently enrolled in a licensed NTP, the NTP may transfer medication to the LTCF with the approval of the State Methadone Authority.
(www.samhsa.gov/centers/csat/content/opat/statemeth.html)
If an individual is not currently enrolled in an NTP and is in an LTCF that is not registered with DEA, a practitioner may administer narcotic drugs to the individual for relieving acute withdrawal symptoms when necessary while arrangements are
being made for referral for treatment. No more than one days medication may be administered to the individual or for the
individuals use at one time. Such emergency treatment may be carried out for no more than three days and may not be renewed or extended. [21 CFR 1306.07(b)]

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Records / Reports
Question: What is meant by "readily retrievable?"
Answer: The term "readily retrievable" means the record is kept or maintained in such a manner that it can be separated out
from all other records in a reasonable time or that it is identified by an asterisk, redline, or some other identifiable manner
such that it is easily distinguishable from all other records.

Question: Is a practitioner required to keep records?

Answer: Each practitioner must maintain inventories and records of controlled substances listed in schedule II separately
from all other records maintained by the registrant. Likewise, inventories and records of controlled substances in schedules
III, IV, and V must be maintained separately or in such a form that they are readily retrievable from the ordinary business records of the practitioner. All records related to controlled substances must be maintained and be available for inspection for a
minimum of two years.
A registered practitioner is required to keep records of controlled substances that are dispensed to the patient, other than by
prescribing or administering, in the lawful course of professional practice. A registered practitioner is not required to keep
records of controlled substances that are prescribed in the lawful course of professional practice, unless such substances are
prescribed in the course of maintenance or detoxification treatment. A registered practitioner is not required to keep records
of controlled substances that are administered in the lawful course of professional practice unless the practitioner regularly
engages in the dispensing or administering of controlled substances and charges patients, either separately or together with
charges for other professional services, for substances so dispensed or administered.
Question: What reports must be filed if a practitioner experiences a theft or significant loss of controlled substances?
Answer: The practitioner shall notify the local DEA office, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The practitioner shall also complete and submit DEA Form
106 which may be found at www.DEAdiversion.usdoj.gov.
Question: How does a DEA registrant report breakage or spillage of controlled substances?
Answer: Breakage of controlled substances does not constitute a "loss" of controlled substances. When there is breakage,
damage, spillage, or some other form of destruction, any recoverable controlled substances must be disposed of according to
DEA requirements. Damaged goods may be disposed of through shipment to a "reverse distributor" or by a DEA approved
process. The DEA recommends that any registrant seeking to dispose of controlled substances first contact the nearest DEA
Diversion Field Office for disposal instructions. In no case should drugs be forwarded to the DEA unless the registrant has
received prior approval from the DEA.
If the breakage or spillage is not recoverable, the registrant must document the circumstances of the breakage in the inventory
records. Two individuals who witnessed the breakage must sign the inventory records indicating what they witnessed. The
submission of a DEA Form 41, Registrants Inventory of Drugs Surrendered, is not required for non-recoverable controlled
substances.
The DEA procedures established for the destruction of controlled substances shall not be construed as altering in any way the
state laws or regulations for the disposal of controlled substances. When this disposal occurs, it must be reported to the DEA
on a DEA Form 41.

Security
Question: Are there any special security requirements a practitioner should follow if a stock of controlled substances
is maintained in their office for dispensing and administering?
Answer: All controlled substances should be stored in a locked cabinet or other secure storage container with limited access
by the office staff.
Question: Is it appropriate to provide a DEA registration number when purchasing items other than controlled substances such as prescription drugs, over-the-counter drugs, or medical supplies from a distributor?

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Answer: DEA strongly opposes the use of a DEA registration number for any purpose other than the one for which it was
intended, to provide certification of DEA registration in transactions involving controlled substances. The use of DEA registration numbers as an identification number is not an appropriate use and could lead to a weakening of the registration system. Although DEA has repeatedly made its position known to industries such as insurance providers and pharmacy benefit
managers, there is currently no legal basis for DEA to prevent or preclude companies from requiring or requesting a
practitioners DEA registration number.
The Centers for Medicare and Medicaid Services has developed a National Provider Identification (NPI) number unique to
each healthcare provider. The Final Rule for establishment of the NPI system was published in the Federal Register (FR
3434, Vol. 69, No. 15) by the Department of Health and Human Services on January 23, 2004. The effective date of this Final
Rule was May 23, 2005; all covered entities were to begin using the NPI in standard transactions by May 23, 2007. A contingency extension was provided to covered entities unable to meet the 2007 deadline. Contingency plans were to not extend
beyond May 23, 2008.

Electronic Prescriptions
General
Q. What is DEAs rule Electronic Prescriptions for Controlled Substances?
A. DEAs rule, Electronic Prescriptions for Controlled Substances revises DEAs regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit
pharmacies to receive, dispense, and archive these electronic prescriptions. The rule was published in the Federal
Register Wednesday, March 31, 2010 and becomes effective on June 1, 2010.
Q. Is the use of electronic prescriptions for controlled substances mandatory?
A. No, the new regulations do not mandate that practitioners prescribe controlled substances using only electronic
prescriptions. Nor do they require pharmacies to accept electronic prescriptions for controlled substances for dispensing. Whether a practitioner or pharmacy uses electronic prescriptions for controlled substances is voluntary from
DEAs perspective. Prescribing practitioners are still able to write, and manually sign, prescriptions for schedule II,
III, IV, and V controlled substances and pharmacies are still able to dispense controlled substances based on those
written prescriptions. Oral prescriptions remain valid for schedule III, IV, and V controlled substances.
Q. Did DEA consider public comment in the development of this rule?
A. DEA considered almost two hundred separate comments received from the public to the Electronic Prescriptions
for Controlled Substances Notice of Proposed Rulemaking (73 FR 36722, June 27, 2008) in the development of this
rule.
Q. Did DEA work with other Federal agencies in the development of this rule?
A. DEA worked closely with a number of components within the Department of Health and Human Services. DEAs
discussions with the Office of the National Coordinator for Health Information Technology (ONC), Centers for
Medicare and Medicaid Services (CMS), and Agency for Healthcare Research and Quality (AHRQ) were instrumental in the development of this rule. DEA also worked closely with the National Institute of Standards and Technology
and the General Services Administration.
Implementation of Rule
Q. When can a practitioner start issuing electronic prescriptions for controlled substances?
A. A practitioner will be able to issue electronic controlled substance prescriptions only when the electronic prescription or electronic health record (EHR) application the practitioner is using complies with the requirements in the interim final rule.
Q. When can a pharmacy start processing electronic prescriptions for controlled substances?
A. A pharmacy will be able to process electronic controlled substance prescriptions only when the pharmacy application the pharmacy is using complies with the requirements in the interim final rule.

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Q. How will a practitioner or pharmacy be able to determine that an application complies with DEAs rule?
A. The application provider must either hire a qualified third party to audit the application or have the application reviewed and certified by an approved certification body. The auditor or certification body will issue a report that states
whether the application complies with DEAs requirements and whether there are any limitations on its use for controlled substance prescriptions. (A limited set of prescriptions require information that may need revision of the basic
prescription standard before they can be reliably accommodated.) The application provider must provide a copy of
the report to practitioners or pharmacies to allow them to determine whether the application is compliant.
Q. Does DEA have an estimate of the number of application providers who have software meeting the current requirements for creating, signing and transmitting controlled substance e-prescriptions?
A. No. DEA did not require that audits be submitted to DEA upon completion because third-party auditors operate
within industry governance and requirements and have demonstrated technical competencies. However, DEA has received information that there is currently software available and we anticipate that registrants will be apprised
through commercial advertising and other direct promotions by these firms.
Q. As a practitioner, until I have received an audit/certification report from my application provider indicating that
the application meets DEA's requirements, how can I use my electronic prescription application or EHR application
to write controlled substances prescriptions?
A. Nothing in this rule prevents a practitioner or a practitioner's agent from using an existing electronic prescription
or EHR application that does not comply with the interim final rule to prepare and print a controlled substance prescription, so that EHR and other electronic prescribing functionality may be used. Until the application is compliant
with the final rule, however, the practitioner will have to print the prescription for manual signature. Such prescriptions are paper prescriptions and subject to the existing requirements for paper prescriptions.
Q. As a pharmacy, until I have received an audit/certification report from my application provider indicating that the
application meets DEA's requirements, how can I use my pharmacy application to process controlled substances prescriptions?
A. A pharmacy cannot process electronic prescriptions for controlled substances until its pharmacy application provider obtains a third party audit or certification review that determines that the application complies with DEAs requirements and the application provider provides the audit/certification report to the pharmacy. The pharmacy may
continue to use its pharmacy application to store and process information from paper or oral controlled substances
prescriptions it receives, but the paper records must be retained.
Q. Is identity proofing of individual prescribing practitioners still required and who will conduct it?
A. Identity proofing is still required. It is critical to the security of electronic prescribing of controlled substances that
authentication credentials used to sign controlled substances prescriptions are issued only to individuals whose identity has been confirmed. Individual practitioners will be required to apply to certain Federally approved credential service providers (CSPs) or certification authorities (CAs) to obtain their two-factor authentication credential or digital
certificates. The CSP or CA will be required to conduct identity proofing that meets National Institute of Standards
and Technology Special Publication 800-63-1 Assurance Level 3. Both in person and remote identity proofing will
be acceptable. Institutional practitioners will have the option to conduct in-person identity proofing in-house as part
of their routine credentialing process.
Q. What two-factor credentials will be acceptable?
A. Under the interim final rule, DEA is allowing the use of two of the following something you know (a knowledge
factor), something you have (a hard token stored separately from the computer being accessed), and something you
are (biometric information). The hard token, if used, must be a cryptographic device or a one-time-password device
that meets Federal Information Processing Standard 140-2 Security Level 1.
Q. How will the two-factor credential be used?
A. The practitioner will use the two-factor credential to sign the prescription; that is, using the two-factor credential
will constitute the legal signature of the DEA-registered prescribing practitioner. When the credential is used, the ap-

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plication must digitally sign and archive at least the DEA-required information contained in the prescription. Because
the record will be digitally signed and archived at that point, the proposed requirement for a lock-out period is not
needed and is not part of the interim final rule.
Q. May a practitioner use his own digital certificate to sign an electronic controlled substance prescription?
A. Yes, the interim final rule allows any practitioner to use his own digital certificate to sign electronic prescriptions
for controlled substances. If the practitioner and his application provider wish to do so, the two-factor authentication
credential can be a digital certificate specific to the practitioner that the practitioner obtains from a Certification Authority that is cross-certified with the Federal Bridge Certification Authority at the basic assurance level.
Q. Must a practitioner separately attest to each prescription?
A. No, the application must include, on the prescription review screen, a statement that the use of the two-factor credential is the legal equivalent of a signature, but no keystroke is required to acknowledge the statement.
Q. Is it permissible to have a staff person in the practitioners office complete all of the required information for a
controlled substance prescription and then have the practitioner sign and authorize the transmission of the prescription?
A. Yes, however, if an agent of the practitioner enters information at the practitioners direction prior to the practitioner reviewing and approving the information, the practitioner is responsible in the event the prescription does not
conform in all essential respects to the law and regulations.
Q. Can a practitioner print a copy of any electronic prescriptions for controlled substances?
A. Yes, the electronic prescription application may print copies of the transmitted prescription(s) if they are clearly
labeled: Copy only not valid for dispensing. Data on the prescription may be electronically transferred to medical
records, and a list of prescriptions transmitted may be printed for patients if the list indicates that it is for informational purposes only and not for dispensing. The copies must be printed after transmission. If an electronic prescription is
printed prior to attempted transmission, the electronic prescription application must not allow it to be transmitted.
Q. Will a practitioner be allowed to simultaneously issue multiple prescriptions for multiple patients with a single signature?
A. A practitioner is not permitted to issue prescriptions for multiple patients with a single signature. However, a practitioner is allowed to sign multiple prescriptions for a single patient at one time. Each controlled substance prescription will have to be indicated as ready for signing, but a single execution of the two-factor authentication protocol can
then sign all prescriptions for a given patient that the practitioner has indicated as being ready to be signed.
Q. Once an electronic controlled substance prescription is signed, must it be transmitted to the pharmacy immediately?
A. No, signing and transmitting an electronic controlled substance prescription are two distinct actions. Electronic
prescriptions for controlled substances should be transmitted as soon as possible after signing, however, it is understood that practitioners may prefer to sign prescriptions before office staff add pharmacy or insurance information,
therefore, DEA is not requiring that transmission of the prescription occur simultaneously with signing the prescription.
Q. If transmission of an electronic prescription fails, may the intermediary convert the electronic prescription to another form (e.g. facsimile) for transmission?
A. No, an electronic prescription must be transmitted from the practitioner to the pharmacy in its electronic form. If
an intermediary cannot complete a transmission of a controlled substance prescription, the intermediary must notify
the practitioner. Under such circumstances, if the prescription is for a schedule III, IV, or V controlled substance, the
practitioner can print the prescription, manually sign it, and fax the prescription directly to the pharmacy. This prescription must indicate that it was originally transmitted to, and provide the name of, a specific pharmacy, the date
and time of transmission, and the fact that the electronic transmission failed.

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Q. What are the restrictions regarding alteration of a prescription during transmission?
A. The (DEA-required) contents of a prescription shall not be altered during transmission between the practitioner
and pharmacy. However, this requirement only applies to the content (not the electronic format used to transmit the
prescription). This requirement applies to actions by intermediaries. It does not apply to changes that occur after receipt at the pharmacy. Changes made by the pharmacy are governed by the same laws and regulations that apply to
paper prescriptions.
Q. Are electronic prescription records required to be backed-up, and if so, how often.
A. Yes, pharmacy application service providers must back up files daily. Also, although it is not required, DEA recommends as a best practice that pharmacies store their back-up copies at another location to prevent the loss of the
records in the event of natural disasters, fires, or system failures.
Q. What should a pharmacist do if he receives a paper or oral prescription that was originally transmitted electronically to the pharmacy?
A. The pharmacist must check the pharmacy records to ensure that the electronic version was not received and the
prescription dispensed. If both prescriptions were received, the pharmacist must mark one as void.
Q. What should a pharmacist do if he receives a paper or oral prescription that indicates that it was originally transmitted electronically to another pharmacy?
A. The pharmacist must check with the other pharmacy to determine whether the prescription was received and dispensed. If the pharmacy that received the original electronic prescription had not dispensed the prescription, that
pharmacy must mark the electronic version as void or canceled. If the pharmacy that received the original electronic
prescription dispensed the prescription, the pharmacy with the paper version must not dispense the paper prescription
and must mark the prescription as void.
Q. What are the DEA requirements regarding the storage of electronic prescription records?
A. Once a prescription is created electronically, all records of the prescription must be retained electronically. As is
the case with paper prescription records, electronic controlled substance prescription records must be kept for a minimum period of two years.
Audits and Certification of Applications
Q. Who can conduct an audit or certify an application?
A. Application providers must obtain a third-party audit or certification to certify that each electronic prescription and
pharmacy application to be used to sign, transmit, or process controlled substances prescriptions is in compliance
with DEA regulations pertaining to electronic prescriptions for controlled substances. The application may undergo a
WebTrust, SysTrust, or SAS 70 audit conducted by a person qualified to conduct such an audit. The application may
undergo an audit conducted by a Certified Information System Auditor who performs compliance audits as a regular
ongoing business activity. The application may have a certification organization whose certification has been approved by DEA verify and certify that the application meets DEAs requirements.
Q. When must a third-party audit or certification be conducted?
A. The third-party audit or certification must be conducted before the electronic prescription application is used to
sign or transmit electronic prescriptions for controlled substances, or before the pharmacy application is used to process electronic prescriptions for controlled substances, respectively. Thereafter, a third-party audit or certification
must be conducted whenever a functionality related to controlled substance prescription requirements is altered or
every two years, whichever occurs first.

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Q. To whom does the third-party audit/certification requirement apply?
A. The requirement for a third-party audit applies to the application provider, not to the individual practitioner, institutional practitioner, or pharmacy that uses the application. Unless an individual practitioner, institutional practitioner, or pharmacy has developed its own application, the practitioner or pharmacy is not subject to the requirement.
Prescritpion Drug Monitoring Programs
1. What is a prescription drug monitoring program (PDMP)?
According to the National Alliance for Model State Drug Laws (NAMSDL), a PDMP is a statewide electronic database which collects designated data on substances dispensed in the state. The PDMP is housed by a specified statewide regulatory, administrative or law enforcement agency. The housing agency distributes data from the database to
individuals who are authorized under state law to receive the information for purposes of their profession.
2. Does the Drug Enforcement Administration (DEA) oversee PDMPs?
The DEA is not involved with the administration of any state PDMP.
3. What are the benefits of having a PDMP?
The overview provided by NAMSDL clearly identifies the benefits of a PDMP: as a tool used by states to address
prescription drug abuse, addiction and diversion, it may serve several purposes such as:
support access to legitimate medical use of controlled substances,
identify and deter or prevent drug abuse and diversion,
facilitate and encourage the identification, intervention with and treatment of persons addicted to prescription drugs,
inform public health initiatives through outlining of use and abuse trends, and
educate individuals about PDMPs and the use, abuse and diversion of and addiction to prescription drugs.
4. Which states currently have a PDMP?
According to the Alliance of States with Prescription Monitoring Programs, (www.pmpalliance.org) as of October
16, 2011, 37 states have operational PDMPs that have the capacity to receive and distribute controlled substance prescription information to authorized users. States with operational programs include:
Alabama, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Mexico, New York, North
Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas,
Utah, Vermont, Virginia, West Virginia, and Wyoming.
Eleven states (Alaska, Arkansas, Delaware, Georgia, Maryland, Montana, Nebraska, New Jersey, South Dakota,
Washington, and Wisconsin) and one U.S. territory (Guam), have enacted legislation to establish a PDMP, but are
not fully operational.
5. Are there other states that are planning to implement a PDMP?
At this time there is no pending legislation for the remaining states.
6. Who can I contact regarding a PDMP in a specific state?
Each state designates a state agency to oversee its PDMP, which may include health departments, pharmacy boards,
or state law enforcement. The Alliance of States with Prescription Monitoring Programs (www.pmpalliance.org)
maintains a list of state contacts.
7. Where can I find state laws pertaining to prescription drug monitoring?
The National Alliance for Model State Drug Laws (www.namsdl.org) provides links to each states statutes and regulations regarding PDMPs.

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8. Who can access the PDMP information collected?
Each state controls who will have access and for what purpose.
9. Is federal funding available for PDMPs?
The Harold Rogers Prescription Drug Monitoring Program (HRPDMP) is administered by the U.S. Department of
Justice, Office of Justice Programs, Bureau of Justice Assistance, to provide three types of grants: planning, implementation, and enhancement. Since inception of the grant program in FY 2002, grants have been awarded to 47 states
and 1 U.S. territory. For FY 2011, HRPDMP funding is approximately $5.6 million. Additional information can be
found at www.ojp.usdoj.gov/BJA/grant/prescripdrugs.html
The National All Schedules Prescription Electronic Reporting Act (NASPER), enacted in 2005, created a U.S. Department of Health and Human Services grant program for states to implement or enhance prescription drug monitoring programs. In FY 2009 and FY 2010 NASPER received $2 million to support NASPER grants in 13 states.
Information on NASPER can be found at www.samhsa.gov.
States can participate in both funding programs, but requirements and priorities for each program may vary.
10. What is the difference between HRPDMP and NASPER?
The purpose of the HRPDMP is to enhance the capacity of regulatory and law enforcement agencies as well as public
health officials to collect and analyze controlled substance prescription data through a centralized database administered by an authorized state agency.
NASPER administers a grant program under the authority of HHS. The intent of the law was to foster the establishment or enhancement of PDMPs that would meet consistent national criteria and have the capacity for the interstate
exchange of information.

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State Pharmacy Law Review

Chapter 5: Massachusetts Statutes
The general framework for Massachusetts pharmacy law is provided in Massachusetts General Laws (MGL). This framework is provided in three different chapters of the MGL. Chapter 13, below, creates the Board of Registration in Pharmacy
and specifies its duties and other operations. Chapter 112 provides specifics regarding the registration of pharmacists, pharmacies, and wholesalers in Massachusetts. Then, MGL Chapter 94C- The Massachusetts Controlled Substances Act- has
broad application to the practice of pharmacynot only in regard to controlled drugs but to pharmacy practice itself. All of
these statutes authorize both the Board of Pharmacy and the Department of Public Health to promulgate regulations that further the purposes of the Laws. Pharmacists who wish to comply with the rule of law in Massachusetts must be familiar with
these statutes and regulations and any other state laws or rules that relate to pharmacy to assure they have covered the bases
of legal authority.
A. Massachusetts General Laws (M.G.L.) Chapter 13. Division and Boards of Registration
CHAPTER 13. DIVISION AND BOARDS OF REGISTRATION
BOARD OF REGISTRATION IN PHARMACY
This chapter provides for the creation of the Board of Registration in Pharmacy. Note the Board consists of 11 members
five of which must be registered pharmacists that have had 10 consecutive years experience. At least one must work in a
chain, one in an independent pharmacy, one in a non-profit hospital, and one have had 10 years experience in a long term
care setting. One member must be a physician and one a nurse. There must be two members of the public on the board.
Chapter 13: Section 22. Board; membership; qualifications; appointment; term
Section 22. There shall be a board of registration in pharmacy, in the 3 following sections called the board, consisting of 11
persons, who shall be residents of the commonwealth. Five of these persons shall be registered pharmacists and shall have
had at least 10 consecutive years of practical experience in the compounding and dispensing of physicians prescriptions,
and shall actually be engaged in the drug business. At the time of appointment to the board, at least 1 of such 5 members
shall be an independent pharmacist employed in the independent pharmacy setting and at least 1 of 5 members shall be a
chain pharmacist employed in the chain pharmacy setting, but not more than 2 pharmacists in any 1 practice setting may
serve on the board at any one time. For the purposes of this section independent pharmacist shall mean a pharmacist actively engaged in the business of retail pharmacy and employed in an organization of 9 or fewer registered retail drugstores
in the commonwealth under the provisions of section 39 of chapter 112 and employing not more than 20 full time pharmacists, and chain pharmacist shall mean a pharmacist in the employ of a retail drug organization operating 10 or more retail drug stores within the commonwealth under the provisions of said section 39; but an independent pharmacist and a chain
pharmacist shall represent two distinct practice settings. One person shall be a registered pharmacist and shall have had at
least 10 years of experience in the compounding and dispensing of physicians prescriptions, and shall actually be engaged
as a pharmacist in a non-profit hospital in the commonwealth. One person shall be a registered pharmacist and shall have
had at least 10 years of experience employed in a long-term care pharmacy setting. Two members shall be representatives of
the public, subject to the provisions of section 9B. One member shall be a physician registered pursuant to chapter 112 and 1
member shall be a nurse registered pursuant to chapter 112. No more than 1 member shall reside in the same senatorial district. One member shall annually in November be appointed by the governor, for 5 years from December first following.
Chapter 13: Section 23. Meetings; officers; secretarys bond
Section 23. The board shall meet on the first Tuesday of December in each year at such time and place as it may determine,
and shall organize by electing a president and secretary, who shall be members of the board, and shall hold their offices for
one year. The secretary shall give to the state treasurer a bond, with sufficient sureties to be approved by the governor and
council, for the faithful performance of his official duties. The board shall annually hold regular meetings on the first Tuesdays of January, May and October, and additional meetings at such times and places as it shall determine.

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Chapter 13: Section 24. Salaries and expenses
Section 24. There shall be paid by the commonwealth to the secretary of the board a salary of twenty-two hundred and fifty
dollars, to each of the other members thereof a salary of one thousand and fifty dollars, and to each member thereof his necessary traveling expenses actually incurred in attending the meetings of the board.
Chapter 13: Section 25. Agents; expenses; duties
Section 25. The board shall appoint no more than six agents who shall be allowed necessary traveling expenses. They shall
inspect drug stores and all other places of business wherein drugs, medicines, patent medicines, medical preparations and
medical supplies of any kind are sold or distributed, and shall make a report of their doings pertaining thereto to the board,
and shall report all violations of the laws relating to pharmacy and the retail drug business and all violations of the rules and
regulations of the board. As directed by the board, they shall file criminal complaints against all violators of such laws, rules
or regulations.
B. Massachusetts General Laws (M.G.L.) Chapter 112 Registration of Certain Professions and Occupations
CHAPTER 112. REGISTRATION OF CERTAIN PROFESSIONS AND OCCUPATIONS
REGISTRATION OF PHARMACISTS
Chapter 112: Section 24. Registration of pharmacists; examination; fees
Section 24. A person who desires to do business as a pharmacist shall, upon payment of a fee, as determined annually by the
commissioner of administration under the provision of section three B of chapter seven, to the board of registration in pharmacy, herein and in sections twenty-five to forty-two, inclusive, called the board, be entitled to examination; provided, that he
shall have been graduated from a school or college of pharmacy approved by the board. If any such person is found qualified
on examination, he shall be registered as a pharmacist, and shall receive a certificate signed by the president and secretary
of the board. Any person failing to pass such examination shall upon request be re-examined, after the expiration of three
months, at any regular meeting of the board, upon payment of a fee determined under the aforementioned provision. The
board may grant certificates of registration as assistants after examination upon the terms above named, and such certificates shall entitle the holder thereof to all the privileges of a registered pharmacist during the temporary absence of the latter, which absence shall be not more than six hours in any one period of twenty-four consecutive hours; provided, that, upon
application to the board, such an assistant may be permitted to exercise the privileges of a registered pharmacist for such
further period as the board shall determine. No such certificate as assistant shall allow the holder thereof to engage in the
drug business on his own account or as a manager to conduct a pharmacy or drug store. The board may grant certificates of
registration to such persons as shall furnish with their applications satisfactory proof that they have been registered by examination in some other state; provided, that such other state shall require a degree of competency equal to that required of applicants in this commonwealth. Every such applicant for registration as a registered pharmacist shall pay to the secretary of
the board a fee determined under the aforementioned chapter seven provision at the time of filing his application. No such
certificate shall be granted until the person applying therefor shall have signified his intention of acting under the same in
this commonwealth.
Chapter 112: Section 24A. Records; expiration of registrations; renewals; reinstatement; fees
Note that registrations are renewed biennially, and registrations expire on Dec. 31st of each even-numbered year.
Section 24A. The board shall keep an official record of the names of all registered pharmacists and registered assistant pharmacists. All registrations of registered pharmacists and registered assistant pharmacists shall expire on December thirty-first
of each even-numbered year. Any holder of a certificate of registration as a pharmacist or assistant pharmacist issued under
section twenty-four and remaining uncancelled shall be entitled to have such certificate biennially renewed by registration by
the board, upon the payment of a biennial renewal fee as determined annually by the commissioner of administration under
the provision of section three B of chapter seven. On the first day of November of each even-numbered year the board shall
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send written notice to this effect to every registered pharmacist and every registered assistant pharmacist, and shall enclose
with each notice a proper blank for such registration. If said blank properly filled out, together with said fee, shall not on or
before the thirty-first day of December of such even-numbered year be received by said board from any pharmacist or assistant pharmacist so notified, said board shall strike from the register the name of such pharmacist or assistant pharmacist;
provided, that at any time thereafter, any pharmacist or assistant pharmacist whose name shall have been so removed from
the register may, upon submission to the board of proof satisfactory to it of his moral and physical fitness, have his name restored by it upon the payment to it of all accrued biennial renewal fees, together with a reinstatement fee determined under
the aforementioned provision.
The board shall adopt rules and regulations for a system of continuing education, compliance with which shall be a requirement and condition precedent to the renewal of licenses issued by the board. The board shall accept all conferences and programs from providers approved by the American Council on Pharmaceutical Education as meeting this requirement.
Chapter 112: Section 24B. Standards for schools of pharmacy; certificates of approval; courses
Section 24B. The board and the commissioner of education shall forthwith establish standards to be met by schools or colleges of pharmacy and when, in the opinion of the board and the commissioner, such standards have been met by any school or
college of pharmacy, a certificate of approval shall be awarded to such approved school or college of pharmacy; provided,
that if at any time such approved school or college of pharmacy has, in the opinion of the board and said commissioner, lowered its standards below that established by the board and said commissioner, such certificate, after notice and hearing, may
be revoked by the board and said commissioner. No person, school or college of pharmacy or other institution of learning
shall establish, conduct or offer any course in pharmacy for residents or non-residents of the commonwealth unless and until
such course meets the standards established by the board and said commissioner under authority of this section. Whoever
violates any provision of this section shall be punished by a fine of not less than one hundred nor more than one thousand
dollars, or by imprisonment for not more than one year, or both.
Chapter 112: Section 25. Records; annual reports
Section 25. The board shall keep a record of the names of all persons examined and registered by it, of all persons to whom
permits are issued under section thirty-nine, and of all money received and disbursed by it, and a duplicate thereof shall be
open to public inspection in the office of the state secretary. The board shall make an annual report of the condition of pharmacy in the commonwealth
Note this requirement.
Chapter 112: Section 26. Display of certificate
Section 26. Every person receiving a certificate of registration from the board shall conspicuously display the same in his
place of business.
Chapter 112: Section 27. Complaint; notice; hearing
Note that three members of the board constitute a quorum for a hearing.
Section 27. The board shall hear all complaints made to it against any person registered as a pharmacist charging him in his
business as a pharmacist with violating any of the rules or regulations of the board or any laws of the commonwealth, and
especially the laws relating to the sale of alcoholic beverages, as defined in section one of chapter one hundred and thirtyeight, and alcohol; or with engaging with, or aiding or abetting another in the violation of said rules, regulations or laws; or,
if he himself is not the owner and actively engaged in such business, with suffering or permitting the use of his name or certificate of registration by others in the conduct of the business of pharmacy. Any complaints which are the result of a conviction
by a court of competent jurisdiction shall be made within twelve months from the date such a conviction becomes known to
the board. The board shall notify the person complained against of the charge against him and of the time and place of the
hearing at which he may appear with his witnesses and be heard by counsel. It may summon witnesses and compel their attendance at said hearings. Witnesses shall testify on oath and may be sworn by a member of the board. Three members of the
board shall be a quorum for any such hearing.

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Chapter 112: Section 28. Decision of board of registration in pharmacy; effect
Section 28. If the full board sitting at such hearing finds the person guilty, the board may suspend the effect of his certificate
of registration as a pharmacist for such term as it fixes. The board may at any time reconsider its action in cases where it has
suspended or revoked the license or certificate of registration of a pharmacist, and may change its determination as justice
shall require.
Chapter 112: Section 29. Suspension of certificate of registration
Section 29. It may, by a majority vote of all its members, after hearing, suspend the certificate of registration of a registered
pharmacist, who, in its judgment, is a menace to the public by reason of the improper use of intoxicating liquor or drugs.
Chapter 112: Section 30. Unlawful dispensing of controlled substances; penalties; clerical and ministerial supportive services excepted
Note this provision
Section 30. No person shall dispense any controlled substance or any substance intended for hypodermic use except a person
registered as a pharmacist or assistant pharmacist under section twenty-four or corresponding provisions of earlier laws
who is acting in the course of his employment in a pharmacy, an intern in pharmacy under the direct supervision of a registered pharmacist in accordance with the regulations of the board, and a practitioner in accordance with the provisions of
chapter ninety-four C. The terms controlled substances, dispense, practitioner, and pharmacy, as used in this section, shall have the same meaning as set forth in section one of said chapter ninety-four C.
Whoever violates any provision of this section shall be punished by imprisonment in a jail or the house of correction for not
more than three months, or by a fine of not more than five hundred dollars, or both.
The registered pharmacist is responsible for action of any supportive personnel under his/her supervision.
Notwithstanding any provision of this section to the contrary, a person under the direction and supervision of a registered
pharmacist may perform those clerical and ministerial supportive services in a pharmacy which do not require the exercise
of professional judgment by a registered pharmacist. The board may make such rules and regulations as it deems necessary
to define the supportive services which an unregistered person may perform in a pharmacy. The registered pharmacist shall
be responsible for the actions of any supportive personnel under his supervision.
Chapter 112: Section 31. Repealed, 1983, 282, Sec. 2
Chapter 112: Section 32. Investigation of complaints
Section 32. The board shall investigate all complaints of the violation of any provision of sections twenty-four to forty-two,
inclusive, or of section sixty-five, so far as it relates to pharmacy, and report the same to the proper prosecuting officers, and
especially investigate and cause to be prosecuted all violations of sections twenty-nine to thirty G, inclusive, of chapter one
hundred and thirty-eight.
Chapter 112: Section 33. Access to documents
Section 33. A registered pharmacist against whom a complaint or charge is pending before the board, or his counsel, shall
have the same right of access to documents in the possession of said board as a person charged with crime in the courts of
the commonwealth would have to documents in the possession of the clerk of the court or the prosecuting officer.
Chapter 112: Section 34. Certificate of conviction of pharmacist; notification of board
Section 34. The court or magistrate before whom a person is convicted of a violation of section thirty of this chapter, or of
any provision of sections twenty-nine to thirty F, inclusive, of chapter one hundred and thirty-eight relating to the retention,
filing or inspection of prescriptions, or of section two of chapter two hundred and seventy shall send to the board a certificate
under seal showing the time, cause and place of conviction.

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Chapter 112: Section 35. Repealed, 1974, 326, Sec. 2
Chapter 112: Section 36. Continuance of business of deceased or incapacitated registered pharmacists
Section 36. The surviving spouse, executor or administrator of a registered pharmacist who has died or the spouse of one
who has become incapacitated may continue his business under a registered pharmacist, who may also be considered qualified to receive a certificate of fitness under section thirty of chapter one hundred and thirty-eight authorizing him to exercise
upon the premises of said deceased or incapacitated pharmacist the rights conferred by section twenty-nine of said chapter
upon holders of said certificates; provided, that the registered pharmacist under whom the business is continued is in charge
of the premises and present therein.
LICENSING OF PERSONS ENGAGED IN THE SALE, DISTRIBUTION OR DELIVERY, AT WHOLESALE, OF DRUGS OR
MEDICINES
Chapter 112: Section 36A. Licensing of sale, distribution and delivery of drugs or medicines
Section 36A. Except as otherwise provided in section thirty-five, no person shall engage in the sale, distribution or delivery,
at wholesale, of drugs or medicines within the commonwealth without a license so to do
Chapter 112: Section 36B. Licenses; fees; renewals
Wholesaler licenses are renewed annually on or before December 1st of each year.
Section 36B. The board shall upon application and the payment of an annual license fee to be determined annually by the
commissioner of administration under the provision of section three B of chapter seven issue licenses required by section
thirty-six A; provided, that no such license shall be issued to any applicant unless the board is satisfied that he or it is actually engaged in and is carrying on such wholesale business. Such license shall be renewed on or before December first of each
year upon the payment of a license fee to be determined annually by the commissioner of administration under the provision
of section three B of chapter seven. Any person who is engaged in the wholesale drug business at more than one location,
shall obtain such a license for each location.
Chapter 112: Section 36C. Use of words wholesale druggist; inspection and investigation of wholesale dealers; reports
of violations; complaints
Section 36C. No person shall use the words wholesale druggist or any other words of similar import, holding himself or
itself out to be engaged in the sale, distribution or delivery of drugs or medicines, at wholesale, without first having been licensed as provided in sections thirty-six A and thirty-six B. The agents of the board shall have authority, during business
hours, to inspect and investigate all wholesale dealers in drugs or medicines, and shall report all violations of sections thirtysix A to thirty-six D, inclusive, to the board, upon the direction of which such agents shall apply for criminal complaints
against persons guilty of any such violations.
Chapter 112: Section 36D. Penalties
Section 36D. Whoever, not being licensed as provided in sections thirty-six A and thirty-six B, engages in the sale, distribution or delivery, at wholesale, of drugs or medicines, or uses the words wholesale druggist or any other words of similar
import in connection with his business to indicate the sale, distribution or delivery of such commodities, at wholesale, or
whoever sells, distributes or delivers such commodities at retail, and holds himself out to be a wholesale druggist by using
the words, wholesale druggist or words of similar import in connection with his business, or in advertising the same, shall
be punished by a fine of not more than one thousand dollars or by imprisonment in a jail or house of correction for not less
than thirty days nor more than one year, or both.

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REGISTERING AND LICENSING STORES FOR TRANSACTING RETAIL DRUG BUSINESS
Chapter 112: Section 37. Drug business; definition
Section 37. Drug business, as used in the two following sections, shall mean the sale, or the keeping or exposing for sale of
drugs, medicines, chemicals or poisons, except as otherwise provided in section thirty-five, also the sale or the keeping or
exposing for sale of opium, morphine, heroin, codeine or other narcotics, or any salt or compound thereof, or any preparation containing the same, or cocaine, alpha or beta eucaine, or any synthetic substitute therefor, or any salt or compound
thereof, or any preparation containing the same, and the said term shall also mean the compounding and dispensing of physicians prescriptions.
Chapter 112: Section 38. Transaction of retail drug business; registration; permit; display of permit
Permit must be conspicuously displayed
Section 38. No store or retail food store pharmacy department or retail store pharmacy department shall be kept open for the
transaction of the retail drug business, or be advertised or represented as transacting such business, by means of any sign or
advertisement containing the words drug store, pharmacy, apothecary, drug, drugs, medicine shop, or any
combination of such words, or otherwise, unless it is registered with, and a permit therefor has been issued by the board as
provided in the following section; provided, however, that said words, or any of them, may, with the written permission of the
board, be used with respect to a store or retail food store pharmacy department or retail store pharmacy department not registered with, and not having a permit issued by, the board as aforesaid, if in the town, or voting precinct thereof, where such
store or retail food store pharmacy department or retail store pharmacy department is located there is no store or retail food
store pharmacy department or retail store pharmacy department so registered and having such a permit. Such permit shall
be displayed in a conspicuous place in the store or retail food store pharmacy department or retail store pharmacy department for which it is issued. The word town, as used in this section, shall not include city. Identification of a retail food
store pharmacy department or retail store pharmacy department by use of the words drug store, pharmacy,
apothecary, drug, drugs, medicine shop, or any combination thereof shall be restricted to the area registered by
the board for the transaction of the retail drug business.
Chapter 112: Section 39. Registration; permits; fees; rendering of final decision
Section 39. The board may, upon application made in such manner and form as it shall determine, register a store or retail
food store pharmacy department or retail store pharmacy department for the transaction of the retail drug business, and issue to such person as it deems qualified to conduct such store or retail food store pharmacy department or retail store pharmacy department, a permit to keep it open; provided, however, that the board may deny such registration and refuse to issue
such permit if, in its reasonable discretion, such store or retail food store pharmacy department or retail store pharmacy department would be inconsistent with or opposed to the best interests of the public health, welfare or safety, but no such registration shall be made or permit issued in the case of a corporation unless it shall appear to the satisfaction of the board that
the management of such drug store or retail food store pharmacy department or retail store pharmacy department is in the
hands of a registered pharmacist. Such permit shall expire on December thirty-first of each uneven numbered year following
the date of its issue, and the fee therefor shall be determined annually by the commissioner of administration under the provision of section three B of chapter seven.
The board has 150 days from time application is made to deny or allow registration.
The board shall, within one hundred and fifty days after the filing of an application render a final decision denying or allowing registration. Failure to render such decision, except when such failure to act is caused by the delay of the applicant, shall
constitute an approval of the application and permit shall be issued. For the purposes of this section and section thirty-eight
the term retail food store pharmacy department shall mean any area for the transaction of the retail drug business which is
located within a retail food store
.

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Chapter 112: Section 39A. Restricted pharmacies; registration
Section 39A. The board may, upon application of the plan administrator or trustee of any trust, fund, pension plan, combination plan or profit sharing plan, which is subject to the provisions of chapter one hundred and fifty-one D, register a facility,
hereinafter called a restricted pharmacy, for the limited transaction of the drug business as defined in section thirty-seven. A
restricted pharmacy may furnish pharmacy services only to beneficiaries, as defined in section one of said chapter one hundred and fifty-one D, of said trust, fund, pension plan, combination plan or profit sharing plan and who reside in the commonwealth or in any other New England state. Charges for such services shall be determined by said trustee or plan
administrator. A restricted pharmacy may, after written notice to the board limit its operation to a specific schedule of drugs.
Said board shall determine which regulations, applicable to a retail drug business registered under section thirty-nine shall
apply to a pharmacy registered under this section and may establish, subject to the provisions of section two of chapter thirty
A, regulations which shall apply only to a restricted pharmacy.
Nothing in this section shall prohibit a restricted pharmacy from accepting and filling prescriptions by mail; provided, however, that, notwithstanding the provisions of paragraph (c) of section eighteen of chapter ninety-four C or any other law to
the contrary, the prescribing physician is verified, according to procedures established by the board, as licensed to practice
in the commonwealth or in any New England state.
Chapter 112: Section 39B. Nuclear pharmacies
Permits expire Dec. 31st of each uneven year.
Section 39B. The board may, upon application, made in such manner and form as it shall determine, register an establishment for transacting business as a nuclear pharmacy as defined in section one of chapter ninety-four C. A nuclear pharmacy
shall not perform any pharmacy functions other than the dispensing of radiopharmaceutical drug products. The board shall
issue a permit to such person as its deems qualified to conduct such pharmacy; provided, however, that the board may deny
such registration and may refuse to issue such permit if, in its discretion, it determines that such pharmacy would be inconsistent with or opposed to the best interest of the public health, welfare and safety. No such registration shall be made or permit issued in the case of a corporation unless it shall appear to the satisfaction of the board that the management of such
nuclear pharmacy is in the hands of a registered pharmacist. Such permit shall expire on December thirty-first of each uneven numbered year following the date of its issue, and the fee therefor shall be determined annually by the commissioner of
administration and finance under the provisions of section three B of chapter seven. The board shall, within one hundred and
fifty days after the filing of an application, render a final decision denying or allowing registration. Failure to render such
decision, except when failure to act is caused by the delay of the applicant, shall constitute an approval of the application
and the permit shall be issued.
The board, in consultation with the department of public health shall promulgate regulations pertaining to the operation of
nuclear pharmacies in the commonwealth. Such regulations may include procedures governing the dispensing of radiopharmaceutical drugs when the name of a patient to whom the drug is to be administered is not known at the time a prescription
order is received, provided that such regulations shall allow a nuclear pharmacist up to seventy-two hours after dispensing a
radiopharmaceutical drug to determine the patients name and record such information on the appropriate form.

Chapter 112: Section 40. Suspension or revocation of registration and permit; notice; hearing
Suspension or revocation requires attendance of at least quorm of 3 board members and an affirmative vote of at least 3
members.
Section 40. The board may suspend or revoke any registration made under section thirty-nine, thirty-nine A or thirty-nine B
and any permit issued thereunder for any violation of the law pertaining to the drug business or the sale of alcoholic beverages, as defined in section one of chapter one hundred and thirty-eight, or for any violation of the rules and regulations established by the board, or for aiding or abetting in a violation of any such law, rules or regulations; but before such
suspension or revocation the board shall give a hearing to the holder of the permit, after due notice to him of the charges

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against him and of the time and place of the hearing. Such holder may appear at the hearing with witnesses and be heard by
counsel. Witnesses shall testify on oath and any member of the board may administer oaths to them. The board may require
the attendance of persons and compel the production of books and documents. Three members of the board shall be a quorum for such a hearing, but no registration or permit shall be suspended or revoked unless upon the affirmative vote of three
or more members thereof.
Chapter 112: Section 41. Penalty
Section 41. Whoever violates any provision of section thirty-eight shall be punished by a fine of not less than five nor more
than one hundred dollars or by imprisonment for not more than one month, or both.
Chapter 112: Section 41A. Patent and proprietary medicines; non-controlled substances; exemption from regulation
Section 41A. Sections thirty-six A to forty-one, inclusive, of this chapter, and sections twenty-nine to thirty G, inclusive, of
chapter one hundred and thirty-eight shall not apply to the manufacture or sale of patent and proprietary medicines or any
substance or drug not included or defined in chapter ninety-four C as a controlled substance.
Chapter 112: Section 42. Authorization of expenditures
Section 42. For the purpose of carrying out the five preceding sections, the board may expend annually a sum not exceeding
one thousand dollars.
Chapter 112: Section 42A. Rules and regulations; suspension or revocation of license or permit; hearing
Allows board to enact rules of professional conduct
Section 42A. The board may make such rules and regulations as it deems necessary to enable it to properly enforce the provisions of law relating to the retail drug business and pharmacy, and regarding any other matter within its jurisdiction; provided, that nothing herein shall authorize the board to make a rule or regulation requiring, as a prerequisite to the examination
of an applicant under section twenty-four, or to his qualification, that he be the holder of a degree, nor a rule or regulation
prohibiting a registered pharmacist connected with and employed by a hospital or clinic from dispensing medicines or drugs
to an employee of such hospital or clinic for the use of such employee, his spouse and his children living in the same household with such employee.
The board may by rule or regulation adopt, amend or repeal rules of professional conduct. Every person who holds a certificate, license, registration or permit to practice pharmacy or engage in the retail drug business in this commonwealth shall be
governed and controlled by the rules and regulations of professional conduct adopted by the board. The board may suspend
or revoke any certificate, license, registration or permit to practice pharmacy or engage in the retail drug business for any
violation of the rules and regulations established hereunder or for aiding or abetting in any violation of such rules or regulations; but before such suspension or revocation, the board shall give a hearing to the holder of the certificate, license, registration or permit, after due notice to him of the charges against him and of the time and place of the hearing. Such holder
may appear at the hearing with witnesses and be heard by counsel. Witnesses shall testify on oath and any member of the
board may administer oaths to them. The board may require the attendance of persons and compel the production of books
and documents. Three members of the board shall be a quorum for such a hearing, but no certificate, license, registration or
permit shall be suspended or revoked unless upon the affirmative vote of three or more members thereof. The rules of professional conduct adopted by the board shall be printed as part of the application blank for permits, licenses, certificates and
registration and for renewals thereof, and every applicant shall subscribe thereto when making an application.

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CHAPTER 112. REGISTRATION OF CERTAIN PROFESSIONS AND OCCUPATIONS
GENERAL PROVISIONS RELATIVE TO EACH BOARD OF REGISTRATION OR EXAMINATION IN THE DIVISION OF
REGISTRATION OF THE DEPARTMENT OF CIVIL SERVICE AND REGISTRATION
Chapter 112: Section 65. Practice during suspension, revocation or cancellation; civil administrative penalties; notice;
expiration and renewal of license; court orders
Section 65. (a) Whoever continues to practice a trade or profession after his certificate, registration, license or authority to
do so has been suspended, revoked or cancelled under section 61, and while such disability continues, shall be punished by a
fine of not more than $2,500 or by imprisonment for not more than 6 months, or both.
(b) Notwithstanding any general or special law to the contrary, each board of registration under the supervision of the division of professional licensure and each board of registration under the supervision of the department of public health may,
after a consent agreement between the parties or after an opportunity for an adjudicatory proceeding held pursuant to chapter 30A, assess and collect a civil administrative penalty of not more than $1,000 for the first violation and not more than
$2,500 for a second or subsequent violation upon a person who practices a trade or profession at a time when his license,
certificate, registration or authority to do so has been suspended, revoked or cancelled by the board of registration that issued the license, and upon any person who knowingly practices a trade or profession at a time when his license, certificate,
registration or authority to do so has expired; provided, however, that if a licensee has, in accordance with any law and with
board regulations, made timely and sufficient application for a renewal, his license shall not expire until his application has
been finally determined by the board; provided further, that prior to the assessment of a civil administrative penalty under
this section, the board shall notify the licensee that he has at least 90 days after the date of expiration within which to submit
an application for renewal during which time the board shall waive any applicable penalties pursuant to this paragraph. An
assessment of a civil administrative penalty under this section shall bar a subsequent imposition of a criminal penalty for the
same violation and an imposition of a criminal penalty under this section shall bar a subsequent assessment of a civil administrative penalty for the same violation.
(c) A board may apply to the appropriate court for an order enjoining the unlicensed practice of a trade or profession or for
an order for payment of an assessed penalty or for such other relief as may be appropriate to enforce this section.
C. Massachusetts General Laws (M.G.L.) Chapter 94C Massachusetts Controlled Substances Act
Close attention must be paid to this statute. Because Massachusetts has a unique way of classifying controlled substances,
this chapter actually applies more generally to the practice of pharmacy. Schedules I-V are identical to the federal schedules.
However, Massachusetts adds a Schedule VI which consists of all prescription drugs not included in schedule I-V. Therefore, this Act applies to not only controlled substances as they are generally known, but to all prescription drugs. Due to the
length of this Act, non-relevant portions have been deleted. You may find the entire act at
http://www.mass.gov/legis/laws/mgl/gl-94c-toc.htm
CHAPTER 94C. CONTROLLED SUBSTANCES ACT
Chapter 94C: Section 1. Definitions
Section 1. As used in this chapter, the following words shall, unless the context clearly requires otherwise, have the following
meanings:
Administer, the direct application of a controlled substance whether by injection, inhalation, ingestion, or any other means
to the body of a patient or research subject by
(a) a practitioner, or
(b) a nurse at the direction of a practitioner in the course of his professional practice, or
(c) an ultimate user or research subject at the direction of a practitioner in the course of his professional practice.

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Agent, an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except
that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carriers or warehousemans business.
Bureau, the Bureau of Narcotics and Dangerous Drugs, United States Department of Justice, or its successor agency.
Class, the lists of controlled substances for the purpose of determining the severity of criminal offenses under this chapter.
Commissioner, the commissioner of public health.
Controlled substance, a drug, substance, or immediate precursor in any schedule or class referred to in this chapter.
Counterfeit substance, a substance which is represented to be a particular controlled drug or substance, but which is in
fact not that drug or substance.
Deliver, to transfer, whether by actual or constructive transfer, a controlled substance from one person to another, whether or not there is an agency relationship.
Department, the department of public health.
Depressant or stimulant substance,
(a) a drug which contains any quantity of barbituric acid or any of the salts of barbituric acid; or any derivative of barbituric
acid which the United States Secretary of Health, Education, and Welfare has by regulation designated as habit forming; or
(b) a drug which contains any quantity of amphetamine or any of its optical isomers; any salt of amphetamine or any salt of
an optical isomer of amphetamine; or any substance which the United States Attorney General has by regulation designated
as habit forming because of its stimulant effect on the central nervous system; or
(c) lysergic acid diethylamide; or
(d) any drug except marihuana which contains any quantity of a substance which the United States Attorney General has by
regulation designated as having a potential for abuse because of its depressant or stimulant effect on the central nervous system or its hallucinogenic effect.
Dispense, to deliver a controlled substance to an ultimate user or research subject or to the agent of an ultimate user or
research subject by a practitioner or pursuant to the order of a practitioner, including the prescribing and administering of a
controlled substance and the packaging, labeling, or compounding necessary for such delivery.
Distribute, to deliver other than by administering or dispensing a controlled substance.
Drug,
(a) substances recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the
United States, or official National Formulary, or any supplement to any of them;
(b) substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals;
(c) substances, other than food, intended to affect the structure, or any function of the body of man and animals; or
(d) substances intended for use as a component of any article specified in clauses (a), (b) or (c), exclusive of devices or their
components, parts or accessories.
.
Immediate precursor, a substance which the commissioner has found to be and by rule designates as being a principal
compound commonly used or produced primarily for use, and which is an immediate chemical intermediary used or likely to
be used in the manufacture of a controlled substance, the control of which is necessary to prevent, curtail, or limit manufacture.
Isomer, the optical isomer, except that wherever appropriate it shall mean the optical, position or geometric isomer.
Manufacture, the production, preparation, propagation, compounding, conversion or processing of a controlled substance, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical
synthesis, including any packaging or repackaging of the substance or labeling or relabeling of its container except that this

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term does not include the preparation or compounding of a controlled substance by an individual for his own use or the preparation, compounding, packaging, or labeling of a controlled substance:
(a) by a practitioner as an incident to his administering a controlled substance in the course of his professional practice, or
(b) by a practitioner, or by his authorized agent under his supervision, for the purpose of, or as an incident to, research,
teaching or chemical analysis and not for sale, or
(c) by a pharmacist in the course of his professional practice.
Narcotic drug, any of the following, whether produced directly or indirectly by extraction from substances of vegetable
origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:
(a) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate;
(b) Any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of the
substances referred to in clause (a), but not including the isoquinoline alkaloids of opium;
(c) Opium poppy and poppy straw;
(d) Coca leaves and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extractions of coca leaves which do not contain cocaine or ecgonine.
Nuclear pharmacy, a facility under the direction or supervision of a registered pharmacist which is authorized by the
board of registration in pharmacy to dispense radiopharmaceutical drugs.
Nurse, a nurse registered or licensed pursuant to the provisions of section seventy-four or seventy-four A of chapter one
hundred and twelve, a graduate nurse as specified in section eighty-one of said chapter one hundred and twelve or a student
nurse enrolled in a school approved by the board of registration in nursing.
Nurse practitioner, a nurse with advanced training who is authorized to practice by the board of registration in nursing as
a nurse practitioner, as provided for in section eighty B of chapter one hundred and twelve.
Opiate, any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable
of conversion into a drug having addiction-forming or addiction-sustaining liability. It does not include, unless specifically
designated as controlled under section two, the dextrorotatory isomer of 3-methoxy-n-methyl-morphinan and its salts, dextromethorphan. It does include its racemic and levorotatory forms.
Opium poppy, the plant of the species Papaver somniferum L., except its seeds.
Oral prescription, an oral order for medication which is dispensed to or for an ultimate user, but not including an order
for medication which is dispensed for immediate administration to the ultimate user by a practitioner, registered nurse, or
practical nurse.
Person, individual, corporation, government, or governmental subdivision or agency, business trust, estate, trust, partnership or association, or any other legal entity.
Pharmacist, any pharmacist registered in the commonwealth to dispense controlled substances, and including any other
person authorized to dispense controlled substances under the supervision of a pharmacist registered in the commonwealth.
Pharmacy, a facility under the direction or supervision of a registered pharmacist which is authorized to dispense controlled substances, including but not limited to retail drug business as defined below.
Physician assistant, a person who is a graduate of an approved program for the training of physician assistants who is
supervised by a registered physician in accordance with sections nine C to nine H, inclusive, of chapter one hundred and
twelve.
Poppy straw, all parts, except the seeds of the opium poppy, after mowing.
Practitioner, (a) A physician, dentist, veterinarian, podiatrist, scientific investigator, or other person registered to distribute, dispense, conduct research with respect to, or use in teaching or chemical analysis, a controlled substance in the course
of professional practice or research in the commonwealth;

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(b) A pharmacy, hospital, or other institution registered to distribute, dispense, conduct research with respect to or to administer a controlled substance in the course of professional practice or research in the commonwealth.
(c) An optometrist authorized by sections 66 and 66B of chapter 112 and registered pursuant to paragraph (h) of section 7 to
utilize and prescribe therapeutic pharmaceutical agents in the course of professional practice in the commonwealth.
Prescription drug, any and all drugs upon which the manufacturer or distributor has, in compliance with federal law and
regulations, placed the following: Caution, Federal law prohibits dispensing without prescription.
Production, includes the manufacture, planting, cultivation, growing, or harvesting of a controlled substance.
Radiopharmaceutical drug, any drug which is radioactive as defined in the Federal Food, Drug and Cosmetic Act.
Registrant, a person who is registered pursuant to any provision of this chapter.
Registration, unless the context specifically indicates otherwise, such registration as is required and permitted only pursuant to the provisions of this chapter.
Registration number, such registration number or numbers, either federal or state, that are required with respect to practitioners by appropriate administrative agencies.
Retail drug business, a store for the transaction of drug business as defined in section thirty-seven of chapter one hundred and twelve.
Schedule, the list of controlled substances established by the commissioner pursuant to the provisions of section two for
purposes of administration and regulation.
State, when applied to a part of the United States other than Massachusetts includes any state, district, commonwealth,
territory, insular possession thereof, and any area subject to the legal authority of the United States of America.
Tetrahydrocannabinol, tetrahydrocannabinol or preparations containing tetrahydrocannabinol excluding marihuana except when it has been established that the concentration of delta-9 tetrahydrocannabinol in said marihuana exceeds two and
one-half per cent.
Ultimate user, a person who lawfully possesses a controlled substance for his own use or for the use of a member of his
household or for the use of a patient in a facility licensed by the department or for administering to an animal owned by him
or by a member of his household.
Written prescription, a lawful order from a practitioner for a drug or device for a specific patient that is communicated
directly to a pharmacist in a licensed pharmacy; provided, however, that written prescription shall not include an order
for medication which is dispensed for immediate administration to the ultimate user by a practitioner, registered nurse or
licensed practical nurse.
Chapter 94C: Section 2. Establishment of schedules of drugs or other controlled substances
Section 2. (a) For the purpose of administration and regulation of the manufacture, distribution, dispensing, and possession
of controlled substances by persons authorized under this chapter, the commissioner shall establish by regulations pursuant
to the provisions of chapter thirty A five schedules incorporating the five schedules of controlled substances under the
Comprehensive Drug Abuse, Prevention and Control Act of 1970 or any amendment thereof. In addition thereto the commissioner shall by regulation as aforesaid establish a sixth schedule which shall include all prescription drugs not included
in the first five schedules.
(a1/2) The commissioner may, pursuant to the provisions of chapter thirty-A, delete or reschedule all substances enumerated
in the schedules established pursuant to the provisions of subsection (a), except that if any substance which has not been
scheduled pursuant to the provisions of this section is designated a controlled substance under the Federal Comprehensive
Drug Abuse Prevention and Control Act of 1970 or any amendment thereof, or if any substance which has been scheduled
pursuant to the provisions of this section is designated a controlled substance of greater abuse liability under the Federal
Comprehensive Drug Abuse Prevention and Control Act of 1970 or any amendment thereof, the commissioner, pursuant to
the provisions of chapter thirty A, shall, not more than thirty days after publication of final notice in the federal register or
not more than thirty days after the effective date of any federal statute affecting the scheduling of controlled substances under
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said federal act or any amendment thereof, issue a regulation controlling the substance in a schedule corresponding to the
federal schedules.
(b) In making any finding under subsection (a) of this section or under subsection (a) of section three, the commissioner shall
consider the following factors with respect to each drug or other substance proposed to be controlled or removed from the
schedules:
(1) Its actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if known.
(3) The state of current scientific knowledge regarding the drug or other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychological or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a substance already controlled under this chapter.
(c) The commissioner acting jointly with the board of registration in pharmacy shall by regulation pursuant to the provisions
of chapter thirty A exclude any non-narcotic substance from a schedule if such substance may, under the Federal
Comprehensive Drug Abuse Prevention and Control Act of 1970 and the Food, Drug, and Cosmetic Act, be lawfully sold
over the counter without a prescription.
(d) Authority to control under this section shall not extend to distilled spirits, wine, malt beverages, or tobacco, as those
terms are defined or used in subtitle E of the Internal Revenue Code of 1954.
Chapter 94C: Section 3. Findings required for placement in schedules
Schedules I-V are identical to federal law. But, Schedule VI is added which consists of all prescription drugs not contained
in schedules I-V.
Section 3. Except in the case of an immediate precursor, a drug or other substance may not be placed in any schedule unless
such drug or substance has been scheduled pursuant to the provisions of the Federal Comprehensive Drug Abuse, Prevention
and Control Act of 1970, or any amendment thereof, or unless the findings required for such schedule are made with respect
to such drug or other substance. The findings required for each of the schedules are as follows:
(1) SCHEDULE I.
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has no currently accepted medical use in treatment in the United States.
(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.
(2) SCHEDULE II.
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.
(C) Abuse of the drug or other substances may lead to severe psychological or physical dependence.
(3) SCHEDULE III.
(A) The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.
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(4) SCHEDULE IV.
(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to
the drugs or other substances in schedule III.
(5) SCHEDULE V.
(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to
the drugs or other substances in schedule IV.
(6) SCHEDULE VI.
(A) The substance is a prescription drug; and
(B) Said prescription drug has not been included in Schedules I through V.
Chapter 94C: Section 4. Exceptions from schedules
Section 4. The commissioner acting jointly with the board of registration in pharmacy may by regulation pursuant to the provisions of chapter thirty A except any compound, mixture or preparation containing any substances in paragraph (a) or (b) of
Schedule III or in Schedule IV, V or VI established pursuant to the provisions of section two from the application of all or any
part of this chapter if
(1) the compound, mixture, or preparation contains one or more active medicinal ingredients not having a depressant or
stimulant effect on the central nervous system, and
(2) such ingredients are included therein in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse of the substances which do have a depressant or stimulant effect on the central nervous system, and
(3) the compound, mixture, or preparation has been similarly excepted under the provisions of the Federal Comprehensive
Drug Abuse, Prevention and Control Act of 1970, or any amendment thereof.
Such regulation shall state the weight of the controlled substance per fluid ounce, or if a solid or semi-solid preparation the
weight in the avoirdupois amounts, and if the metric system is used, the weight in grams per hundred cubic centimeters in the
case of a fluid, or the weight per gram in the case of a solid or semi-solid preparation.
The commissioner shall by regulation modify, rescind or revoke an exception whenever it has been modified, rescinded or
revoked under the provisions of the Federal Comprehensive Drug Abuse, Prevention and Control Act of 1970 or any amendment thereof.
Chapter 94C: Section 5. Dispensing controlled substances excepted under Sec. 4
This refers to those substances in Schedule V which may be dispensed without a prescriptionthis mirrors federal law.
Section 5. Controlled substances which are excepted pursuant to section four may be dispensed, or sold at retail, except that
the exception authorized by this section shall be subject to the following conditions:
(1) that such preparation shall be dispensed, or sold in good faith as a medicine, and not for the purpose of evading the provisions of the controlled substances law; (2) that the purchaser of such preparation identify himself to the satisfaction of the
pharmacist; and (3) that of such preparation not more than four ounces are dispensed, or sold to a person during any 48
hour period.
The pharmacist dispensing such excepted substances shall keep an accurate record book including the name and address of
the purchaser, the name of the preparation, the strength per dosage unit, the quantity dispensed and the date.

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Chapter 94C: Section 6. Rules and regulations
Section 6. The board of registration in pharmacy in the case of a retail drug business or wholesale druggist and the commissioner in all other cases may promulgate rules and regulations relative to registration and control of the manufacture, distribution, dispensing and possession of controlled substances within the commonwealth
Chapter 94C: Section 7. Registration of persons who manufacture, distribute, dispense or possess controlled substances
See regulations at 247 CMR 11.00 et.seq.
Section 7. (a) Except in the case of a pharmacy or wholesale druggist, every person who manufactures, distributes or dispenses, or possesses with intent to manufacture, distribute or dispense any controlled substance within the commonwealth
shall upon payment of a fee, the amount of which shall be determined annually by the commissioner of administration under
the provision of section three B of chapter seven, register with the commissioner of public health, in accordance with his regulations, said registration to be effective for one year from the date of issuance. Every wholesale druggist shall register with
the board of registration in pharmacy in accordance with its regulations. Such registration shall be effective until July first,
nineteen hundred and seventy-four, if such registration is issued prior to July first, nineteen hundred and seventy-four. Such
registration shall be effective until January first, nineteen hundred and seventy-six, if such registration is issued between July
first, nineteen hundred and seventy-four, and January first, nineteen hundred and seventy-six. Such registration shall be effective until the end of the calendar year in which said registration is issued if registration is issued subsequent to December
thirty-first, nineteen hundred and seventy-five; provided, that such wholesale druggist shall pay a registration fee of twentyfive dollars for any initial registration issued prior to July first, nineteen hundred and seventy-four, and shall pay any registration fee of thirty-seven dollars and fifty cents for a registration which is issued between July first, nineteen hundred and
seventy-four, and January first, nineteen hundred and seventy-six. Such wholesale druggist shall, commencing January first,
nineteen hundred and seventy-six, pay an annual registration fee, the amount of which shall be determined by the commissioner of administration, for each year or any part thereof. For the purposes of this section, "wholesale druggist'' shall mean
any person who distributes controlled substances at wholesale. Every pharmacy shall register with the said board in accordance with its regulations. Such registration shall be effective until July first, nineteen hundred and seventy-four, if any registration is issued prior to July first, nineteen hundred and seventy-four. Such registration shall be effective until January first,
nineteen hundred and seventy-six, if such registration is issued between July first, nineteen hundred and seventy-four, and
January first, nineteen hundred and seventy-six. Such registration shall be effective until the end of the first uneven numbered
year following the date of issuance of such registration if such registration is issued subsequent to December thirty-first,
nineteen hundred and seventy-five; provided, that such pharmacy shall pay a registration fee of twenty-five dollars for an initial registration issued prior to midnight of July first, nineteen hundred and seventy-four, and shall pay a registration fee of
thirty-seven dollars and fifty cents for any registration issued between July first, nineteen hundred and seventy-four, and January first, nineteen hundred and seventy-six, and shall, commencing January first, nineteen hundred and seventy-six, pay a
biennial registration fee, the amount of which shall be determined by the commissioner of administration, for every two
years, or any part thereof.
.
(c) A person registered under this chapter to manufacture, distribute, dispense, or possess controlled substances may possess,
manufacture, distribute, or dispense those substances to the extent authorized by his registration and in conformity with the
other provisions of this chapter.
.
(g) The commissioner may by regulation authorize the registration for a specific activity or activities requiring registration
under this section of such persons as he determines to be qualified for such registration.

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Allows regulations to be established (and they have been--as you will see later) providing registration of nurse practitioners,
psychiatric nurse mental health clinical specialists, certified nurse-midwives and physician assistants to issue written prescriptions for patients.
The commissioner shall promulgate regulations which provide for the registration of nurse practitioners and for psychiatric
nurse mental health clinical specialists, as defined in section eighty B of chapter one hundred and twelve, to issue written
prescriptions for patients pursuant to guidelines mutually developed and agreed upon by the nurse and supervising physician
under regulations approved by the board of registration in nursing and the board of registration in medicine. Prior to promulgating such regulations, the commissioner shall consult with the board of registration in nursing, the board of registration in medicine and the board of registration in pharmacy with regard to those schedules of controlled substances for which
nurse practitioners and psychiatric nurse mental health clinical specialists may be registered.
The commissioner shall promulgate regulations which provide for the registration of certified nurse-midwives, as provided
in section eighty C of chapter one hundred and twelve, to issue written prescriptions for patients pursuant to guidelines mutually developed and agreed upon by the certified nurse-midwife and the supervising physician in accordance with regulations
approved by the board of registration in medicine and the board of registration in nursing. Prior to promulgating such regulations, the commissioner shall consult with the board of registration in nursing, the board of registration in medicine and
the board of registration in pharmacy with regard to those schedules of controlled substances for which certified nurse-midwives may be registered.
The commissioner shall promulgate regulations which provide for the registration of physicians assistants to issue written
prescriptions for patients pursuant to guidelines mutually developed and agreed upon by the supervising physician and the
physician assistant. Prior to promulgating such regulations, the commissioner shall consult with the board of registration of
physician assistants, the board of registration in medicine and the board of registration in pharmacy with regard to those
schedules of controlled substances for which physician assistants may be registered to issue written prescriptions therefor;
provided, however, that a physician assistant who has not successfully passed the national certification examination for physician assistants or who does not meet all of the current requirements for obtaining an initial physician assistant's registration as listed in section nine I of chapter one hundred and twelve may not be authorized to write prescriptions under any
circumstances.
The following paragraphs in subsection (g) were added by 2008, 528, Sec. 1 and were effective April 15, 2009. These paragraphs allow for collaborative practice agreements between pharmacists and physicians. The Board of Pharmacy has proposed regulations implementing this section. It is contained in Chapter 6.
The commissioner shall issue regulations authorizing pharmacists, who have been duly registered in accordance with section 241/2 of chapter 112, to engage in collaborative drug therapy management and to issue written prescriptions in accordance with the provisions of said section 241/2 of said chapter 112 and guidelines mutually developed and agreed upon by
the supervising physician and the pharmacist in a collaborative practice agreement, as defined in section 241/2 of said chapter 112, established in accordance with regulations of the board of registration in medicine and board of registration in
pharmacy. Prior to issuing such regulations, the commissioner shall consult with the board of registration in medicine and
the board of registration in pharmacy with regard to the schedules of controlled substances for which a pharmacist may be
authorized to prescribe within the scope of his collaborative practice.
The commissioner may gather patient outcome and cost-savings data if available from objective sources and review community retail drug business-based collaborative drug therapy management. If the commissioner finds that sufficient data and
funding sources exist to conduct a valid study, he shall conduct a study within 2 years after that finding. The study shall include representatives of the board of registration in medicine and the board of registration in pharmacy. In conducting the
study, the commissioner shall hold at least 1 public hearing to receive testimony from the public, including representatives of
pharmacy and medicine and other concerned parties.
Optometrists have certain prescriptive authoritysee later regulations.
(h) The commissioner shall promulgate regulations which provide for the automatic registration of optometrists, upon the
receipt of the fee as herein provided, to issue written prescriptions in accordance with the provisions of sections 66 and 66B
of chapter 112, unless the registration of such optometrist has been suspended or revoked pursuant to the provisions of sec-

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tion 13 or section 14 or unless such registration is denied for cause by the commissioner pursuant to the provisions of chapter 30A. Prior to promulgating such regulations, the commissioner shall consult with the board of registration in optometry.
Chapter 94C: Section 9. Administering and dispensing of controlled substances in course of professional practice; records
and inspection
This statute was amended by 2008, 528, Sec. 2 effective April 15, 2009 to allow pharmacists, under specific conditions (those
required for collaborative practice in Section 24B1/2 and 24 B3/4) for the alleviation of pain and suffering or for the treatment
or alleviation of disease, to possess controlled substances as may reasonably be required for the purpose of patient treatment
and may administer controlled substances or cause a nurse to administer such substances. The Board has not enacted
regulations pertaining to this section yet.
Section 9. (a) A physician, dentist, podiatrist, optometrist as limited by sections 66 and 66B of chapter 112 and subsection (h)
of section 7, nurse practitioner and psychiatric nurse mental health clinical specialist as limited by subsection (g) of said
section 7 and section 80E of said chapter 112, physician assistant as limited by said subsection (g) of said section 7 and section
9E of said chapter 112, certified nurse-midwife as provided in section 80C of said chapter 112, pharmacist as limited by said
subsection (g) of said section 7 and section 24B 1/2/ of said chapter 112, or veterinarian when registered pursuant to said
section 7, may, when acting in accordance with applicable federal law and any provision of this chapter which is consistent
with federal law and in good faith and in the course of a professional practice for the alleviation of pain and suffering or for
the treatment or alleviation of disease, possess controlled substances as may reasonably be required for the purpose of patient
treatment and may administer controlled substances or may cause the same to be administered under his direction by a nurse.
A practitioner may cause controlled substances to be administered under his direction by a licensed dental hygienist, for the
purposes of local anesthesia only.
Allows pharmacists, under specific conditions and when authorized by a prescriber, to dispense a controlled substance in a
single dose or quantity that the prescriber deems essential for the treatment of the patient. The quantity is limited to that
necessary for immediate proper treatment until possible for patient to have a prescription filled at a pharmacy.
(b) Notwithstanding section 17, a physician, physician assistant, dentist, podiatrist, optometrist, certified nurse-midwife, nurse
practitioner, psychiatric nurse mental health clinical specialist, pharmacist as limited by said subsection (g) of said section 7
and section 24B1/2/ of said chapter 112, or veterinarian registered pursuant to said section 7, may, when acting in good faith
and in the practice of medicine, dentistry, podiatry, optometry, nurse-midwifery, pharmacy or veterinary medicine or as a
nurse, as the case may be, and when authorized by a physician, dentist, podiatrist, optometrist, nurse practitioner, physician
assistant, certified nurse-midwife, psychiatric nurse mental health clinical specialist or veterinarian in the course of such
nurse's professional practice, dispense by delivering to an ultimate user a controlled substance in a single dose or in a quantity
that is, in the opinion of such physician, dentist, podiatrist, optometrist, nurse practitioner, physician assistant, certified
midwife, psychiatric nurse mental health clinical specialist, pharmacist or veterinarian, essential for the treatment of the
patient. The amount or quantity of any controlled substance dispensed under this subsection shall not exceed the quantity of a
controlled substance necessary for the immediate and proper treatment of the patient until it is possible for the patient to have
a prescription filled by a pharmacy. All controlled substances required by the patient as part of his treatment shall be dispensed
by prescription to the ultimate user in accordance with this chapter.
This section shall not prohibit or limit the dispensing of a prescription medication that is classified by the department as
schedule VI and that is provided by the manufacturer as part of an indigent patient program or for use as samples if the
prescription medication is: (i) dispensed to the patient by a professional authorized to dispense controlled substances pursuant
to this section; (ii) dispensed in the package provided by the manufacturer; and (iii) provided at no charge to the patient. The
department shall promulgate rules and regulations governing the dispensing of medication pursuant to this section. These rules
and regulations shall include, but not be limited to, those concerning the types and amounts of medications that may be
dispensed and the appropriate safeguards for the labeling and dispensing of such medications.
(c) A nurse who has obtained from a physician, dentist, physician assistant, podiatrist, certified nurse-midwife, nurse
practitioner, psychiatric nurse mental health clinical specialist, pharmacist or veterinarian a controlled substance for
dispensing to an ultimate user pursuant to subsection (b) or for administration to a patient pursuant to subsection (a) during
the absence of the physician, physician assistant, dentist, podiatrist, certified nurse-midwife, nurse practitioner, psychiatric
nurse mental health clinical specialist, pharmacist or veterinarian, shall return to the physician, physician assistant, dentist,

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podiatrist, certified nurse-midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, pharmacist or
veterinarian any unused portion of the controlled substance which is no longer required by the patient.
A licensed dental hygienist who has obtained a controlled substance from a practitioner for dispensing to an ultimate user
pursuant to subsection (a) shall return to such practitioner any unused portion of the substance which is no longer required by
the patient.
Note the records that must be kept pursuant to this statute.
(d) Every physician, physician assistant, dentist, podiatrist, certified nurse-midwife, nurse practitioner, psychiatric nurse
mental health clinical specialist, pharmacist or veterinarian shall, in the course of a professional practice, keep and maintain
records, open to inspection by the commissioner during reasonable business hours, which shall include the following: the
names and quantities of any controlled substances in schedules I, II or III received by the practitioner; the name and address
of each patient to whom such controlled substance is administered or dispensed; the name, dosage and strength per dosage
unit of each such controlled substance; and the date of such administration or dispensing.
(e) Notwithstanding subsection (b), a physician, nurse practitioner, physician assistant, pharmacist as limited by subsection
(g) of section 7 and section 24B1/2/ of said chapter 112 or certified nurse-midwife, when acting in good faith and providing
care under a program funded in whole or in part by 42 U.S.C. 300, or in a clinic licensed by the department to provide
comparable medical services or a registered nurse, registered pursuant to section 74 of said chapter 112 and authorized by
such physician, nurse practitioner, physician assistant, pharmacist as limited by said subsection (g) of said section 7 and
section 24B1/2/ of said chapter 112, or certified nurse-midwife, may lawfully dispense controlled substances pursuant to
schedule VI to recipients of such services in such quantity as needed for treatment and shall be exempt from the requirement
that such dispensing be in a single dosage or as necessary for immediate and proper treatment under subsection (b). A
registered nurse shall dispense under this subsection only as provided in section 17. The department may establish rules and
regulations controlling the dispensing of these medications, including, but not limited to, the types and amounts of medications
dispensed and appropriate safeguards for dispensing.
Chapter 94C: Section 10. Separate registration
Section 10. A separate registration shall be required at each principal place of business or professional practice where the
registrant manufactures, distributes, or dispenses controlled substances.
Chapter 94C: Section 11. Inspection of establishments of registrants or applicants
Section 11. The board of registration in pharmacy in the case of a pharmacy and the commissioner in any case may inspect
in accordance with his or its rules and regulations the establishment of a registrant or applicant for registration pursuant to
the provisions of this chapter.
Chapter 94C: Section 12. Issuance of registration to manufacture or distribute controlled substances
Section 12. (a) The board of registration in pharmacy in the case of a retail drug business or wholesale druggist and the
commissioner in all other cases shall register an applicant to manufacture or distribute controlled substances included in the
schedules established pursuant to section two unless he determines that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the board of registration in pharmacy in the case of a retail
drug store or a wholesale druggist and the commissioner in all other cases shall consider the following factors:
(1) maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific,
or industrial channels;
(2) compliance with applicable federal, state and local law;
(3) any conviction of the applicant under any federal and state law relating to any controlled substance;
(4) past experience in the manufacture or distribution of controlled substances, and the existence in the applicants establishment of effective controls against diversion;

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(5) furnishing by the applicant of false or fraudulent material in any application filed under the provisions of this chapter;
(6) suspension or revocation of the applicants federal registration to manufacture, distribute or dispense controlled substances as authorized by federal law; and
(7) any other factors relevant to and consistent with the public health and safety.
(b) Registration under subsection (a) of this section shall not entitle a registrant to manufacture or distribute controlled substances in Schedules I or II established pursuant to the provisions of section two except to the extent specified in the registration.
Chapter 94C: Section 13. Suspension or revocation of registration; report of criminal violations; controlled substances
affected placed under embargo; forfeiture; notice to bureau
Section 13. (a) The board of registration in pharmacy in the case of a retail drug business or wholesale druggist and the
commissioner in all other cases may suspend or revoke a registration to manufacture, distribute, dispense or possess a controlled substance, after a hearing pursuant to the provisions of chapter thirty A upon a finding that the registrant:
(1) has furnished false or fraudulent material information in any application filed under the provisions of this chapter;
(2) has been convicted under any state or federal law of any criminal violation relating to his fitness to be registered under
this chapter;
(3) has had his federal registration suspended or revoked to manufacture, distribute, dispense, administer or possess controlled substances; or
(4) is, upon good cause, found to be unfit or unqualified to manufacture, distribute, dispense, or possess any controlled substance.
(b) The board of registration in pharmacy in the case of a retail drug business or wholesale druggist and the commissioner in
all other cases may pursuant to the provisions of this section or section fourteen suspend or revoke any registration issued by
him or it for violation of any provision of this chapter.
(c) Whenever the commissioner, the board of registration in pharmacy, or the commissioner of mental health has substantial
reason to believe that a registrant has committed a criminal violation of any provision of this chapter, he or it shall promptly
report all pertinent facts to the district attorney in the county where the violation is believed to have occurred, or to the attorney general.
(d) The board of registration in pharmacy in the case of a retail drug business or wholesale druggist and the commissioner in
all other cases may limit revocation or suspension of a registration to the particular controlled substance with respect to
which grounds for revocation or suspension exists.
(e) If the board of registration in pharmacy in the case of a retail drug business or wholesale druggist or the commissioner in
all other cases suspends or revokes a registration, all controlled substances which are affected by such suspension or revocation order at the time of suspension or the effective date of the revocation order shall be placed under embargo pursuant to
the procedures prescribed in sections one hundred and eighty-nine and one hundred and eighty-nine A of chapter ninety-four.
No disposition may be made of substances under such embargo until the time for taking an appeal has elapsed or until all
appeals have been concluded unless a court, upon application therefor, orders the sale of perishable substances and the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all controlled substances may be
forfeited to the commonwealth under the provisions of section forty-seven.
(f) The board of registration in pharmacy in the case of a retail drug business or wholesale druggist and the commissioner in
all other cases shall promptly notify the bureau of all orders suspending or revoking a registration and all forfeitures of controlled substances.
Chapter 94C: Section 14. Suspension of or refusal to renew registration pending proceedings in cases of imminent danger
to public
Section 14. The board of registration in pharmacy in the case of a retail drug business or wholesale druggist or the commissioner in all other cases may without hearing suspend or refuse to renew any registration if he finds that there is an imminent
danger to the public health or safety which warrants this action, provided he promptly affords the registrant an opportunity
for a hearing under chapter thirty A. The suspension shall continue in effect until the conclusion of the proceedings including
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judicial review thereof, unless sooner dissolved by a court of competent jurisdiction, or withdrawn by the board of registration in pharmacy in the case of a retail drug business or wholesale druggist, or withdrawn by the commissioner in any other
case.
Chapter 94C: Section 15. Record-keeping and inventory requirements
Recordkeeping must comply with federal law.
Section 15. Persons registered to manufacture, distribute, dispense, or possess controlled substances shall keep records and
maintain inventories in conformance with the record-keeping and inventory requirements of the Federal Comprehensive
Drug Prevention and Control Act of 1970 or any amendment thereof, and the Federal Food, Drug and Cosmetic Act, and
with any additional rules or regulations promulgated by the board of registration in pharmacy in the case of a retail drug
business or wholesale druggist or by the commissioner in all other cases.
Chapter 94C: Section 16. Distribution between registrants; order form
Section 16. Controlled substances in Schedules I and II shall be distributed by a registrant to another registrant only pursuant to such order form as may be required by the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970
or any amendment thereof and the Federal Food, Drug, and Cosmetic Act.
Chapter 94C: Section 17. Necessity of prescription for dispensing controlled substances
Schedule II requires written prescription unless it is an emergency situation. See regulation at 247 CMR 5.03 for more specific requirements.
Section 17. (a) No controlled substance in Schedule II may be dispensed without the written prescription of a practitioner,
except that
(b) In emergency situations, as defined by rule or regulation of the commissioner acting jointly with the board of registration
in pharmacy, drugs in said Schedule II may be dispensed upon oral prescription of a practitioner, reduced promptly to writing and filed by the pharmacy, pursuant to the provisions of subsection (a) of section twenty.
(c) A controlled substance included in Schedule III, IV, V or VI shall not be dispensed without a written or oral prescription
of a practitioner.
Chapter 94C: Section 18. Issuance of prescription by practitioner or physician
Section 18. (a) A prescription for a controlled substance may be issued only by a practitioner who is:
(1) authorized to prescribe controlled substances; and
(2) registered pursuant to the provisions of this chapter.
Note this requirement.
(b) An oral prescription issued by a practitioner may be communicated to a pharmacist by an expressly authorized employee
or agent of the practitioner.
An out of state physician may write prescriptions for controlled substances in Schedules III-VI. The pharmacist 1) shall verify validity by phone or other means 2) shall not fill w/ out verification 3) is not liable for not filling the prescription In addition, the prescription must have been issued within past 30 days.
(c) A prescription for a controlled substance contained in schedules III to VI, inclusive, as defined in section three may also
be issued by an authorized practitioner who is duly licensed to practice medicine and duly registered in the state wherein he
resides, if required, and duly registered under federal law to write prescriptions. It is the duty of the registered pharmacist
who is filling a prescription under this paragraph to determine, in accordance with professional standards and personal
judgment, that such prescription is authentic and valid; provided, however, that if the substance is in schedules III to V, inclusive, the registered pharmacist shall verify the prescription by telephone or other means. A pharmacist shall not fill a pre-

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scription for which said verification cannot be obtained. The pharmacist shall not be held liable for refusing to fill a
prescription for which said verification cannot be obtained, provided that documented good faith efforts were made to determine the authenticity and validity of the prescription. This paragraph shall be valid only for the purpose of authorizing the
filling of prescriptions, issued within the preceding thirty days, and shall not authorize said physician to process, administer
or dispense controlled substances as provided in section nine or to practice medicine within the commonwealth. In the case
of any oral prescription for a schedule III through V substance, the pharmacist shall record that he has requested that the
practitioner deliver or mail to the dispensing pharmacy a written prescription for the controlled substance within seven days
or such shorter period required by Federal law. Any prescription issued under this paragraph shall be issued in the manner
prescribed in section twenty-two and all relevant provisions of this chapter shall apply to such physician and prescription.
Nothing contained in this section shall be deemed to authorize any mail order pharmacies.
The following provision allows a physician from out of state to prescribe a Schedule II controlled substance. The pharmacist
1) shall verify validity by phone or other means 2) shall not fill w/ out verification 3) is not liable for not filling the prescription. In addition, the prescription must have been issued within the last 5 days. Then, the pharmacist, within 30 days, must
deliver to department of Public Health a copy of the prescription without the name and address of the patient.
(d) A prescription for a controlled substance contained in Schedule II of section three may also be issued by a physician who
is licensed to practice medicine and registered in another state where he resides or practices, if required, and registered under federal law to write prescriptions. A registered pharmacist filling a prescription under the provisions of this paragraph
shall determine, in accordance with professional standards and personal judgment, that such prescription is authentic and
valid; and shall verify such prescription by telephone or other means. A pharmacist shall not fill a prescription for which
said verification cannot be obtained. A pharmacist shall not be held liable for refusing to fill such prescription for which said
verification cannot be obtained; provided, however, that documented good faith efforts were made to determine the authenticity and validity of such prescription. This paragraph is only for the purpose of authorizing the filling of prescriptions within the commonwealth, issued within the preceding five days, and shall not authorize such practitioner to possess, administer
or dispense controlled substances as provided in section nine, or to practice medicine within the commonwealth. Any prescription issued under the provisions of this paragraph shall be issued in the manner prescribed in section twenty-two and all
relevant provisions of this chapter shall apply to such practitioner and prescription. In the case of any prescription for a
Schedule II substance filled under the provisions of this paragraph, a pharmacist filling such prescription shall within thirty
days after the filling of such prescription deliver to the department a copy of each such Schedule II prescription; provided,
however, that such copy shall not include the name and address of the patient for whom the prescription is issued and that
such copy and the information contained thereon shall not be deemed to be public record within the meaning of section seven
of chapter four and shall be subject to the restrictions set forth in section two of chapter sixty-six A. Nothing contained in this
section shall be deemed to authorize any mail order pharmacies.
Chapter 94C: Section 19. Prescription; restrictions on issuance
The pharmacist has corresponding responsibility with prescriber that the prescription is for a legitimate medical purpose---the
pharmacist must not knowingly dispense otherwise.
Section 19. (a) A prescription for a controlled substance to be valid shall be issued for a legitimate medical purpose by a
practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances shall be upon the prescribing practitioner, but a corresponding responsibility shall rest with the
pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional
treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section one and the
person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided by sections thirty-two, thirty-two A, thirty-two B, thirty-two C, thirty-two D, thirty-two E, thirty-two F, thirty-two G, and
thirty-two H, as applicable.
(b) No prescription shall be issued in order for a practitioner to obtain controlled substances for supplying the practitioner
for the purpose of general dispensing to patients.
(c) Unless permitted by federal law, a prescription shall not be issued for the dispensing of drugs or controlled substances as
defined in section thirty-eight of chapter one hundred and twenty-three, listed in any schedule to a drug dependent person for

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the purpose of continuing his dependence upon such drugs, in the course of conducting an authorized clinical investigation
pursuant to an addict rehabilitation program.
This section allows pharmacists to dispense Emergency Contraception (EC) if: written procedures and protocols developed
by a physician (a standing orders) are in place in the pharmacy and at board of pharmacy; the pharmacist completes an approved training program; and the pharmacist reports to the department of public health, annually, the number of times EC is
dispensed.
Chapter 94C: Section 19A. Emergency contraception
Section 19A. (a) As used in this section emergency contraception shall, unless the context clearly requires otherwise, mean
any drug approved by the federal Food and Drug Administration as a contraceptive method for use after sexual intercourse.
(b) Notwithstanding any other law, a licensed pharmacist may dispense emergency contraception in accordance with written,
standardized procedures or protocols developed by an actively practicing physician registered with the commissioner to distribute or dispense a controlled substance in the course of professional practice pursuant to section 7 if such procedures or
protocols are filed at the pharmacists place of practice and with the board of registration in pharmacy before implementation.
(c) Before dispensing emergency contraception authorized under this section, a pharmacist shall complete a training program approved by the commissioner on emergency contraception, which training shall include but not be limited to proper
documentation, quality assurance, and referral to additional services, including appropriate recommendation that the patient
follow-up with a medical practitioner.
(d) A pharmacist dispensing emergency contraception under this section shall annually provide to the department of public
health the number of times such emergency contraception is dispensed. Reports made pursuant to this section shall not identify any individual patient, shall be confidential and shall not be public records as defined by clause twenty-sixth of section 7
of chapter 4.
(e) The department of public health, board of registration in medicine, and board of registration in pharmacy shall adopt
regulations to implement this section.
Chapter 94C: Section 20. Oral prescriptions
This section applies to Schedule III-V-- NOT to Schedule VI. Note that one of these requirements is for the pharmacist to
record the name of the expressly authorized representative if the prescription is not called in by the practitioner.
Section 20. (a) Upon receiving an oral prescription for a controlled substance or instrument described in section twenty-seven from an authorized practitioner, the pharmacist shall immediately reduce the prescription to writing on a prescription
form and shall record the name, address and registration number of the practitioner and the name of any expressly authorized representative, the date of the prescription, the name, dosage and strength per dosage unit of the controlled substance,
the serial number assigned to the prescription by the dispensing pharmacy, the name of said pharmacy, the name and address of the patient unless it is a veterinary prescription, the directions for use and any cautionary statements required, and a
statement indicating the number of times to be refilled.
(b) If the prescribing practitioner is not known to the pharmacist, he shall make a reasonable effort to determine that the oral
authorization came from a registered practitioner.
(c) Whenever a practitioner dispenses a controlled substance by oral prescription, such practitioner shall, within a period of
not more than seven days or such shorter period that is required by federal law cause a written prescription for the prescribed controlled substance to be delivered to the dispensing pharmacy. The prescription may be delivered to the pharmacy
in person or by mail, but if delivered by mail the envelope shall be postmarked within the seven-day period or such shorter
period that is required by federal law. Upon receipt, the dispensing pharmacy shall attach said prescription to the oral prescription which the pharmacy has reduced to writing. Persons charged with the enforcement of this chapter shall report violations of this subsection to the board of registration in medicine, the board of registration in dentistry, the board of
registration in podiatry or the board of registration in veterinary medicine, whichever is applicable, and to the commissioner

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or board of registration in pharmacy, whichever is applicable. The requirements of this subsection shall not apply to controlled substances in Schedule VI of section 3.
Chapter 94C: Section 19A. Emergency contraception
Note requirements for the dispensing of Emergency Oral Contraception. See also Board Policy 2006-1 in Chapter 6 this Review.
Section 19A. (a) As used in this section emergency contraception shall, unless the context clearly requires otherwise, mean
any drug approved by the federal Food and Drug Administration as a contraceptive method for use after sexual intercourse.
(b) Notwithstanding any other law, a licensed pharmacist may dispense emergency contraception in accordance with written,
standardized procedures or protocols developed by an actively practicing physician registered with the commissioner to distribute or dispense a controlled substance in the course of professional practice pursuant to section 7 if such procedures or
protocols are filed at the pharmacists place of practice and with the board of registration in pharmacy before implementation.
(c) Before dispensing emergency contraception authorized under this section, a pharmacist shall complete a training program approved by the commissioner on emergency contraception, which training shall include but not be limited to proper
documentation, quality assurance, and referral to additional services, including appropriate recommendation that the patient
follow-up with a medical practitioner.
(d) A pharmacist dispensing emergency contraception under this section shall annually provide to the department of public
health the number of times such emergency contraception is dispensed. Reports made pursuant to this section shall not identify any individual patient, shall be confidential and shall not be public records as defined by clause twenty-sixth of section 7
of chapter 4.
(e) The department of public health, board of registration in medicine, and board of registration in pharmacy shall adopt
regulations to implement this section.
Chapter 94C: Section 20A. Radiopharmaceutical drugs
Instructions for an oral prescription.
Section 20A. Notwithstanding any other provisions of this chapter, a prescription for a radiopharmaceutical drug shall be
dispensed only to an individual authorized by the nuclear regulatory commission to possess and administer such drug. Upon
receiving an oral prescription for a radiopharmaceutical drug from an authorized practitioner, the nuclear pharmacist shall
immediately reduce the prescription to writing and shall record the name, address and registration number of the practitioner and the name of any expressly authorized representative, the date of the prescription, the name and the dose of the radiopharmaceutical drug, the serial number assigned to the prescription by the dispensing nuclear pharmacy, the name of said
nuclear pharmacy, the name and address of the patient and any specific instructions required. If the radiopharmaceutical
drug is not administered, it shall be returned to the nuclear pharmacy to be disposed of in accordance with requirements established by the nuclear regulatory commission and any applicable law and the nuclear pharmacist shall note on the prescription form the amount of the radiopharmaceutical drug that has been returned and disposed of as required.
Chapter 94C: Section 21. Packaging and labeling by pharmacist filling prescription
Note requirements:
Section 21. The pharmacist filling a written or oral prescription for a controlled substance shall package the controlled substance in a container, affixing to the container a label showing the date of filling, the pharmacy name and address, the filling
pharmacists initials, the serial number of the prescription, the name of the patient, unless it is a veterinary prescription, the
name of the prescribing practitioner, the name of the controlled substance, directions for use and cautionary statements, if
any, contained in such prescription or required by law, and if the controlled substance is dispensed as tablets or capsules the
number of same in such container.

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Note requirement upon request by elderly.
Upon the request of an elderly person, as defined in section fourteen of chapter nineteen A or a person visually impaired, directions on the label affixed by the pharmacist to a container of a prescription drug shall be typed in a print size allowing no
more than ten characters per inch.
Chapter 94C: Section 21A. Prescriptions; prospective drug review and counseling by pharmacist
Note the word SHALL. Note all the requirements.
Section 21A. A pharmacist shall conduct a prospective drug review before each new prescription is dispensed or delivered to
a patient or a person acting on behalf of such patient. Such review may include, but not be limited to, screening for potential
drug therapy problems due to therapeutic duplication, drug disease contraindication, drug interactions, including serious
interactions with nonprescription or over-the-counter drugs, incorrect drug dosage, duration of drug treatment, drug allergy
interactions and clinical abuse or misuse.
Offer may be made by pharmacist designee.
A pharmacist shall offer to counsel any person who presents a new prescription for filling. Such offer shall be made either by
face to face communication between the pharmacist or the pharmacists designee and the patient, or by telephone, except
when the patients needs or availability require an alternative method of counseling.
If a person elects delivery of a prescription drug at a location other than a pharmacy, the requirements of this section may be
satisfied by providing such person with access to a toll-free telephone service to facilitate communication between such person and the pharmacist at such pharmacy. The number of such toll-free telephone service shall be printed on a label affixed
to each container of a prescription drug dispensed by a pharmacy to a patient.
For the purposes of medical assistance and other third party reimbursements or payment programs, any of the above methods, or a combination thereof, shall constitute an acceptable offer to provide counseling.
If an offer to provide counseling is accepted, the pharmacist shall counsel the person presenting the prescription to the extent
the pharmacist deems appropriate. Such counseling may include, but not be limited to, the following:
(1) the name and description of the medication;
(2) the dosage form, dosage, route of administration and duration of drug therapy;
(3) special instructions and precautions for preparation, administration and use by the patient;
(4) common adverse or severe side effects or interactions and therapeutic contraindications that may be encountered, including their avoidance and the action required if they occur;
(5) techniques for self-monitoring drug therapy;
(6) proper storage;
(7) prescription refill information; and
(8) action to be taken in the event of a missed dose.
Nothing in this section shall be construed to require a pharmacist to provide counseling if the person presenting the prescription declines to accept such offer for counseling.
The pharmacist or his designee shall make reasonable efforts to obtain, record and maintain the following patient information generated at an individual pharmacy:
(1) the name, address, telephone number, date of birth or age, and gender;
(2) individual history where significant, including known allergies and drug reactions, and a comprehensive list of medications and relevant devices; and
(3) any additional comments relevant to the patients drug use, including any failure to accept the pharmacists offer to counsel.
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Such information may be recorded in the patients manual or electronic profile or in the prescription signature log, or in any
other system of records and may be considered by the pharmacist in the exercise of his professional judgement concerning
both the offer to counsel and the content of counseling. The absence of any record of a failure to accept the pharmacists offer to counsel shall create a presumption that such counseling was provided.
The provisions of this section shall not apply to any drug dispensed to an inpatient at a hospital or nursing home, except to
the extent required by regulations promulgated by the Federal Health Care Financing Administration pursuant to the provisions of 42 USC 1396r-8.
Chapter 94C: Section 22. Contents of prescription written by practitioner
Section 22. (a) A practitioner who dispenses a controlled substance by issuing a written prescription shall state on the prescription the name, address and registration number of the practitioner, the date of delivery of the prescription, the name,
dosage and strength per dosage unit of the controlled substance, the name and address of the patient unless it is a veterinary
prescription, the directions for use and any cautionary statements required, and a statement indicating the number of times to
be refilled.
(b) A practitioner who dispenses by delivering to an ultimate user a controlled substance which is not for immediate administration shall package the controlled substance in a container, affixing to the container a label bearing the practitioners
name and address, the date of dispensing, the name of the patient unless it is a veterinary prescription, the name, dosage and
strength per dosage unit, of the controlled substance, directions for use and any necessary cautionary statements.
Note these specific requirements including that the pharmacist sign the face of a Schedule II prescription.
Generally Schedule II or III prescriptions may only be filled for a 30 day supply.
Chapter 94C: Section 23. Written prescriptions; requirements and restrictions
Section 23. (a) A written prescription for a controlled substance in Schedule II shall become invalid 30 days after the date of
issuance.
(b) A written prescription for a controlled substance in Schedule II shall not be refilled and shall be kept in a separate file.
(c) The pharmacist filling a written prescription for a controlled substance in Schedule II shall endorse his own signature on
the face thereof.
Note these two exceptions to the 30 day rule.
(d) In regard to a controlled substance in Schedule II or III, no prescription shall be filled for more than a thirty-day supply
of such substance upon any single filling; provided, however, that with regard to dextro amphetamine sulphate and methyl
phenidate hydrochloride, a prescription may be filled for up to a sixty-day supply of such substance upon any single filling if
said substance is being used for the treatment of minimal brain dysfunction or narcolepsy; provided further, that subject to
regulations of the department and the board of pharmacy, prescriptions for implantable infusion pumps consisting of Schedule II or Schedule III controlled substances may be filled for a maximum of 90 days.
(e) All prescriptions for controlled substances shall be kept for two years by the pharmacy and shall be subject to inspection
pursuant to the provisions of this chapter.
(f) No prescription for a controlled substance shall be refilled unless the original prescription provides for such refilling and
unless the number of refills has been specified in said prescription.
(g) Unless otherwise prohibited by law, a prescription shall be: (1) written in ink, indelible pencil or by other means; or (2)
transmitted electronically; and (3) signed by the prescriber. A prescription may be transmitted electronically with the electronic signature and electronic instructions of the prescriber, and shall be transmitted directly from the prescriber to the
pharmacy designated by the patient without alteration of the prescription information, except that third-party intermediaries
may act as conduits to route the prescription from the prescriber to the pharmacy.

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(h) Clinic pharmacies operated by a health maintenance organization licensed under chapter one hundred and seventy-six G
and licensed pursuant to section fifty-one of chapter one hundred and eleven may refill prescriptions which have been previously dispensed by another health maintenance organization clinic pharmacy, provided that prior to dispensing a refill, the
pharmacy refilling the prescription verifies the appropriateness of the refill through a centralized database.
Chapter 94C: Section 24. Dispensing by practitioner for narcotic drug research or treatment of drug dependent persons
Section 24. (a) If the commissioner determines that a research subject or patient is receiving a controlled substance from
more than one source and in quantities which he determines to be harmful to the health of such research subject or patient,
said commissioner shall so notify the practitioners who have dispensed the controlled substance
(b) In order to prevent the dispensing of controlled substances to the same individual from multiple sources or the unlawful
diversion of controlled substances, the commissioner shall, pursuant to the provisions of chapter 30A, adopt rules and regulations for carrying out the provisions of this section.
2008, 528 Section 3 effective April 15, 2009 added these sections which provide for collaborative drug therapy management
between pharmacists and physicians. The Board of Pharmacy has proposed regulations implementing this statute at 247
CMR 16.00 et. seq. as reproduced in Chapter 6 of this Review.
Section 24B.
(a) As used in this section and section 24B the following words shall, unless the context clearly requires otherwise, have
the following meanings:Collaborative drug therapy management, the initiating, monitoring, modifying and discontinuing of a patient's drug therapy by a pharmacist in accordance with a collaborative practice agreement; provided, however, that collaborative drug therapy management may include: collecting and reviewing patient histories; obtaining and checking vital signs, including pulse,
temperature, blood pressure and respiration; and, under the supervision of, or in direct consultation with, a physician, ordering and evaluating the results of laboratory tests directly related to drug therapy when performed in accordance with approved protocols applicable to the practice setting and when the evaluation shall not include a diagnostic component.
Collaborative practice agreement, a written and signed agreement between a pharmacist with training and experience relevant to the scope of the collaborative practice and a supervising physician that defines the collaborative practice in which
the pharmacist and supervising physician propose to engage. The collaborative practice shall be within the scope of the supervising physicians practice. Each collaborative practice agreement shall be subject to review and renewal on a biennial
basis. A collaborative practice agreement shall include individually developed guidelines for any prescriptive practice of the
pharmacist.
Commissioner, the commissioner of the department of public health.
Department, the department of public health.
Patient, a person who is referred to a pharmacist by his supervising physician for the purpose of receiving collaborative
drug therapy management services from the pharmacist. The supervising physician shall assess the patient and include a diagnosis when referring the patient to the collaborating pharmacist. The patient shall be notified of, and shall consent to, the
collaborative drug therapy management services in the retail drug business setting. Individual referral and consent shall be
recorded by the pharmacist and the supervising physician in the patients record.
Note the requirements in order for a pharmacist to enter into a collaborative practice agreement.
(b) In order for a pharmacist to enter into a collaborative practice agreement, the pharmacist shall: (1) hold a current license to practice pharmacy in the commonwealth and currently be engaged in pharmacy practice in the commonwealth; (2)
have at least $1,000,000 of professional liability insurance; (3) have earned a doctor of pharmacy degree or have completed

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5 years of experience as a licensed pharmacist or the equivalent; (4) agree to devote a portion of his practice to the defined
drug therapy area that the pharmacist shall co-manage; and (5) agree to complete, in each year of the agreement, at least 5
additional contact hours or 0.5 continuing education units of board-approved continuing education that addresses areas of
practice generally related to collaborative practice agreements.
Note the settings in which CDT is allowed and the limits on CDT in a retail setting.
(c) Collaborative drug therapy management shall only be allowed in the following settings: (1) hospitals licensed pursuant
to section 51 of chapter 111, subject to approval by the medical staff executive committee at a licensed hospital or designee;
(2) long-term care facilities licensed pursuant to section 71 of chapter 111, subject to approval by the long-term care facilities medical director or designee; (3) inpatient or outpatient hospice settings licensed pursuant to section 57D of chapter
111, subject to approval by the hospices medical director or designee; (4) ambulatory care clinics licensed pursuant to section 51 of chapter 111, with on-site supervision by the attending physician and a collaborating pharmacist, subject to approval by the ambulatory care clinics medical staff executive committee or designee, or medical director or designee; (5) a
collaborating pharmacist in a retail drug business, as registered in section 38 of chapter 112 and limited by this section, with
supervision by a physician according to the terms of his collaborative practice agreement and limited to the following: patients 18 years of age or older; an extension by 30 days of current drug therapy prescribed by the supervising physician; and
administration of vaccines or the modification of dosages of medications prescribed by the supervising physician for asthma,
chronic obstructive pulmonary disease, diabetes, hypertension, hyperlipidemia, congestive heart failure, HIV or AIDS, osteoporosis and co-morbidities identified by the supervising physician for the individual patient along with the primary
diagnosis. The collaborative practice agreement shall specifically reference each disease state being co-managed. A patient
shall be referred by a supervising physician to that physicians collaborating pharmacist and shall be given notice of the collaboration and shall consent to the collaboration. No collaborative practice agreement in the retail drug business setting may
permit the prescribing of schedule II through V controlled substances, as defined in section 3 of chapter 94C. A pharmacist
in the retail setting, who has a collaborative practice agreement with a supervising physician which specifically allows initial
prescriptions for referred patients of the supervising physician, may issue prescriptions for schedule VI controlled substances, as defined in clause 6 of section 3 of chapter 94C. Such prescriptions shall be for a patient diagnosis specified in the supervising physicians individual referral of that patient. A copy of the prescription shall be sent to the supervising physician
within 24 hours.
(d) A retail drug business practicing in collaborative drug therapy management under this section shall not be required to
register as a Health Facility under 105 CMR 700.004(A)(2)(d).
Note that a pharmacy may not employ a physician for the purpose of maintaining, establishing or entering into a collaborative
practice agreement with a patient.
(e) A physician or a physician group may hire pharmacists for the purpose of practicing collaborative drug therapy management under a collaborative practice agreement, as defined in subsection (a), for the benefit of a patient of that physician or
physician group. No retail pharmacy may employ a physician for the purpose of maintaining, establishing or entering into a
collaborative practice agreement with a patient. Nothing shall prohibit a retail pharmacy from hiring a physician or licensed medical practitioner for the purpose of conducting quality assurance reviews of its pharmacists that are engaged in
the practice of collaborative drug therapy.
This section directs the board of pharmacy and board of medicine to enact regulations promulgating this statute. These regulations are reproduced in Chapter 6. The Board of Pharmacy Regulation is still a proposed regulation and the Board of
Medicines Regulation is a DRAFT.
Section 24B. The board of registration in medicine and the board of registration in pharmacy shall issue rules and regulations to implement collaborative drug therapy management pursuant to section 24B and sections 7 and 9 of chapter
94C. To aid in the implementation, the board of registration in medicine and the board of registration in pharmacy shall consult with at least 1 individual from each of the following groups: the department of public health; the Massachusetts Society
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State Pharmacy Law Review

of Health-System Pharmacists; the Massachusetts chapter of the American Society of Consultant Pharmacists; the Massachusetts Pharmacists Association; the Massachusetts Independent Pharmacists Association; the Massachusetts Chain Pharmacy
Council; the Massachusetts College of Pharmacy and Health Sciences; the Bouv College of Health Sciences at Northeastern
University; the Massachusetts Medical Society; the Massachusetts Academy of Family Physicians; the Massachusetts Chapter of the American Academy of Pediatrics; the Massachusetts Psychiatric Society; the Massachusetts chapter of the American Academy of Emergency Physicians; the Massachusetts Chapter of the American Medical Directors Association; and the
Massachusetts Hospital Association. The rules and regulations shall govern each collaborative practice agreement, shall be
defined and limited by section 24B, chapter 94C and other applicable statutes. The board of registration in medicine and
the board of registration in pharmacy shall address the following issues: (1) further limitations and conditions on sites and
settings where a collaborative practice may take place beyond those of section 24; (2) the qualifications of participating
pharmacists and physicians; (3) the scope of conditions or diseases to be managed, the initial list of which shall not include
more than 5 disease states considered appropriate for collaborative management, providing that the 5 diseases selected for
collaborative management in the retail setting must be from among those referenced in clause (5) of subsection (c) of section
24B; (4) practice protocols; (5) risk management activities; (6) documentation of any initiation, modification or discontinuation of a patient's medication therapy in the patient's permanent medical record; (7) outcome measurements; and (8) informed consent procedures. The board of registration in medicine and the board of registration in pharmacy shall
reconsider these regulations on a periodic basis, as considered appropriate by the commissioner for the purposes of adding
or removing disease states to be managed under collaborative drug therapy treatment, as well as for the purpose of updating
the rules and regulations governing collaborative drug therapy management, as necessary.
Approved January 15, 2009
Chapter 94C: Section 25. Restrictions
Requirements for all registrantsviolation of any of these statutes subjects a registrant to criminal penalties.
Section 25. No person
(1) who is subject to the requirements of sections six and seven and twelve to seventeen, inclusive, shall dispense a controlled
substance in violation of said section seventeen;
(2) shall distribute or dispense a controlled substance not authorized by his registration to another registrant or other authorized person or manufacturer a controlled substance not authorized by his registration;
(3) who is a registrant shall distribute a controlled substance in violation of section sixteen;
(4) shall remove, alter, or obliterate a symbol or label required by federal law and the laws of the commonwealth;
(5) shall refuse or fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement,
invoice, or information required under this chapter;
(6) shall refuse any entry into any premises or inspection authorized by this chapter;
(7) shall remove, break, injure, or deface a seal placed upon controlled substances pursuant to this chapter, or remove or
dispose of substances so placed under seal;
(8) shall use, to his own advantage, or reveal, other than to duly authorized officers or employees of the United States or of
the commonwealth or to the courts when relevant in any judicial proceeding under this chapter, any information acquired in
the course of an inspection authorized by this chapter concerning any method or process which is a trade secret.
No person who is a registrant shall manufacture a controlled substance in Schedule I or II which is not expressly authorized
by his registration.
Chapter 94C: Section 26. Distribution in course of business in violation of Sec. 16 or furnishing false information in application, etc., prohibited
Section 26. No person who is a registrant shall knowingly or intentionally;

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(1) distribute a controlled substance classified in Schedule I or II in the course of his legitimate business, except pursuant to
an order or an order form as required by section sixteen; or
(2) furnish false or fraudulent material information in, or omit any material information from, any application, report, record, or other document required to be made, kept, or filed pursuant to the provisions of this chapter.
Chapter 94C: Section 27. Sale of hypodermic syringes or hypodermic needles
Section 27. Hypodermic syringes or hypodermic needles for the administration of controlled substances by injection may be
sold in the commonwealth, but only to persons who have attained the age of 18 years and only by a pharmacist or wholesale
druggist licensed under the provisions of chapter 112, a manufacturer of or dealer in surgical supplies or a manufacturer of
or dealer in embalming supplies. When selling hypodermic syringes or hypodermic needles without a prescription, a pharmacist or wholesale druggist must require proof of identification that validates the individuals age.
Chapter 94C: Section 28. Jurisdiction of superior court
Section 28. Upon petition of the board of registration in pharmacy or the commissioner in the case of a pharmacy, or upon
petition of the commissioner in any case, the superior court shall have jurisdiction to restrain or enjoin a violation of this
chapter.
Chapter 94C: Section 30. Administrative inspection of controlled premises
Section 30. (a) Administrative inspection warrants shall issue for the inspection of controlled premises in accordance with
the provisions of this section. As used in this section administrative inspection warrants are warrants for the purpose of
inspecting, copying and verifying the correctness of records, reports or other documents required to be kept by a registrant
on controlled premises and for the seizure of property appropriate to such inspection. For the purposes of this section
controlled premises means any place or area, including but not limited to any building, conveyance, warehouse, factory,
or establishment, in which persons registered under the provisions of this chapter or required thereunder to keep records, are
permitted to hold, manufacture, compound, process, distribute, deliver, dispense, or administer any controlled substance or
in which such persons make or maintain records pertaining thereto.
(b) A district court or justice or superior court justice may, upon proper oath or affirmation by the commissioner or his designee except in the case of a pharmacy, by the commissioner or his designee or by the designee of the board of registration in
pharmacy, or by a police officer showing probable cause, issue warrants for the purpose of conducting administrative inspections authorized by this chapter or rules hereunder, and seizures of property if appropriate to the inspections. For the
purposes of the issuance of administrative inspection warrants, probable cause exists upon a showing of a reasonable and
valid public interest in the effective enforcement of this chapter or rules or regulations hereunder under a general plan sufficient to justify administrative inspection of an area, premises, buildings or conveyances in the circumstances specified in the
application or such warrant.
(c) An administrative inspection warrant shall issue only upon affidavit sworn to before the court, or justice establishing the
grounds for issuing the warrant. If the court or justice is satisfied that grounds for the issuance of such warrant exists or that
there is probable cause to believe they exist, he shall issue such warrant identifying the area, premises, buildings or conveyances to be inspected, the purpose of the inspection, and, if appropriate, the type of property to be inspected, if any. Such
warrant shall:
(1) be directed to the commissioner or his designee, except in the case of a pharmacy to the commissioner or to the designee
of the board of registration in pharmacy, or to a police officer;
(2) command the person to whom it is directed to inspect the area, premises, buildings or conveyances identified for the purpose specified and, if appropriate, direct the seizure of the property specified;
(3) describe the item or types of property to be inspected or seized, if any;
(4) direct that it be served during normal business hours.

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(d) An administrative inspection warrant issued and executed pursuant to the provisions of this section shall be returned to
the issuing court, except if said warrant is issued by the superior court it shall be returned to any court named in such warrant, within ten days of the date of issuance thereof unless, upon a showing of a need for additional time, the court or justice
orders otherwise. If property is seized pursuant to such warrant, a copy of the inventory shall be given to the person from
whom or from whose premises the property is taken, together with a receipt for the property taken. The inventory shall be
made in the presence of the person executing such warrant and of the person from whose possession or premises the property
was taken, if present. A copy of the inventory shall be delivered to the person from whom or from whose premises the property was taken and to the applicant for such warrant at the time it is returned to a court.
(e) When authorized by an administrative inspection warrant issued pursuant to this section a person designated by the commissioner, except in the case of a pharmacy by the commissioner or by the board of registration in pharmacy, upon showing
such warrant to the owner, operator, or agent in charge, may enter controlled premises for the purpose of conducting an administrative inspection.
(f) A person executing an administrative inspection warrant may:
(1) use reasonable force and means to execute the warrant;
(2) inspect and copy records required by this chapter to be kept;
(3) inspect, within reasonable limits and in a reasonable manner, controlled premises and all pertinent equipment, finished
and unfinished material, containers and labeling found therein, and except as provided in subsection (h), all other things
therein, including records, files, papers, processes, controls, and facilities bearing on violation of this chapter; and
(4) inventory any stock of any controlled substance therein and obtain samples thereof.
Note situations where warrant may not be required.
(g) This section shall not prevent entries and administrative inspections, including seizures of property, without a warrant:
(1) if the owner, operator, or agent in charge of the controlled premises consents;
(2) in situations presenting imminent danger to health or safety;
(3) in situations involving inspection of conveyances if there is reasonable cause to believe that the mobility of the conveyance makes it impracticable to obtain a warrant;
(4) in any other exceptional or emergency circumstance where time or opportunity to apply for a warrant is lacking; or
(5) in all other situations in which a warrant is not required by the laws and constitution of the commonwealth or of the United States.
(h) An inspection authorized by this section shall not extend to financial data, sales data, other than shipment data, or pricing
data unless the owner, operator, or agent in charge of the controlled premises consents in writing.
Massachusetts, for purposes of establishing criminal penalties for violations of law, has established 5 classes of controlled
substances---Classes A-E. The list of these classes has been omitted due to its length. You may find this section of the law--including the penalties for violations concerning these classes at http://www.mass.gov/legis/laws/mgl/gl-94c-toc.htm
Chapter 94C: Section 31. Classes of controlled substances; establishment of criminal penalties for violations of this chapter

Chapter 94C: Section 32G. Counterfeit substances; unlawful creation, distribution, dispensing or possession with intent to
distribute or dispense
Section 32G. Any person who knowingly or intentionally creates, distributes, dispenses or possesses with intent to distribute
or dispense a counterfeit substance shall be punished by imprisonment in a jail or house of correction for not more than one
year or by a fine of not less than two hundred and fifty nor more than two thousand and five hundred dollars, or both such
fine and imprisonment.

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Chapter 94C: Section 32H. Prosecutions not to be continued or placed on file; suspension or reduction of sentence; eligibility for parole, etc.
Section 32H. A prosecution commenced under paragraph (b) of section thirty-two, paragraphs (b), (c) and (d) of section thirty-two A, paragraph (b) of section thirty-two B, sections thirty-two E thirty-two F and thirty-two J shall not be placed on file
or continued without a finding, and the sentence imposed upon a person convicted of violating any provision of said sections
shall not be reduced to less than the mandatory minimum term of imprisonment as established in said section, nor shall any
sentence of imprisonment imposed upon any person be suspended or reduced until such person shall have served said mandatory minimum term of imprisonment.
A person convicted of violating any provisions of said sections shall not, until he shall have served the mandatory minimum
term of imprisonment established, in said sections, be eligible for probation, parole, furlough, work release, or receive any
deduction from his sentence for good conduct under sections one hundred and twenty-nine, one hundred and twenty-nine A,
one hundred and twenty-nine C and one hundred and twenty-nine D of chapter one hundred and twenty-seven; provided,
however, that the commissioner of correction may, on the recommendation of the warden, superintendent, or other person in
charge of the correctional institution, grant to said offender a temporary release in the custody of an officer of such institution for the following purposes: to attend the funeral of a relative, to visit a critically ill relative, or to obtain emergency medical or psychiatric services unavailable at said institution. The provisions of section thirty-one of chapter two hundred and
seventy-nine shall not apply to any person convicted of violating any provisions of said sections. The provisions of section
eighty-seven of chapter two hundred and seventy-six shall not apply to any person, seventeen years of age or over, charged
with a violation of said sections, or to any child between age fourteen and seventeen, so charged, if the court is of the opinion
that the interests of the public require that he shall be tried for such offense instead of being dealt with as a child.
Chapter 94C: Section 33. Unlawful use of registration numbers in manufacture or distribution, or fraudulently obtaining
possession, of controlled substances; criminal penalties
Section 33. (a) No person shall knowingly or intentionally use in the course of the manufacture or distribution of a controlled
substance a registration number which is fictitious, revoked, suspended, or issued to another person.
(b) No person shall utter a false prescription for a controlled substance, nor knowingly or intentionally acquire or obtain
possession of a controlled substance by means of forgery, fraud, deception or subterfuge, including but not limited to the
forgery or falsification of a prescription or the nondisclosure of a material fact in order to obtain a controlled substance
from a practitioner.
(c) Whoever violates any provision of this section shall be punished by imprisonment in the state prison for not more than
four years or in a house of correction for not more than two and one half years or by a fine of not more than twenty thousand
dollars, or by both such fine and imprisonment. Whoever violates any provision of this section after one or more prior convictions of a violation of this section, or of a felony under any other provision of this chapter, or under a provision of prior
law relative to the sale or manufacture of a narcotic drug or a harmful drug as defined in said earlier law shall be punished
by imprisonment in the state prison for not more than eight years or in a jail or house of correction for not more than two
and one half years, or by a fine of not more than thirty thousand dollars or by both such fine and imprisonment.
Chapter 94C: Section 37. Theft of controlled substances from persons authorized to dispense or possess
Section 37. Whoever steals a controlled substance from a registered manufacturer, wholesale druggist, pharmacy or other
person authorized to dispense or possess any controlled substance shall be punished by imprisonment in the state prison for
not more than ten years or in a jail or house of correction for not more than two and one-half years or by a fine of not more
than five hundred dollars.
Disclaimer: This is a review only. For more complete information please refer to the Massachusetts Board of Pharmacy website at
http://www.mass.gov/dph/boards/pharmacy. The state portion of this guide was last updated: 1/14.://www.mass.gov

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Chapter 6: Massachusetts Administrative Rules
Unlike other states in which pharmacy law is contained generally in one set of statutes (usually the state pharmacy practice
act) and one set of administrative rules, Massachusetts Pharmacy law is more complex. The framework and general principles of the law are contained in three sections of Massachusetts General Laws (see chapter 5 for specifics). The specific requirements of the law that actually implement these statutes are contained in two sections of administrative rules. The first
are the rules of the Board of Registration in Pharmacy (Board Regulations). The second is a combination of rules promulgated by the Department of Public Health. Only the regulations of the Department of Public Health that apply to pharmacists
and pharmacies have been included here. These rules implement the Massachusetts Controlled Substances Act, specify standards for the prescription format and its security standards and set forth Dispensing Procedures for Pharmacists. The following regulations have the force and effect of law. Failure to adhere to these rules subjects the violator to administrative
penalties which could include, among other things, revocation or suspension of a pharmacist or pharmacy license. For general Board of Pharmacy information see the board website at: http://www.mass.gov/dph/boards/pharmacy
247 CMR 2.00:
DEFINITIONS
Section
A. 2.00: Definitions
Additional definitions pertaining to:
(1) nuclear pharmacies are contained in 247 CMR 13.00;
(2) disciplinary proceedings are contained in 247 CMR 10.00; and
(3) continuous quality improvement programs are contained in 247 CMR 15.00.
(4) duty to report certain factors of pharmacy operations are contained in 247 CMR 6.15.
B. Section 247 CMR 6.15- Duty to Report Certain Factors of Pharmacy Operations
The following definitions apply to 247 CMR.
ACPE means the Accreditation Council for Pharmacy Education.
Accreditation means a process by which a professional association or non-governmental agency grants
recognition to a pharmacy for demonstrated ability to meet certain pre-defined criteria.
Disciplinary Actions means actions including, but not limited to revocation, suspension, probation, censure,
reprimand, or restriction of the license to operate a pharmacy or practice pharmacy, denial of application for
renewal, denial or restriction of privileges or termination from Medicare or Medcaid programs including any
adverse actions or fines imposed by a state or federal agency.
ACPE-approved Provider means an institution, organization or agency that is recognized by the ACPE, in
accordance with its policies and procedures, as qualified to provide continuing education for pharmacists.
(Beginning with 2012 graduates, the Board will consider graduates of ACPE colleges/schools of pharmacy to
have completely satisfied the 1500 intern hour requirement.)

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Approved College/School of Pharmacy means a college or school of pharmacy which has been accredited by the
ACPE or approved by the Board.
Authorized Provider means a person who or agency which, sponsors or co-sponsors one or more contact hours
of continuing education for pharmacists and which has received the approval of the ACPE, CME/Category 1, or
the Board.
Blood means whole blood collected from a single donor and processed, whether for transfusion or further
manufacturing.
Blood Component means that part of blood separated by physical or mechanical means.
Board means the Massachusetts Board of Registration in Pharmacy.
Board-approved Program means a program which has been approved by the Board for continuing education
credits. Such program may be sponsored by the ACPE, and/or sponsored or co-sponsored by any person who
has been granted prior written approval by the Board for the particular program. The Board may, within its
discretion, accept comparable continuing education hours approved by other Boards of Pharmacy.
Certificate of Approved CEUs means a document, issued to a named pharmacist by an authorized provider,
certifying that the pharmacist has satisfactorily completed a specified number of CEUs.
Certificate of Fitness means a document issued by the Board to a pharmacy or pharmacy department which
permits a pharmacy or pharmacy department to use alcohol for the manufacture of U.S. Pharmacopoeia or
National Formulary preparations and all medicinal preparations unfit for beverage purposes, and to sell alcohol
as authorized under M.G.L. c. 138.
Certified Pharmacy Technician means a pharmacy technician who is currently:
(a) registered by the Board; and
(b) certified by a Board-approved certifying body.
A pharmacy technician may perform the duties authorized to be performed by a certified pharmacy technician
in 247 CMR 8.04 when Board-approved certification is current. If certification lapses, the individual is required
to function as a pharmacy technician until certification is current.
Contact Hour means a unit of measure of educational credit which is a minimum of 50 minutes, or the equivalent as
determined by the Board, of satisfactory participation in a Board-approved program of continuing education.
Continuing Education (CE) means participation by registered pharmacists in Board-approved educational programs
and is a prerequisite for the renewal of a personal registration.
Continuing Education Unit (CEU) means a unit of measure of educational credit which is equal to ten contact hours,
or it's equivalent as determined by the Board, of satisfactory participation in a Board-approved program of continuing
education.
Controlled Substance means a drug, substance, or immediate precursor in any schedule or class referred to in M.G.L.
c. 94C.

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Controlled Substance Registration means a document issued by the Board which allows the holder to receive and
dispense, pursuant to a valid prescription, controlled substances.
CME/Category 1 means continuing medical education (CME) credits sponsored by an organization accredited for
CME by the Accreditation Council for Continuing Medical Education, the Postgraduate Medical Institute or the state
medical society.
Customer identifier means the identification number on a valid government issued identification, as specified by the
Department, which a pharmacy obtains by inspecting the identification of the ultimate user or agent of the ultimate
user to whom a prescription is dispensed (105 CMR 700.001).
Department means the Massachusetts Department of Public Health.

Direct Supervision means:

(a) the type of supervision a Board-approved registered pharmacist preceptor in a pharmacy, pharmacy
department, or institutional pharmacy is required to provide to a pharmacy intern when said preceptor oversees
and directs the professional activities of the pharmacy intern, and includes directly reviewing the work of the
intern; and
(b) the type of supervision a registered pharmacist in a pharmacy, pharmacy department, hospital pharmacy,
or institutional pharmacy is required to provide a pharmacy technician when said pharmacist oversees and
directs the activities of the pharmacy technician.
Dispensing means the physical act of delivering a drug, chemical, device or combination thereof to an ultimate user
pursuant to the lawful order of a practitioner, as defined in M.G.L. c. 94C, 1, including the utilization of the
professional judgment of the pharmacist and the packaging, labeling, or compounding necessary to prepare the drug,
chemical, or device for delivery.
Drug Sample means a unit of a prescription drug that is not intended to be sold.
Electronically Transmitted Prescription means an order of a practitioner which has been transmitted electronically to
a pharmacy in accordance with 105 CMR 721.020.
Facsimile Machine (fax) means a machine that electronically transmits exact images through connection with an
electronic network.
Federal Agency means any U.S. Government agency that has regulatory purview over the clinical practice of
pharmacy or of pharmacy operations, including, but not limited to, all agencies in the U.S. Department of Health and
Human Services, the U.S. Occupational Safety and Health Administration, and the U.S. Department of Justice.
FPGEC means the NABP's Foreign Pharmacy Graduate Examination Committee.
FPGEC Certificate means a document issued by the NABP evidencing the assessment of the educational equivalency
of a graduate of a non-approved college/school of pharmacy.
FPGEC Certification means the NABPs Foreign Pharmacy Graduate Examination Committees process of document190

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State Pharmacy Law Review

ing and assessing the educational equivalency of a graduate of a non-approved college/school of pharmacy.
FPGEE means the NABPs Foreign Pharmacy Graduate Equivalency Examination.
Good Moral Character means those virtues of a person which are generally recognized as beneficial to the public
health, safety and welfare.
Good Standing means the pharmacists personal registration is not currently being sanctioned by the Board.
Graduate of Non-approved College/School of Pharmacy means a pharmacist whose undergraduate pharmacy
degree was not conferred by an ACPE-accredited or Board-approved college/school of pharmacy yet was
conferred by a recognized college/school of pharmacy outside of the United States, the District of Columbia and
Puerto Rico. Recognized colleges/schools of pharmacy are those colleges and universities listed in the World
Health Organizations World Directory of Schools of Pharmacy, or otherwise approved by the FPGEC.
Home-study and Other Mediated Instruction means continuing education activities which do not provide for
direct interaction between faculty and participants and may include audio tapes, video tapes, cable television,
computer assisted instruction, journal articles and monographs.
Institutional Pharmacy means the physical portion of an organization, including but not limited to hospitals,
health maintenance organizations and clinic pharmacies, whose primary purpose is to a provide a physical
environment for patients to obtain health care services under the supervision and direction of a registered
pharmacist and is authorized to dispense controlled substances.
Internship means the period of training under the supervision of a Board-approved registered pharmacist
preceptor, which training is a prerequisite to examination for personal registration as a pharmacist in the
Commonwealth of Massachusetts. (1500 intern hour requirement for Pharmacist Licensure)
Legend Drug, Device or Gas means a drug, device or gas which by federal law must bear the legend: "Caution:
Federal law prohibits dispensing without prescription."
Live Program means a continuing education program that provides for direct interaction between faculty and
participants and may include, but not be limited to, lectures, symposia, live teleconferences and workshops.
Note this term
Manager of Record or Pharmacist Manager of Record means a pharmacist, currently registered by the Board
pursuant to 247 CMR 6.07, who is responsible for the operation of a pharmacy or pharmacy department in
conformance with all laws and regulations pertinent to the practice of pharmacy and the distribution of drugs.
Manufacturer means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling a prescription drug.
MPJE means the Multistate Pharmacy Jurisprudence Examination.
NABP means the National Association of Boards of Pharmacy.

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NABP Number means a unique seven digit number issued by the National Council for Prescription Drug Programs.
NAPLEX means the North American Pharmacist Licensure Examination.
National Drug Code (NDC) Number means a nationally recognized standard which identifies drug products
using a unique number issued by the United States Food and Drug Administration. The NDC number has three
components: the first component identifies the drug manufacturer ("Labeler No."); the second component
identifies the product ("Product No."); and the third component identifies the package size ("Pkg.").
NCPDP means the National Council for Prescription Drug Programs.
Over-the-counter Drug means any drug whose availability is not restricted to an order of a practitioner.
Person means an individual, corporation, government, governmental subdivision or agency, business trust, estate
trust, partnership or association, or any other legal entity.
Personal Registration means a document issued by the Board to a qualified pharmacist, under the provisions of
M.G.L. c. 112, 24, permitting the pharmacist to engage in the practice of pharmacy.
Pharmacy means a facility under the direction or supervision of a registered pharmacist which is authorized to
dispense controlled substances. The term "pharmacy" shall not include institutional pharmacies or pharmacy
departments except as otherwise provided in 247 CMR.
Pharmacy Department means that part of a retail store registered by the Board in which a drug business, as
defined in M.G.L. c. 112, 37, is transacted.
Pharmacy Intern means an individual who has completed two years of academic curriculum or who has standing
as a student beyond the second-year class in the undergraduate academic sequence of an approved
college/school of pharmacy, and who is registered by the Board to acquire, under the direction of a Boardapproved registered pharmacist preceptor to whom he or she has been assigned, that practical experience which
is a prerequisite to examination for personal registration as a pharmacist. A pharmacy intern may engage in the
full range of activities conducted by a registered pharmacist provided that at all time he or she is under the direct
supervision of a registered pharmacist preceptor.
Pharmacy Permit means a document issued by the Board to a registered pharmacist in the name of a pharmacy
or pharmacy department to manage and operate a pharmacy or a pharmacy department.
Note the difference between technician and certified technician
Pharmacy Technician means an individual who is registered by the Board, pursuant to 247 CMR 8.02, who
performs pharmacy duties under the direct supervision of a pharmacist.
Pharmacy Technician Trainee means an individual preparing to be registered as a pharmacy technician who
performs pharmacy duties under the direct supervision of a pharmacist.
Postgraduate means graduation and award of an entry-level degree in pharmacy from a Board-approved or
ACPE-accredited college/school of pharmacy.

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Practitioner means any person with prescriptive privileges as defined in M.G.L. c. 94C, 1.
Preceptor means a registered pharmacist in good standing who has completed at least one year of the actual
practice of pharmacy and who the Board has approved to supervise and direct the training of pharmacy interns
and to assist in the training of other pharmacy interns.
Note who is allowed to transmit a prescription
Prescription means an order for a drug, chemical, device or combination thereof, either written, given orally or
otherwise transmitted to a registered pharmacy by a practitioner or his or her expressly authorized agent, to be
dispensed or compounded in a registered pharmacy and dispensed by a registered pharmacist to a patient or his
or her agent with necessary and appropriate counseling.
Prescription Drug means any and all drugs which, under Federal Law, are required, prior to being dispensed or
delivered, to be labeled with the statement Caution, Federal law prohibits dispensing without prescription" or
a drug which is required by any applicable Federal or State law or regulation to be dispensed pursuant only to
a prescription drug order.
Prescription Device means an instrument, apparatus, implement, machine, contrivance, implant, or other similar
related article, including any component part or accessory, which is required by federal law and regulations to
bear the label, Caution, Federal law prohibits dispensing without prescription or a device which is required
by any applicable Federal or State law or regulation to be dispensed pursuant only to a prescription order.
Program means an educational course, lecture, seminar, conference, session or exercise.
Registered Pharmacist (R.Ph.) means a pharmacist who, pursuant to the provisions of M.G.L. c. 112, 24, is
registered by the Board to practice pharmacy.
Restricted Pharmacy means a pharmacy licensed by the Board for the limited transaction of a drug business as
defined in M.G.L. c. 112, 37.
State agency means any U.S. State or Territory that license or otherwise regulates pharmacies or pharmacist
practice.
Sterile Compounding means the preparation, mixing, assembling, packaging, and labeling of a drug or device
that is required to be prepared in accordance with United States Pharmacopeia Standard 797 and pursuant to a
valid prescription as defined by M.G.L. C. 94C.
(a) Every pharmacist licensed pursuant to M. G.L c. 112, 39, and pharmacist licensed or registered
pursuant to M.G.L. C. 112, 24, shall report to the Board within 7 business days of receipt, in a manner and
format determined by the Board, all non-routine notices, correspondence, and disciplinary actions as defined
herein.
(b) Every pharmacy licensed pursuant to M.G.L. C. 112 39, and pharmacist licensed or registered pursuant
to M.G.L. C. 112 24, shall report to the Board any adverse change in status of accreditation, including but not
limited to withdrawal, discontinuance, termination, revocation, suspension, probation, or warning, All such
reports shall be made within 7 bunsiness days of an action taken by the accrediting agency, and in a manner
determined by the Board.

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(c ) Every pharmacy licensed pursuant to M.G.L. C. 112, 39, that performs central intravenous admixture
services (CIVAS), or engages in sterile compounding, shall report to the Board every six months, or upon request
by the Board, at a minimum, the following information:
* total number of prescriptions dispensed, distribution data identifying the states in which the prescriptions
were distributed, status of any non-resident licenses issued by other states, hood certifications required by 247
CMR 6.01(5)(c ) 5, status of CIVAS approval (s) where applicable, and any other information required by the
Board.
* All such reports shall be accurate and comply with the Boards reporting requirements.
* All reports shall be accompanied by an affidavit attesting compliance with all laws and regulations
pertinent to sterile compounding. This attestation shall be made under pains and penalties of perjury, and include
attestation to the following this registrant/licensee only prepares and dispenses medication pursuant to a valid
prescription as defined in M.G.L. C. 94C for a single patient, regardless of whether the medication is prepared
for a Massachusetts or out-of-state patient.
(d) Every pharmacy licensed pursuant to M.G.L. C. 112 39 shall report within 7 business days all adverse
events relating to preparation of medications in that pharmacy.
(e) Every pharmacy licensed pursuant to M.G.L. C. 112 , 39 shall report wihtin 7 business days all
abnormal results, including failture of certification as required pursuant to 247 CMR 6.01 (5), and identification of environmental contaiminants in that pharmacy.
(f) Failure to comply with reporting requirements described in 247 CMR 6.15 (2)- (7) or to cooperate fully
in the Boards investigation of any such report to the Board shall be grounds for disciplinary action.
Universal Claim Form (UCF) means a nationally recognized standard form developed by the NCPDP used for
billing prescription drug claims to insurance plans. Universal Claim Forms are available through a pharmacy's
local wholesaler.
Wholesale Distribution means distribution of prescription drugs and prescription devices to persons other than
a consumer or patient, but does not include:
(a) Intracompany sales;
(b) the purchase or other acquisition by a hospital or other health care entity that is a member of a group
purchasing organization of a drug or device for its own use from the group purchasing organization or from
other hospitals or healthcare entities that are members of such organizations;
(c) the sale, purchase or trade of a drug or device or an offer to sell, purchase or trade a drug by a charitable
organization described in section 501(c)(3) of the Internal Revenue Code of 1954 to a nonprofit affiliate of
the organization to the extent otherwise permitted by law;
(d) the sale, purchase or trade of a drug or device or an offer to sell, purchase or trade a drug or device
among hospitals or other health care entities that are under common control; for purposes of 247 CMR 7.00,
"common control" means that power to direct or cause the direction of the management and policies of a
person or an organization, whether by ownership of stock, voting rights, by contract or otherwise;
(e) the sale, purchase or trade of a drug or device or an offer to sell, purchase, or trade a drug or device for
emergency medical reasons; for purposes of 247 CMR 7.00, "emergency medical reasons" includes transfers
of prescription drugs or devices by a retail pharmacy to another retail pharmacy to alleviate a temporary
shortage;
(f) the sale, purchase or trade of a drug or device, an offer to sell, purchase or trade a drug or device, or the
dispensing of a drug or device pursuant to a prescription;
(g) the lawful distribution of drug samples by manufacturers' representatives or distributors' representatives; or

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(h) the sale, purchase or trade of blood and blood components intended for transfusion.
Wholesale Distributor means a person engaged in wholesale distribution of prescription drugs or devices
including, but not limited to, manufacturers; repackers; own-label distributors; private-label distributors;
jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses,
and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct
wholesale distributions.
REGULATORY AUTHORITY247 CMR 2.00: M.G.L. c. 112, 24 and 42A STATUTORY AUTHORITY
247 CMR 3.00: M.G.L. c. 112, 24 and 42A.
247 CMR 3.00:
PERSONAL REGISTRATION REQUIREMENTS
Section
3.01: Examination for Personal Registration as a Pharmacist
3.02: Personal Registration by Reciprocity
3.03: Duplicate Certificate of Personal Registration
3.01: Examination for Personal Registration as a Pharmacist
In order to be registered as a pharmacist by examination by the Board, an applicant must meet the
requirements set forth in 247 CMR 3.01(1) or (2).
(1) Graduates of ACPE-accredited and Board-approved colleges/schools of pharmacy:
(a) An applicant shall be eligible for examination for personal registration as a pharmacist provided the
applicant:
1. is 18 years old by the scheduled date of the examination applied for;
2. has earned a qualifying degree in pharmacy from a college/school of pharmacy accredited by the
ACPE or approved by the Board;
3. has acquired no less than 1500 hours of practical experience as a pharmacy intern under the
supervision of a Board-approved pharmacist preceptor, of which at least 1000 hours must be completed
in a pharmacy or pharmacy related setting, as set forth in 247 CMR 8.01; and
4. is of good moral character.
(b) An applicant shall properly apply to take NAPLEX and MPJE. A completed application for examination
shall:
1. be fully and correctly completed by the applicant;
2. include a recent passport-size photograph of the applicant showing the applicants likeness;
3. include a certified birth certificate or other sufficient proof of place and date of birth;
4. in the case of a name change, include a written notification to the Board or the Boards designee of
such name change; and
5. be accompanied by a check or money order in the proper amount made payable as directed on the
examination application form;
(c) An applicant for personal registration as a pharmacist must pass both NAPLEX and MPJE.
(d) To qualify for personal registration, the applicant must achieve a NAPLEX score of not less than 75%
and an MPJE score of not less than 75%.
(e) An applicant who fails to achieve a passing score on either or both NAPLEX or MPJE may be
re-examined on either or both examinations provided that the applicant submits a new application for
examination to the Board or Board-approved testing service, accompanied by a check or money order made
payable, in the proper amount, to the Board's designee as appears on the examination application form.
(f) An applicant who fails either NAPLEX or MPJE must reapply and sit for the examination which the
applicant failed within one year of the administration date of the original examination in order for both

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examination scores to be considered together. If the applicant does not pass both NAPLEX and MPJE within
this one-year period, the applicant must apply to retake both NAPLEX and MPJE.
(2) Graduates of non-approved colleges/schools of pharmacy:
(a) In order for a graduate of a non-approved college/school of pharmacy to be eligible to apply for
examination for personal registration as a pharmacist, the applicant shall must have received Foreign
Pharmacy Graduate Examination Committee (FPGEC) Certification from NABP.
(b) An applicant who has graduated from a non-approved college/school of pharmacy shall be eligible for
examination for personal registration as a pharmacist provided the following requirements are met:
1. the applicant is 18 years old by the scheduled date of the examination applied for;
2. the applicant has received official FPGEC Certification from NABP;
3. the applicant has submitted an official copy of the applicant's FPGEC Certificate to the Board;
4. the Board has received official notification from the NABP of the applicant's FPGEC Certification;
5. the applicant has acquired no less than 1500 hours of practical experience as a pharmacy intern
under the supervision of a Board-approved pharmacist preceptor, of which at least 1000 hours must be
completed in a pharmacy or pharmacy related setting, as set forth in 247 CMR 8.01; and
6. is of good moral character.
(c) An applicant who has graduated from a non-approved college/school of pharmacy shall properly apply
to take NAPLEX and MPJE. A completed application for examination shall:
1. be fully and correctly completed by the applicant;
2. include a recent passport-size photograph of the applicant showing the applicants likeness;
3. include a certified birth certificate or other sufficient proof of place and date of birth;
4. in the case of a name change, include a written notification to the Board or Boards designee of such
name change; and
5. be accompanied by required fee(s).
(d) An applicant for personal registration as a pharmacist who has graduated from a non-approved
college/school of pharmacy must pass NAPLEX and MPJE in accordance with the requirements set forth in
247 CMR 3.01(1)(c) through (f).
(3) The Board may refuse to consider any application that has not been properly completed.
(4) All fees submitted to the Board in connection with an application for personal registration as a pharmacist,
reviewed and acted upon by the Board, are nonrefundable.
3.02: Personal Registration by Reciprocity
The Board may grant personal registration as a pharmacist to an applicant who furnishes proof satisfactory
to the Board that the applicant has been registered by examination in another state or jurisdiction and that the
applicant is in good standing in all states where the applicant holds a registration, provided that such other state
or jurisdiction requires a degree of competency equal to that required of applicants in Massachusetts, and
provided further that the Board recognizes the other state or jurisdiction for purposes of personal registration by
reciprocity.
An applicant who seeks personal registration by reciprocity from the Board shall submit a preliminary
application to NABP for license transfer. NABP, as agent of the Board, will conduct the preliminary evaluation
of an applicants qualifications for personal registration by reciprocity.
(1) General Requirements:
(a) Whenever an applicant has been notified by NABP that the applicant does not meet the requirements for
personal registration by reciprocity, the applicant may in writing request the Board to review the basis of
NABPs decision.
(b) The Board shall make the final determination of any applicants eligibility to be registered as a

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pharmacist by reciprocity.
(c) A reciprocity application shall be valid for one year after the date of approval by NABP.
(d) All fees submitted to the Board in connection with an application for personal registra-tion by
reciprocity, reviewed and acted upon by the Board, are nonrefundable.
(2) Specific Requirements for Graduates of ACPE-accredited or Board-approved Colleges/ Schools of Pharmacy.
(a) The requirements for the issuance by the Board of a personal registration by reciprocity to an applicant
who has graduated from an ACPE-accredited or Board-approved college/ school of pharmacy shall include
the following:
1. NABP approval;
2. documentation of intership experience as required by 247 CMR 8.01;
3. passing score (at least 75%) on MPJE; and
4. if requested, the applicant shall personally appear before the Board to discuss any matter related to
the application.
(b) Upon receipt by the Board of evidence of an applicants NABP approval and the appropriate fee, the
applicant may register with NABP to take MPJE.
(3) Specific requirements for graduates of non-approved colleges/schools of pharmacy:
(a) The requirements for the issuance of a personal registration by reciprocity to an applicant who has
graduated from a non-approved college/school of pharmacy shall include:
1. Receipt by the Board of an official copy of the applicant's FPGEC Certificate from NABP;
2. documentation satisfactory to the Board of practical experience as required by 247 CMR 8.01;
3. passing score (at least 75%) on MPJE; and
4. if requested, the applicant shall personally appear before the Board to discuss any matter related to
the application.
(b) Upon receipt by the Board of evidence of an applicants NABP approval and the appropriate fee(s), the
applicant must register with NABP to take MPJE.
3.03: Duplicate Certificate of Registration
To request a duplicate certificate of personal registration (wallet card), a registrant shall submit a Boardapproved form and required documentation. In the event that an original certificate of registration is recovered
after a duplicate certificate has been issued, the duplicate shall be promptly returned to the Board.
REGULATORY AUTHORITY247 CMR 3.00: M.G.L. c. 112, 24 and 42A.
247 CMR 4.00: PERSONAL REGISTRATION RENEWAL; CONTINUING EDUCATION REQUIREMENT
Section
4.01: Authority and Purpose
4.02: Personal Registration Expiration and Renewal
4.03: Continuing Education Requirement
4.04: Board Continuing Education Committee
4.05: Criteria for Board Approval of Continuing Education Programs
4.06: Certificate of Completion of CEU's
4.07: Record-Keeping by Authorized Providers
4.08: Record-Keeping by Registered Pharmacists
4.09: Continuing Education Credit for Pharmacist Instructors
4.10: Continuing Education Credit for Postgraduate Pharmacy Curriculum/Program
4.01: Authority and Purpose

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Board regulations at 247 CMR 4.00 are promulgated under the authority of M.G.L. c. 112, 24A and 42A,
and are designed to maintain pharmacists' professional competencies and to promote the highest standards of
professional practice.
4.02: Personal Registration Expiration and Renewal
Note that pharmacist registrations expire Dec. 31st of each even-numbered year
(1) All personal registrations shall expire on December 31st of each even-numbered year and shall be timely
renewed if the registrant intends to continue his or her practice of pharmacy.
(2) A registrant who has not renewed his or her personal registration before the date of its expiration may renew
such registration upon payment of an annual license fee, applicable back license fees, and a late fee as established
by the Commissioner of Administration and Finance under M.G.L. c. 7, 3B.
(3) Any practice of pharmacy by a registrant after the expiration of his or her personal registration shall
constitute the unlicensed practice of pharmacy and shall be subject to any and all penalties established for such
unlicensed practice of pharmacy.
(4) An applicant who has failed to renew his or her personal registration for a period of more than 60 days, and
whose personal registration has not been suspended or revoked by the Board, may apply for a renewal of
personal registration upon satisfying conditions imposed by the Board, which may include the completion of
additional CEUs.
(5) An applicant for personal registration renewal who has failed to renew his or her personal registration for
more than two years, and whose personal registration has not been suspended or revoked by the Board, shall take
and pass the Massachusetts Pharmacy Law Examination and meet all other conditions as determined by the
Board as a prerequisite to registration renewal.
(6) An applicant for personal registration renewal whose personal registration has been revoked or has been
suspended for between six months and two years shall take and pass the Massachusetts Pharmacy Law Examination and meet all conditions as determined by the Board as a prerequisite to registration renewal.
(7) An applicant for personal registration renewal whose personal registration has been revoked or suspended
for more than two years shall take and pass the Massachusetts Pharmacy Law Examination and meet all other
conditions as determined by the Board, which may include taking and passing the NABPLEX, as a prerequisite
to registration renewal.
(8) Notwithstanding any other provisions of 247 CMR 4.00, whenever the personal registration of an applicant
has expired while the applicant was actively serving in the Armed Forces of the United States or the Public Health
Service of the United States and the applicant has applied for personal registration renewal during the six months
immediately following termination of said service, the Board, in accordance with the provisions of St. 1951 c.
627, 51 shall renew the applicant's personal registration upon payment of the appropriate fee; provided
however, that the applicant is of good moral character and renewal of his or her personal registration would be
in the best interest of the public. No payment shall be required for the period of time when the applicant was
actively serving in the Armed Forces or in the Public Health Service, unless the applicant was practicing
pharmacy independent of such Armed Forces or Public Health Service.
4.03: Continuing Education Requirement
(1) As set forth by M.G.L. c. 112, 24A, each registered pharmacist seeking personal registration renewal shall

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complete continuing education as a condition precedent to such renewal.
(2) No registrant shall be eligible for renewal of a personal registration without completion of the requisite
number of CEUs for such renewal.
(3) A registrant seeking renewal of a personal registration shall submit to the Board with a renewal application
a statement, signed under the penalties of perjury, that the applicant has satisfactorily completed a minimum of
3.0 CEUs (30 contact hours) required for such renewal.
Note Continuing Education requirements
(4) A registrant seeking renewal of a personal registration must complete a minimum of 1.5 CEUs (15 contact
hours) each calendar year of the two-year renewal cycle. Of the 15 contact hours, effective for the renewal period
beginning January 1, 1991:
(a) at least two contact hours shall be in the area of pharmacy law; and
(b) not more than ten contact hours shall be acquired through home study and other mediated instruction.
(5) No CEUs may be carried over from one calendar year to another.
(6) Notwithstanding any other provisions of 247 CMR 4.03, in the event of extenuating circumstances an
applicant for renewal of personal registration who has failed to complete the requisite number of CEUs, or is
unable because of a physical disability to conform to the limitation on the number of CEUs acquired through
home study and other mediated instruction, shall submit to the Board a detailed statement, signed under the
penalties of perjury, setting forth with detail and specificity such extenuating circumstances. In such case, the
Board shall determine whether or not a renewal shall be granted. The Board shall notify the applicant of the
Board's determination and its reasons therefore.
(7) Notwithstanding any other provisions of 247 CMR 4.00, CEUs shall not be required of any applicant for
personal registration renewal for the period of time when the applicant was actively serving in the Armed Forces
of the United States or in the Public Health Service of the United States, unless the applicant was actively
practicing pharmacy independent of said Armed Forces or Public Health Service.
(8) A registrant may not earn more than eight hours of continuing education in a calendar day.
(9) A registrant shall not be required to complete continuing education in the calendar year in which the
registrant has graduated from an approved college/school of pharmacy.
4.04: Board Continuing Education Committee
(1) The Board shall establish a Continuing Education Committee composed of three Board members whose
responsibility it shall be to review all requests from providers for authorization to sponsor continuing education
programs and the approval of such programs. The Committee shall have the authority to grant or deny requests
for provider authorization and program approval, provided that any denial shall be subject to full Board review
as provided by 247 CMR 4.04(4).
(2) Each request for provider authorization, or program approval from an authorized provider, shall be
submitted to the Board Continuing Education Committee no less than 30 days in advance of the date of the
proposed program's presentation.

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(3) The Board Continuing Education Committee shall notify providers submitting requests for authorization to
sponsor an approved program, or seeking program approval, of the Committee's decision to grant or deny such
request for authorization or approval.
(4) A provider whose request for provider authorization or program approval is denied and who seeks further
review of his of her request may appeal the Continuing Education Committee's decision to the full Board.

(5) Notwithstanding any provision of 247 CMR 4.04, whenever the Board or its Continuing Education
Committee has received notice that a person or agency has received current program approval from and is in
good standing with the ACPE or the American Medical Association CME-1, then the person or agency sponsoring or co-sponsoring the program shall be considered an authorized provider.
4.05: Criteria for Board Approval of Continuing Education Programs
The following guidelines are to assist the registered pharmacist in selecting an appropriate continuing
education program and the provider in preparing and implementing continuing education programs for Board
approval as an authorized provider.
(1) An applicant for status as a Board-approved provider of a continuing education program shall submit a
completed application form, available from the Board, for each continuing education program for which the
applicant is seeking approval. The form shall include the following:
(a) The objectives of the program, which shall be:
1. clearly stated;
2. the basis for determining content, learning experience, teaching methodologies, and evaluation;
3. specific;
4. obtainable;
5. measurable; and
6. describe the expected outcomes for the learner.
(b) The appropriate subject matter, which shall include one or more of the following:
1. pharmacy practice management;
2. disease states/therapeutics;
3. research in pharmacy and health care;
4. patient management;
5. clinical topics;
6. drugs and dosage forms;
7. laws and regulations in relation to the practice of pharmacy; and
8. other topics which the Board may find important in educating the pharmacist.
(c) The subject matter shall be described in outline form as follows:
1. learner objectives:
2. content;
3. time allotment;
4. teaching methods; and
5. evaluation format.
(d) Whether the program will be live or a home-study or other mediated instruction.
(e) The date(s) of the intended program.
(f) The location(s) of the intended program, if applicable.
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(g)
(h)
(i)
(j)
(k)

The sponsors(s) of the program.

The tuition required to attend the program.
The amount of continuing education credit, in CEU's, which the program is intended to provide.
The qualifications of the faculty preparing and teaching the intended program.
Other information which the Board may deem important.

(2) When the intended program is an academic course, the course shall be within the framework of curriculum
that leads to an academic degree in pharmacy or is relevant to pharmacy, or a course within that curriculum that
is necessary to an individual's growth and development within the profession as outlined in 247 CMR 4.11.
(3) When the intended program is intended for home-study or other mediated instruction, it shall:
(a) Be developed by a professional group;
(b) follow a logical sequence;
(c) involve the learner by requiring an active response to materials and provide feedback;
(d) contain a test to indicate progress and to verify the completion of program; and
(e) supply a bibliography for continued study.
(4) When the intended program is a live program, it shall:
(a) Involve direct interaction between the faculty and participants; and
(b) the faculty should possess the appropriate credentials related to the discipline being taught.
(5) Education Methods shall conform to the following:
(a) Learning experiences and teaching methods shall be appropriate to achieve the objectives of the program;
(b) principles of adult education shall be used in the design of the program;
(c) time allotted for each activity shall be sufficient for the learner to meet the objective of the program; and
(d) facilities and educational resources shall be adequate to implement the program.
(6) The faculty shall present documentation satisfactory to the Board indicating his or her competence to teach
the content of the intended program and that he or she possesses knowledge of the principles of adult education.
(7) Attendee and program evaluation:
(a) A provision shall be made for evaluating the program participants' attainment of the stated learner
objectives; and
(b) program participants shall be given the opportunity to evaluate faculty, learning experiences, instructional methods, facilities and educational resources used for the program.
4.06: Certificate of Completion of CEUs
(1) An authorized provider shall issue to each pharmacist who has satisfactorily completed a program sponsored
or co-sponsored by that provider a certificate of completion of CEUs certifying that the pharmacist has completed
a specified number of CEUs.
(2) The following information shall be included on each certificate of completion of CEUs issued by an
authorized provider:
(a) The name and address of the authorized provider;
(b) the participant's name;
(c) the title of the continuing education program;
(d) the location of the program;
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(e) the date of completion of the program; and
(f) the number of CEUs earned.
(3) The CEUs noted on the certificate of completion of CEU's may be stated in whole numbers or as decimals
or fractions.
4.07: Record-Keeping by Authorized Providers
(1) Authorized providers shall be responsible for retaining records of the program, including:
(a) The name of each participant;
(b) the content of the program sponsored;
(c) the provider authorization number;
(d)
(e)
(f)
(g)

the date of the continuing education program;

the location of continuing education program;
the name of the approved instructor; and
an indication of whether the program was completed by home-study or other mediated instruction.

(2) Authorized providers shall maintain program records for a period of no less than three years from the date
of presentation of the program.
(3) Program records are subject to Board review and shall be made available to the Board and program
participants upon request.
4.08: Record-keeping by Registered Pharmacists
Note that pharmacists must keep records of C.E. for a period of two years and produce them to the board upon request.
(1) A pharmacist to whom a certificate of completion of CEUs has been issued shall retain that certificate for a
period of at least two years from the date of completion.
(2) Certificates of completion of CEUs are subject to Board review and shall be made available to the Board
upon request.
4.09: Continuing Education Credit for Pharmacist Instructors
A registered pharmacist who is a Board-approved continuing education instructor shall receive continuing
education credit for the program taught on a one-time basis annually.
4.10: Continuing Education Credit for Postgraduate Pharmacy Curriculum/Program
A registered pharmacist who enrolls in a postgraduate pharmacy curriculum, postgraduate pharmacy
program or Board-approved postgraduate medical program, shall be awarded CEUs for satisfactory completion
of each course within said curriculum or program, provided that the sponsor or co-sponsor of the postgraduate
curriculum or program is a Board-authorized or ACPE accredited provider of continuing professional education,
and provided further that the course provides instruction in one or more of the following areas: pharmacy,
pharmaceutical sciences, pharmacy practice, or pharmacy law.
REGULATORY AUTHORITY247 CMR 4.00: M.G.L. c. 112, 24A and 42A.

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247 CMR
5.00: ORALLY AND ELECTRONICALLY TRANSMITTED PRESCRIPTIONS; REPORTING REQUIREMENTS TO THE PRESCRIPTION MONITORING PROGRAM (PMP)
Section
5.01: Foreword
5.02: Electronically Transmitted Prescriptions
5.03: Emergency Situations in Which Controlled Substances in Schedule II May be Dispensed Upon
Orally or Electronically Transmitted Prescription
5.04: Reporting Requirements to the Prescription Monitoring Program (PMP)
5.01: Foreword
Except for the regulations pertaining to electronically transmitted prescriptions, the Department of Public
Health and the Board of Registration in Pharmacy, acting jointly under authority of M.G.L. c. 94C, and every
other act thereto enabling, and in accordance with the procedures set forth in M.G.L. c. 30A, hereby establish
regulations for the implementation of M.G.L. c. 94C.
5.02: Electronically Transmitted Prescriptions
Note who may transmit electronic orderssee also 105 CMR 721 et seq. Patient confidentiality must be maintained.
(1) Prescriptions or drug orders may be electronically transmitted from an authorized prescribing practitioner
or his or her expressly authorized agent to a pharmacy or pharmacy department of the patients choice. The
prescription or drug order shall be electronically transmitted in a manner that maintains patient confidentiality
and in accordance with the requirements of M.G.L. c. 94C, 23(g) and 105 CMR 721.000 et seq.
(2) A pharmacist or pharmacy shall not enter into any agreement concerning the provision of a computer,
facsimile machine, computer modem or any other electronic device which would adversely affect a patient's
freedom to select the pharmacy or pharmacy department of his or her choice.
(3) A pharmacist or pharmacy shall not provide a computer, facsimile machine, computer modem or any other
electronic device to a prescriber or health care facility for the purpose of providing an incentive to refer patients
to a particular pharmacy or pharmacy department.
5.03: Emergency Situations in Which Controlled Substances in Schedule II May be Dispensed Upon Orally or Electronically
Transmitted Prescription
Note what constitutes an emergency situation.
(1) "Emergency situations", for the purpose of permitting the dispensing of any controlled substance in Schedule
II upon orally or electronically transmitted prescription, means those situations in which the practitioner who
intends to prescribe a controlled substance in Schedule II determines:
(a) That the immediate administration of the controlled substance is necessary for the proper treatment of
the intended ultimate user;
(b) that no appropriate alternative treatment is available, including administration of a controlled substance
which is not in Schedule II; and
(c) that it is not reasonably possible for the prescribing practitioner to provide a written prescription to be
presented to the person dispensing the controlled substance prior to the dispensing.
(2) In case of an emergency situation as defined in 247 CMR 5.03(1), a pharmacist may dispense a controlled
substance in Schedule II upon receiving the orally or electronically transmitted authorization of a prescribing
practitioner, provided that:

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(a) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the
emergency period
Check the requirements for the Rx in MGL 94C 20 (a)
(b) the prescription contains all information required by M.G.L. c. 94C, 20(a) except for the actual
signature of the prescribing practitioner, and in the case of an oral prescription, or prescription transmitted
electronically by computer modem or other similar electronic device, the prescription is immediately reduced
to writing by the dispensing pharmacist; and
(c) the dispensing pharmacist makes a reasonable good faith effort to determine that the
orally or
electronically transmitted authorization was issued by an authorized practitioner, which effort may include a
callback to the prescribing practitioner or other good faith efforts to ensure the prescribing practitioner's
identity.
This specific requirement mirrors federal law.
(3) Within seven days after authorizing an emergency oral prescription, the prescribing practitioner shall cause
a written prescription for the emergency quantity prescribed to be delivered to the pharmacy which must have
written on its face "Authorization for Emergency Dispensing" and should comply with federal and state law.
In addition to notifying the DEA, the pharmacist must also notify the Dept. of Justice as well as the Commissioner
of Public Health a written Rx does not follow within 7 daysthis differs slightly from federal law.
(4) Upon receipt of the written prescription, the dispensing pharmacist shall attach the prescription to the orally
or electronically transmitted emergency prescription which had earlier been reduced to writing. The pharmacist
shall notify the nearest office of the Drug Enforcement Administration, U.S. Department of Justice, and the
Commissioner of Public Health, Massachusetts Department of Public Health, if the prescribing practitioner fails
to deliver a written prescription within seven days.
Massachusetts has enacted a Prescription Monitoring Program to address the problem of drug abuse and diverson.
5.04: Reporting Requirements to the Prescription Monitoring Program (PMP)
247 CMR 5.04, in conjunction with regulations of the Department at 105 CMR 700.000 and 105 CMR 701.000,
are intended to address the problem of prescription drug abuse and diversion. By requiring the reporting of
information relative to prescriptions for controlled substances in Schedule II, a more efficient means of monitoring
distribution between the practitioner, dispenser, and patient is provided. Effective December 1, 2008, revisions to the
reporting requirements of 247 CMR 5.04, which regulations were promulgated by the Board in conjunction with
Department reporting requirement revisions to 105 CMR 700.00 and 105 CMR 701.000 (effective August 8, 2008),
shall have been implemented by pharmacies required to report to the Department.
Note the information required to be reported.
(1) Pharmacy Reporting Requirements (105 CMR 700.006(J)).
(a) Every pharmacy registered by the Board and every pharmacy located in a health facility registered with the
Commissioner of the Department that dispenses controlled substances in Schedule II pursuant to a prescription
shall, in accordance with standards established by the Department, transmit to the Department or its agent the
following information for each prescription:
1. pharmacy number;
2. pharmacy prescription number;
3 customer identifier, as defined in 105 CMR 700.001;
4. patient name;
5. patient address;
6. patient date of birth;
7. patient gender;

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8.
9.
10.
11.
12.
13.
14.
15.

relationship of customer to patient;

National Drug Code (NDC) of controlled substance dispensed;
date prescription written by prescriber;
date the controlled substance is dispensed;
metric quantity of controlled substance dispensed;
estimated days supply of controlled substance dispensed;
prescriber's U.S. Drug Enforcement Administration (DEA) registration number; and
prescription coverage type.

(b) 247 CMR 5.04(1) does not apply to medication orders in hospitals. (105 CMR
700.006(J).
Note definition of customer identifier in definition section 247 CMR 2.00 et. seq.
(c) A pharmacy that dispenses a Schedule II controlled substance in accordance with
105 CMR 701.004, but is unable to obtain and report the customer identifier required by
105 CMR 701.004, shall leave the customer identifier field blank or otherwise complete the
field as directed by the Department.
d)The requirement in 105 CMR 701.004(A) that a pharmacy require a customer identifier
be presented by the ultimate user or agent of the ultimate user to whom a prescription for a controlled substance in Schedule II is dispensed may be waived provided that:
Note these exceptions to obtaining the customer identification.
1. the pharmacy has reason to believe that the failure to dispense the controlled substance would result in a serious hardship for the ultimate
user or agent of the ultimate user, and
documents the reason; and
2. the ultimate user or agent of the ultimate user prints his or her name and address on the reverse
side of the prescription and signs his or her name thereto.
3.
Note the time frame required for reporting information
(e) The information required by 247 CMR 5.04, in accordance with 105 CMR 700.006(J), shall be transmitted to the Department or its agent, in accordance with any procedures established by the Department, no
later than 15 days following the last day of the month in which the prescription was dispensed by use of:
1. An electronic device, including but not limited to computer diskette, compact disk, magnetic tape, or
modem transmission, each of which shall be in a format approved by the Department, or other acceptable
electronic method approved by the Department; or
2. Universal Claim Form or other form approved by the Department
.
Pharmacies reporting more than 25 prescriptions per month must report them electronically.
(f) Pharmacies reporting data from 25 or more prescriptions in any given month shall provide the required
information in accordance with 247 CMR 5.04(1)(e)1., in accordance with 105 CMR 700.006(J)(1)(d)(i).
(2) Penalties. Failure to comply with the reporting requirements set forth in 247 CMR 5.04(1), in accordance
with 105 CMR 700.006(J)(1), and/or any state law or regulation relating to such reporting requirements may
result in formal disciplinary action being initiated against the licensed pharmacist and/or the pharmacy by the
Board and/or other state and federal law enforcement agencies.

247 CMR 6.00:

REGISTRATION, MANAGEMENT AND OPERATION OF A PHARMACY OR PHARMACY DEPARTMENT

Section

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6.01: Application for a Registration to Manage and Operate a Pharmacy or Pharmacy Department;
Inspection of Proposed Pharmacy or Pharmacy Department
6.02: Conditions for Continuing Registration and Operation of a Pharmacy or Pharmacy Department
6.03: Requirements for Reporting to the Board a Change in the Management, Operation and/or Ownership
of a Pharmacy or Pharmacy Department
6.04: Requirements for Reporting to the Board Changes in the Configuration, Square Footage or Location
of a Pharmacy or Pharmacy Department.
6.05: Continuing Responsibilities of All Registered Pharmacists
6.06: Renewal of a Pharmacy Permit
6.07: Pharmacist Manager of Record
6.08: Certificate of Fitness Issued by the Board Permitting Manufacture the and Sale of Alcoholic Beverages
6.09: Closing a Pharmacy or Pharmacy Department
6.10: Distribution of Controlled Substances Upon Discontinuance or Transfer of Business of a Pharmacy
or Pharmacy Department
6.11: Inspections of Pharmacies and Pharmacy Departments
6.12: Deficiency Statements
6.13: Plans of Correction
6.01: Application for Registration to Manage and Operate a Pharmacy or a Pharmacy Department;
Inspection of a Proposed Pharmacy or Pharmacy Department
(1) In order to be registered by the Board to manage and operate a pharmacy or pharmacy department and be
issued a permit to do so, the registered pharmacist who shall be responsible for the management and operation
of the pharmacy or pharmacy department shall obtain and submit to the Board an application for registration to
manage and operate a pharmacy or pharmacy department available from the Board. A completed application
shall be:
(a) fully and properly completed and signed, under the penalties of perjury, by the pharmacist who is to
manage and operate the pharmacy or pharmacy department;
(b) accompanied by a statement of the scheduled hours during which the pharmacy or pharmacy department
is to remain open, including the time of opening and closing during regular business hours for each day of
the week;
(c) accompanied by an application, available from the Board, for a Massachusetts controlled substance
registration;
(d) accompanied by an application, available from the Board, for a certificate of fitness, if applicable;
(e) accompanied by a check or money order made payable, in the proper amount, to the Commonwealth
of Massachusetts Board of Registration in Pharmacy; and
(f) accompanied by any additional information as determined by the Board.
(2) A completed application to operate a pharmacy shall include:
(a) a copy of the corporation's Articles of Organization, signed and sealed by the Secretary of State if the
corporation is incorporated in the Commonwealth;
(b) a copy of the corporation's Foreign Corporation Certificate, signed and sealed by the Secretary of State
pursuant to M.G.L. c. 181, 4, if the corporation in incorporated in another state;
(c) a statement of the name and address of each officer and director of the corporation and the position held;
(d) the d/b/a name of the corporation; and
(f) if the corporation is not publicly owned, the total amount and type of stock issued to each stockholder
and the names and addresses of said stockholder(s).
Note this provision.
(3) The Board shall not register nor permit ownership of a pharmacy or pharmacy department by a practitioner
with prescriptive privileges.

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(4) Before acting upon any application for registration to manage and operate a pharmacy or pharmacy
department, the Board may require a hearing and, if requested to do so, the applicant shall personally appear
before the Board to answer questions to enable the Board to determine that issuance of a permit would be in the
best interests of the public health, welfare and safety as set forth in M.G.L. c. 112, 39.
(5) The Board may require an inspection of the pharmacy or pharmacy department before final approval of the
application is granted. All proposed pharmacies and pharmacy departments shall comply with the following
requirements:
(a) No application for registration to manage and operate a pharmacy or pharmacy department shall be
approved unless, upon inspection, the following is maintained on the pharmacy premises:
Note the items required to be in each pharmacy.
1. a current copy or electronic version of the Massachusetts List of Interchangeable Drugs (MLID),
including the Orange Book, Additional List, Exception List, and the latest supplements thereto;
2. a current copy or electronic version (with quarterly updates) of a compendia appropriate to the
practice setting approved by the pharmacist manager of record.
3. a current copy or electronic version of Board Regulations 247 CMR 1.00 et seq.;
4. a balance capable of accurately weighing quantities as small as 13 milligrams, which balance shall
be tested and sealed by the state or local sealer of weights and measures annually;
5. the equipment necessary to conduct the practice of pharmacy according to the standards set forth by
most current edition of the United States Pharmacopoeia;
6. prescription labels which bear the name and address of the proposed pharmacy;
7. appropriate sanitary appliances, including a suitable sink which shall be equipped for hot and cold
running water and which shall be situated in or near the area in which prescriptions are to be filled;
8. whenever applicable, at least one bound book for recording sales of controlled substances which may
be sold over-the-counter without a prescription; and
9. whenever applicable, at least one book for recording sales of alcoholic beverages and signatures of
the purchasers of these beverages.
Note the size requirements of clean room if applicable.
(b) There shall be within every pharmacy or pharmacy department a prescription area of not less than 300
square feet to accommodate the appropriate pharmaceutical equipment, apparatus, and supplies, and to
facilitate the proper preparation and compounding of prescribed medications. This area shall provide for an
arrangement and storage of drugs that is calculated to prevent their accidental misuse.
(c) Any pharmacy or pharmacy department which establishes a central intravenous admixture service
(CIVAS) shall, in addition to the 300 square feet required by 247 CMR 6.01(6)(b), provide for a separate
room referred to as a "clean room" apart from all other areas of the pharmacy or pharmacy department. The
pharmacy shall obtain approval from the Board indicating compliance with these requirements prior to
initial operation of central intravenous admixture services. The Boards approval shall be posted conspicuously, visible to th e public, on the pharmacy premises.
This clean room shall meet the following requirements:
1. There shall be a minimum working area of 72 square feet;
2. it shall be closed on all sides except for a door and an opening to allow for the passage of materials;
3. it shall have a laminar flow hood with either vertical or horizontal air flow;
4. the laminar flow hood standards of operation of HEPA (High Energy Particulate Air) filters and
prefilters must be determined and certification shall be made annually by a Board-approved hood
certification service;
5. the Board shall be notified before beginning operation of the clean room to verify hood certification;
6. the area of the clean room shall be under continual positive pressure unless the hood is self-venting;
and

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7. applications for construction of a pharmacy with a clean room received after September 30, 1996
shall show the clean room located directly adjacent to the prescription area/department.
Note requirement and signage.
(d) Patient Consultation Area.
1. A pharmacy must provide a designated consultation area, with signage stating Patient Consultation
Area, designed to provide adequate privacy for confidential visual and auditory patient counseling. The
private consultation area must be accessible by a patient from the outside of the prescription dispensing
area without having to traverse a stockroom or the prescription dispensing area.
2. 247 CMR 6.01(5)(d) shall be effective for all new or relocating pharmacies on April 1, 2005. All
existing pharmacies must comply with 247 CMR 6.01(5)(d) by January 1, 2007.
(6) The Board shall issue a permit indicating the pharmacy or pharmacy departments registration number if
the Board finds, in its reasonable discretion, that approving the application would be consistent with the best
interest of public health, welfare and safety.
(7) All fees submitted to the Board in connection with an application for registration to operate a pharmacy or
pharmacy department, which are reviewed and acted upon by the Board, are nonrefundable.
6.02: Conditions for Continuing Registration and Operation of a Pharmacy or Pharmacy Department
Except as provided by exemptions set forth in 247 CMR 12.00 with respect to restricted pharmacies and 247
CMR 13.00 with respect to nuclear pharmacies, the following conditions shall apply to the continuing operation
of a pharmacy or pharmacy department:
(1) The premises of the pharmacy or pharmacy department shall at all times be kept in a clean and sanitary
manner.
(2) The equipment and publications set forth in 247 CMR 6.01(6)(a) shall be maintained in the pharmacy or
pharmacy department at all times.
Note what needs to be conspicuously displayed in pharmacy.
(3) The following shall be conspicuously displayed within the pharmacy or pharmacy depart-ment:
(a) the pharmacy permit;
(b) the pharmacy's Massachusetts controlled substance registration;
(c) the pharmacy's U.S. Drug Enforcement Administration controlled substance registra-tion; and
(d) whenever applicable, the pharmacy's certificate of fitness.
(4) The pharmacy or pharmacy department shall maintain on the premises at all times a sufficient variety and
supply of medicinal chemicals and preparations which are necessary to compound and dispense commonly
prescribed medications in accordance with the usual needs of the community.
Note that a sign is required.
(5) A pharmacy or pharmacy department shall have a reasonably-sized sign affixed to the main entrance of the
business or otherwise installed in an easily observable area outside the premises, identifying the presence of a
pharmacy or pharmacy department.
Note security requirements-including how and where to store scheduled drugs.
(6) A pharmacy or pharmacy department shall conform to the following security requirements:
(a) All controlled substances in Schedules II through V shall be stored within the prescription area;
(b) controlled substances in Schedule VI shall be stored within the prescription area or in the clean room if

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the clean room is directly adjacent to the prescription area;
(c) controlled substances in Schedules II, III, IV, and V shall be stored in a securely locked and substantially
constructed cabinet, or dispersed in the prescription-drug storage area throughout the stock of Schedule VI
controlled substances in such a manner as to obstruct the theft or diversion of these controlled substances;
(d) there shall be a separate working alarm for the pharmacy or pharmacy department which shall be
activated when the pharmacy or pharmacy department is closed;
(e) a pharmacy department must be secured by a floor to ceiling barrier, securely locked and separately
alarmed at all times when the pharmacy department is closed;
(f) the pharmacist Manager of Record and the pharmacist on duty shall be responsible for pharmacy security
and shall control access to the prescription area;

(g) all drug order deliveries containing controlled substances shall be delivered directly to the pharmacy or
pharmacy department or to a secured area if the pharmacy is closed, and the security of those controlled
substances is the responsibility of the pharmacist Manager of Record; and
(h) each pharmacy or pharmacy department shall comply with all other security require-ments which the
Board may deem necessary for the protection of the public.
(7) A pharmacy or a pharmacy department shall conspicuously display, in legible letters not less than one inch
high, over, on or adjacent to the main entrance of the pharmacy or pharmacy department, the name of the
pharmacist Manager of Record who is responsible for the management and operation of the pharmacy or
pharmacy department.
Note requirement for posting of pharmacy department hours.
(8) A pharmacy or pharmacy department shall meet the following requirements concerning the posting of hours
of operation:
(a) The hours of operation shall be prominently posted at all consumer entrances to the pharmacy and, in
the case of a pharmacy department, the hours shall also be posted at all consumer entrances to the retail store
and at the pharmacy department;
(b) if the hours of operation of a pharmacy department, subject to the requirements of 247 CMR 6.02(6)(e)
and (10), are different from those of the retail store in which it is located, all advertising referring to the
pharmacy department shall clearly specify the pharmacy department's hours of operation; and
(c) if the hours of operation of a pharmacy's prescription area, subject to the requirements of 247 CMR
6.02(10), are different from the hours of operation for its non-prescription business, all advertising for the
pharmacy shall clearly specify the hours of operation of the pharmacy's prescription area
.
Note that registered pharmacist must be present at all times that non-pharmacist personnel have access.
(9) A pharmacy or pharmacy department shall meet the following requirements concerning registered pharmacists on duty and shall be present at all times when non-pharmacist personal have unrestricted access to the
pharmacy or pharmacy department:
(a) A registered pharmacist shall be on duty and on the pharmacy premises at all times the pharmacy or
pharmacy department is open for business and shall be present at all times when non-pharmacist personal
have unrestricted access to the pharmacy or pharmacy department;
(b) each registered pharmacist who is a full-time employee of the pharmacy shall have readily available, or
displayed in a conspicuous place, his or her certificate of registration to practice pharmacy and the original
or a copy of, his or her current wallet registration card; and
Note limit on pharmacist work hours.
(c) a registered pharmacist shall not remain on duty for more than 12 hours per day.
Note requirements for reporting loss or theft of controlled substances
(10) A pharmacy or pharmacy department shall report a theft or loss of a significant amount of controlled

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substances by submitting to the Board a copy of " Report of Theft or Loss of Controlled Substance" (DEA BND
Form 106), within seven days of such theft or significant loss and, where applicable, shall comply with the
reporting requirements of the DEA, the Department and the state and local police.
* Conviction: shall include any guilty verdict or finding of guilt and any admission to or finding of sufficient
facts to warrant a finding of guilt, regardless of adjudication, a continuance without a finding, and any ples of
guilty or nolo contendere, of or to a crime in any jurisdiction, which has been accepted by the court, whether or
not a sentence has been imposed. A conviction of any person licensed or registered by the Board shall be
conclusive evidence of the commission of that crime in any disciplinary proceeding against such person based
upon the conviction.
6.03: Requirements for Reporting to the Board a Change in the Management, Operation and/or Ownership of a Pharmacy or
Pharmacy Department
Note requirements when pharmacist Manager of Record changes.
(1) Whenever there is a change in the pharmacist Manager of Record of a pharmacy or pharmacy department,
an application for a change in pharmacist Manager of Record shall be obtained from and promptly submitted to
the Board. A completed application shall be fully and properly completed and signed, under the penalties of
perjury, by a duly authorized representative of the pharmacy or pharmacy department and include;
(a) a sworn statement confirming that a complete inventory of controlled substances in Schedules II, III, IV
and V signed by the outgoing pharmacist Manager of Record and the incoming pharmacist Manager of
Record has been taken and filed with the pharmacys controlled substance records. In the event the outgoing
pharmacist Manager of Record is unavailable due to death, serious illness, or termination for inappropriate
handling of controlled substances, a staff pharmacist may be authorized to sign the inventory, provided the
Board is notified at the time the application is submitted why the staff pharmacist is signing the inventory;
(b) an application for a certificate of fitness, if applicable;
(c) the pharmacy permit and, if applicable, the pharmacy or pharmacy department's certificate of fitness;
(d) required fee(s); and
(e) any additional information as determined by the Board.
(2) Whenever there is to be a transfer of ownership of a pharmacy or pharmacy department or if the pharmacy
or pharmacy department is to be owned by a person or entity other than the person or entity who was listed on
the initial application for registration to manage and operate a pharmacy or pharmacy department, an application for transfer of ownership shall be obtained from, and submitted to, the Board. A completed application shall:
(a) Meet all the requirements of 247 CMR 6.03(1), if there is a change of pharmacist Manager of Record;
(b) state the full name of the new owner;
(c) have attached thereto an official bill of sale; and
(d) if the new owner is a corporation:
1. have attached thereto a copy of the corporation's Articles of Organization, signed and sealed by the
Secretary of State, if the corporation is incorporated in the Common-wealth;
2. have attached thereto a copy of the corporation's Foreign Corporation Certificate, signed and sealed
by the Secretary of State pursuant to M.G.L. c. 181, 4, if the corporation in incorporated in another
state;
3. indicate of the name and address of each officer and director of the corporation and the position held;
4. indicate the d/b/a name of the corporation; and
5. if the corporation is not publicly owned, indicate the total amount and type of stock issued to each
stockholder and the names and addresses of said stockholder(s).
Note the reporting requirement upon employment or termination of a pharmacist
(3) A registered pharmacist who manages and operates a pharmacy or pharmacy department shall, within ten
working days of the commencement or termination of employment, report in writing to the Board such commencement or termination of employment.

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(4) Upon commencement of the employment of a registered pharmacist, the pharmacist's employer or the
pharmacist Manager of Record shall verify with the Board that the pharmacist's personal registration issued by
the Board is current.
(5) A corporation or partnership which owns a pharmacy or pharmacy department which is registered by the
Board shall notify the Board, within ten working days, in writing,of the following:
(a) Any change in its Articles of Organization;
(b) any change in its Foreign Corporate Certificate;
(c) any change in the d/b/a name of the corporation accompanied by appropriate authorizing documentation;
(d) any change in the names and addresses of its officers and/or directors, and/or in their positions; and
(e) unless the stock of the corporation is publicly traded, any change in the total amount of stock issued or,
names and addresses of the stockholders and the kinds and amounts of stock which they respectively own.

(6) Pursuant to the provisions of M.G.L. c. 112, 36, a surviving spouse, executor or administrator of a
registered pharmacist who has died or the spouse of one who has become incapacitated who has been authorized
to continue operation of a pharmacy or pharmacy department shall, within five days of any change in employment
of a registered pharmacist, whether by dismissal, resignation, lay-off or additional hiring, notify the Board
thereof in writing.
6.04: Requirements for Reporting to the Board a Change in the Configuration, Square Footage, or Location of a Pharmacy
or Pharmacy Department
Any physical changes to a pharmacy must have prior approval by the board.
(1) Any pharmacy or pharmacy department which is being remodeled in a manner which changes the
configuration or square footage of the prescription area shall before commencing any remodeling, submit copies
of its structural plans to the Board for approval.
(2) The following requirements shall apply to any pharmacy or pharmacy department moving to a new address.
The pharmacy or pharmacy department shall:
(a) submit to the Board a new application and payment of the appropriate fee in accordance with the
requirements of 247 CMR 6.01(1) in advance of any relocation;
(b) return previously issued permits with the application; and
(c) a pharmacy or pharmacy department which has moved to a new address shall not begin to operate in
said location until the application has been approved by the Board and until the pharmacy or pharmacy
department has received from the Board a permit to manage and operate the pharmacy and a controlled
substances registration.
6.05 Continuing Responsibilities of All Registered Pharmacists
Note requirement to notify board of change of address or name with 10 working days.
(1) A registered pharmacist who changes his or her mailing address or name shall notify the Board of such
change(s) in writing within ten working days of such change(s). In the case of a change of name, the pharmacist
shall submit a sworn statement indicating that the pharmacist has changed his or her name with a photocopy of
a valid picture identification card and any other documentation that may be required by the Board.

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(2) A registered pharmacist shall not allow or cause to be displayed, in any pharmacy or pharmacy department
where said pharmacist is not employed or associated with the pharmacy business, his or her certificate of
personal registration to practice pharmacy.
Pharmacist must have proof of registration at all times where he/she is employed.
(3) A pharmacist shall carry, or have readily available at all times where the pharmacist is employed, a
certificate of personal registration or an official statement from the Board which indicates that the pharmacist is
currently registered by the Board to practice pharmacy.
6.06: Renewal of a Pharmacy Permit
Note biennial expiration date of pharmacy department permitDec. 31st of each uneven year.
(1) Each pharmacy or pharmacy department permit issued by the Board shall expire on December 31st of each
uneven numbered year following the date of its issuance.
(2) Application for renewal of a pharmacy or pharmacy department permit shall be made by a duly authorized
representative of the pharmacy on a renewal application form provided by the Board. Such renewal from shall
be fully and properly completed and submitted to the Board in a timely manner.
(3) Each renewal application form submitted to the Board shall be accompanied by a check or money order in
the required amount made payable to the "Commonwealth of Massachusetts Board of Registration in Pharmacy".
6.07: Pharmacist Manager of Record
Note all the responsibilities of the Pharmacist Manager of Record
(1) The responsibilities of the pharmacist Manager of Record shall include, but may not be limited, to the
following:
(a) The maintenance of necessary pharmaceutical equipment and reference texts in accordance with the
requirements at 247 CMR 6.01(6)(a);
This would include inventory records.
(b) the proper maintenance of records as required by the Massachusetts Controlled Substances Act (M.G.L.
c. 94C), Board regulations at 247 CMR 2.00 et seq., and all other applicable state and federal laws and
regulations;
Security is addressed in 247 CMR 6.02(6)
(c) the maintenance at all times of adequate pharmacy and pharmacy department security consistent Board
regulations at 247 CMR 2.00 et seq., and all other applicable state and federal laws and regulations;
(d) the establishment, monitoring and enforcement of policies and procedures which encourage acceptable
standards of practice consistent with Board regulations at 247 CMR 2.00 et seq., and all other applicable
federal and state laws and regulations;
(e) the establishment, monitoring and enforcement of policies and procedures which maintain the standards
of professional practice as such standards relate to the dispensing of pharmaceuticals, including the proper
supervision of technicians, and the delegation of authority to another pharmacist when not on duty;
(f) the maintenance of adequate staff in the pharmacy or pharmacy department in order to ensure that the
practice of pharmacy shall be carried out in accordance with Board regulations at 247 CMR 2.00 et seq. and
all other applicable federal and state laws and regulations;
(g) the maintenance of records relating to the responsibilities of pharmacy technicians as outlined in 247
CMR 8.02(6);
(h) notification to the Board in writing of his or her termination as pharmacist Manager of Record within
ten working days;

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Note that inventory of controlled substances mirrors the federal law.
(i) taking an inventory of controlled substances in Schedules II, III, IV and V, based upon federal biennial
inventory requirements, pursuant to the requirements of 247 CMR 6.03(b); and
(j) the establishment of procedures for validating questionable purported controlled sub-stance prescriptions and for reviewing existing prescription information, to deter the willful and unlawful dispensing of
controlled substances.
(2) A pharmacist Manager of Record shall not be the Manager of Record of more than one pharmacy or
pharmacy department at a time.

6.08: Certificate of Fitness Issued by the Board Permitting the Manufacture and Sale of Alcoholic Beverages
This section would apply today to pharmacies that use alcohol to compound medicinal preparations. The statutes allowing this
may be found at MGL Chapter 138 Sec. 29 and 30. According to the statute, the certificate of fitness issued to a pharmacist
expires Dec. 31st of each uneven year.
(1) Pursuant to authority granted to it under M.G.L. c. 138, 29, the Board may issue to a registered pharmacist
who is the Manager of Record of a pharmacy or pharmacy department a certificate of fitness permitting the
pharmacy to use alcohol for the manufacture of U.S. Pharmacopoeia or National Formulary preparations and
all medicinal preparations unfit for beverage purposes, and to sell alcohol as authorized under M.G.L. c. 138.
(2) A pharmacist Manager of Record, acting on behalf of a pharmacy or pharmacy department, may apply to
the Board for the issuance of a certificate of fitness. A completed application shall:
(a) be fully and properly completed and signed, under penalties of perjury, by the pharma-cist Manager of
Record who shall manage and operate the pharmacy or pharmacy department; and
(b) be accompanied by a check or money order, in the proper amount, made payable to the Commonwealth
of Massachusetts Board of Registration in Pharmacy.
(3) An applicant for a certificate of fitness may be required by the Board to furnish evidence satisfactory to the
Board that he or she is a proper person to be entrusted with the authority to manufacture and sell alcoholic
beverages and that the issuance of such certificate shall promote the public good.
(4) The Board may require a personal interview with an applicant for a certificate of fitness to determine the
merits of any application for such certificate.
(5) A certificate of fitness which is issued by the Board to a pharmacy or pharmacy department shall be issued
in the name of the pharmacist who manages and operates the pharmacy or pharmacy department and is not
transferable.
(6) A pharmacy or pharmacy department under the supervision of its pharmacist Manager of Record shall
comply with the following requirements regarding the sale or transfer of alcohol or alcoholic beverages:
(a) Prescriptions for alcoholic beverages shall be maintained in a separate file and shall not be refilled;
(b) any authorized sale or transfer of alcohol or alcoholic beverages which can be used for human
consumption shall be made by a registered pharmacist, or by an adult non-pharmacist employee at the

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direction, and under the supervision of, a registered pharmacist on the premises;
(c) no sale or transfer of any alcohol or alcoholic beverage which can be used for human consumption shall
be made to a minor;
(d) except upon the written prescription of a practitioner, or except as may be otherwise provided by the
local licensing authorities, a pharmacy or pharmacy department which is licensed by the local licensing
authority under the provisions of M.G.L. c. 138, 30A to sell or transfer alcoholic beverages shall neither
sell nor transfer such alcoholic beverages on Sundays or legal holidays, or during polling hours, or on any
day on which a state or municipal election, caucus, or primary is held in the city or town in which said
pharmacy or pharmacy department is located;
(e) a pharmacy or pharmacy department which holds a license, issued by local licensing authorities under
the provisions of M.G.L. c. 138, or which holds a certificate of fitness under the provisions of M.G.L. c. 138,
29 and 30, shall not in any way advertise the sale of alcohol, wines, malt beverages, or alcoholic beverages;
(f) prior to the sale or transfer of any alcoholic beverage, a pharmacy or pharmacy department which is
licensed by the local licensing authorities under the provisions of M.G.L. c. 138, 30A shall record in a
bound record book , organized in accordance with M.G.L. c. 138, 30E, at the time of every sale, the date of
the sale or transfer, the name and address of the purchaser, and the kind, quantity, price and intended use of
said beverage;
(g)
in accordance with the provisions of 247 CMR 6.08(7)(f), whenever a pharmacy or pharmacy
department which is licensed by local licensing authorities under the provisions of M.G.L. c. 138, 30A sells
or transfers an alcoholic beverage to a purchaser, said purchaser shall sign in the bound record book a dated
statement substantially as follows: "I wish to purchase (name of alcoholic beverage). I certify that I am of
statutory age to purchase alcoholic beverages and that the alcoholic beverage is to be used for mechanical,
chemical, medicinal purpose." (A line shall be drawn through the words which do not indicate the purpose
of the purchase.)
(h)
in accordance with the provisions of 247 CMR 6.08(7)(f), whenever a pharmacy or pharmacy
department which is licensed by local licensing authorities under the provisions of M.G.L. c. 138, 30A
transacts a sale or transfer pursuant to the written prescription of a practitioner, in addition to the
information required by 247 CMR 6.08 (7)(f), there shall also be recorded in the bound record book the name
of the practitioner; and
(i) a pharmacy or pharmacy department which is licensed by local licensing authorities under the provisions
of M.G.L. c. 138, 30A may display alcoholic beverages only in a small case or on shelving located at the
rear of the pharmacy, provided that the total area used for such display shall not exceed 18 square feet.
(7) The Board or local licensing authorities, may, after giving a hearing to the interested parties, revoke or
suspend the certificate of fitness for any cause which they may deem proper, and such revocation shall suspend
all authority the pharmacist, pharmacy or pharmacy department was granted by 247 CMR 6.08(7).
6.09: Closing of a Pharmacy or Pharmacy Department
Notice must be made by certified mail at least 14 days prior to closing
(1) Any person who intends to close a pharmacy or pharmacy department registered by the Board shall officially
notify the Board in writing, by certified mail, at least 14 days, before the intended closing, unless otherwise
authorized by the Board, and shall provide the Board with the following information:
(a) The name, address and telephone number of the pharmacy or pharmacy department;
(b) the pharmacy permit number;
(c) the pharmacy controlled substance registration number issued by the Board;
(d) the pharmacy certificate of fitness number issued by the Board, if applicable;
(e) the name of the pharmacist Manager of Record of the pharmacy or pharmacy depart-ment;
(f) the date on which the intended closure shall take place;
(g) the intended procedures for closing the pharmacy or pharmacy department;

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(h) verification that adequate advance notice of the closure has been given to customers of the pharmacy or
pharmacy department; and
(i) the intended procedures for disposal of controlled substances, or the intended procedures for transfer of
controlled substance in accordance with 247 CMR 6.10.
Following must be done within 10 days of closure.
(2) Within ten days of the closure of a pharmacy or pharmacy department, the following shall be completed by
the pharmacy or pharmacy department:
(a) the pharmacy permit shall be returned to the Board;
(b) the pharmacy controlled substance registration shall be returned to the Board;
(c) the pharmacy certificate of fitness, if issued, shall be returned to the Board; and
(d) the Board shall be notified that all controlled substances have been disposed of in accordance with
federal regulations at 21 CFR 1307.21.

6.10: Distribution of Controlled Substances Upon Discontinuance or Transfer of Business of a Pharmacy or Pharmacy
Department
(1) Any person who intends to transfer controlled substances in Schedules II through VI from one pharmacy or
pharmacy department to another pharmacy or pharmacy department within the Commonwealth shall officially
notify the Board in writing, by certified mail at least 14 days before the intended transfer, unless otherwise
authorized by the Board, and shall provide the Board with the following information:
(a) The name, address and telephone number of the transferor pharmacy or pharmacy department;
(b) the name, address and telephone number of the transferee pharmacy or pharmacy department.
(c) the pharmacy permit number of the transferor pharmacy or pharmacy department;
(d) the pharmacy permit number of the transferee pharmacy or pharmacy department;
(e) the pharmacy controlled substance registration number of the transferor pharmacy or pharmacy
department;
(f) the pharmacy controlled substance registration number of the transferee pharmacy or pharmacy
department;
(g) the name and pharmacist registration number of the Manager of Record of the transferor pharmacy or
pharmacy department;
(h) the name and pharmacist registration number of the Manager of Record of the transferee pharmacy or
pharmacy department;
(i) the date on which the transfer of the controlled substances will take place; and
(j) the intended security procedures for transfer of the controlled substances.
(2) After proper notification, the transfer of controlled substances may occur provided the following procedures
are adhered to:
(a) On the date of the transfer, a complete inventory of all controlled substances in Schedules II through V
shall be taken in accordance with federal and state law;
(b) said inventory shall be signed by the pharmacist Manager of Record of the transferor pharmacy or
pharmacy department and the pharmacist Manager of Record of the transferee pharmacy or pharmacy
department. In the event that either pharmacist Manager of Record is unavailable due to death, serious
illness, or termination for inappropriate handling of controlled substances, a staff pharmacist may be
authorized to sign the inventory, provided the Board is notified at the time the application is submitted as to
why the staff pharmacist is signing the inventory;
(c) both the transferor and transferee pharmacy or pharmacy department shall maintain a copy of the

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inventory for two years or as otherwise required by law;
(d) a copy of said inventory shall be filed with the Board within ten days of the transfer;
(e) the transferee pharmacy or pharmacy department shall receive all required controlled substance and
controlled substance inventory records on the date of the transfer and maintain those records for two years;
and
(f) the transferor pharmacy or pharmacy department shall not possess any controlled substances after the
date of transfer.
6.11: Inspections of Pharmacies and Pharmacy Departments
The Board or its designees may visit a pharmacy or pharmacy department at any time without prior notice
and inspect it, its staff, activities, and records to determine compliance with state law and 247 CMR 2.00 et seq.
The Board may also inspect pharmacies and pharmacy department premises pursuant to 247 CMR 11.12.

6.12: Deficiency Statements

After every Board inspection in which any violation of 247 CMR 2.00 et seq. is observed, the Board or its
designees shall prepare a deficiency statement citing every violation observed, a copy of which shall be sent to
the pharmacy or pharmacy department.
6.13: Plans of Correction
A pharmacy or pharmacy department shall submit to the Board a written plan of correction of violations cited
in a deficiency statement prepared pursuant to 247 CMR 6.12 within fifteen (15) business days after the
deficiency statement is sent. Every plan of correction shall set forth, with respect to each deficiency, the specific
corrective step(s) to be taken, a timetable for such steps, and the date by which compliance with the relevant 247
CMR section will be achieved. The timetable and the compliance dates shall be consistent with achievement of
compliance in the most expeditious manner possible. A plan of correction which does not meet the requirements
of the relevant 247 CMR section shall be considered unacceptable by the Board and returned to the pharmacy or
pharmacy department.
Note: As of March 22, 2010 the following regulation is listed as new see:
http://www.mass.gov/?pageID=eohhs2terminal&L=5&L0=Home&L1=Government&L2=Laws%2c+Regulations+and+Polici
es&L3=Department+of+Public+Health+Regulations+%26+Policies&L4=Proposed+Amendments+to+Regulations&sid=Eeo
hhs2&b=terminalcontent&f=dph_legal_board_pharmacy&csid=Eeohhs2

6.14:

Duty to Report Certain Medication Errors to the Board

This rule requires a pharmacy to report to the Board of Pharmacy an improper dispensing of a prescription drug that results
in serious injury or death.
Pursuant to Massachusetts General Laws (M.G.L.) c. 112, s. 39D, a pharmacy licensed by the Board is required to report to
the Board any improper dispensing of a prescription drug that results in serious injury or death, as defined by the Board, as

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soon as is reasonably and practicably possible but not later than 15 business days after discovery or being informed of the
improper dispensing. The duty to report to the Board pursuant to M.G.L. c. 112, s. 39D and 247 CMR 6.14(2) shall be in
addition to the Continuous Quality Improvement (CQI) Program requirements of 247 CMR 15.00.
(1) Definitions. For purposes of reporting to the Board, as required by M.G.L. c. 112, s. 39D:
(a) Improper dispensing of a prescription drug shall mean the incorrect dispensing of a prescribed medication
that is received by a patient, as more particularly described in the definition of Quality-Related Event or QRE
appearing in 247 CMR 15.01.
(b) Pharmacy, as referenced in 247 CMR 6.14, means a pharmacy, or a group of pharmacies under common
ownership and control of one entity, licensed by the Board pursuant to M.G.L. c. 112.
(c) Serious injury shall mean an injury that is life threatening, results in serious
disability or death, or requires a patient to undergo significant additional
treatment measures.
(d) Serious disability shall include, but is not limited to, injuries requiring major
intervention and loss, or substantial limitation, of bodily function lasting greater than 7 days (e.g. bodily
function related to breathing, dressing/undressing; drinking; eating; eliminating waste products; getting into and
out of bed, chair, etc.; hearing; seeing; sitting; sleeping or walking)
.
Report must be made within 15 days of the pharmacy discovering or being informed of the improper dispensing.
(2) Reporting Responsibility. A pharmacy shall file a report of the improper dispensing of a prescription drug with the Board,
on a form to be provided by the Board, within 15 business days of the pharmacy discovering or being informed of the improper
dispensing. A pharmacy shall provide all records relating to the medication error to the Board upon request.
(3) Records Retention. The pharmacy shall retain all records relating to a medication error required to be reported to the
Board in accordance with the requirements of M.G.L. c. 112,
s. 39D and 247 CMR 6.14(2) for a minimum period of two years from the date the report is filed with the Board.
REGULATORY AUTHORITY247 CMR 6.00: M.G.L. c. 112, 42A and 30; c. 138, 29 through 30G.
247 CMR 7:00:

WHOLESALE DRUGGISTS

Section
7.01: Scope and Purpose
7.02: Licensing Requirements
7.03: Penalties
7.04: Minimum Requirements for the Storage and Handling of Prescription Drugs and for the Establishment and Maintenance
of Prescription Drug Distribution Records
7.01: Scope and Purpose
The purpose of 247 CMR 7.00 is to implement the Federal Prescription Drug Marketing Act of 1987
("PDMA"), U.S. Public Law 100-293, codified at 21 U.S.C. 321 et seq. The PDMA requires that all entities
engaged in the interstate and/or intrastate wholesale distribution of prescription drugs be licensed in each state
where they are engaged in such activity.
247 CMR 7.00 applies to every wholesale distributor located in the Commonwealth of Massachusetts who

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engages in the sale, distribution, or delivery at wholesale of prescription drugs.
The purpose of 247 CMR 7.00 is to provide minimum standards, terms and conditions for the licensing by the
Board of Registration in Pharmacy of persons located in Massachusetts who engage in the sale, distribution, or
delivery at wholesale of prescription drugs.
7.02: Licensing Requirements
(1) Every wholesale distributor located in the Commonwealth of Massachusetts who engages in wholesale
distribution of prescription drugs shall be licensed by the Board in accordance with the laws and regulations of
the Commonwealth before engaging in such wholesale distribution.
(2) Applications for a license to conduct a wholesale drug business in the Commonwealth shall be made upon
application forms furnished by the Board. Each application shall be completely filled out and signed by each
applicant under oath before a notary public. The Board shall not consider any applications within 15 days after
the date of its filing with the Board. The Board shall not consider any application which has been improperly
completed or which is not accompanied by the appropriate fee(s).

(3) The Board may require a hearing upon the merits of any application for a license to conduct a wholesale
drug business. Where such a hearing is required, the Board shall give the applicant seven days notice by certified
mail, of the date, time, and place of the hearing.
(4) Any person who is engaged in the wholesale drug business at more than one location shall obtain a license
for each location.
(5) Minimum Required Information for Licensure. The Board requires the following information from each
wholesale drug distributor as part of the initial licensing procedure and as part of any renewal of such license:
(a) The name, full business address, and telephone number of the applicant or licensee;
(b) all trade or business names used by the applicant or licensee;
(c) addresses, telephone numbers, and the names of contact persons for each facility used by the applicant
or licensee for the storage, handling, and distribution of prescription drugs;
(d) the type of ownership or operation (i.e., partnership, corporation, or sole proprietor-ship); and
1. if a person, the name of the person;
2. if a partnership, the name of each partner, and the name of the partnership;
3. if a corporation, the name and title of each corporate officer and director, the corpor-ate names, and
the name of the state of incorporation, and the name of the parent company, if any;
4. if a sole proprietorship, the full name of the sole proprietor and the name of the business entity;
5. an indication as to whether the applicant or licensee will distribute controlled substances, legend
drugs, and/or over-the-counter drugs, as well as a statement concerning the types of drugs to be
distributed.
(6) Changes in any information in 247 CMR 7.02(5) shall be submitted to the Board in writing within 30 days
after such change.
(7) Minimum Qualifications. The Board shall consider the following factors at a minimum in issuing, renewing,
or revoking a license to engage in the wholesale distribution of prescription drugs:
(a) Any convictions of the applicant or licensee under any federal, state, or local laws relat-ing to drug
samples, wholesale or retail drug distribution, or distribution of controlled substances;
(b) any felony convictions of the applicant or licensee under federal, state, or local laws;
(c) the past experience of the applicant or licensee in the manufacture or distribution of prescription drugs,
including controlled substances;

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(d) the furnishing by the applicant or licensee of false or fraudulent material in any application made in
connection with drug manufacturing or distribution;
(e) suspension, revocation, or other sanction(s) by federal, state, or local government of any license or
registration currently or previously held by the applicant or licensee for the manufacture or distribution of
any drugs, including controlled substances;
(f) compliance with licensing or registration requirements under previously granted licenses or registrations, if any;
(g) compliance with the requirements to maintain and/or make available to state licensing authorities or to
federal, state, or local law enforcement officials those records required to be maintained by wholesale drug
distributors;
(h) failure to provide adequate control over the distribution, diversion, theft, and/or loss of drugs;
(i) compliance with all requirements set forth in 247 CMR 7.00; and
(j) any other factors or qualifications the Board considers relevant to and consistent with the public health
and safety.
(8) The Board reserves the right to deny a license to an applicant if it determines that the granting of such a
license would not be in the public interest.
(9) Personnel. As a condition for receiving and retaining a wholesale drug distributor license, the licensee shall
require each person employed in any prescription drug wholesale distribution activity to have education,
training, and experience, or any combination thereof, sufficient for that person to perform the assigned functions
in such a manner as to provide assurance that the drug product quality, safety, and security will at all times be
maintained as required by law.
7.03: Penalties
(1) The agents of the Board may inspect and investigate all wholesale drug distributors of drugs and medicines
and shall report all violations of Board regulations and statutes to the Board. Board agents shall provide to the
licensee a copy of the inspection report within 15 days of such inspection. At the direction of the Board, Board
agents may apply for criminal complaints to be issued against persons guilty of any such violations.
(2) Every person who is licensed to conduct a wholesale drug business shall not sell or deliver drugs to any
unauthorized person, whether upon prescription, at retail, or otherwise.
Note requirements for wholesalers for repackaging or re-labeling drugs.
(3) Except under the direct supervision of a registered pharmacist, and in compliance with federal Current Good
Manufacturing Practices (CGMP's), a person who is licensed to conduct a wholesale drug business shall not
package or repackage any drug for resale, nor shall said person label or relabel any drug container.
(4) The Board may, after hearing or by agreement, suspend or revoke any licenses granted under 247 CMR 7.00
for any violation of federal, state or local drug laws or regulations or for any violation of Board laws or
regulations governing the wholesale drug business.
7.04: Minimum Requirements for the Storage and Handling of Prescription Drugs and for the Establishment and Maintenance
of Prescription Drug Distribution Records
The following shall constitute minimum requirements for the storage and handling of prescription drugs, and
for the establishment and maintenance of prescription drug distribution records by wholesale drug distributors
and their officers, agents, representatives, and employees:
(1)

Facilities. All facilities at which prescription drugs are stored, warehoused, handled, held, offered,

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State Pharmacy Law Review

marketed, or displayed shall:
(a) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;
(b) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity,
space, equipment, and security conditions;
(c) have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated,
misbranded, or adulterated, or that are in immediate or sealed secondary containers that have been opened;
(d) be maintained in a clean and orderly condition; and
(e) be free from infestation by insects, rodents, birds, or vermin of any kind.
(2) Security. All facilities used for wholesale drug distribution shall be secure from unauthorized entry in
accordance with the requirements of the Board and federal regulations. The following guidelines shall be
observed:
(a) Access from outside the premises shall be kept to a minimum and be well-controlled.
(b) The outside perimeter of the premises shall be well-lighted.
(c) Entry into areas where prescription drugs are held shall be limited to authorized personnel.
(d) All facilities shall be equipped with an alarm system to detect entry after hours.

(e) All facilities shall be equipped with a security system that will provide suitable protec-tion against theft
and diversion. When appropriate, the security system shall provide protection against theft or diversion that
is facilitated or hidden by tampering with computers or electronic records.
(f) All facilities shall conduct a thorough background check for each employee.
Note requirement for reporting loss or theft of controlled substances.
(g) All facilities shall report a theft or loss of a significant amount of controlled substances by submitting
to the Board a copy of Report or Loss of Controlled Substances (DEA BND Form 106) within seven days
of such theft or significant loss, and where applicable, shall comply with the reporting requirements of the
DEA, the Department, and the state and local police.
(3) Storage.
Note that drugs must be stored in compliance with requirements s of drug labeling or at controlled room temperature as
defined by an official compendium such as USP/NF
(a) All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in
accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current
edition of an official compendium such as the United States Pharmacopoeia/National Formulary (USP/NF).
(b) If no storage requirements are established for a prescription drug, the drug may be held at "controlled"
room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and
purity are not adversely affected.
(c) appropriate manual, electromechanical, or electronic temperature and humidity record-ing equipment,
devices, and/or logs shall be utilized to document proper storage of prescription drugs.
(d) The record-keeping requirements in 247 CMR 7.04(6) shall be followed for all stored drugs.
(4) Examination of Materials.
(a) Upon receipt, each outside shipping container shall be visually examined for identity to prevent the
acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution.
This examination shall be adequate to reveal container damage that would suggest possible contamination
or other damage to the contents.
(b) Each outgoing shipment shall be carefully inspected for identity of the prescription drug products and
to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under
improper conditions.
(c) The record keeping requirements in 247 CMR 7.04(6) shall be followed for all incoming and outgoing

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prescription drugs.
(5) Returned, Damaged, and Outdated Prescription Drugs.
(a) Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be
quarantined and physically separated from other prescription drugs until they are destroyed in accordance
with all applicable state and federal regulations or returned to the supplier.
(b) Any prescription drugs whose immediate or sealed outer or sealed secondary containers have been
opened or used shall be identified as such, and shall be quarantined and physically separated from other
prescription drugs until they are either destroyed in accordance with all applicable state and federal
regulations or returned to the supplier.
(c) If the conditions under which a prescription drug has been returned cast doubt on the drug's safety,
identity, strength, quality, or purity, then the drug shall be destroyed in accordance with all applicable state
and federal regulations, or returned to the supplier, unless examination, testing or other investigation proves
that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining
whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity,
strength, quality, or purity, the wholesale drug distributor shall consider, among other things, the conditions
under which the drug has been held, stored, or shipped before or during its return and the condition of the
drug and its container, carton, or labeling, as a result of storage or shipping.
(d) The record-keeping requirements in 247 CMR 7.04(6) shall be followed for all out-dated, damaged,
deteriorated, misbranded, or adulterated prescription drugs.
(6) Record Keeping.
(a) Wholesale drug distributors shall establish and maintain, in a manner consistent with good business
practices, complete and accurate inventories and records of all transactions regarding the receipt and
distribution or other disposition of prescription drugs. These records shall include the following information:
1. The source of the drugs, including the name and principal address of the seller or transferor, and the
address of the location from which the drugs were shipped, or in the case of distribution, the name and
address of the purchaser;
2. the identity and quantity of the drugs received and distributed or disposed of; and
3. the dates of receipt and distribution or other disposition of the drugs. In the case of registered
wholesale drug distributors who are also licensed by the Board as pharmacies, no records shall be
required to be maintained for the receipt or disposition of over-the-counter drugs.
(b) Inventories and records shall be made available for inspection and photocopying by any authorized
official of any governmental entity charged with enforcement of 247 CMR 7.00 for a period of two years
following disposition of the drugs.
Records must be maintained for two years.
(c) Records described in 247 CMR 7.04(6) that are kept at the inspection site or that can be immediately
retrieved by computer or other electronic means shall be readily available for authorized inspection during
the two-year retention period. Records kept at a central location apart from the inspection site and not
electronically retrievable shall be made available for inspection within two working days of a request by an
authorized official of any governmental agency charged with enforcement of 247 CMR 7.00.
(7) Written Policies and Procedures. Wholesale drug distributors shall establish, maintain, and adhere to
written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and
distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting
losses or thefts, and for correcting all errors and inaccuracies in inventories. Wholesale drug distributors shall
include in their written policies and procedures the following:
(a) A procedure whereby the oldest approved stock of a prescription drug product is distributed first. The
procedure may permit deviation from this requirement if such deviation is temporary and appropriate.
(b) A procedure to be followed for handling recalls and withdrawals of prescription drugs. Such procedure

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State Pharmacy Law Review

shall be adequate to deal with recalls and withdrawals due to:
1. Any action initiated at the request of the United States Food and Drug Administration or other
federal, state, or local law enforcement or other government agency, including the Board;
2. any voluntary action by the manufacturer to remove defective or potentially defective drugs from the
market; or
3. any action undertaken to promote public health and safety by replacing of existing merchandise with
an improved product or new package design.
(c) A procedure to ensure that wholesale drug distributors prepare for, protect against, and handle any
crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural
disaster, or other situations of local, state, or national emergency.
(d) A procedure to ensure that any outdated prescription drugs shall be segregated from other drugs and
either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of
the disposition of outdated prescription drugs. This documentation shall be maintained for two years after
disposition of the outdated drugs.

Note this:
(e) In the case of wholesale drug distributors who are also licensed by the Board as pharma-cies, the
requirements of 247 CMR 7.05 shall apply to legend drugs only.
(8) Responsible Persons. Wholesale drug distributors shall establish and maintain lists of officers, directors,
managers, and other persons in charge of wholesale drug distribution, storage, and handling, including a
description of their duties and a summary of their qualifications.
(9) Compliance with Federal, State, and Local Laws.
(a) Wholesale drug distributors shall operate in compliance with applicable federal, state, and local laws
and regulations.
(b) Wholesale drug distributors shall permit the agents of the Board and authorized federal, state, and local
law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records
and written operating procedures, at reasonable times and in a reasonable manner, to the extent authorized
by law.
Note registration requirements for wholesalers.
(c) Wholesale drug distributors that deal in controlled substances as defined in M.G.L. c. 94C shall register
with the Board, the Massachusetts Department of Public Health and with the United States Drug Enforcement
Administration (DEA), and shall comply with all applicable state, local and federal regulations.
(d) Wholesale drug distributors shall be subject to the provisions of any applicable federal, state, and local
laws that relate to prescription drug product salvaging or reprocessing.
REGULATORY AUTHORITY247 CMR 7.00: M.G.L. c. 112, . 36A, 36B, 36C and 42A; c. 94C, 6.
247 CMR 8.00:
PHARMACY INTERNS AND TECHNICIANS
Section
8.01: Pharmacy Interns
8.02: Pharmacy Technicians
8.03: Pharmacy Technician Trainees
8.04: Certified Pharmacy Technicians
8.05: Requirements for the Handling of Schedule II Controlled Substances by Pharmacy Interns, Certified

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Pharmacy Technicians, Pharmacy Technicians, and Pharmacy Technician Trainees
8.06: Duties of Pharmacist Utilizing Pharmacy Interns, Certified Pharmacy Technicians, Pharmacy
Technicians, and Pharmacy Technician Trainees
8.07: Registration and Renewal Procedures; General Requirements
Note this section applies to all types of pharmacies.
For the purposes of 247 CMR 8.00 "pharmacy" shall include retail, institutional, restricted and nuclear
pharmacies and pharmacy departments.
8.01: Pharmacy Interns
(1) To be eligible for personal registration as a pharmacist a candidate shall have competed a pharmacy
internship. A pharmacy intern shall have:
(a) completed two years of education, or achieved standing as a student beyond the second year, in an
approved college/school of pharmacy in which the candidate is currently enrolled; and

(b) completed 1500 hours of Board-approved pharmacy internship experience, of which:

1. at least 1000 hours has been acquired in a pharmacy or pharmacy-related setting approved by the
Board; and
2. no more than 500 hours has been acquired in any one, or any combination of Board-approved
internships(s) in the following areas:
a. clinical pharmacy;
b. demonstration project;
c. manufacturing; or
d. analytical and/or industrial pharmacy.
(2) The pharmacy internship shall be performed under the direct supervision of a registered pharmacist preceptor.
Note:
(3) A pharmacy intern may receive credit for up to 12 hours of pharmacy internship credit per day.
(4) Pharmacy internship hours may be acquired throughout a calendar year.
(5)(a) Before the commencement of a pharmacy internship in Massachusetts, persons who are
enrolled, either full or part-time, in an approved college/school of pharmacy shall record, on a form provided
by the Board, certain information regarding the internship as the Board shall require. This form shall be
fully completed and returned to the Board before commencement of any internship. This information shall
include:
1. the applicant's name;
2. the applicant's address;
3. the applicant's date of birth;
4. have attached thereto a recent passport-size photo revealing the applicant's likeness; and
5. a certified statement by the approved college/school of pharmacy which indicates that the applicant
has completed two years of education or has achieved standing as a student beyond the second year.
(b) Graduates of Non-approved Colleges/Schools of Pharmacy. Before the commencement of a pharmacy
internship in Massachusetts, a graduate of a non-approved college/school of pharmacy must have authoriza-

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tion from NABP to sit for the FPGEE (issued within the preceding year) and must provide a copy of the NABP
FPGEE authorization to the Board and any other documentation required by the Board.
(6) During the course of the pharmacy internship, preceptors and pharmacy interns shall, in a timely manner
submit, on a form provided by the Board, such information as the Board may require regarding the internship.
(7) A pharmacy intern who has graduated from an approved college/school of pharmacy may continue to act
in the capacity of pharmacy intern until he or she becomes registered as a pharmacist.
Credit may be given for out of state internship experience.
(8) The Board may grant credit for out-of-state pharmacy internship experience where an affidavit or certificate
of approval issued by the jurisdiction wherein the experience was acquired, is presented to the Board indicating
that such internship experience has been duly approved in the jurisdiction.
(9) Massachusetts approved colleges/schools of pharmacy shall submit to the Board a written description of
each demonstration project or clinical pharmacy program for which pharmacy internship credit is desired. The
Board shall review this information and determine whether or not student participation in such project(s) or
program(s) may be credited to the internship requirement.
(10) The Board shall issue a Summary of Objectives and Procedures for Pharmacy Internship and guidelines
for registered pharmacist preceptors and pharmacy interns.
Note (11) (12) and (13)
(11) A pharmacy intern shall wear a name tag which indicates the intern's name and the words "pharmacy
intern."
(12) A pharmacy intern acting under the direct supervision of an approved registered pharmacy preceptor may
supervise pharmacy technicians.
(13) A registered pharmacist preceptor shall not directly supervise more than two pharmacy interns at one time.
(14) A pharmacy intern found to have engaged in conduct in violation of federal and/or state laws and/or
regulations may be prohibited from taking the examination for personal registration, in addition to other
sanctions imposed by the Board.
8.02 : Pharmacy Technicians
Note requirements for registration of pharmacy technicians.
(1) Requirements for Registration as a Pharmacy Technician.
(a) An applicant for registration as a pharmacy technician must meet the following requirements:
1. be at least 18 years of age;
2. be a high school graduate or the equivalent or currently enrolled in a program which awards such
degree or certificate;
3. be of good moral character;
4. not been convicted of a drug related felony or admitted to sufficient facts to warrant such findings;
5. Training/Experience Requirement. An applicant for registration as a pharmacy technician must meet
the following training program or experience requirements:

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a. have successfully completed a Board-approved pharmacy technician training program, which
training program shall include coverage of the topics of job descriptions, pharmacy security,
commonly used medical abbreviations, routes of administration, product selection, final check by
pharmacists, guidelines for the use of pharmacy technicians, and any other requirements of the
Board. Training programs which may be approved by the Board include:
i. a pharmacy technician training program accredited by the American Society of Health System
Pharmacists;
ii. a pharmacy technician training program provided by a branch of the United States Armed
Services or Public Health Service;
iii. a Board-approved pharmacy technician training program which includes a minimum of 240
hours of theoretical and practical instruction; provided a minimum of 120 training hours are in
theoretical instruction in a curriculum; or
iv. any other pharmacy technician training course approved by the Board; or
b. have successfully completed a minimum of 500 hours of employment as a pharmacy technician
trainee. Documentation of completion of the required 500 hours of experience shall be attested to
by the applicant under the pains and penalties of perjury and witnessed by the employer; and
6. Examination Requirement. An applicant for registration as a pharmacy technician must achieve a
Board-approved passing score on either:
a. a Board-approved pharmacy technician assessment examination administered by the employer
or the employers agent. The examination must cover the following knowledge based areas:
i. practice settings;
ii. duties and responsibilities of a pharmacy technician in relationship to other pharmacy
personnel;
iii. laws and regulations regarding the practice of pharmacy and patient confidentiality;
iv. medical abbreviations and symbols;
v. common dosage calculations; and
vi. identification of drugs, dosages, routes of administration, and storage requirements; or
b. a Board-approved national technician certification examination..
(2) Reciprocity Registration. A pharmacy technician currently registered and in good standing in another state
may be registered by the Board; provided the requirements for registration in the state of original and current
registration are equivalent to the requirements of the Board.
Note with specificity duties and responsibilities of Pharmacy technicians.
(3) Pharmacy Technician Duties and Responsibilities.
(a) A pharmacy technician shall wear a name tag which indicates the individuals name and the title
Pharmacy Technician.
(b) A pharmacy technician may relay to the patient or responsible person the pharmacists offer to
counsel, as referenced in M.G.L. c. 94C, 21A and 247 CMR 9.07(3).
(c) With the approval of the pharmacist on duty, a pharmacy technician may request and accept authorizations for refills from the presecriber or prescribers agent provided that no information has changed from the
previous prescription.
(d) A pharmacy technician may not administer controlled substances; perform drug utilization review;
conduct clinical conflict resolution; contact prescribers concerning drug order clarification or therapy
modification; provide patient counseling; perform dispensing process validation; receive new prescription

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drug orders; or conduct prescription transfers.
8.03: Pharmacy Technician Trainees
(1) A pharmacy technician trainee must meet the following requirements:
(a) be at least 16 years of age;
(b) be a high school graduate or the equivalent or currently enrolled in a program which awards such degree;
(c) be of good moral character; and
(d) not been convicted of a drug related felony or admitted to sufficient facts to warrant such findings.
(2) Pharmacy Technician Trainee Duties and Responsibilities.
Note these:
(a) A pharmacy technician trainee shall wear a name tag with the individuals name and the title Pharmacy
Technician Trainee.
(b) Except as set forth below, a pharmacy technician trainee may be authorized to perform the duties of a
pharmacy technician while receiving the training and supervision required by 247 CMR 8.02(1)(a)5. and
acting under the direct supervision of a pharmacist.
(c) A pharmacy technician trainee is not authorized to take prescriptions over the telephone.
PTTs under 16 not subject to 100 hr. limitation.
(3) Limitation on Period of Employment as a Pharmacy Technician Trainee. An individual may act and be
designated as a pharmacy technician trainee for not more than 1000 hours, unless an extension is granted by the
Board. Pharmacy technician trainees under the age of 18 are not subject to the 1000 hour limitation.
8.04: Certified Pharmacy Technicians
(1) Qualifications.
(a) A pharmacy technician currently:
1. registered by the Board; and
2. certified by a Board-approved certifying body may perform the duties as authorized to be performed
by a certified pharmacy technician in 247 CMR 8.04(2).
(b) At any time that certification lapses, the certified pharmacy technician:
1. is limited to performing the functions of a pharmacy technician;
2. must use the title pharmacy technician and be limited to performing the duties authorized to be
performed by pharmacy technicians, as set forth in 247 CMR 8.02; and
3. must be counted as a pharmacy technician in calculating supervisory ratios, as set forth in 247
CMR 8.06(3).
(2) Certified Pharmacy Technician Duties and Responsibilities.
Note these carefully.
(a) A pharmacy technician eligible to function as a certified pharmacy technician shall wear a name tag with
the individuals name and the title Certified Pharmacy Technician.
(b) A certified pharmacy technician may relay to the patient or responsible person the pharmacists offer
to counsel, as referenced in M.G.L. c. 94C, 21A and 247 CMR 9.07(3).
(c) A certified pharmacy technician, after identifying him/herself as such, may request refill authorizations

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from the prescriber or prescribers agent and, with the approval of the pharmacist on duty, receive new or
omitted prescription information from the prescriber or agent, except where otherwise prohibited by federal
or state law and regulations.
(d) A certified pharmacy technician may, with the approval of the pharmacist on duty, perform prescription
transfers between pharmacies or pharmacy departments for prescriptions issued for controlled substances in
Schedule VI only, any such transfer to be in accordance with the requirements of 247 CMR 9.02.
(e) A certified pharmacy technician may not administer controlled substances; perform drug utilization
review; conduct clinical conflict resolution; contact prescribers concerning prescription drug order clarification or therapy modification; provide patient counseling; or perform dispensing process validation.
8.05: Requirements for the Handling of Schedule II Controlled Substances by Pharmacy Interns, CertifiedPharmacy
Technicians, Pharmacy Technicians, and Pharmacy Technician Trainees
Pharmacist is directly responsible for accountability and security of Schedule II drugs.
(1) Accountability for and security of Schedule II controlled substances shall be the direct responsibilities of the
pharmacist.
Distinction made between transporting and handling.
(2) Under the supervision of a pharmacist:
(a) a pharmacy technician may assist in the transporting of Schedule II controlled substances; and
(b) a certified pharmacy technician may assist in the transporting and handling of Schedule II controlled
substances; provided, the pharmacist has approved the certified pharmacy technician or pharmacy technician to assist the pharmacist in the handling or transporting of Schedule II controlled substances, in
accordance with 247 CMR 8.05(2) and as evidenced by written policies and procedures to be followed in the
pharmacy in the transporting and handling Schedule II controlled substances, such policies and procedures
to be made available to the Board on request.
8.06: Duties of a Pharmacist Utilizing Pharmacy Interns, Certified Pharmacy Technicians, Pharmacy
Technicians and Pharmacy Technician Trainees
In addition to the requirements of 247 CMR 8.02 to 8.05, the following shall apply to a pharmacist utilizing
pharmacy interns, certified pharmacy technicians, pharmacy technicians and pharmacy technician trainees:
(1) A pharmacist Manager of Record of a pharmacy or pharmacy department or the Director of Pharmacy in
an institutional pharmacy which utilizes certified pharmacy technicians, pharmacy technicians, or pharmacy
technician trainees shall make the following available to the Board upon request:
The following must be done and available to the Board upon request
(a) a list of currently employed certified pharmacy technicians, pharmacy technicians, and pharmacy
technician trainees;
(b) a written description of the duties delegated to certified pharmacy technicians, pharmacy technicians,
and pharmacy technician trainees; and
(c) a written description of the scopes of responsibility for certified pharmacy technicians, pharmacy
technicians, and pharmacy technician trainees.
Written training guidelines required.

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(2) A pharmacist may train a pharmacy technician or pharmacy technician trainee through an on-the-job
training program, in accordance with the requirements of 247 CMR 8.02(1)(a)5.a. and b. All such training
programs shall comply with written guidelines formulated by the pharmacy or pharmacy department in a manner
consistent with professional, ethical, and legal standards of proper pharmacy practice. Copies of training
program guidelines shall be provided to the Board on request.
Note these requirements:
(3) Supervisory Ratios.
(a) A pharmacist utilizing pharmacy interns, certified pharmacy technicians, pharmacy technicians, and
pharmacy technician trainees to assist in filling prescriptions may utilize such support personnel in accordance with the following ratio requirements:
1. 1:4 One pharmacist for a maximum of four support personnel; provided:
a. at least one of the four support personnel is a certified pharmacy technician and one is a
pharmacy intern; or
b. at least two of the support personnel are certified pharmacy technicians.
2. 1:3 One pharmacist for a maximum of three support personnel; provided at least one of the three
support personnel is a pharmacy intern or a certified pharmacy technician.
(b) Sales clerks, messengers, delivery personnel, secretaries and any other persons who do not fall within
the definitions of a pharmacy intern, certified pharmacy technician, pharmacy technician or pharmacy
technician trainee shall not be included for purposes of determining the ratios set forth in 247 CMR 8.06(3)
as long as such persons are not supporting the pharmacist in any professional capacity.
8.07: Registration and Renewal Procedures; General Requirements
(1) Application for Registration. Upon meeting the requirements for registration as a pharmacy technician, an
applicant may apply for registration on forms provided by the Board.
(2) Renewal of Registration.
(a) Pharmacy technician registrations expire every two years on the birthdate of the registrant.
(b) A pharmacy technician registration must be timely renewed to continue practice as a pharmacy
technician. Any practice as a pharmacy technician after the expiration date of a pharmacy technician
registration shall constitute unlicensed practice as a pharmacy technician subjecting the individual to any
and all penalties established for unlicensed practice.
(c) A pharmacy technician whose registration has lapsed may renew such registration upon filing of a
renewal application and payment of an annual license, applicable back fees, and a late fee, as established
by the Commissioner of Administration and Finance, pursuant to M.G.L. c. 7, 3B.
(d) A pharmacy technician whose registration has lapsed for more than two years may be required to meet
other conditions as determined by the Board as a prerequisite to registration renewal.
(3) General Requirements.
(a) A pharmacy technician who changes his or her mailing address or name shall notify the Board of such
change(s) in writing within ten working days of such changes(s) (M.G.L. c. 112, 24F). In the case of a
change of name, the pharmacy technician shall submit a sworn statement indicating that the pharmacy
technician has changed his or her name with a photocopy of a valid picture identification card.
(b) A pharmacy technician shall carry, or have readily available, at all times where the pharmacy technician
is employed, evidence of current registration with the Board.

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REGULATORY AUTHORITY247 CMR 8.00: M.G.L. c. 112, 30 and 42A.
247 CMR 9.00:

CODE OF PROFESSIONAL CONDUCT; PROFESSIONAL STANDARDS FOR REGISTERED

PHARMACISTS, PHARMACIES AND PHARMACY DEPARTMENTS

Section
9.01: Code of Professional Conduct for Registered Pharmacists, Pharmacies and Pharmacy Departments
9.02: Transfer of Prescriptions
9.03: Advertising
9.04: Requirements for Dispensing and Refilling Prescriptions
9.05: Maintenance of Prescription Files
9.06: Procedures for Verifying a Practitioner's Prescriptive Authority
9.07: Maintaining Patient Records, Conducting a Prospective Drug Utilization Review and Patient
Counseling
For the purposes of 247 CMR 9.00 "pharmacy" shall include retail, restricted and nuclear pharmacies, and
pharmacy departments.
9.01: Code of Professional Conduct for Registered Pharmacists, Pharmacies and Pharmacy Departments
Be very familiar with these:
(1) A registered pharmacist shall at all times conduct professional activities in conformity with federal, state and
municipal laws, ordinances and/or regulations, including the regulations of the Board.
(2) A pharmacist shall not dispense drugs, devices, or other substances in a manner which is intended, either
directly or indirectly, to circumvent the law.
(3) A pharmacist shall observe the standards of the current United States Pharmacopoeia.
(4) Unless otherwise permitted by law, a pharmacist shall not redispense any medication which has been
previously dispensed.
(5) While on duty, a pharmacist shall be responsible for the proper preservation and security of all drugs in the
pharmacy or pharmacy department, including the proper refrigeration and storage of said drugs.
(6) A pharmacist shall not engage in any fraudulent or deceptive act.
(7) A pharmacist shall not enter into an agreement or arrangement with any person for the purpose of dispensing
drugs which have been ordered by coded prescriptions.
(8) A pharmacist, pharmacy or pharmacy department shall not promise to any person who owns, operates,
manages or is an employee of a hospital, nursing home or other health care facility, or to any authorized
practitioner, any rebate, refund, discount, commission or other valuable consideration for, or on account of, or
based upon income received or resulting from, the sale, or furnishing of any such pharmacist, pharmacy, or
pharmacy department, of drugs devices or services to patients of such persons, organizations or facilities.
(9) A pharmacist shall not in any way aid or abet the unlawful practice of pharmacy.

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(10) A pharmacist shall not dispense or distribute expired, outdated or otherwise substandard drugs or devices
or counterfeit drugs or devices to any person or entity who is not licensed or legally authorized to receive such
drugs or devices.
Dispensing by mail is allowed.
(11) A pharmacist may dispense prescription drugs by mail or common carrier in a manner consistent with
federal and state laws and regulations, including the regulations of the Board. All pharmacists shall have
available sufficient information to contact the patient and the prescribing practitioner.
(12) Unless otherwise permitted by law, a pharmacist connected with, or employed by, a hospital or clinic shall
not dispense drugs to any person other than inpatients or outpatients, or to employees of said hospital or clinic,
or to said employees' spouses and children who live in the same household with said employees.
(13) A pharmacist, pharmacy, pharmacy department, pharmaceutical organization or pharmacy corporation
shall not provide any practitioner with prescription blanks which refer to any pharmacist, pharmacy or pharmacy
department.
Perpetual inventory of Schedule II drugs is required and to be reconciled every 10 days.
(14) A pharmacist shall keep a perpetual inventory of each controlled substance in Schedules II which the
pharmacist has received, dispensed or disposed of in accordance with the law. This inventory must be reconciled
at least once every ten days.
(15) Unless otherwise provided for by law, a pharmacist shall not limit his or her services to a particular
segment or segments of the general public.
(16) A pharmacist shall not refuse to compound customary pharmaceutical preparations except upon extenuating circumstances.
(17) A pharmacist shall not purchase drug samples for the purpose of compounding, dispens-ing, or in any way
reselling these samples.
(18) A pharmacist shall comply with the mandatory counseling provisions contained in M.G.L. c. 94C, 21A.
(19) A pharmacist shall maintain patient confidentiality at all times. Confidential information shall include
information maintained by the pharmacist in the patients records or information which is communicated to the
patient as part of patient counseling, which is privileged and may be released only to the patient or to those
practitioners and other pharmacists where, in the pharmacists professional judgment, such release is necessary
to protect the patients health and well being; and to such other persons or governmental agencies authorized by
law to receive such confidential information.
9.02: Transfer of Prescriptions
FYI Note that the Board has established Policy 2010-01: Authorizing Transfer of an Original Schedule VI Prescription Not
Dispensed Within One Year of Issue Date.this policy is reproduced later in this section.
(1) A prescription may be transferred between pharmacies or pharmacy departments, at the patients request,

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for the purpose of dispensing authorized refills on the prescription provided that:
(a) refills remain on the prescription; and
(b) the prescription authorizing the refill has not expired.
Note procedure for transfer of prescriptions in Schedules II-V for the pharmacist transferring the prescription and the
pharmacist receiving the transfer.
(2) The procedure for transferring a prescription between pharmacies or pharmacy departments for prescriptions issued for controlled substances in Schedules III, IV and V shall be as follows:
(a) The transferring pharmacist must record the following information:
1. Write the word VOID on the face of the invalidated prescription;
2. record on the reverse of the invalidated prescription the name, address and DEA registration number
of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription
information; and
3. record, on a written transfer log or by entry into a computerized system, the prescription number, date
of the transfer, the name or identification of the pharmacist transferring the information and the name of
the pharmacy or pharmacy department to which the prescription is transferred.
(b) The transferring pharmacist shall cancel all refills remaining on the transferred prescription.
(c) The pharmacist receiving the transferred prescription information shall complete the following:
1. Write the word transfer on the face of the transferred prescription; and
2. write all information required by state and federal law to be on the prescription and include:
a. the date of issuance of the original prescription;
b. the original number of refills authorized on the original prescription;
c. the date of original dispensing;
d. the number of valid refills remaining and date of last refill; and
e. the pharmacists name, address, DEA number and original prescription number from which the
prescription information was transferred; and the name of the transferor pharmacist.
(d) The pharmacist receiving the transferred information shall inform the patient that the original
prescriptions refills have been canceled at the pharmacy or pharmacy department from which it has been
transferred.
Note the differences in procedure between Schedule II-IV and Schedule VI. Certified Pharmacy Technicians may transfer only
Schedule VI prescriptions.
(3) The procedure for transferring a prescription between pharmacies or pharmacy departments for prescriptions issued for controlled substances in Schedule VI shall be as follows:
(a) The transferring pharmacist or certified pharmacy technician must record, on a written transfer log or
by entry into a computerized system the following: the prescription number; date of the transfer; the name or
identification of the pharmacist transferring the information; and the name of the pharmacy or pharmacy
department to which the prescription is being transferred.
(b) The transferring pharmacist or certified pharmacy technician shall cancel all refills remaining on the
transferred prescription.
(c) The pharmacist or certified pharmacy technician receiving the transferred prescription information shall:
1. write the word transfer on the face of the transferred prescription;
2. write all information required by state and federal law to be on the prescription including:
a. the date of issuance of the original prescription;
b. the original number of refills authorized on the original prescription;
c. the date of original dispensing;

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d. the number of valid refills remaining and date of last refill; and
e. the pharmacys name, address, DEA number and original prescription number from which the
prescription information was transferred; and the name of the transferor pharmacist.
(d) The pharmacist or certified pharmacy technician receiving the transferred prescription shall inform the
patient that the original prescriptions refills have been canceled at the pharmacy or pharmacy department
from which it has been transferred.
Note this:
(4) Prescriptions authorizing refills for Schedule III through V controlled substances may be transferred
between pharmacies or pharmacy departments on a one-time only basis except as otherwise permitted by law.
(5)
Prescriptions authorizing refills for Schedule VI controlled substances may be transferred between
pharmacies or pharmacy departments within one year of the date of issuance.
(6) Both the original and transferred prescriptions must be maintained for a period of two years from the date
of last refill.

9.03: Advertising
(1) A pharmacist shall not utilize false, deceptive or misleading advertising.
Pharmacists may advertise prescription drug prices to consumers as long as specific information is included in the with specific
requirements.
(2) Whenever a pharmacist advertises the consumer price for a particular prescription drug, said advertisement
shall not contain any representation, either expressed or implied, concerning that drug's safety, effectiveness, or
indications for use.
(3) Any pharmacist who advertises a prescription drug in a manner which provides price information to
consumers shall include the following information regarding each advertised prescription drug:
(a) The proprietary name, if any;
(b) the established or generic name, if any;
(c) the quantity of active ingredient per dosage unit of the prescription drug product when-ever the
prescription contains a single active ingredient;
(d) the strength of the prescription whenever said product contains more than one active ingredient by a
relevant strength that can be associated with the product without indicating each active ingredient; the
established name and quantity of each active ingredient shall not be required whenever said product contains
more than one active ingredient;
(e) the dosage form; and
(f) the price charged for filling a prescription.
(4) A pharmacist who advertises prescription drugs in a manner which provides price informa-tion to consumers
may identify professional or convenience services provided by the pharmacy or pharmacy department, or may
include other written, printed or graphic matter, provided that no information included in such advertising shall
be false, deceptive or misleading.
(5) Whenever a pharmacist advertises prescription drugs in a manner that provides price information to
consumers, any stated price with respect to a particular prescription drug shall include all charges to the

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consumer. These charges shall include, but not be limited to, any professional or handling fees and any mailing
and delivery fees. This advertising may indicate each separate fee which is to be added to the price of the
prescription drug.
Several scenarios are deemed to be advertising under these regulations.
(6) The requirements of 247 CMR 9.03 apply to all prescription drug advertisements, including price lists,
catalogs, and other promotional material, whether mailed, posted in a pharmacy, placed in a newspaper, or aired
on radio or television, which serve to provide consumers with information regarding the price charged for
prescriptions.
9.04: Requirements for Dispensing and Refilling Prescriptions
(1) Whenever a prescription drug has been distributed solely under a generic name, the dispens-ing pharmacist
shall record on the prescription the name of the manufacturer or, if the manufacturer's name is not available, the
name of the distributor, packer, or repacker.

(2) The information on the label which the pharmacist, pharmacy intern, pharmacy technician or pharmacy
technician trainee affixes to a prescription drug container shall be clearly printed or typed.
Note who may receive new prescription over the phone:
(3) Only a pharmacist, pharmacy intern, and certified pharmacy technician who has the approval of the
pharmacist on duty may receive new prescriptions over the telephone from a prescriber or authorized agent.
(4) A pharmacist who refills a prescription for a controlled substance in Schedules III through VI shall record
on the prescription:
(a) the date of dispensing;
(b) the amount of the drug dispensed; and
(c) his or her initials.
(5) A dispensing pharmacist who does not indicate the quantity of a drug dispensed on the back of a prescription
which the pharmacist has refilled shall be deemed to have dispensed a refill for the full face amount of the
prescription.
(6) Subject to the provisions of federal regulations at 21 CFR 1306, an automated data- processing system may
be used as an alternative to the provisions of 247 CMR 9.04 (4) and (5). This data-processing system may be
used for the storage and retrieval of information pertaining to the refilling of prescriptions for controlled
substances in Schedules III through VI.
(7) A pharmacist or anyone acting on behalf of a pharmacy or pharmacy department shall not collect
prescriptions at industrial plants, places of business, or other sites where specific groups of people are regularly
employed or affiliated, unless the prescriptions meet the following requirements:
(a) the prescriptions are for persons regularly employed at, or affiliated with, such plant, place of business
or other such site;
(b) the prescriptions are collected in person by a pharmacist, pharmacy employee, or authorized agent of
the pharmacy;
(c) the prescriptions are distributed in person to the patients or an authorized agent of the patient by a

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pharmacist, pharmacy employee, or authorized agent of the pharmacy; and
(d) the pharmacist shall be responsible for the conduct of any pharmacy employee or authorized agent acting
on the pharmacist's behalf, and for verifying the authority of any person purporting to act on a patient's
behalf; nothing in 247 CMR 9.04(7) shall be deemed to permit conduct of a prescription business in violation
of any other regulation of the Board.
9.05: Maintenance of Prescription Files
A pharmacist shall maintain prescription files as follows:
Note filing requirements for Schedule II-V prescriptions
(1) Prescriptions for controlled substances in Schedule II shall be segregated from all other records and shall
be maintained in a separate file identified as such.
(2) Prescriptions for controlled substances in Schedules III, IV, and V shall be maintained in a separate file
identified as such.
(3) Prescriptions for controlled substances in Schedule VI, prescriptions for non-controlled substances, and
prescriptions for syringes and instruments adaptable to hypodermic administration, shall be segregated from all
other records and shall be maintained together in a separate file identified as such.
9.06: Procedures for Verifying a Practitioner's Prescriptive Authority
A prescription written by a practitioner may be filled only if the pharmacist called upon to fill such
prescription, in the exercise of that pharmacist's professional judgment, determines that:
(1) The prescription is issued pursuant to a valid patient/practitioner relationship and for a legitimate medical
purpose by an authorized practitioner acting in the course of his or her professional practice;
(2) the prescription is authentic; and
This provision refers to concept of the corresponding responsibility of the pharmacist for the proper prescribing and dispensing
of a controlled substancewhich in Massachusetts includes all prescription drugs.
(3) the dispensing is in accordance with M.G.L. c. 94C, 19(a).
9.07: Maintaining Patient Records, Conducting a Prospective Drug Utilization Review and Patient
Counseling
The purpose of 247 CMR 9.07 is to enhance the public health and welfare by requiring that pharmacists offer
consultation to patients regarding their prescriptions in order to promote optimum therapeutic outcomes, avoid
patient injury and reduce medication errors.
Note the requirements of patient records.
(1) Patient Records.
(a) A pharmacist or pharmacists designee shall maintain a confidential record for all patients for whom
prescriptions are dispensed. The patient record system shall provide for the immediate retrieval of information necessary for the pharmacist to identify previously dispensed drugs at the time the prescription is

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presented for dispensing. The pharmacist or pharmacists designee shall make a reasonable effort to obtain,
record and maintain the following information:
1. name, address, telephone number, date of birth or age, and gender of the patient for whom the
prescription is intended;
2. individual history, including known drug allergies and drug reactions;
3. a comprehensive list of medications and relevant devices dispensed by the pharmacy; and
4. the pharmacists comments relevant to the patients drug therapy.
(b) A pharmacist shall maintain the patients record for a period of not less than 12 months from the date
of the last entry in the profile record, except as otherwise required by state and federal law. This record may
be computerized.

(2) Prospective Drug Utilization Review.

Must be done for each new prescription.
(a) A pharmacist shall conduct a prospective drug utilization review (DUR) before each new prescription
is dispensed or delivered to a patient or a person acting on behalf of the patient. This DUR may include a
review of the patient record and each new prescription presented for dispensing, for the purpose of promoting
therapeutic appropriateness, by making a reasonable effort to identify the following:
Note what constitutes prospective DUR.
1. over-utilization or under-utilization
2. therapeutic duplication;
3. drug-disease contraindication;
4. drug-drug interaction;
5. incorrect drug dosage or duration of drug treatment;
6. drug-allergy interactions;
7. clinical abuse or misuse; and
8. any significant change in drug, dose or directions.
(b) Upon identifying any of the above, the pharmacist shall take appropriate measures to ensure the proper
care of the patient which may include consultation with the prescribing practitioner and/or direct consultation with the patient.
(c) The review shall be based upon current standards which may include the following:
1. The American Hospital Formulary Service Drug Information;
2. the United States Pharmacopoeia Drug Information;
3. the American Medication Association Drug Evaluations; and
4. other peer-reviewed medical literature.
(3) Patient Counseling
Be aware of who is authorized to offer the pharmacists counseling..
(a) The pharmacist or pharmacists designee shall offer the services of the pharmacist to discuss, with all
persons presenting new prescriptions, issues that in the pharmacists professional judgment are deemed to

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be significant for the health and safety of the patient.
(b) The pharmacists designee shall be an individual appropriately trained to make the offer to counsel and
under the direct supervision of the pharmacist.
Note requirement for sign.
(c) A sign of not less than 11 inches in height by 14 inches in width shall be posted in a conspicuous place,
adjacent to the area where prescriptions are dispensed, informing customers of their rights, pursuant to 247
CMR 9.00 and to M.G.L. c. 94C, 21A, to counseling by a pharmacist where their prescription was filled.
Said sign shall read, in letters not less than in height: Dear patients, you have the right to know about
the proper use of your medication and its effects. If you need more information please ask the pharmacist.
Note what counseling may include.
(d) When the offer to counsel is accepted, the pharmacist shall provide such information which, in the
pharmacists professional judgment, is necessary for the patient to understand the proper use of the patients
prescription which may include the following:
1. Name and description of the medication;
2. dosage form, dosage, route of administration and duration of therapy;
3. special directions and instructions for preparation, administration and use by the patient;
4. common severe side and adverse effects or interactions and therapeutic contraindications or
precautions with legend and non-legend medications which the pharmacist deems relevant;
5. techniques for self-monitoring drug therapy;
6. proper storage;
7. prescription refill information; and
8. action to be taken in the event of a missed dose or adverse reaction.
Note language required if offer to counsel is made in writing.
(e) The offer to counsel shall be made to the patient, or the person acting on behalf of the patient when confidentiality can be
maintained, either by face to face communication or telephone. If the patient does not pick up the prescription at a pharmacy
or the offer is not made by telephone then the offer must be made in writing. This offer must provide a toll-free telephone service
to facilitate communication between such person and the pharmacist and must state the following: Dear patient, you have the
right to know about the proper use of your medication and its effects. If you need more information please ask the pharmacist.
Printed material containing information on the drug may accompany this written offer to counsel provided the patient is
informed that said information is not comprehensive and that the patient should call for further information if needed.
(f) Counseling must be made by a pharmacist, or a pharmacy intern under the direct supervision of the
pharmacist if deemed appropriate by the pharmacist.
(g) Counseling must be available at all times when a pharmacy is open for business.
Counseling requirements apply to patients being discharged from hospital
(h) The provisions of 247 CMR 9.07 shall apply to pharmacists who directly dispense medications to
outpatients and patients being discharged from hospitals, institutions and clinics.
i) The provisions of 247 CMR 9.00 shall not apply to any drug dispensed to an inpatient at a hospital,
nursing home or any other setting where medication is administered by an authorized individual, except to
the extent required by the Federal Health Care Financing Administration pursuant to the provisions of 42
USC 139r-8.
REGULATORY AUTHORITY247 CMR 9.00: M.G.L. c. 112, 30 and 42A.

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247 CMR 10.00:
Section
10.01:
10.02:
10.03:
10.04:
10.05:
10.06:
10.07:

DISCIPLINARY PROCEEDINGS

Purpose
Definitions
Grounds for Discipline
Investigative Conference
Disposition by the Board
Disciplinary Action
Suspension Prior to Hearing

10.01: Purpose
The purpose of 247 CMR 10.00 is to outline the procedures used by the Board in order to handle complaints
received against Board registrants or licensees. The Board may take disciplinary action against a registered
pharmacist, pharmacy technician, pharmacy, pharmacy department, wholesale license, and/or controlled substance registration issued by the Board.

10.02: Definitions
Adjudicatory Hearing means a formal administrative hearing held by the Board conducted to determine the truth
and validity of complaints filed against a registrant or licensee. Such hearing is held pursuant to M.G.L. c. 30A
and 801 CMR 1.01.
Complaint means a communication filed with the Board or the Division of Health Professions Licensure which
the Board determines, after investigation, merits further consideration or action.
Conviction shall include any guilty verdict or finding of guilt and any admission to or finding of sufficient facts
to warrant a finding of guilt, regardless of adjudication, a continuance without a finding, and any pleas of guilty
or nolo contendere, of or to a crime in any jurisdiction, which has been accepted by the court, whether or not a
sentence has been imposed. A conviction of any person licensed or registered by the Board shall be conclusive
evidence of the commission of that crime in any disciplinary proceeding against such person based upon the
conviction.
Investigative Conference means an informal discussion relating to a complaint held with the Board.
Order to Show Cause means a document served by the Board upon a registrant ordering the registrant or licensee
to appear before the Board for a formal adjudicatory hearing.
10.03:

Grounds for Discipline

MGL c. 112 s. 61 is the statutory authority that boards have to discipline their registrants.
(1) The Board may impose disciplinary action against an individual or entity licensed or registered by the Board, on
one or more of the grounds for discipline listed in M.G.L. c. 112, s. 61 or one or more of the following grounds:
Note the grounds on which the Board may take disciplinary action.
(a) Violating any of the duties and standards set out in Board regulations (247 CMR 2.00
et seq.) or any rule or written policy adopted by the Board;
*Failing to report or failing to accurately report to the Board in writing within 30 days, any disciplinary action (247 CMR 10.06) taken against a registrant or licensee by an entity or its agent, including but not limited to, a

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governmental authority, a health care facility, an employer, or a professional pharmacy related society
(international, national, state or local), on the basis of actions listed in 247 CMR 10.03 (1).
* Failing to report to Board, in writing, within 30 days, any final action (including license surrender or resignation) regarding a registrant or licensee, including any against any other health care related professional registration or license held by a registrant or licensee, by any other governmental authority in this state or another
jurisdiction.
(b) Violating any provision of M.G.L. c. 112, ss. 24 through 42A or any provision of
state or federal statutes or rules or regulations promulgated thereunder related to the practice of the profession;
(c) Failing to submit an acceptable plan of correction pursuant to 247 CMR 6.13;
(d) Failing to remedy or correct a violation cited in a deficiency statement by the date specified in the plan of correction submitted in accordance with 247 CMR 6.13, as accepted or modified by the Board, unless the pharmacy or
pharmacy department demonstrates to the satisfaction of the Board that such failure was not due to any neglect of
duty and occurred despite his/her good faith attempt to remedy or correct the violations(s) by the specified time;
(e) Engaging in misconduct in the practice of the profession;
(f) Engaging in conduct beyond the authorized scope of a pharmacist, pharmacy intern or pharmacy technician;
(g) Practicing the profession while the ability to practice is impaired by illness, use of alcohol, drugs, chemicals, or
any other type of substance, or as a result of any mental or physical condition;
(h) Engaging in abuse or illegal use of prescription drugs or controlled substances;
(i) Continuing to practice the profession after a registration is lapsed, suspended or revoked;
(j) Violating the terms of a Consent Agreement, Final Decision and Order, Surrender Agreement or any other order
issued by or agreement entered into with the Board;
(k) Engaging in conduct that has the capacity or potential to place the public health, safety or welfare at risk;
(l) Engaging in conduct that has the capacity or potential to deceive or defraud;
(m) Knowingly permitting, aiding or abetting an unlicensed person to perform activities requiring a license or registration;
(n) Being convicted of any crime, entering a plea of guilty to any crime, entering a plea of nolo contendere to any
crime, or admitting to sufficient facts to warrant a finding of guilty of any crime;
(o) Fraudulently procuring a license or registration or its renewal;
(p) Providing false information on an application for a license or registration or its renewal;
(q) Failing without cause, to cooperate with any request by the Board to appear before it or to provide requested information; failing to respond to a Board subpoena or failing to furnish the Board, its investigators or representatives
with records, documents, information or testimony to which the Board is legally entitled;
(r) Engaging in conduct that demonstrates a lack of good moral character;
(s) Cheating on or attempting to compromise the integrity of any licensing or registration examination;
(t) Having been disciplined in another jurisdiction in any way for reasons substantially the same as those set forth in
this section;
(u) Engaging in conduct which undermines public confidence in the integrity of the profession;
(v) Committing an act that violates recognized standards of pharmacy practice;
(w) Failing to comply with recognized ethical standards of the profession, including, but not limited to, the standards
of practice of pharmacists, pharmacy interns, pharmacies and pharmacy departments set forth in 247 CMR 9.01
Code of Conduct for Registered Pharmacists, Pharmacies and Pharmacy Departments; and
(x) Violation of M.G.L. c. 94C or any rules or regulations promulgated thereunder.
(y) Failing to report or failing to accurately report to the Board in writing, within 30 days, any disciplinary action
taken against a registrant or licensee by an entity or its agent, including but not limited to, a governmental authority,
a health care facility, an employer, or a professional pharmacy related society, on the basis of actions
(z) Failing to report to the Board, in writing, within 30 days, any final action regarding a registrant or licensee, including any against any other health care professional registrant or licensee held by a registrant or licensee, by any
other governmental authority in this state or another jurisdiction
(aa) Failing to report to the Board, in writing, within 30 days, any pending criminal charge or conviction, as defined
in 247 CMR 10.02, of a registrant or licensee, in Massachusetts or any other jurisdiction
(bb) Failure to comply with reporting requirements described in 247 CMR 6.15(2)-(7) or to cooperate fully in the

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Boards investigation of any such report.
(2) Nothing herein shall limit the Board's adoption of policies and grounds for discipline through adjudication as well as
through rulemaking.

10.04: Investigative Conference

To facilitate disposition of any complaint, the Board may schedule an investigative conference at any time
prior to the commencement of a formal adjudicatory proceeding. The Board shall give timely notice of the
conference, and this notice shall include a general statement of the nature of the issues to be discussed.
10.05: Disposition by the Board
After receipt of a complaint and all related investigative materials, the Board may schedule an investigative
conference or may schedule a formal adjudicatory hearing pursuant to M.G.L. c. 30A and 801 CMR 1.01 if it
determines that one is required.
10.06: Disciplinary Action
Actions which may be taken by the Board :
Note the forms of disciplinary actions the Board my take.
(1) Dismissal of the complaint.
(2) Advisory Letter. An official written document retained in the Boards files delineating the Boards concerns
with the registrant's or licensees professional practice. An advisory letter does not constitute formal disciplinary
action.
(3) Reprimand or Censure of the Registrant or Licensee. A reprimand constitutes formal disciplinary action.
A censure is a severe reprimand.
(4) Probation. Probation constitutes disciplinary action against the registrant or licensee and consists of a
period of time during which the registrant or licensee may practice under conditions imposed by the Board
pursuant to a formal adjudicatory hearing or consent agreement.
(5) Suspension/Revocation of Personal Registration, Pharmacy Permit, License or Controlled Substances
Registration. Suspension or revocation of a personal registration, pharmacy permit, license or controlled
substance registration may be imposed pursuant to a decision and order of the Board following a formal
adjudicatory hearing or following the execution of a consent agreement.
(6) Consent Agreement. A resolution of a complaint agreed upon by the Board and the registrant or licensee
which may contain conditions placed by the Board on the registrant's or licensees professional conduct and
practice and which may include the voluntary suspension or surrender of a personal registration, pharmacy
permit, license or controlled substance registration. The voluntary surrender of a personal registration,
pharmacy permit, license, or controlled substance registration, may be permanent or for a fixed period of time.
The voluntary surrender agreement shall:
(a) be in writing and be signed by the registrant or the licensee and the Board;
(b) recite the facts upon which the agreement is based and shall include, but not be limited to provisions
addressing reinstatement and any conditions the Board may elect to impose;
(c) state that the registrant or licensee realizes that the voluntary surrender of his or her personal
registration, pharmacy permit, license or controlled substance registration, is an act which deprives him or

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her of all privileges of registration and is not subject to judicial review; and
(d) be placed in the registrant's or licensees Board file as part of the registrant's or licensees permanent
Board records.
(7) Disciplinary Action Against a Massachusetts Registrant or Licensee Taken in Another State. Disciplinary
action taken against a Massachusetts registrant or licensee by another state or jurisdiction in which that
person is also registered or licensed may be the basis for initiation by the Board of disciplinary action
against the Massachusetts registrant or licensee provided that the conduct disciplined in another state or
jurisdiction constitutes a violation of Massachusetts law.
(8) Summary Cease and Desist Notice A summary cease and desist notice may be imposed by the Board or Board
President prior to hearing in order to stop or restrict operations by a registrant or licensee to immediately
protect the public health, safety or welfare.
(9) Summary Quarantine Notice A summary quarantine notice may be imposed by the Board or Board President
prior to hearing in order to prevent the use of medications prepared by or in possession of a registrant or
licensee to immediately protect the public health, safety or welfare.
10.07: Suspension Prior to Hearing
If, based upon affidavits or other documentary evidence, the Board determines that a licensee is an immediate or
serious threat to the public health, safety, or welfare, the Board may suspend or refuse to renew a license pending a
final hearing on the merits of the allegations regarding the licensee. A hearing limited to the determination of the
necessity of the summary action shall be afforded the licensee within seven days of the Boards action.
10.08: Summary Cease and Desist and Quarantine
(1) If, based upon affidavits or other evidence, the Board or Board President determines that a registrant or
licensee or the products prepared by a registrant or licensee are an immediate or serious threat to the public health, safety, or
welfare, the Board or Board President may:
(a ) Issue a Cease and Desist Notice and/or Quarantine Notice, requiring cessation or restriction of any and all
pharmacy operations, and prohibiting the use of medications prepared by or in possession of a pharmacy.
(b) issue a Cease and Desist Notice placing non-disciplinary restrictions on a Board registrant or licensee, to the
extent necessary to avert a continued threat, pending final investigation results.
(2) Requirements of the Cease and Desist Order and/or Quarantine Notice shall remain in effect until the Board
rescinds such requirements or until such time as the Board takes final action on any related pending complaint and the Board
issues a final decision.
(3) A hearing limited to the determination of the necessity of Notices issued pursuant to 247 CMR 10.08 (1) shall
be afforded the registrant or licensee within 21 days of the Board or Board Presidents action.
REGULATORY AUTHORITY 247 CMR 10.00: 801 CMR 1.01; M.G.L. c. 112, 24 and 42A; c. 30A.

247 CMR 11.00:

Section
11.01:
11:02:
11.03:
11.04:
11.05:
11.06:

REGISTRATION UNDER THE CONTROLLED SUBSTANCES ACT (M.G.L. c. 94C)

Controlled Substance Registration

Requirement of a Controlled Substance Registration
Standard for Issuance of a Controlled Substance Registration
Requirement of a Pharmacy Permit or Wholesale Druggist License
Application for a Controlled Substance Registration
Separate Registration Required

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11.07:
11.08:
11.09:
11.10:
11:11:
11.12:
11.13:
11.14:
11.15:

Expiration of a Controlled Substance Registration

Renewal of a Controlled Substance Registration
Changes in the Name, Address and/or Status of Registrant
Transfer or Assignment of a Controlled Substance Registration Prohibited
Wholesale Druggist Activities Limited
Inspection of Registered Premises
Records and Inventories
Revocation and Suspension of a Controlled Substance Registration; Grounds; Effect
Summary Suspension of a Controlled Substance Registration

11.01: Controlled Substance Registration

For the purposes of 247 CMR 11.00, the term "registrant" shall mean the individual to whom a controlled
substance registration is issued by the Board.
For the purposes of 247 CMR 11.00, the term pharmacy shall mean a retail, restricted, and nuclear
pharmacy and a pharmacy department.
11.02: Requirement of a Controlled Substance Registration
(1) In accordance with the Massachusetts Controlled Substances Act, M.G.L. c. 94C, the Board may issue a
controlled substance registration to a qualified owner or operator of pharmacy or of a wholesale drug business
who intends to engage in any activity for which a controlled substance registration is required by law.
(2) No pharmacy or wholesale drug business shall engage in any activity for which registration is required until
a controlled substance registration has been issued by the Board.
11.03: Standard for Issuance of a Controlled Substance Registration
The Board shall issue a controlled substance registration to an applicant unless it determines that the
issuance of that registration would be inconsistent with the public interest. In determining the public interest, the
Board shall consider, but shall not be limited to considering, the following factors:
(1) The maintenance of effective controls against diversion of controlled substances;
(2) compliance with applicable federal, state and local laws and regulations;
(3) any conviction of the applicant under any federal and/or state law relating to any controlled substance;
(4) past experience in the manufacture or distribution of controlled substances;
(5) furnishing by the applicant of false or fraudulent material in any application filed under the provisions of
M.G.L. c. 94C or other applicable state or federal law or regulation;
(6) suspension or revocation of the applicant's federal registration to manufacture, distribute or dispense
controlled substances as authorized by federal law; and
(7) any other factors relevant to, and consistent with, the public health and safety.
11.04: Requirement of a Pharmacy Permit or Wholesale Druggist License

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All applicants for a controlled substance registration shall be determined by the Board to be qualified to
receive a Board pharmacy permit or a Board wholesale druggist license before being issued a controlled
substance registration.

11.05: Application for a Controlled Substance Registration

Application for a controlled substance registration shall be made on a form provided by the Board. All
applications submitted to the Board shall:
(1) be fully and properly completed, and
(2) be accompanied by a check or money order payable to the "Commonwealth of Massa-chusetts Board of
Registration in Pharmacy" in the appropriate amount, which shall be non-refundable.
11.06: Separate Registration Required
A separate controlled substance registration shall be required at each principal place of business where the
registrant manufactures, distributes or dispenses controlled substances.
11.07: Expiration of a Controlled Substance Registration
A controlled substance registration issued by the Board shall be valid as follows:
Note when registrations expire.
(1) Pharmacy: The controlled substance registration issued to a pharmacy shall be valid for two years
beginning January 1st of each even-numbered year.
(2) Wholesale druggist: The controlled substance registration issued to a wholesale druggist shall be valid for
one year beginning on December 1st of each year.
11.08: Renewal of a Controlled Substance Registration
(1) A registrant may renew a controlled substance registration on a renewal form provided by the Board. All
renewal applications submitted to the Board shall:
(a) be submitted in a timely manner:
(b) be fully and properly completed: and
(c) be accompanied by a check or money order payable to the "Commonwealth of Massa-chusetts Board of
Registration in Pharmacy" in the appropriate amount, which shall be non-refundable.
(2) Renewal of a controlled substance registration shall be made prior to the following dates:
(a) December 31st of each odd-numbered year for a pharmacy; and
(b) November 30th of each year for a wholesale druggist.
(3) Failure by a registrant to renew a controlled substance registration in a timely manner may result in the

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imposition of a late renewal fee.
11:09: Changes in the Name, Address and/or Status of Registrant
(1) The controlled substance registration of any registrant shall automatically terminate and become invalid if:
(a) the person named on the controlled substance registration dies;
(b) the pharmacy or wholesale business named on the controlled substance registration ceases to exist;
(c) the name and/or address of the pharmacy or wholesale business to which the controlled substance
resignation was issued changes; or
(d) the pharmacy or wholesale business to which the controlled substance registration was originally issued
is sold.
Notification requirements to Board and DEA..
(2) A registrant affected by 247 CMR 11.09(1) shall notify the Board in writing within ten days of such change(s).
(3) A registrant affected by 247 CMR 11.09(1) shall make application to the Board for the issuance of a new
controlled substance registration. Such application may be submitted to the Board before the effective date of
such change. The Board shall review such application as a first-time application for a controlled substance
registration.
(4) A registrant affected by 247 CMR 11.09(1) shall promptly provide written notice thereof to the regional office
of the U.S. Drug Enforcement Administration.
11.10: Transfer or Assignment of a Controlled Substance Registration Prohibited
A controlled substances registration issued by the Board, or any authority conferred thereby, shall not be
assigned or transferred.
11.11: Wholesale Druggist Activities Limited
A wholesale druggist which is registered to distribute a controlled substance or class of controlled substances
shall be authorized to distribute only that controlled substance or class of controlled substances.
11.12: Inspection of Registered Premises
The Board or its authorized agents may inspect, in accordance with Board regulations, the establishment of
a registrant or of an applicant for a controlled substance registration.
11.13: Records and Inventories
Requirements for records and inventories are the same as the federal requirements.
Registrants shall keep records and maintain inventories in conformance with the record-keeping and
inventory requirements of the federal "Comprehensive Drug Prevention and Control Act of 1970", or any
amendment thereof, and 21 U.S.C. 301 et seq. (Federal Food, Drug and Cosmetic Act), and with all other
applicable state laws and regulations.
11.14: Revocation and Suspension of Registration; Grounds; Effect
Note grounds for revocation or suspension of registration. Remember, also, that in Mass., because all prescription drug are
controlled substancesthe revocation of a license is essentially a revocation of a registration to practice pharmacy at all.
(1) The Board may suspend or revoke a controlled substance registration issued by it after a hearing pursuant

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to the provisions of M.G.L. c. 30A upon a finding that the registrant:
(a) has furnished false or fraudulent material information in any application filed under the provisions of
M.G.L. c. 94C;
(b) has been convicted under any state or federal law of any criminal violation relating to his or her fitness
to be registered under M.G.L. c. 94C;
(c) has had his or her state or federal controlled substance registration to manufacture, distribute, dispense,
administer or possess controlled substances susupended or revoked, or has voluntarily surrendered said
controlled substance registration;
(d) is, upon good cause, found to be unfit or unqualified to manufacture, distribute, dis-pense, or possess
any controlled substance; or
(e) has violated any provision of M.G.L. c. 94C and/or any other applicable federal or state laws and
regulations.
(2) The suspension or revocation by the Board of a controlled substance registration shall be grounds for the
suspension or revocation of the retail pharmacy's permit or wholesale druggist's license issued by the Board.
(3) The Board may limit revocation or suspension of a controlled substance registration issued by it to the
particular controlled substance with respect to which grounds for revocation or suspension exist.
(4) Whenever the Board has substantial reason to believe that a registrant to whom it has issued a controlled
substance registration has committed a criminal violation of any provision of M.G.L. c. 94C, the Board shall
promptly report all pertinent facts to the district attorney in the county where the violation is believed to have
occurred or to the attorney general.
(5) If the Board suspends or revokes a controlled substances registration issued by it, all controlled substances
which are affected by such suspension or revocation order at the time of suspension or the effective date of the
revocation order shall be placed under embargo pursuant to the procedures prescribed in M.G.L. c. 94, 189
and 189A. No disposition may be made of substances under such embargo until the time for taking an appeal has
elapsed or until all appeals have been concluded unless a court, upon application therefor, orders the sale of
perishable substances and the deposit of the proceeds of the sale with the court. Upon a revocation order
becoming final, all controlled substances may be forfeited to the Common-wealth.
(6) The Board shall promptly notify the U.S. Drug Enforcement Administration and, where appropriate the
Department of Public Health of all orders suspending or revoking a controlled substances registration and all
forfeitures of controlled substances.
11.15: Summary Suspension of a Controlled Substance Registration
(1) The Board may, without hearing, suspend or refuse to renew any controlled substance registration issued by
it if it finds that there is an imminent danger to the public health or safety which warrants this action; provided,
however, that the Board promptly affords the registrant an opportunity for a hearing in accordance with M.G.L.
c. 30A, 801 CMR 1.01 and 247 CMR 10.00.
(2) Any suspension summarily imposed by the Board shall continue in effect until the conclu-sion of the final
hearing on the merits of any Order to Show Cause issued by the Board in connection with its investigation of the
pharmacy or wholesale druggist, including judicial review thereof, unless sooner dissolved by a court of
competent jurisdiction, or withdrawn by the Board.
(3) The procedure for summary suspension is as follows:
(a) Closure of Pharmacy: Upon receipt by the Board of reliable information that a registrant is an imminent

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and serious threat to the public health or safety, the Board shall vote to take summary action on the
registrant's controlled substances registration. Upon the Board's vote to summarily suspend such registration, Board Agents are authorized to:
1. immediately close the registrant's establishment or business;
2. at the registrant's expense, replace the locks on all doors to the registrant's establish-ment or business
and retain the key(s);
3. conspicuously display at the entrance(s) to the registrant's establishment or business a sign, in letters
no less than one inch in height and one inch wide, stating: "THE REGISTRATION OF THIS PHARMACY/ ESTABLISHMENT HAS BEEN SUS-PENDED BY ORDER OF THE MASSACHUSETTS BOARD
OF REGISTRATION IN PHARMACY."; and
4. conduct an inventory and audit of all drugs and record of drugs within the registrant's establishment
or business.
(b) Order of Suspension: The Board shall promptly issue an Order of Suspension of Controlled Substance
Registration and shall send such Order, with a Notice of Hearing as set forth in 247 CMR 11.15(3)(c), to the
establishment's owner or pharmacy's Manager of Record by certified mail, or shall deliver such Order and
Notice of Hearing by hand.
(c) Hearing on Necessity for the Summary Action: The Board shall convene a hearing on the necessity for
the summary suspension of a controlled substance registration within seven days after the order of
suspension. The establishment's owner and/or pharmacy's Manager of Record shall be notified of the date,
time and place of the hearing. At the hearing, the Board shall receive testimony and documentary evidence
limited to determining whether the summary suspension of the controlled substance registration shall
continue in effect pending a final hearing on the merits of any Order to Show Cause issued by the Board
against the pharmacy or establishment in connection with its investigation.Following the hearing, the Board
shall vote on whether to continue the summary suspension in effect and shall promptly notify the registrant
in writing of its decision.
(4) The Board's summary suspension of a controlled substance registration shall be grounds for the summary
suspension of the pharmacy's permit or wholesale druggist's license issued by the Board. The summary
suspension of a pharmacy's permit or wholesale druggists license permit shall continue in effect pending a final
hearing on the merits of any Order to Show Cause issued by the Board against the pharmacy or wholesale
druggist in connection with its investigation, including judicial review thereof, unless sooner dissolved by a court
of competent jurisdiction or withdrawn by the Board.
REGULATORY AUTHORITY 247 CMR 11.00: M.G.L. c. 112, 30 and 42A; c. 94C, 6, 7 and 10 through 15.

247 CMR: 12.00:

RESTRICTED PHARMACY
Section
12.01: Authority
12.02: Limitation on the Functions and Operations of a Restricted Pharmacy
12.03: Application for an Initial Permit
12.04: Renewal of a Permit
12.05: General Requirements for the Operation of a Restricted Pharmacy
12.01: Authority
The Board may, under authority granted to it by M.G.L. c. 112, 39A, register a restricted pharmacy for the
limited transaction of a drug business as defined in M.G.L. c. 112, 37. A restricted pharmacy may furnish
pharmacy services only to beneficiaries, as defined in M.G.L. c. 151D, 1, of a trust, fund, pension plan,
combination plan, or profit-sharing plan which is subject to the provisions of M.G.L. c. 151D.

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12.02: Limitation on the Functions and Operations of a Restricted Pharmacy
Registration as a restricted pharmacy shall not authorize such a restricted pharmacy to function or operate
as a retail pharmacy as defined in M.G.L. c. 112, 39.
12.03: Application for an Initial Registration
(1) Application for an initial permit to operate as a restricted pharmacy shall be made by the plan administrator
or trustee of the trust, fund, pension plan, combination plan, or profit-sharing plan on a form provided by the
Board.
(2) A restricted pharmacy shall comply with the requirements for the issuance of a pharmacy permit as provided
by 247 CMR 6.00.
12.04: Renewal of a Permit
A restricted pharmacy shall comply with the requirements for permit renewal as provided by 247 CMR 6.00.
12.05: General Requirements for the Operation of a Restricted Pharmacy
(1) A restricted pharmacy may, after written notice to the Board, limit its operation to a specific schedule of
drugs.
(2) A restricted pharmacy shall be exempt from the application of 247 CMR 9.01(15).
(3) A restricted pharmacy shall be subject to all applicable provisions of 247 CMR except as specifically
exempted by the Board.
REGULATORY AUTHORITY 247 CMR 12.00: M.G.L. c. 112, 39A and 42A.

247 CMR 13.00:

Section
13.01:
13.02:
13.03:
13.04:
13.05:
13.06:

REGISTRATION REQUIREMENTS AND MINIMAL PROFESSIONAL STANDARDS

FOR NUCLEAR PHARMACIES

Authority and Purpose

Definitions
Requirements for the Issuance of a Nuclear Pharmacy Permit
Renewal of Nuclear Pharmacy Permit
General Requirements for Nuclear Pharmacies
Educational and Experience Requirements of a Qualified Nuclear Pharmacist

13.01: Authority and Purpose

247 CMR 13.00 is promulgated under the authority granted the Board by M.G.L. c. 112, 39B to register
an establishment for transacting business as a nuclear pharmacy as defined in M.G.L. c. 94C. The purpose of
247 CMR 13.00 is to establish minimum professional standards for the operation of a nuclear pharmacy in order
to safeguard the public health and welfare.
13:02: Definitions
Authentication of product history means the identification of the purchasing source, or of any intermediate
handler, or of the ultimate fate of any radiopharmaceutical or component thereof.

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Authorized practitioner means a practitioner who is legally authorized to receive and administer radiopharmaceutical drugs.
Compounding of radiopharmaceuticals means the addition of a radioactive substance, or the use of a radioactive
substance in preparation of a single-dose or multiple-dose medication, pursuant to the prescription of an
authorized practitioner for a patient who is being treated by the that practitioner. Such compounding of
radiopharmaceuticals includes, but is not limited to, loading and eluting of radionuclide generators, using
manufactured reagent kits to prepare radio-pharmaceuticals, preparing reagent kits, aliquoting reagents, and
formulating and conducting quality assurance tests of radiochemicals which are to be used as radiopharmaceuticals.
Internal test assessment means such testing or quality assurance which is necessary to insure the integrity of a
particular test.
Nuclear pharmacy means a facility under the direction or supervision of a registered pharmacist which is
registered by the Board to dispense radiopharmaceutical drugs pursuant to M.G.L. c. 112, 39 and 247 CMR
13.00.
NRC means the Nuclear Regulatory Commission.
Qualified nuclear pharmacist means, for the purposes of 247 CMR 13.00, a pharmacist who is registered as a
pharmacist by the Board pursuant to the provisions of M.G.L. c. 112, 24, who is employed in a nuclear
pharmacy, and who has submitted evidence satisfactory to the Board that he or she meets the requirements of 247
CMR 13.00 in regard to education, training and experience, and who has received from the Board an official
letter stating that, on the basis of the evidence submitted, he or she has been found qualified to deal with
radiopharmaceutical drugs and to handle radiopharmaceutical services.
Radioactive biological product means a biological product which is labeled with a radionuclide or intended to
be labeled solely with a radionuclide.
Radiolabeling means the process of adding a radioisotope to a suitable nonradioactive substance.
Radiopharmaceutical means a radioactive drug or other radioactive pharmaceutical products.
Radiopharmaceutical drug means any substance defined as a drug in section 201(g)(1) of 21 USCA 321 et seq.
(Federal Food, Drug and Cosmetic Act) which exhibits spontaneous disintegration of unstable nuclei with the
emission of nuclear particles or photons, and includes any nonradioactive reagent kit or nuclide generator which
is intended to be used in the preparation of any such substance, but does not include drugs such as carboncontaining compounds or potassium-containing salts which contain trace quantities of naturally occurring
radionuclides.
Radiopharmaceutical quality assurance means the performance of appropriate chemical, biological and physical
tests on potential radiopharmaceuticals, and the interpretation of the resulting data to determine the suitability
of the radiopharmaceutical for use in humans or animals. The term includes internal test assessment, authentication of product history, and the maintenance of proper records.
Radiopharmaceutical service means the counting, dispensing, labeling, and delivery of radiopharmaceuticals;
participating in radiopharmaceutical selection and radiopharmaceutical utilization reviews; properly and safely
storing and distributing radiopharmaceuticals; maintaining radiopharmaceutical quality assurance; advising on
therapeutic values, hazards, and use of radiopharmaceuticals; and offering or performing those acts, services,

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State Pharmacy Law Review

operations or transactions necessary in the conduct, operation, management and control of radio-pharmaceutical services within a nuclear pharmacy.
13.03: Requirements for the Issuance of Nuclear Pharmacy Permit
(1) An applicant for an initial permit to establish a nuclear pharmacy shall be made by submitting to the Board
a fully and properly completed application form provided by the Board.
(2) An application for a nuclear pharmacy permit shall be accompanied by a check or money order in the
required amount payable to the "Commonwealth of Massachusetts Board of Registration in Pharmacy".
(3) No permit shall be issued to a proposed nuclear pharmacy unless there are maintained on the pharmacy
premises the following publications:
(a) The most recent edition of the United States Pharmacopoeia, including the latest supplement thereto;
(b) the most recent edition of Remington's Pharmaceutical Sciences; and
(c) current texts on the practice of nuclear pharmacy and radiation safety.
(4) No permit shall be issued to a proposed nuclear pharmacy by the Board unless said proposed nuclear
pharmacy maintains on the premises the following equipment:
(a) A dose preparation station;
(b) a dose calibrator;
(c) an exhaust hood and filter system for handling radioactive gases or volatile radioactive materials;
(d) a refrigerator for exclusive storage of radioactive materials or reagent kits which require refrigeration;
(e) chromatographic apparatus as required for radiopharmaceutical quality assurance;
(f) a portable radiation survey meter capable of detecting 0.005 microcuries of radio-nuclides;
(g) area radiation detection room monitors;
(h) personnel dosimeters;
(i) a single-channel or multichannel scintillation analyzer; and
(j) supplies necessary for dispensing including, but not limited to, sterile multi-dose vials, syringes,
disposable alcohol swabs, and adequate shielding for each dosage dispensed.
(5) No permit shall be issued to a proposed nuclear pharmacy by the Board unless said proposed pharmacy
conforms to the following conditions:
(a) The premises are clean and sanitary; and
(b) no entrances or exits shall connect directly with other places of business.
(6) Prior to acting upon any application for the issuance of a permit for a nuclear pharmacy, the Board may
require the applicant to appear before the Board to discuss the merits of the application.
(7) The Board shall issue a nuclear pharmacy permit to such person as it deems qualified to conduct such a
pharmacy; provided, however, that the Board may deny the issuance of a permit if, in its discretion, it determines
that such pharmacy would be inconsistent with, or opposed to, the best interest of the public health, welfare, and
safety.
(8) The Board shall, within 150 days after the filing of an application for an initial nuclear pharmacy permit,
render a final decision denying or allowing the issuance of such permit. Failure to render such decision; except
when failure to act is caused by the delay of the applicant, shall constitute the approval of the application and the
permit shall be issued.
(9) The Board shall not issue a nuclear pharmacy permit to a corporation unless it appears to the satisfaction
of the Board that such nuclear pharmacy is managed and operated by a registered pharmacist in good standing

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State Pharmacy Law Review

with the Board.
(10) When the Board is satisfied that a proposed nuclear pharmacy has complied with the requirements of 247
CMR 13.00 and shall be operated in compliance with applicable federal, state and local statutes, ordinances,
and/or regulations, it shall issue a permit to the applicant nuclear pharmacy.
13.04: Renewal of a Nuclear Pharmacy Permit
Note when Nuclear pharmacy registration expires.
(1) Each nuclear pharmacy permit issued by the Board shall expire on December 31st of each uneven numbered
year following the date of its issuance.
(2) Application for renewal of a nuclear pharmacy permit shall be made on a renewal application form provided
by the Board. Such renewal form shall be fully and properly completed and submitted to the Board in a timely
manner.
(3) Each renewal application form submitted to the Board shall be accompanied by a check or money order in
the required amount made payable to the "Commonwealth of Massachusetts Board of Registration in Pharmacy".
13.05: General Requirements for Nuclear Pharmacies
(1) A nuclear pharmacy registered pursuant to 247 CMR 13.00 shall comply with all applicable laws,
regulations, and guidelines of the United States Nuclear Regulatory Commission, the United States Food and
Drug Administration, and other appropriate federal and state agencies.
(2) No person other than a qualified nuclear pharmacist shall be employed by a nuclear pharmacy to direct and
manage the pharmacy.
(3) Only designated qualified nuclear pharmacists shall conduct the radiopharmaceutical activities of a nuclear
pharmacy, and at least one qualified nuclear pharmacist shall be in personal attendance at the pharmacy at all
times.
(4) A nuclear pharmacy shall not dispense those radiopharmaceuticals which do not comply with acceptable
professional standards of radiopharmaceutical quality assurance.
(5) A nuclear pharmacy shall maintain in readily retrievable form for at least three years detailed records of the
acquisition and disposition of all radiopharmaceuticals. These records shall be available to the Board or its
agents for inspection upon request.
(6) A nuclear pharmacy shall not prepare, compound, or dispense radiopharmaceutical drugs except upon a
valid prescription from an authorized practitioner. In order to be valid, a prescription for radiopharmaceutical
drugs shall contain the following information:
(a) the name, address, registration number and, in the case of a written prescription, the signature of the
practitioner;
(b) the date of the prescription;
(c) the name, dosage unit, and strength per dosage unit of the radiopharmaceutical drug;
(d) the name and address of the patient; if the name of the patient is unknown at the time the prescription
is received, the nuclear pharmacy shall obtain the name and address of the patient within 72 hours after
dispensing the radiopharmaceutical drug; the address of the facility where the patient is being treated will
be sufficient if his or her residential address is unavailable; and

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(e) any specific instructions required.
(7) A nuclear pharmacy shall assign a serial number to each radiopharmaceutical drug it dispenses.
(8) A nuclear pharmacist shall, upon receiving an oral prescription for a radiopharmaceutical drug from a
practitioner or his or her expressly authorized representative, immediately reduce such prescription to writing
on a prescription form, record on it the same information required under 247 CMR 13.05(6), and assign a serial
number to such prescription.

(9) In the event a prescribed radiopharmaceutical drug is not administered, it shall be returned to the nuclear
pharmacy to be disposed of in accordance with the requirements established by the Nuclear Regulatory Commission and the nuclear pharmacy shall note on the prescription form, or shall record on a readily retrievable record
form, that the radiopharmaceutical drug has been returned and shall state the amount of the radiopharmaceutical
drug that has been returned. The nuclear pharmacy shall comply with all NRC regulations regarding the return
and disposal of radioactive materials.
(10) A nuclear pharmacy may, with proper record-keeping, transfer to authorized persons radioactive materials
or side-products which are not intended for medicinal use.
(11)(a) Radiopharmaceuticals may be dispensed in bulk amounts necessary to activate the
single unit doses. The bulk radioactivity shall be supplied no more than once in a 12-hour period. If an
emergency radiopharmaceutical is used, the nuclear pharmacy shall, within 72 hours, obtain a written or
oral prescription for the radiopharmaceutical which shall contain all the information included in 247 CMR
13.04(5). If the bulk radioactivity is not used, the nuclear pharmacy shall obtain and record a written or oral
verification to that effect from the authorized practitioner to whom it was dispensed.
(b) A nuclear pharmacy shall maintain records on all emergency supplies it dispenses as set out in 247 CMR
13.04(11)(a). The records shall include the names of the authorized practitioner and the institution within
which he is or she is practicing, the amounts of non-radioactive material and radioactive material supplied,
the dates supplied, the dates the radiopharmaceutical was administered, and the prescription serial number
for each dose that was administered. The nuclear pharmacist's records shall also contain the authorized
practitioner's written or oral verification when the bulk radioactivity is not used. These records shall be made
available for inspection by the Board or its agents upon request.
(12) In addition to any other labeling required by federal, state, or local laws or regulations, a registered
nuclear pharmacy which dispenses radiopharmaceuticals shall place each such pharmaceutical in an outer
container and affix to said container a label bearing the following information:
(a) the standard radiation symbol;
(b) the words "Caution - Radioactive Material";
(c) the name of the radionuclide;
(d) the chemical form or common name;
(e) the amount of radioactive material, stated in millicuries or microcuries, or in SI units (becquerels) at
the time of calibration;
(f) if a liquid, the volume in cubic centimeters or milliliters;
(g) auxiliary warning labels, if any, as needed; and
(h) the expiration date or time.
(13) In the case of investigational radioactive drugs, the nuclear pharmacy's records shall include an investigator's protocol for the preparation of radioactive drugs, a copy of the Human Use Committee Approval, a copy of
the approved patient consent form, and a letter from the manufacturer - "sponsor" indicating that the physician

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requesting the radioactive drug is a qualified investigator.
(14) The premises of a nuclear pharmacy shall at all times be kept in a clean and sanitary manner.
(15) A nuclear pharmacy shall, in legible letters not less than one inch high, conspicuously display the name of
the director of pharmacy services on the premises.
(16) A nuclear pharmacy shall have a qualified nuclear pharmacist on the premises during the entire time when
said pharmacy is open for business.

(17) A nuclear pharmacy shall keep posted and displayed in a conspicuous place its permit and the certificate
of personal registration to practice pharmacy of each registered pharmacist who is employed on a full-time basis
by the pharmacy.
(18) A nuclear pharmacy shall in advance of any move to a new location submit to the Board an application for
a new permit and payment of the appropriate fees.
(19) Any nuclear pharmacy which is being established, remodeled, or relocated must first submit to the Board
for review and approval copies of its structural plans.
(20) A nuclear pharmacy which has moved to a new location shall not operate in said location until said nuclear
pharmacy has been approved by the Board and until it has received from the Board a new permit to manage and
operate a nuclear pharmacy and a new controlled substances registration.
(21) Each nuclear pharmacy shall, within ten days of the commencement of employment of any pharmacist, or
within ten days of the termination of employment of any pharmacist, report to the Board such employment or
termination of employment. Such reports may be made upon forms available from the Board.
(22) A nuclear pharmacy shall maintain adequate security measures which are consistent with federal
regulations and with the requirements of the Board.
(23) A nuclear pharmacy shall not perform any pharmacy functions other than the dispensing of radiopharmaceutical drug products; it shall not perform the functions of, or operate as, a retail pharmacy or institutional
pharmacy.
(24) Only a nuclear pharmacy shall keep in stock or handle radiopharmaceuticals.
(25) No nuclear pharmacy shall require or permit the same nuclear pharmacist to remain on duty for more than
12 hours per day.
(26) A nuclear pharmacy shall be exempt from the following regulations of the Board:
(a) 247 CMR 6.01;
(b) 247 CMR 6.02;
(c) 247 CMR 6.08;
(d) 247 CMR 9.01(12), (15) and (16); and
(e) 247 CMR 9.04(4) and (6).
Note: No (f) or (g) exists in copy of regulations
(g) auxiliary warning labels, if any, as needed; and
(h) the expiration date or time.

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State Pharmacy Law Review

(13) In the case of investigational radioactive drugs, the nuclear pharmacy's records shall include an investigator's protocol for the preparation of radioactive drugs, a copy of the Human Use Committee Approval, a copy of
the approved patient consent form, and a letter from the manufacturer - "sponsor" indicating that the physician
requesting the radioactive drug is a qualified investigator.
(14) The premises of a nuclear pharmacy shall at all times be kept in a clean and sanitary manner.
(15) A nuclear pharmacy shall, in legible letters not less than one inch high, conspicuously display the name of
the director of pharmacy services on the premises.
(16) A nuclear pharmacy shall have a qualified nuclear pharmacist on the premises during the entire time when
said pharmacy is open for business.
(17) A nuclear pharmacy shall keep posted and displayed in a conspicuous place its permit and the certificate
of personal registration to practice pharmacy of each registered pharmacist who is employed on a full-time basis
by the pharmacy.
(18) A nuclear pharmacy shall in advance of any move to a new location submit to the Board an application for
a new permit and payment of the appropriate fees.
(19) Any nuclear pharmacy which is being established, remodeled, or relocated must first submit to the Board
for review and approval copies of its structural plans.
(20) A nuclear pharmacy which has moved to a new location shall not operate in said location until said nuclear
pharmacy has been approved by the Board and until it has received from the Board a new permit to manage and
operate a nuclear pharmacy and a new controlled substances registration.
(21) Each nuclear pharmacy shall, within ten days of the commencement of employment of any pharmacist, or
within ten days of the termination of employment of any pharmacist, report to the Board such employment or
termination of employment. Such reports may be made upon forms available from the Board.
(22) A nuclear pharmacy shall maintain adequate security measures which are consistent with federal
regulations and with the requirements of the Board.
(23) A nuclear pharmacy shall be separate from, and independent of, any other business or store.
(24) A nuclear pharmacy shall not perform any pharmacy functions other than the dispensing of radiopharmaceutical drug products; it shall not perform the functions of, or operate as, a retail pharmacy or institutional
pharmacy.
(25) Only a nuclear pharmacy shall keep in stock or handle radiopharmaceuticals.
(26) No nuclear pharmacy shall require or permit the same nuclear pharmacist to remain on duty for more than
12 hours per day.
(27) A nuclear pharmacy shall be exempt from the following regulations of the Board:
(a) 247 CMR 6.01;
(b) 247 CMR 6.02;
(c) 247 CMR 6.08;
(d) 247 CMR 9.01(12), (15) and (16); and

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(e) 247 CMR 9.04(4) and (6).
13.06: Education and Experience Requirements of a Qualified Nuclear Pharmacist
A qualified nuclear pharmacist shall:
Note requirements to be a qualified Nuclear pharmacist.
(1) Be currently registered under M.G.L. c. 112, 24;

(2) have received 200 contact hours of formal academic training in the area of radio-pharmaceutical preparation and handling, with no more than 60 of said hours being acquired through laboratory training;
(3) have received, in addition to formal academic training, a minimum of three months of full-time, or 500 hours
of actual on the job practical experience in the field of radioactive drugs and radiopharmaceutical services under
the supervision of a qualified nuclear pharmacist in a nuclear pharmacy providing nuclear pharmacy services,
or in a structured nuclear pharmacy training program of a Board-approved college/school of pharmacy; and
(4) submit a detailed affidavit of experience and training to the Board.
REGULATORY AUTHORITY 247 CMR 13.00: M.G.L. 112, 24, 39B and 42A.
.
247 CMR 14.00:
PETITION FOR WAIVER
Section
14.01: Petition to the Board to Grant a Waiver to the Provisions of 247 CMR for Licensure of a
Pharmacy/Pharmacy Department
(1) The Board may grant a waiver to the provisions of 247 CMR, pertaining to the licensure of a pharmacy or pharmacy
department, if the Board finds:
(a) that there is a compelling public interest which would be served by the granting of such
a waiver;
(b) that adherence to a particular provision of 247 CMR would be impractical and unduly
burdensome; and
(c) that sufficient safeguards are in place to protect the public health, welfare and safety.
(2) Unless otherwise prohibited by law, when the Board finds that a provision of 247 CMR, may be waived, it may issue a
special or limited-use pharmacy or pharmacy department permit. Such permit shall be issued when the scope, degree or type
of pharmacy practice is of a special, limited or unusual nature as compared to a regular pharmacy service. In order to request
a waiver of a Board regulation, the registered pharmacist who shall be responsible for the management and operation of a
pharmacy or pharmacy department shall submit to the Board a Petition for Waiver of Board Regulations, upon a form supplied
by the Board. A completed petition shall:
(a) List the regulatory requirement(s) for which a waiver is requested and a brief explanation as to why each
regulation should not apply to that pharmacy or pharmacy department;
(b) explain why there is a compelling public interest which would be served by granting the waiver;
(c) explain why adherence to the regulation(s) would be impractical and unduly burdensome to the petitioner;
(d) include a comprehensive statement of the policies and procedures of the proposed operation, including safeguards
to protect the public health, welfare and safety; and
(e) be accompanied by any additional information as determined by the Board.
(3) Before acting upon any petition, the Board may require the applicant to personally appear before the Board to answer
questions that would enable the Board to determine that the issuance of a permit would be in the best interest of the public

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health, welfare and safety and adherence to 247 CMR would be unreasonable.
(4) Upon the granting of a waiver and issuance of a special or limited-use permit, the Board shall issue a written finding that
recites the specific Board regulation(s) which are being waived, the reasons the Board is waiving the regulation(s) at issue,
and lists any contingent restrictions under which the pharmacy or pharmacy department may operate.
REGULATORY AUTHORITY 247 CMR 14.00: M.G.L. c. 112, 36A through 42A.

247 CMR 15.00:

CONTINUOUS QUALITY IMPROVEMENT PROGRAM
Section
15.01: Definitions
15.02: Continuous Quality Improvement Program
15.03: Quality Related Event Discovery, Notification and Documentation
15.04: Records
15.01: Definitions
Continuous Quality Improvement Program or CQI Program means a system of standards and procedures to identify and
evaluate quality-related events and improve patient care.
Note the definition of a QRE.
Quality-Related Event or QRE means the incorrect dispensing of a prescribed medication that is received by a patient, including:
(a) a variation from the prescriber's prescription order, including, but not limited to:
1. dispensing an incorrect drug;
2. dispensing an incorrect drug strength;
3. dispensing an incorrect dosage form;
4. dispensing the drug to the wrong patient; or
5. providing inadequate or incorrect packaging, labeling, or directions; or
(b) a failure to identify and manage:
1. over-utilization;
2. therapeutic duplication;
3. drug-disease contraindications;
4. drug-drug interactions;
5. incorrect drug dosage or duration of drug treatment;
6. drug-allergy interactions; or
7. clinical abuse/misuse.
Pharmacy, as referenced in 247 CMR 15.00, means a pharmacy, or a group of pharmacies under common ownership and
control of one entity, licensed by the Board pursuant to M.G.L. c. 112.
Pharmacy Personnel means pharmacist, pharmacy intern, pharmacy technician and pharmacy support personnel.
15.02: Continuous Quality Improvement Program
(1) Continuous Quality Improvement Program Requirements. Each pharmacy shall establish a Continuous Quality
Improvement (CQI) Program for the purpose of detecting, documenting, assessing and preventing Quality-Related Events
(QREs). At a minimum, a CQI program shall include provisions to:

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Note requirements of CQI program.
(a) designate an individual or individuals responsible for monitoring CQI Program compliance with the requirements of 247
CMR 15.00;
(b) identify and document QREs;
(c) minimize impact of QREs on patients;
(d) analyze data collected in response to QREs to assess causes and any contributing factors;
(e) use the findings of the analysis to formulate an appropriate response and develop pharmacy systems and workflow
processes designed to prevent QREs; and
(f) provide ongoing education at least annually in the area of CQI to pharmacy personnel.

(2) Implementation Date. The CQI Program requirements of 247 CMR 15.00 shall be implemented by each pharmacy by
December 31, 2005.
15.03: Quality Related Event Discovery, Notification and Documentation
(1) QRE Discovery and Notification. All pharmacy personnel shall be trained to bring any QRE to the attention of the
pharmacist on duty or the pharmacist Manager of Record immediately upon discovery.
Note that upon discovery of a QRE the pharmacist must immediately contact patient and prescriber if indicated.
The pharmacist who has discovered or been informed of a QRE shall immediately provide:
(a) notification to the patient or patient's representative, the prescriber (if indicated in the professional judgment of
the pharmacist) and other members of the healthcare team;
(b) directions for correcting the error; and
(c) instructions for minimizing the negative impact on the patient.
(2) QRE Documentation.
Note these requirements.
(a) A QRE shall be initially documented by the pharmacist who has discovered or been informed of the QRE on the
same day the QRE is discovered by or described to the pharmacist.
(b) QRE documentation shall include a description of the event that is sufficient to permit categorization and analysis
of the event. QRE documentation shall include:
1. the date when the pharmacist discovered or received notification of the QRE and the name of the person who
notified the pharmacy;
2. the names and titles of the persons recording the QRE information and performing the QRE analysis;
3. a description of the QRE reviewed; and
4. documentation of the contact with the patient, or patients representative, and prescribing practitioner (if
indicated in the professional judgment of the pharmacist), and other members of the healthcare team.
(3) QRE Analysis and Response.
(a) QRE Analysis. The investigative and other pertinent data collected in response to QREs shall be analyzed,
individually and collectively, to assess the cause and any contributing factors such as system or process failures. The
QRE analysis and assessment shall include:
1. a consideration of the effects on quality assurance related to workflow processes, technological support,
personnel training and staffing levels;
2. any recommended remedial changes to pharmacy policies, procedures, systems, or processes; and
3. the development of indicators that identify means against which a pharmacys program intends to measure
its standards over a designated period of time.
(b) Response. Each pharmacy shall inform pharmacy personnel of changes to pharmacy policies, procedures,
systems, or processes resulting from recommendations generated by the CQI Program.

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15.04: Records
Note copy of CQI program must be on the pharmacy premises.
(1) Each pharmacy shall maintain a written copy of its CQI Program description on the pharmacy premises. The CQI
Program description shall be readily available to all pharmacy personnel.
Note requirements of records of QREs.
(2) Each pharmacy shall maintain a record of all QREs for a minimum period of two years from the date of the QRE
report.
(3) QRE records shall be maintained in an orderly manner and filed by date.
(4) QRE records may be stored at a site other than the pharmacy where the QRE occurred.
REGULATORY AUTHORITY 247 CMR 15.00: M.G.L. c. 112, 37 through 39 and 42A.

B. Proposed Board of Pharmacy Regulation--Collaborative Drug Therapy Management

247 CMR 16.00:

COLLABORATIVE DRUG THERAPY MANAGEMENT

NOTE:
The
following
is
listed
as
of
March
22,
2010
at
http://www.mass.gov/?pageID=eohhs2terminal&L=5&L0=Home&L1=Government&L2=Laws%2c+Regulations+and+Polici
es&L3=Department+of+Public+Health+Regulations+%26+Policies&L4=Proposed+Amendments+to+Regulations&sid=Eeo
hhs2&b=terminalcontent&f=dph_legal_g_drug&csid=Eeohhs2 as a proposed regulation on collaborative drug therapy
management. Proposed regulations do not yet have the force and effect of law, but pharmacists should be familiar with them
as the statute is already in effect..
16.00: Preface
16.01: Definitions
16.02: Pharmacist Qualifications
16.03: Practice Setting Requirements
16.04: Collaborative Practice Agreements Required Agreement Terms for All Practice
Settings; Duties; Biennial Renewal; Termination; Agreement to be Filed in Primary
Practice Setting; Employment Relationships
16.00: Preface
Chapter 528 of the Acts of 2008, amending G.L. c. 94C, ss. 7 and 9 and G.L. c. 112, ss. 24B1/2 and 24B3/4, authorized pharmacists and physicians to engage in collaborative drug therapy management (CDTM) in the Commonwealth pursuant to collaborative practice agreements meeting the requirements of regulations adopted by the Boards of Registration in Pharmacy
and Medicine. The Board of Registration in Pharmacy has promulgated 247 CMR 16.00 in accordance with G.L. c. 112, s.
24B1/2 and 24B3/4. Board of Registration in Medicine regulations (243 CMR 2.12) include additional definitions and requirements applicable to pharmacists and physicians entering into collaborative practice agreements to practice CDTM in
the Commonwealth.
16.01: Definitions
Additional definitions applicable to the practice of CDTM in the Commonwealth appear in
Board of Registration in Medicine regulations at 243 CMR 2.12 and Board of Registration in Pharmacy regulations at 247
CMR 2.00.
A DRAFT of 243 CMR 2.12 is reproduced below after the pharmacy regulations.

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As used in this section and defined in G.L. c. 112, ss. 24B1/2, subsection (a), the following words shall have the following
meanings:
Authorized pharmacist means a pharmacist who (1) is currently registered by the Board and in good standing; (2) meets the
requirements of 247 CMR 16.02; and (3) is participating in drug therapy management with a supervising physician pursuant
to a written CDTM agreement with written protocols.

Collaborative drug therapy management or CDTM means the initiating, monitoring, modifying and discontinuing of a patient's drug therapy by an authorized pharmacist under the supervision of a physician in accordance with a collaborative
practice agreement. Collaborative drug therapy management may include: collecting and reviewing patient histories; obtaining and checking vital signs, including pulse, temperature, blood pressure and respiration; and, under the supervision of, or
in direct consultation with, a physician, ordering and evaluating the results of laboratory tests directly related to drug therapy when performed in accordance with approved protocols applicable to the practice setting and when the evaluation shall
not include a diagnostic component.
Collaborative practice agreement or CDTM agreement means a written and signed agreement between an authorized pharmacist with training and experience relevant to the scope of the collaborative practice and a supervising physician that defines the collaborative practice in which the authorized pharmacist and supervising physician propose to engage. The
collaborative practice must be within the scope of the supervising physicians practice. In the community pharmacy setting,
the CDTM agreement shall include: (1) a written referral of a specific patient from the supervising physician to an authorized pharmacist; and (2) the written consent of the patient to the CDTM agreement.
Community pharmacy means a pharmacy or pharmacy department, as defined in 247 CMR 2.00, in a retail drug business
setting, as referenced in G.L. c. 112, 24B1/2, currently licensed by the Board pursuant to G.L. c. 112, ss. 38 and 39.
Patient means a person who is referred to an authorized pharmacist by a supervising physician for the purpose of receiving
collaborative drug therapy management services from the pharmacist. In a community pharmacy, (1) the patient must be notified of, and provide written consent to, the collaborative drug therapy management services, and (2 ) in accordance with
243 CMR 2.12, the supervising physician must provide the patient with a copy of the referral to the authorized pharmacist
and the written consent to the referral provided by the patient.
Referral means the individual patient referral by a supervising physician to an authorized pharmacist for the purpose of receiving CDTM services in a community pharmacy setting. In accordance with 243 CMR 2.12, the supervising physician shall
execute a written CDTM referral which shall include, but not be limited to, the patients name and address, the primary diagnosis for which CDTM services are authorized, the diagnosis of any co-morbid conditions for which CDTM services are authorized, any known patient drug allergies, a statement that the patient has executed a written consent to CDTM services and
any other specific instructions to the authorized pharmacist.
Supervising physician, as defined in 243 CMR 2.12(1), means a physician who (1) holds an active license in good standing to
practice medicine in the Commonwealth of Massachusetts; and (2) may delegate specific CDTM services to an authorized
pharmacist pursuant to the terms of the CDTM agreement with the authorized pharmacist.
16.02: Pharmacist Qualifications
(1) In accordance with G.L. c. 112, s. 24B1/2, subsection (b), to qualify to enter into a collaborative practice agreement, a
pharmacist must:

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(a) hold a current unrestricted license in good standing to practice pharmacy in the Commonwealth and currently be
engaged in pharmacy practice in the Commonwealth;
(b) agree to maintain at least $1,000,000 (per occurrence) of professional liability insurance during the term of the
agreement which specifically covers drug therapy management;
(c) have earned a doctor of pharmacy degree or have completed 5 years of experience as a licensed pharmacist;
(d) agree to devote a portion of practice to the defined drug therapy area that the pharmacist shall co-manage;
(e) agree to complete, in each year of the term of the agreement, at least 5 additional contact hours or 0.5 continuing
education units of Board-approved continuing education that address areas of practice generally related to the particular collaborative practice agreement; and
(f) if prescriptive practices are included in the collaborative practice agreement, agree to maintain a current controlled substance registration issued by the Department during the term of the agreement, pursuant to G.L. c. 94C,
ss. 7 and 9 and 105 CMR 700.000.
(2) An authorized pharmacist participating in CDTM must maintain evidence of completion of required continuing education
units for at least two years after the date of the current collaborative practice agreement.
(3) Whenever an authorized pharmacist participating in CDTM is disciplined by the Board, whether by agreement or Board
order, or otherwise subject to any practice restrictions, the authorized pharmacist must provide written notification of such
discipline or practice restriction to each supervising physician.
16.03: Practice Setting Requirements
In accordance with G.L. c. 112, s. 24B1/2, subsection (c), collaborative drug therapy management may be performed in the
following settings by pharmacists meeting the requirements of 247 CMR 16.02(1) and authorized by a supervising physician
pursuant to a current collaborative practice agreement:
(1) Hospitals licensed pursuant to G.L. c. 111, s. 51, subject to approval by the hospital medical staff executive committee or
designee;
(2) Long-Term Care Facilities licensed pursuant to G.L. c. 111, s. 71, subject to approval by the long-term care facility medical director or designee;
(3) Inpatient or Outpatient Hospice Settings licensed pursuant to G.L. c. 111, s. 57D, subject to approval by the hospice medical director or designee;
(4) Ambulatory Care Clinics licensed pursuant to G.L. s. 111, s. 51, with on-site supervision by the attending physician and
an authorized pharmacist, subject to approval by the ambulatory care clinic medical staff executive committee or designee,
or medical director or designee;
(5) Community Pharmacies (retail drug business settings) licensed by the Board pursuant to G.L. c. 112, s. 39, subject to the
restrictions listed below and pursuant to a current collaborative practice agreement that includes the following requirements:
(a) Patient Age. Patients must be 18 years of age or older.
(b) Vaccine Administration. Pharmacists, as authorized pursuant to a collaborative
practice agreement, may administer vaccines.
(c) Patient Referral and Consent. In accordance with 243 CMR 2.12, the collaborative practice agreement must
provide that the supervising physician will:
1. provide a written referral of the patient to the authorized pharmacist;
2. specify the primary diagnosis for the patient and any secondary diagnoses in the written referral or a subsequent referral;
3. provide a copy of the written referral of the patient to the authorized pharmacist for CDTM services to the
patient; and
4. obtain the patients written informed consent to the collaboration in the collaborative practice agreement
and provide a copy of the consent to the patient.

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(d) Record of Referral and Consent. The authorized pharmacist and supervising
physician must maintain a written record of both the individual patient referral and the
patients written informed consent to the collaboration in the patients records which are maintained by the authorized pharmacist and the supervising physician. In accordance with 243 CMR 2.12, the supervising physician shall:
(1) maintain the original patient consent to the referral in the record in the custody of the supervising physician; (2)
transmit a copy of the patients consent to the authorized pharmacist within 24 hours; and (3) provide copies of the
referral and consent to the patient in a timely manner.

(e) Limited Prescribing Authority.

1. An authorized pharmacist currently registered by the Department, pursuant to G.L. c. 94C, ss. 7 and 9
and 105 CMR 700.000, to prescribe and possess controlled substances, who practices in a community pharmacy pursuant to a collaborative practice agreement that includes individually developed prescriptive practice guidelines pursuant to which the supervising physician has authorized the pharmacist to prescribe, may:
a. extend current drug therapy by 30 days for one 30 day period only;
b. initiate, modify or discontinue dosages of medications prescribed by the supervising physician for:
i. asthma;
ii. chronic obstructive pulmonary disease;
iii. diabetes;
iv. hypertension;
v. hyperlipidemia;
vi. congestive heart failure;
vii. HIV or AIDS;
viii. osteoporosis; and
ix. co-morbidities listed in i. - vii. above and identified by the
supervising physician along with the primary diagnosis in the
supervising physicians referral of the patient.
2. An authorized pharmacist must provide a copy of an initial prescription or a modification or discontinuation of a prescription to the supervising physician within 24 hours of its issuance, unless more urgent notification is required under the circumstances. A copy of all prescriptions must be included in the patients
medical record in the custody of the supervising physician; and
3. No authorized pharmacist in a community pharmacy may prescribe or be
authorized to prescribe Schedule II through V controlled substances, as defined in G.L. c. 94C, s. 3, subsections (2) through (5).
4. An authorized pharmacist in a community pharmacy may be authorized by a supervising physician to issue prescriptions for Schedule VI controlled substances, as defined in G.L. c. 94C, s. 3, subsection (6), for
the diagnoses specified in the supervising physicians patient referral.
16.04: Collaborative Practice Agreements Required Agreement Terms for All Practice Settings; Duties; Biennial Renewal; Termination; Agreement to be Filed in Primary Practice Setting; and Employment Relationships
(1) Required Agreement Terms for All Practice Settings. In addition to specific practice setting collaborative practice
agreement requirements, pursuant to 247 CMR 16.03, and in accordance with G.L. c. 112, s. 24B3/4 and 243 CMR
2.12, all collaborative practice agreements must also include:
(a) specific disease state(s) being co-managed, with each disease state identified as either primary or co-morbid;
(b) specific pharmacist prescribing authority pursuant to the CDTM agreement;
(c) detailed practice protocols;

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(d) description of risk management activities;
(e) documentation of any initiation, modification or discontinuation of a patients medication in the patients
permanent medical record;
(f) description of outcome measurements;
(g) detailed informed consent procedures;

(h) detailed procedures and periods by which time any test results, copies of initial
prescriptions, modifications or discontinuances, copies of the patient consent and
the CDTM agreement, and other patient information will be forwarded by the
authorized pharmacist to the supervising
physician, and a specific procedure for the authorized pharmacist to identify and transmit any urgent communications; description of the nature and form of the supervision of the authorized pharmacist
by
the supervising physician, and a description of the procedure to follow when
either the authorized pharmacist or supervising physician is unavailable or absent;
(i) the authorized pharmacists attestation of satisfaction of the qualifications listed in
247 CMR16.02 (1) for participating in collaborative drug therapy management;
and
(j) the supervising physicians attestation of satisfaction of the qualifications listed in
243 CMR 2.12 for participating in collaborative drug therapy management.
(2) Duties. A collaborative practice agreement shall specify those duties of the
authorized pharmacist that may be delegated to other appropriately trained and authorized staff and those duties under the agreement that shall not be delegated. A collaborative practice agreement shall specify when and how an
authorized pharmacist may delegate duties under the agreement, and the duration and scope of the delegation.
Pharmacy interns and pharmacy technician duties providing support to an authorized pharmacist acting pursuant to
a collaborative practice agreement must perform services in accordance with 247 CMR sections 8.01 (pharmacy interns) and 8.02 through 8.06 (pharmacy technicians).
(3) Biennial Renewal. A collaborative practice agreement must be reviewed and renewed by
the authorized pharmacist and supervising physician(s) at least every two years.
(4) Termination. Prior to termination or non-renewal of a CDTM agreement, an authorized
pharmacist and supervising physician shall arrange for an uninterrupted continuation of
the patients drug therapy, in accordance with the terms of the CDTM agreement. When
a CDTM agreement is not renewed or CDTM is otherwise terminated, an authorized
pharmacist and supervising physician shall inform the patient in writing of the
termination and of the procedures in place for the continuation of the patients drug
therapy, in accordance with the terms of the CDTM agreement.
(5) Agreement to be Filed in Primary Practice Setting. An authorized pharmacist must
maintain a copy of the current CDTM agreement, including copies of current patient referral and patient consent, in
the primary practice setting, readily retrievable at the request of the Boards of Registration in Pharmacy and Medicine. In accordance with 243 CMR 2.12, the supervising physician must maintain the original of the current CDTM
agreement, including original of current patient referral and patient consent, in the patients medical record in the
custody of the supervising physician.
(6) Employment Relationships. In accordance with G.L. c. 112, s. 24B1/2, subsection (e):
(a) A qualified pharmacist may be hired by a physician or group of physicians for the purpose of practicing collaborative drug therapy management under an agreement for the benefit of a patient of that physician or physician group;

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(b) A community pharmacy may hire a physician or licensed medical practitioner to conduct quality assurance reviews of pharmacists engaged in collaborative drug therapy management; and
(c) No community pharmacy may employ a physician for the purpose of maintaining, establishing or entering into a
collaborative practice agreement.

C. Draft of Board of Medicine Regulation concerning Collaborative Drug Therapy Management with
Pharmacists/Physicians
DRAFT
243 CMR: BOARD OF REGISTRATION IN MEDICINE
243 CMR 2.12:

COLLABORATIVE DRUG THERAPY MANAGEMENT

2.12: Collaborative Drug Therapy Management (CDTM) with Authorized Pharmacists

Chapter 528 of the Acts of 2008 (amending G.L. c. 94C, 7 and 9 and G.L. c. 112, 24B and 24B ) authorized pharmacists and physicians to engage in collaborative drug therapy management (CDTM) in the Commonwealth pursuant to collaborative practice agreements meeting the requirements of regulations adopted by the Boards
of Registration in Pharmacy and Medicine. The Board of Registration in Pharmacy has promulgated 247 CMR
16.00 in accordance with G.L. c. 112, 24B and 24B . Board of Registration in Medicine regulations (243
CMR 2.12) include additional definitions and requirements applicable to pharmacists and physicians entering into
collaborative practice agreements to practice CDTM in the Commonwealth.
(1) Definitions. Additional definitions applicable to the practice of CDTM in the Commonwealth appear in Board of
Registration in Medicine regulations at 243 CMR 2.12 and Board of Registration in Pharmacy regulations at 247
CMR 16.00.
As used in this section and defined in G.L. c. 112, 24B , subsection (a), the following words shall have the following meanings:
Authorized pharmacist means a pharmacist who (1) is currently registered by the Board of Registration in Pharmacy
and is in good standing; (2) meets the requirements of 247 CMR 16.02; and (3) is participating in drug therapy management with a supervising physician pursuant to a written CDTM agreement with written protocols.
Board means the Board of Registration in Medicine.
Collaborative drug therapy management or CDTM means the initiating, monitoring, modifying and discontinuing
of a patients drug therapy by an authorized pharmacist under the supervision of a physician in accordance with a
collaborative practice agreement. Collaborative drug therapy management may include: collecting and reviewing
patient histories; obtaining and checking vital signs, including pulse, temperature, blood pressure and respiration;
and, under the supervision of, or in direct consultation with, a physician, ordering and evaluating the results of laboratory tests directly related to drug therapy when performed in accordance with approved protocols applicable to the
practice setting and when the evaluation shall not include a diagnostic component.

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State Pharmacy Law Review

Collaborative practice agreement or CDTM agreement means a written and signed agreement between an authorized pharmacist with training and experience relevant to the scope of the collaborative practice and a supervising
physician that defines the collaborative practice in which the authorized pharmacist and supervising physician propose to practice. The collaborative practice must be within the scope of the supervising physicians practice. In the
community pharmacy setting, the CDTM agreement shall include a written referral of an identified patient from the
supervising physician to an authorized pharmacist, and shall include a written consent to the CDTM agreement by
the named patient.

Community Pharmacy means a retail drug business setting, licensed pursuant to G.L. c. 112, 38-39. When there is
a collaborative drug therapy management agreement between an authorized pharmacist in a community pharmacy
and a supervising physician, the physician must obtain the informed consent of the patient in writing prior to participating in CDTM.
License means a certificate of registration which the board issues to a person pursuant to the requirements of M.G.L.
c. 112, 2, 9 and 9B, and which authorizes the person to engage in the practice of medicine.
Patient means a person who is referred to an authorized pharmacist by a supervising physician for the purpose of
receiving collaborative drug therapy management services from the pharmacist. In the community pharmacy setting,
(1) the patient must be notified of, and provide written consent to, the collaborative drug therapy management services, and (2) the supervising physician must provide the patient with a copy of the referral to the authorized pharmacist
and the written consent to the referral provided by the patient.
Referral means the individual patient referral by a supervising physician to an authorized pharmacist for the purpose
of receiving CDTM services in a community pharmacy setting. The supervising physician shall execute a written
CDTM referral which shall include, but is not limited to, the patients name and address, the primary diagnosis for
which CDTM services are authorized, the diagnosis of any co-morbid conditions for which CDTM services are authorized, any known patient drug allergies, a statement that the patient has executed a written consent to CDTM services, and any other specific instructions to the authorized pharmacist.
Supervising physician means a physician who holds an active license to practice medicine in the Commonwealth of
Massachusetts. A supervising physician in a CDTM agreement may only delegate to an authorized pharmacist pursuant to the written agreement and protocols with the pharmacist.
(2) Pharmacist Qualifications. In accordance with G.L. c. 112, 24B , subsection (b), to qualify to enter into a collaborative practice agreement, a pharmacist must:
(a) hold a current unrestricted license in good standing to practice pharmacy in the commonwealth and cur
rently be engaged in pharmacy practice in the Commonwealth;
(b) agree to maintain at least $1,000,000 (per occurrence) of professional liability insurance during the term
of the agreement which specifically covers drug therapy management;
(c) have earned a doctor of pharmacy degree or have completed 5 years of experience as a licensed pharma
cist;
(d) devote a portion of the practice to the defined drug therapy area that the pharmacist shall co-manage;
(e) agree to complete, in each year of the term of the agreement, at least 5 additional contact hours or 0.5
continuing education units (CEUs) of Board of Registration in Pharmacy-approved continuing education
that ad dress areas of practice generally related to the particular collaborative practice agreement; and

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(f) if prescriptive practices are included in the collaborative practice agreement, agree to maintain a current
controlled substance registration issued by the Department during the term of the agreement, pursuant to
G.L. c. 94C, 7 and 9 and 105 CMR 700.000.
(g) Whenever an authorized pharmacist participating in a CDTM agreement is disciplined by the Board of
Registration in Pharmacy, whether by consent agreement or by a final decision and order, or otherwise sub
ject to any practice restrictions, the authorized pharmacist must provide written notification of such disci
pline or practice restriction to each supervising physician.

(3) Physician Qualifications.

(a) To be eligible to participate in a collaborative drug therapy management agreement, a physician must
possess an active license to practice medicine issued by the board, and must be actively engaged in the clini
cal practice of medicine and the provision of patient care in the particular field of medicine in which the col
laborative drug therapy management is to take place.
(b) The physician is the supervisor in the CDTM agreement and retains the ultimate responsibility for the
care of the patient. In a community pharmacy setting, a physician should enter into only as many CDTM
agreements setting as he/she can reasonably and safely supervise at one time.
(c) The supervising physician shall assess the patient and make a written referral of the identified patient to
the authorized pharmacist. The supervising physicians written referral shall include a primary diagnosis
and any co-morbid conditions that are included in the CDTM.
(d) A physician is ineligible to participate in a CDTM if he is in a Voluntary Agreement Not to Practice
Medicine with the board, or has had his license to practice medicine temporarily suspended or revoked by
the board. A physician shall be deemed ineligible to participate in CDTM if he has voluntarily surrendered
or had suspended, revoked or restricted his/her controlled substances license, permit or registration, either
state or federal. The board may revoke a physicians right to participate in a CDTM agreement for any of
the grounds for discipline enumerated in 243 CMR 1.03(5).
(e) Whenever the board enters into a Voluntary Agreement Not to Practice with a licensee, or summarily sus
pends a physicians license, the board may require that the physician provide written notification to each
authorized pharmacist with whom the physician is in a CDTM agreement. Whenever the board takes final
disciplinary action against a licensee, either by a final decision and order or by consent agreement, the
board may require that the physician provide written notification to each authorized pharmacist with whom
he/she is in a CDTM agreement.
(4) Practice Setting Requirements. In accordance with G.L. c. 112, 24B, subsection (c), collaborative drug therapy management may be performed in the following settings by pharmacists meeting the requirements of 247 CMR
16.02(1) and authorized by a supervising physician pursuant to a current collaborative practice agreement:
(a) Hospitals licensed pursuant to G.L. c. 111, 51, subject to approval by the medical staff executive com
mittee at a licensed hospital or designee;
(b) Long-Term Care Facilities licensed pursuant to G.L. c. 111, 71, subject to approval by the long-term
care facility medical director or designee;
(c) Inpatient or Outpatient Hospice Settings licensed pursuant to G.L. c. 111, 57D, subject to approval by
the hospice medical director or designee;
(d) Ambulatory Care Clinics licensed pursuant to G.L. c. 111, 51, with on-site supervision by the attending
physician and an authorized pharmacist, subject to approval by the ambulatory care clinic medical staff ex
ecutive committee or designee, or medical director or designee;

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(e) Community Pharmacies (retail drug business settings) licensed by the Board of Registration in Pharmacy
pursuant to c. 112, 39, subject to restrictions listed below and pursuant to a current collaborative practice
agreement that includes the following requirements:
1. Patient Age. Patients must be 18 years of age or older;
2. Vaccine Administration. Pharmacists, as authorized pursuant to a collaborative practice agree
ment, may administer vaccines;
3. Patient Referral and Consent. The collaborative practice agreement must provide that the super
vising physician will:
a. provide a written referral of the patient to the authorized pharmacist
b. specify the primary diagnosis for the patient and any secondary diagnoses in a written
referral or a subsequent referral;
c. provide a copy of the written referral of the patient to the authorized pharmacist for
CDTM services to the patient; and
c. obtain the patients written and informed consent to the collaboration and provide a copy
of the consent to the patient.
4. The patients written consent form shall include the following: The pharmacist shall not sup
plant the physician as the principal medical decision maker;
5. Record of Referral and Consent. The authorized pharmacist and supervising physician must maintain a written record of both the individual patient referral and the patients written informed consent to the collaboration in the patients record to be maintained by the authorized pharmacist and the supervising physician. The
supervising physician shall: (1) maintain the original patient consent to the referral in the record in the custody of
the supervising physician; (2) transmit a copy of the patients consent to the authorized pharmacist within 24 hours;
and (3) provide copies of the referral and consent to the patient in a timely manner.
6. Limited Prescribing Authority. A pharmacist currently registered by the Department, pursuant to
G.L. c. 94C, 7 and 9 and 105 CMR 700.00, to prescribe and possess controlled substances, who
practices
in a
community pharmacy pursuant to a collaborative practice agreement that
includes individually de veloped
prescriptive practice guidelines pursuant to which
the supervising physician has authorized the pharmacist to prescribe, may:
a. extend current drug therapy prescribed by the supervising physician by 30 days for one 30
day
period only;
b. initiate, modify or discontinue dosages of medications prescribed by the supervising phy
sician for:
i.
asthma;
ii.
chronic obstructive pulmonary disease;
iii.
diabetes;
iv.
hypertension;
v.
hyperlipidemia;
vi.
congestive heart failure;
vii.
HIV or AIDS;
viii.
osteoporosis; and
ix.
co-morbidities, listed in (i-viii) above, and identified by the supervising phy
sician along with the primary diagnosis on the physicians referral of the patient.
c. The authorized pharmacist must provide a copy of an initial prescription, a modification
or a discontinuation of a prescription to the supervising physician within 24 hours of its is
suance, unless more urgent notification is required under the circumstances. A copy of all

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State Pharmacy Law Review

prescriptions must be included in the patients medical record in the custody of the supervis
ing physician.
7. No authorized pharmacist in a community pharmacy may prescribe or be authorized to prescribe
Schedule II through V controlled substances, as defined in G.L. c. 94C, 3, subsections (2) through
(5).
8. An authorized pharmacist in a community pharmacy may be authorized by a supervising physician
to issue prescriptions for Schedule VI controlled substances, as defined in G.L. c. 94C, 3, subsec
tion (6), for the diagnoses specified in the supervising physicians patient referral.

(5) Collaborative Practice Agreements

(a) Required Agreement Terms for All Practice Settings. In addition to specific practice setting collaborative
practice agreement requirements, pursuant to 247 CMR 16.03, and in accordance with G.L. c. 112, 24B ,
all collaborative practice agreements must also include:
1. specific disease state(s) being co-managed, with each disease state identified as either primary or
co-mor bid;
2. specific pharmacist prescribing authority pursuant to the agreement;
3. detailed practice protocols;
4. description of risk management activities;
5. documentation of any initiation, modification or discontinuation of a patients medication in the
patients medical record in the custody of the supervising physician;
6. description of outcome measurements;
7. detailed informed consent procedures;
8. detailed procedures and periods by which time any test results, copies of initial prescriptions,
modifications or discontinuances, copies of the patient consent and the CDTM agreement, and other
patient information will be forwarded from the authorized pharmacist to the supervising physician,
and a specific procedure for the pharmacist to identify and transmit any urgent communications; and
description of the nature and form of the supervision of the authorized pharmacist by the supervising
physician, and a description of the procedure to follow when either the authorized pharmacist or the
supervising physician is unavailable or absent;
9. the authorized pharmacists attestation of satisfaction of the qualifications listed in 247 CMR
16.02(1) for participating in collaborative drug therapy management; and
10. the supervising physicians attestation of satisfaction of the qualifications listed in 243 CMR 2.12
for participating in collaborative drug therapy management.
(b) Duties. A collaborative practice agreement shall specify those duties of the authorized pharmacist that may be
delegated to other staff and those duties under the agreement that shall not be delegated. A collaborative practice
agreement shall specify when and how a supervising physician may delegate duties under the agreement, and the duration and scope of the delegation.
(c) Biennial Renewal. A collaborative practice agreement must be reviewed and renewed by the authorized pharmacist and supervising physician(s) at least every two years.
(d) Termination. Prior to terminating a CDTM agreement, the parties shall arrange for an uninterrupted continuation of the patients drug therapy. When CDTM is terminated, the patient shall be informed in writing of the termina-

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State Pharmacy Law Review

tion and of the procedures in place for continuation of his or her drug therapy. The supervising physician has an
ongoing responsibility for patient care unless and until the physician-patient relationship is terminated.
(e) Agreement to be Filed in Primary Practice Setting. An authorized pharmacist must maintain a copy of the current collaborative practice agreement in the primary practice setting, readily retrievable at the request of the Board
of Registration in Medicine and the Board of Registration in Pharmacy. The supervising physician must maintain the
original of the current collaborative practice agreement and the original of the patients written consent in the
patients medical record in his/her custody. The supervising physician must maintain the patients medical record in
his/her custody and make it available upon request during an investigation by the Board of Registration in Medicine.
(f) Employment Relationships. In accordance with G.L. c. 112, 24B , subsection (e):
1. A qualified pharmacist may be hired by a physician or group of physicians for the purpose of practicing
collaborative drug therapy management under an agreement for the benefit of the patient of that physician or
physician group;
2. A community pharmacy may hire a physician or licensed medical practitioner to conduct quality assur
ance reviews of pharmacists engaged in collaborative drug therapy management; and
3. No community pharmacy may employ a physician for the purpose of maintaining, establishing or entering
into an agreement.

D. Department of Public Health Regulations

Due to the length of the following regulations, those not directly related to pharmacy have been excluded. To see full text of
following regulations go to: http://www.mass.gov/dph/dcp

105 CMR 700.000: IMPLEMENTATION OF M.G.L. c. 94C

MGL c. 94 C is the Controlled Substances Act of Massachusetts
Section
700.001: Definitions
700.002: Schedules of Controlled Substances
700.003: Registration of Persons for a Specific Activity or Activities in Accordance with M.G.L. c. 94C,
7(g)
700.004: Registration Requirements
700.005: Security Requirements
700.006: Requirements for Records, Inventories, and Reports
700.007: Inspection of Premises
700.011: Issuance of Prescriptions or Medication Orders for Implantable Infusion Pumps Containing
Schedule II or Schedule III Controlled Substance
700.001: Definitions
For the purpose of 105 CMR 700.000, the following definitions apply, in addition to those definitions appearing in M.G.L. c.
94C, 1, unless the context or subject matter requires a different meaning.
Administer means the direct application of a controlled substance whether by injection, inhalation, ingestion or any other
means to the body of a patient or research subject by:
(1) A practitioner or

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State Pharmacy Law Review

(2) A registered nurse or licensed practical nurse at the direction of a practitioner in the course of his professional
practice, or
(3) An ultimate user or research subject at the direction of a practitioner in the course of his professional practice.

Bureau means the Bureau of Narcotics and Dangerous Drugs, United States Department of Justice or its successor agency.
Certified Nurse Midwife means a nurse authorized to practice as a nurse midwife by the Board of Registration in Nursing, as
provided for in M.G.L. c. 112, 80B and 80C and regulations of the Board of Registration in Nursing, 244 CMR 4.00 et seq.,
most specifically 244 CMR 4.11 through 4.27.
.
Commissioner means the Commissioner of Public Health or his duly authorized agent.
.
Controlled Substance means a drug, substance, or immediate precursor in any schedule or class referred to in M.G.L. c. 94C
or 105 CMR 700.000.
Compounding means in the definition of "Manufacture", compounding a controlled substance other than:
(1) By a practitioner or,
(2) By a pharmacist subject to a prescription.
Customer Identifier means the identification number on a valid government issued identification, as specified by the Department, which a pharmacy obtains by inspecting the identification of the ultimate user or agent of the ultimate user to whom a
prescription is dispensed.
Deliver means to transfer, whether by actual or constructive transfer, a controlled substance from one person to another,
whether or not there is an agency relationship
.
Department means the Department of Public Health.
Department of Mental Health means the Massachusetts Department of Mental Health.
Depressant or Stimulant Substance means:
(1) A drug which contains any quantity of barbituric acid or any of the salts of barbituric acid; or any derivative of
barbituric acid which the United States Secretary of Health, Education and Welfare has by regulation designated as
habit forming; or
(2) A drug which contains any quantity of amphetamine or any of its optical isomers; any salt of amphetamine or any
salt of an optical isomer of amphetamine; or any substance which the United States Attorney General has by regulation
designated as habit forming because of its stimulant effect on the central nervous system; or
(3) Lysergic acid diethylamide; or
(4) Any drug except marihuana which contains any quantity of a substance which the United States Attorney General
has by regulation designated as having a potential for abuse because of its depressant or stimulant effect on the central
nervous system or its hallucinogenic effect.

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State Pharmacy Law Review

Dispense means to deliver a controlled substance to an ultimate user or research subject or to the agent of an ultimate user or
research subject by a practitioner or pursuant to the order of a practitioner, including the prescribing and administering of a
controlled substance and the packaging, labeling, or compounding necessary for such delivery.
Distribute means to deliver other than by administering or dispensing a controlled substance.
Drug means:
(1) Substances recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the
United States or official National Formulary or any supplement to any of them;
(2) Substances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or animals;
(3) Substances, other than food, intended to affect the structure or any function of the body of man and animals; or
(4) Substances intended for use as a component of any article specified in 105 CMR 700.001(M)(1) through 700.001(M)(3),
exclusive of devices or their components, parts or accessories.
.
Health Facility means:
(1) A hospital, hospital pharmacy, long-term care facility, or clinic or institution for unwed mothers, infirmary
maintained in a town, convalescent home, nursing home or charitable home for the aged, licensed or maintained by
the Department; or
(2) A public medical institution as defined in M.G.L. c. 118E, 2; or
(3) Any institution licensed or maintained by the Department of Mental Health; or
(4) Any hospital, long-term care facility or clinic maintained by the Commonwealth.
(5) Any ambulance service licensed by the Department to provide Advanced Life Support services.
.
Hospital a means any institution, however named, whether conducted for charity or for profit, which is advertised, announced,
established or maintained for the purpose of caring for persons admitted thereto for diagnosis, medical, surgical or restorative
treatment which is rendered within said institution.
Immediate Precursor means a substance which the Commissioner has found to be and by rule designates as being the principal
compound commonly used or produced primarily for use, and which is an immediate chemical intermediary used or likely to
be used in the manufacture of a controlled substance, the control of which is necessary to prevent, curtail or limit manufacture.
Implantable Infusion Pump means a device that is intended to be implanted in the human body for the purpose of delivering a
controlled flow of drug(s).

Isomer means the optical isomer, except that wherever appropriate it shall mean the optical, position or geometric isomer.
Labeling means in the definition of "manufacture", labeling or relabeling other than:
(1) By a practitioner, or
(2) By a pharmacist.
Long-term Care Facility means any institution whether conducted for charity or profit, which is advertised, announced or
maintained for the express or implied purpose of providing three or more individuals admitted thereto with long-term resident,
nursing, convalescent or rehabilitative care; supervision and care incident to old age for ambulatory persons; or retirement
home care for elderly persons. For the purposes of 105 CMR 700.000 only, long-term care facility shall include hospitals which

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are licensed solely to provide chronic and/or rehabilitative care, state schools for mentally retarded persons, state hospitals
for mentally ill persons, convalescent or nursing homes, rest homes, infirmaries maintained in towns and charitable homes for
the aged.
(1) "Convalescent or nursing homes, rest homes, infirmaries maintained in a town, and charitable homes for the aged"
shall have the same meanings as those terms defined in M.G.L. c. 111, 71.
(2) "Long-term Care" means care of significant duration, as distinguished from acute short-term care provided in a
general hospital, and shall not include care provided in a hospital licensed to provide acute care.
Manufacture means the production, preparation, propagation, compounding, conversion or processing of a controlled
substance, either directly or indirectly by extraction from substances of natural origin or independently by means of chemical
synthesis, including any packaging or repackaging of the substance or labeling or relabeling of its container except that this
term does not include the preparation or compounding of a controlled substance by an individual for his own use or the
preparation, compounding, packaging or labeling of a controlled substance:
(1) By a practitioner as an incident to his administering a controlled substance in the course of his professional
practice, or
(2) By a practitioner, or by his authorized agent under his supervision, for the purpose of, or as an incident to,
research, teaching or chemical analysis and not for sale.
.
Medication Order means a written order for medication entered on a patient's medical record maintained at a hospital or other
inpatient health facility and is dispensed for immediate administration to the ultimate user by an individual authorized by
M.G.L. c. 94C to administer such medication.
Narcotic drug means any of the following, whether produced directly or indirectly by extraction from substances of vegetable
origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:
(1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate;
(2) Any salt, compound, isomer, derivative or preparation thereof which is chemically equivalent or identical with any
of the substances referred to in 105 CMR 700.001(T)(1), but not including the isoquinoline alkaloids of opium;
(3) Opium poppy and poppy straw;
(4) Coca leaves and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, isomer,
derivative or preparation thereof which is chemically equivalent or identical with any of these substances, but not
including decocainized coca leaves or extractions of coca leaves which do not contain cocaine or ecgonine.
National Association of Boards of Pharmacy (NABP) Number means a unique seven digit number issued by the National
Council for Prescription Drug Programs (NCPDP).
National Drug Code Number (NDC) means a nationally recognized standard which identifies drug products using a unique
number, issued by the United States Food and Drug Administration, involving three components. The first component identifies
the drug manufacturer ("LABELER NO.") the second identifies the product "PRODUCT NO.", the third identifies the package
size "PKG".
.
Nurse Practitioner means a nurse authorized to practice as a nurse practitioner by the Board of Registration in Nursing as
provided for in M.G.L. c. 112, 80B and regulations of the Board of Registration in Nursing, 244 CMR 4.00 et seq., most
specifically 244 CMR 4.11 through 4.27.
Opiate means any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being
capable of conversion into a drug having addiction-forming or addiction-sustaining liability. It does not include, unless

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State Pharmacy Law Review

specifically designated as controlled under M.G.L. c. 94C, 2, the dextrorotatory isomer of 3-methoxy-n-methyl-morphinan
and its salts, dextromethorphan. It does include its racemic and levorotatory forms.
Opium Poppy means the plant of the species Papaver somniferum L., except its seeds.
Oral Prescription means an oral order for medication which is dispensed to or for an ultimate user, but not including an order
for medication which is dispensed for immediate administration to the ultimate user by a practitioner, registered nurse, or
practical nurse.
Packaging means in the definition of "manufacture", packaging or repackaging a controlled substance other than:
(1) By a practitioner or,
(2) By a pharmacist.
Person means individual, corporation, government, governmental subdivision or agency, business trust, estate, trust, partnership, association, or any other legal entity.
Physician Assistant means a physician assistant authorized to practice by the Board of Registration of Physician Assistants, as
provided for in accordance with M.G.L. c. 112, 91 and authorized to prescribe by St. 1991, c. 445, 7(g) in accordance with
regulations of the Board of Registration of Physician Assistants, 263 CMR 2.00 et seq.
Poppy Straw means all parts, except the seeds of the opium poppy, after mowing.
Practical Nurse means a nurse who is licensed pursuant to the provisions of M.G.L. c. 112, 74A.
Practitioner means:
(1) A physician, dentist, veterinarian, podiatrist, scientific investigator or other person registered to distribute,
dispense, conduct research with respect to, or use in teaching or chemical analysis, a controlled substance in the
course of professional practice or research in the commonwealth;
(2) A pharmacy, hospital or other institution registered to distribute, dispense, conduct research with respect to or to
administer a controlled substance in the course of professional practice or research in the commonwealth.
(3) An optometrist authorized by M.G.L. c. 112, 66 and 66B and registered pursuant to M.G.L. c. 94C, 7(h) to
utilize and prescribe topical therapeutic pharmaceutical agents, as defined in M. c. 112, 66B, in the course of
professional practice in the commonwealth..
Prescription Drug means any and all drugs upon which the manufacturer or distributor has, in compliance with federal laws
and regulations, placed the following: "Caution, Federal law prohibits dispensing without prescription."
Psychiatric Nurse means a nurse authorized to practice as a psychiatric nurse mental health clinical specialist by the Board of
Registration in Nursing, as provided for in M.G.L. c. 112, 80B and regulations of the Board of Registration in Nursing, 244
CMR 4.00 et seq., most specifically 244 CMR 4.11 through 4.27.
Registered Individual Practitioner shall mean a physician, dentist, veterinarian, podiatrist, certified nurse midwife, nurse
practitioner, psychiatric nurse or physician assistant who is registered pursuant to 105 CMR 700.004.
Registered Nurse means a nurse who is registered pursuant to the provisions of M.G.L. c. 112, 74.
Registrant means a person who is registered pursuant to any provision of M.G.L. c. 94C.

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Registration means unless the context specifically indicates otherwise such registration as is required and permitted only
pursuant to the provisions of M.G.L. c. 94C.
Registration Number means the unique registration number required with respect to a practitioner by, and assigned to a
practitioner by, the Bureau of Narcotics and Dangerous Drugs or by the Department of Public Health or both
.
Sample Medication for the purpose of 105 CMR 700.000 shall mean a unit of prescription drug distributed by the manufacturer
or distributor to practitioners in the original package from the manufacturer, not repackaged and given free of charge to
patients. Such medications shall include but not be limited to those medications dispensed as part of an indigent patient drug
program.
Schedule means the list of controlled substances established by the Commissioner pursuant to the provisions of M.G.L. c. 94C,
2 for purposes of administration and regulation.

Self-medicating means personally taking or applying prescription medication in the manner directed by the prescribing
practitioner, with no more than minimal assistance or direction from program staff, in accordance with procedures and criteria
established by the Department of Mental Health or Department of Mental Retardation and approved by the Department of
Public Health.
Supervising Physician means a physician who provides supervision to a physician assistant in accordance with M.G.L. c. 112,
9C through 9H, or who provides supervision to a certified nurse midwife, a nurse practitioner or psychiatric nurse mental
health clinical specialist as provided for in 244 CMR 4.05(9) (Board of Registration in Nursing).
..
Ultimate User means a person who lawfully possesses a controlled substance for his own use or for the use of a member of his
household or for administering to an animal owned by him or by a member of his household.
Universal Claim Form (UCF) means a nationally recognized standard form developed by the National Council for Prescription
Drug Programs, used for billing prescription drug claims to insurance plans and available through the pharmacy's local
wholesaler.
Written Prescription means a written order for medication which is dispensed to or for an ultimate user, but not including an
order for medication which is dispensed for immediate administration to the ultimate user by a practitioner, registered nurse
or practical nurse.
700.002: Schedules of Controlled Substances
Note that the schedules II-IV of drugs in Mass. are identical to the schedules contained in federal law. However, Masschusetts classifies all other prescription drugs as Schedule VItherefore the Mass. Controlled Substances Act and its implementing regulations apply to all prescription drugs.
The following schedules of controlled substances are established:
(A) Schedule I. Schedule I shall consist of the drugs and other substances, by whatever official name, common or usual name,
chemical name, or brand name designated, listed in 21 CFR 1308.11.
(B) Schedule II. Schedule II shall consist of the drugs and other substances, by whatever official name, common or usual name,
chemical name, or brand name designated, listed in 21 CFR 1308.12.

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State Pharmacy Law Review

(C) Schedule III. Schedule III shall consist of the drugs and other substances, by whatever official name, common or usual
name, chemical name, or brand name designated, listed in 21 CFR 1308.13.
(D) Schedule IV. Schedule IV shall consist of the drugs and other substances, by whatever official name, common or usual
name, chemical name, or brand name designated, listed in 21 CFR 1308.14.
(E) Schedule V. Schedule V shall consist of the drugs and other substances, by whatever official name, common or usual name,
chemical name, or brand name designated, listed in 21 CFR 1308.15.
(F) Schedule VI. Schedule VI shall consist of all prescription drugs, which are not included in any other schedule established
by the Commissioner.

Pharmacists are registered under the Controlled Substances Act through the State Board of Pharmacy.
700.003: Registration of Persons for a Specific Activity or Activities in Accordance with M.G.L. c. 94C, 7(g)

Note that certified midwives, nurse practitioners, psychiatric nurses or physician assistants may issue written prescriptions for
Schedule II-VI under the following conditions.
C) A certified nurse midwife, nurse practitioner, psychiatric nurse or physician assistant may issue written prescriptions and
medication orders for Schedule II through VI controlled substances, provided that the following requirements are met:
(1) The certified nurse midwife, nurse practitioner and psychiatric nurse meets all requirements set forth in regulations
established by the Board of Registration in Nursing, 244 CMR 4.00 et seq. and M.G.L. c. 112, 80B, 80C, 80E, and
80F.
(2) The physician assistant meets all requirements set forth in regulations established by the Board of Registration of
Physician Assistants, 263 CMR 2.00 et seq. and M.G.L. c. 13, 10B and M.G.L. c. 112, 9C through 9K.
(3) The certified nurse midwife, nurse practitioner, psychiatric nurse or physician assistant registers with the Department's Division of Food and Drugs, in accordance with 105 CMR 700.004 and with the Drug Enforcement Administration, in accordance with 21 CFR 1300
4) The certified nurse midwife, nurse practitioner, psychiatric nurse or physician assistant practices in accordance
with written guidelines governing the prescription of medication mutually developed and agreed upon by the certified
nurse midwife, nurse practitioner, psychiatric nurse or physician assistant and a supervising physician pursuant to
regulations promulgated under M.G.L. c. 112, 80B, 80C, 80E and 80G and M.G.L. c. 112, 9E that describes the
methods to be followed in managing a health care situation or in resolving a health care problem. 105 CMR
700.03(C)(4)(a) and (b) will remain in full force and effect until such time as regulations are promulgated by the Board
of Registration in Nursing in accordance with M.G.L. c. 112, 80B, 80C, 80E and 80G and by the Board of
Registration of Physician Assistants in accordance with M.G.L. c. 112, 9E.
(a) Such guidelines for the certified nurse midwife, nurse practitioner, psychiatric nurse or physician assistant
shall address, but need not be limited to, such issues as frequency of medication review by the certified nurse
midwife, nurse practitioner, psychiatric nurse or physician assistant and the supervising physician; review of
initial prescriptions or changes in medication by the supervising physician; procedures for initiating intravenous solutions; and limits, if any, on the types of medication to be prescribed, the quantity and duration of
prescriptions and the issuance of refill prescriptions.

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State Pharmacy Law Review

(b) In the case of a Schedule II drug as defined in 105 CMR 700.002, a prescription shall be reviewed by a
supervising physician within 72 hours of issuance.
(5) All prescriptions issued by the certified nurse midwife, nurse practitioner, psychiatric nurse or physician assistant
are consistent with the scope of practice as defined by 244 CMR 4.26 for nurses practicing in the expanded role and
263 CMR 2.00 for physician assistants.
(6) The certified nurse midwife, nurse practitioner, psychiatric nurse or physician assistant may order controlled
substances in Schedule VI from a drug wholesaler, manufacturer, laboratory or distributor. For the purpose of
dispensing medication in Schedules II-V for immediate treatment, the certified nurse midwife, nurse practitioner,
psychiatric nurse or physician assistant may obtain such medication only as supplied by the supervising physician or
obtained through a written prescription for the patient.

Note requirements for oral prescriptions.

(7) A certified nurse midwife, nurse practitioner, psychiatric nurse or physician assistant may issue oral prescriptions
in accordance with M.G.L. c. 94C, 20, provided that the person issuing the prescription clearly identifies his or her
name and professional designation to the pharmacist and provides his or her registration number, work address, phone
number, and the name of the supervising physician. An oral prescription shall be followed up with a written
prescription by the certified nurse midwife, nurse practitioner, psychiatric nurse or physician assistant to be provided
to the pharmacist or postmarked within a period of not more than seven days or such shorter period as required by
federal law, in accordance with M.G.L. c. 94C, 20.
(8) A certified nurse midwife, nurse practitioner, psychiatric nurse or physician assistant may prescribe controlled
substances for a patient in a health facility or other setting through use of written medication orders entered on the
patient's medical record maintained at the facility, provided that such written orders meet all applicable provisions of
105 CMR 700.000.

Optometrists prescription privileges are limited to the following:

(G) Optometrists may utilize and issue written prescriptions and medication orders, in accordance with the provisions of
M.G.L. c. 112, 66 and 66B, for those topical pharmaceutical agents in Schedule VI required for the diagnosis, prevention,
management or treatment of abnormal ocular conditions or diseases as defined in M.G.L. c. 112, 66, except glaucoma.

700.004: Registration Requirements

This section authorizes pharmacists to administer (dispense by administration) influenza vaccine and other immunizations.
Note the requirements of 1) patient 18 years or older 2) order of a practitioner and 3) done in accordance with guidelines
specified in (c) below.
(6) A registered pharmacist may dispense by administration influenza vaccine and other immunizations designated by
the Department to persons 18 years of age or older provided that:
(a) Such registered pharmacist is authorized to dispense controlled substances in accordance with M.G.L. c. 112;
(b) Such administration is conducted pursuant to the order of a practitioner; and
(c) Such activity is conducted in accordance with guidelines adopted by the Department which shall include, but not
be limited to, requirements for:

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1. training accredited by the Centers for Disease Control and Prevention, the American Council on Pharmaceutical Education or a similar health authority or professional body; and
2. pre-administration education and screening;
3. vaccine storage and handling;
4. administration of medication, including administration of controlled substances as necessary for the
management of medical emergencies;
5. record keeping; and
6. reporting of adverse events.
700.005: Security Requirements
Pharmacists are subject to the security requirements contained in the Board Regulations at 247 CMR 2.00 et. seq.
(A) Physical Security Requirements. All applicants and registrants shall provide effective physical security controls against
theft and other diversion of controlled substances. All applicants and registrants shall provide physical security controls which
meet the conditions of the Director of the Bureau of Narcotics and Dangerous Drugs.
(B) Personnel Security Requirements. All applicants and registrants shall screen before employement new employees who may
work in or around areas where controlled substances are handled.
(1) Such screening shall be made solely for the purpose of determining whether the prospective employee is a responsible
person. Documentation of such screening shall be made available by applicants and registrants to the Commissioner upon his
request.
(2) No registrant shall knowingly employ any agent or employee who has had an application for registration denied for
violation of any law or regulation or has had his registration revoked for violation of any law or regulation at any time.
(C) Security of Mail. Every registrant shall ensure that mail which can reasonably be believed to contain controlled substances
and which is addressed to any person at the registrant's place of business or professional practice, is safeguarded until
delivered directly to the addressee, or immediately returned to the sender.
(D) Report of Theft or Loss. A registrant shall report the theft or loss of any controlled substances to the designated agent of
the Commissioner by telephone upon discovery of such theft or loss, and shall submit to said Commissioner a copy of "Report
of Theft of Controlled Substances" (BND Form 106), within seven days of such theft or loss.
700.006: Requirements for Records, Inventories, and Reports
.
Pharmacists are subject to the inventory requirements in 247 CMR 2,00 et.seq.
(E) Inventory Requirements. Every registrant shall take an initial inventory and biennial inventories thereafter.
(1) Every registrant required to take inventories under Federal Law and Regulations shall follow those requirements,
which are deemed to include Schedules I, II, III, IV, and V only.

These provisions mirror the regulations contained in board of Pharmacy regulations at 247 CMR 5.04or
(J) Prescription Monitoring Program.
(1) Pharmacy Reporting Requirements.
(a) Every pharmacy located in a health facility registered with the Commissioner that dispenses controlled
substances in Schedule II pursuant to a prescription shall, in accordance with standards established by the
Department, transmit to the Department or its agent the following information for each such prescription:
1. pharmacy number;

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2. pharmacy prescription number;
3. customer identifier, as defined in 105 CMR 700.001;
4. patient name;
5. patient address;
6. patient date of birth;
7. patient gender;
8. relationship of customer to patient;
9. national drug code (NDC) of controlled substance dispensed;
10. date prescription written by prescriber;
11. date the controlled substance is dispensed;
12. metric quantity of controlled substance dispensed;
13. estimated days supply of controlled substance dispensed;
14. prescriber's U.S. Drug Enforcement Administration (DEA) registration number; and
15. prescription coverage type.
(b) 105 CMR 700.006(J) shall not apply to medication orders in hospitals.
(c) A pharmacy that dispenses a Schedule II controlled substance in accordance with 105 CMR 701.004, but is unable
to obtain and report the customer identifier required by 105 CMR 701.004, shall leave the customer identifier field
blank or otherwise complete the field as directed by the Department.
(d) The information required by 105 CMR 700.006(J) shall be transmitted to the Department or its agent, in
accordance with any procedures established by the Department, no later than 15 days following the last day of the
month in which the prescription was dispensed by use of:
1. electronic device, including but not limited to computer diskette, compact disk, magnetic tape, or
modem transmission in a format approved by the Department, or other acceptable electronic method
approved by the Department; or
2. Universal Claim Form or other form approved by the Department.
Pharmacies reporting more than 25 prescriptions per month must report information bv an electronic devicenot a Universal
Claim Form.
(e) Pharmacies reporting data from 25 or more prescriptions in any given month must provide the required
information in accordance with 105 CMR 700.006(J)(1)(d)1.
(2) Prescription Monitoring Program Advisory Board.
(a) The Commissioner of the Department of Public Health shall establish a Prescription Monitoring Program
Advisory Board to assist in the implementation of 105 CMR 700.006(J) and any other related regulations. The
membership of this Advisory Board shall include representatives of the Department of Public Health; Executive Office of Public Safety; disciplinary authorities, including the Boards of Registration in Medicine,
Pharmacy, Dentistry, Podiatry, Veterinary Medicine, Nursing and Physician Assistants; representatives of
associations or societies representing professions authorized to issue or dispense prescriptions, patient
interests, and privacy interests; and a person with expertise in the design or operation of a secure automated
data system.
(b) The Prescription Monitoring Program Advisory Board shall assist the Department in designing education
programs for the proper use of Schedule II drugs.
(3) Prescription Monitoring Program Medical Review Group.
(a) The Commissioner shall establish Prescription Monitoring Program Medical Review Groups, to recommend accepted medical practice standards for the implementation of 105 CMR 700.006(J) and related
regulations. The membership of each Medical Review Group shall consist of two or more registered practitioners, one of whom shall be affiliated with a health care facility, and at least one registered pharmacist. In all
cases, members of the Medical Review Groups shall be registered health care practitioners and a majority
shall be registered in the same discipline as the practitioner whose records are under review. Registered
practitioners shall be designated by the Commissioner from lists approved by the appropriate Boards of
Registration in the discipline under which records will be reviewed. Such lists shall be provided by the

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respective statewide professional societies, whose membership shall fully represent the complete geographic
and practice differences represented in the state as a whole.
1. In the event that insufficient listings are available to comprise the appropriate membership of any
particular Medical Review Group, the Commissioner may appoint additional members.
2. Whenever possible, the practitioners on a particular Medical Review Group shall be specialists, as
designated by a national accrediting board acceptable to the Commissioner, in the same field as the
practitioner whose records are being reviewed.
3. In all cases, practitioners serving on the Medical Review Group must have a valid Controlled
Substances Registration for prescribing Schedule II drugs, pursuant to M.G.L. c. 94C, 18.
(b) The Medical Review Group shall assist the Department in the evaluation of
prescription information.
(4) Privacy and Confidentiality.
Note those to whom information obtained through the reporting program may be disseminated.
(a) Except where otherwise provided by law or judicial order, the information collected pursuant to 105 CMR
700.006(J) shall not be disseminated by the Department to anyone other than:
1. a duly authorized representative of the board or agency responsible for registration, regulation or
discipline of practitioners authorized to prescribe or dispense Schedule II controlled substances acting
in accordance with official duties;
2. a law enforcement agency when acting in accordance with its official duties in conducting a bona
fide criminal investigation or prosecution of criminal violations. Requests for inspection of these
records shall first be directed to the Office of the Attorney General of Massachusetts, or the Massachusetts State Police Diversion Investigation Unit, or the United States Drug Enforcement Administration,
for notification and approval prior to action by the Department;
3. the Executive Office of Health and Human Services for the purpose of identifying suspected fraud
or abuse of the MassHealth program;
4. a practitioner, including a pharmacy, in accordance with 105 CMR 700.006(J)(4)(d); or
5. an individual who is the data subject who has access to this data pursuant to a statute or regulation
of the Commonwealth.
(b) All requests for information pursuant to 105 CMR 700.006(J)(4)(a)1., 2. and 3. shall be in writing. All such
information generated shall be reviewed and approved by the Commissioner or his or her designee and the
Medical Review Group prior to release by the Department.
(c) In the event that the Department, through computer analysis and review of the records generated by the
prescription monitoring program, finds patterns of prescribing or dispensing that raise questions regarding
the activity of a patient, practitioner or pharmacy, the Department shall provide such information to the
appropriate Medical Review Group for review and possible referral, as provided for in 105 CMR
700.006(J)(4)(a)1., 2. and 3.
(d) Notwithstanding the provisions of 105 CMR 700.006(J)(4)(c), in order to prevent the diversion of Schedule
II controlled substances and to identify persons who may be in need of treatment for drug abuse, the
Commissioner or his or her designee may disclose to practitioners and pharmacies who have dispensed or are
evaluating the dispensing of such controlled substances information concerning prior dispensing of such
controlled substances to a patient or his or her agents.
1. Such information may be disclosed only upon determination by the Commissioner or his or
her designee that a patient is receiving a Schedule II controlled substance from more than one
source and in quantities that he/she determines to be harmful to the health of the patient or
that disclosure otherwise is necessary to prevent the unlawful diversion of a Schedule Il
controlled substance.
2. Such disclosure shall be in conformance with protocols established by the Department, in
consultation with the Medical Review Group and the Prescription Monitoring Program
Advisory Board, concerning appropriate identification of persons potentially engaged in
diversion and in need of medical intervention. The Medical Review Group shall as needed
thereafter review the content and application of the protocols and make recommendations to

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the Department for improvement of the disclosure process. In undertaking such review, the
Medical Review Group shall be provided upon request with all pertinent information as to
disclosures made pursuant to 105 CMR 700.006(J)(4)(d).
3. Such disclosure may be at the initiation of the Department or in response to an inquiry by
a practitioner. The disclosure shall be for the purpose of assisting the practitioner or pharmacy to assess the possibility of abuse or diversion, but shall not require or direct the practitioner
to take action that the practitioner believes to be contrary to the patient's best interests.
700.007: Inspection of Premises
..
Pharmacists are subject to inspection requirements of the Board of Pharmacy.
.
700.011: Issuance of Prescriptions or Medication Orders for Implantable Infusion Pumps Containing Schedule II or Schedule III Controlled Substance
A prescription or medication order for an implantable infusion pump containing a Schedule II or Schedule III controlled substance may be filled for a maximum of a 90 day supply.
REGULATORY AUTHORITY 105 CMR 700.000: M.G.L. c. 94C, 2.

105 CMR 701.000:

REGULATIONS ADOPTED JOINTLY BY THE DEPARTMENT OF PUBLIC HEALTH AND
THE BOARD OF REGISTRATION IN PHARMACY FOR THE IMPLEMENTATION OF M.G.L. c. 94C
Section
701.001: Excluded Non-Narcotic Substances
701.002: Excepted Compounds
701.003: Emergency Situations in Which Controlled Substances in Schedule II May Be Dispensed upon
Oral Prescription
701.001: Excluded Non-Narcotic Substances
The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic Act be lawfully sold over the
counter without a prescription, are excluded from all schedules.
This
table
has
not
been
reproduced
due
http://www.mass.gov/Eeohhs2/docs/dph/regs/105cmr701.pdf

to

its

size

It

may

be

found

at

701.002: Excepted Compounds

This table may be found at: http://www.mass.gov/Eeohhs2/docs/dph/regs/105cmr701.pdf
(A) The following drugs in dosage unit form, and any other drug of the quantitative composition shown below for one of the
following drugs or which is the same except that it contains a lesser quantity of controlled substances or other substances which
do not have a stimulant, depressant, or hallucinogenic effect, and which are restricted by law to dispensing on prescription,
are excepted from all schedules except Schedule VI.

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Note that these regulations mirror federal laws.
(B) A controlled substance in Schedule V may be dispensed by a pharmacist without a prescription to a purchaser at retail
provided that:
(1) The compound, mixture or preparation containing the controlled substance is not a prescription drug and,
(2) The compound, mixture, or preparation contains not more than 100 milligrams of opium per 100 milliliters or per
100 grams.
(C) Substances Excepted from Schedule V are subject to the following conditions:
(1) That such preparation shall be dispensed or sold in good faith as a medicine and not for the purpose of evading
the provisions of the controlled substance law; and
(2) That the purchaser of such preparation identify himself to the satisfaction of the pharmacist; and

(3) That no more than four ounces of such preparation are dispensed or sold to a person during any 48 hour period,
and
(4) That the pharmacist dispensing such excepted substances shall keep an accurate record book including the name
and address of the purchaser, the name of the preparation, the strength per dosage unit, the quantity dispensed and the
date.
701.003: Emergency Situations in Which Controlled Substances in Schedule II May Be Dispensed upon
Oral Prescription
(A) "Emergency situations", for the purpose of permitting the dispensing of any controlled substance in Schedule II upon oral
prescription, means those situations in which the practitioner who proposes to prescribe a controlled substance in Schedule II
determines:
(1) That the immediate administration of the controlled substance is necessary for proper treatment of the intended
ultimate user, and
(2) That no appropriate alternative treatment is available, including administration of a controlled substance which
is not in Schedule II, and
(3) That it is not reasonably possible for the practitioner to provide a written prescription to be presented to the person
dispensing the controlled substance prior to the dispensing.
(B) In case of an emergency situation as defined above, a pharmacist may dispense a controlled substance in Schedule II upon
receiving oral authorization of a prescribing individual practitioner; provided that:
(1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency
period; and
(2) The prescription is immediately reduced to writing by the pharmacist and contains all information required in
M.G.L. c. 94C, 20(a), except for the signature of the prescribing individual practitioner; and
(3) If the prescribing individual practitioner is not known to the pharmacist, he makes reasonable good faith effort to
determine that the oral authorization came from a registered individual practitioner, including a callback to the
prescribing individual practitioner using his phone number listed in the telephone directory or other good faith efforts
to insure his identity.
.
(D) Upon receipt of the written prescription the dispensing pharmacist shall attach the prescription to the oral emergency
prescription which had earlier been reduced to writing. The pharmacist shall notify the nearest office of the Bureau of

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Narcotics and Dangerous Drugs, U.S. Department of Justice and the Commissioner of Public Health if the prescribing
individual practitioner fails to deliver a written prescription to him within seven days.
REGULATORY AUTHORITY105 CMR 701.000: M.G.L. c. 94C, 4.

105 CMR 720.000:

LIST OF INTERCHANGEABLE DRUG PRODUCTS

See
also
Board
policy
referring
to
drug
interchangeability
at
http://www.mass.gov/?pageID=eohhs2subtopic&L=7&L0=Home&L1=Government&L2=Laws%2c+Regulations+and+Polici
es&L3=Department+of+Public+Health+Regulations+%26+Policies&L4=Regulations+and+Other+Publications++M+to+P&L5=Pharmacy+Licensing&L6=Board+of+Registration+in+Pharmacy%3a+Policies&sid=Eeohhs2

Section
720.001:
720.002:
720.010:
720.020:

Purpose
Citation
Scope and Application
Definitions

Standards
720:040: Commission Review of Relevant Drug Products
720.050: List of Interchangeable Drug Products
720.060: Drug Products Excluded
720.070: Amendments to the Massachusetts List of Interchangeable Drugs
Procedures for Amending List of Interchangeable Drug Products
720.080: Procedures for Amending the Massachusetts List of Interchangeable Drugs
720.081: Petition to Amend List of Interchangeable Drug Products
720.082: Commission Review of Petition
720.083: Notice of Public Comment Period
720.084: Commission Recommendation of Amendments to Department
720.090: Department Adoption of Amendments
720.100: Severability
720.200: Appendix A: List of Interchangeable Drugs

720.001: Purpose
The purpose of 105 CMR 720.000 is to establish a drug formulary, or list of interchangeable drug products, for use by
physicians, other practitioners, and pharmacists licensed to practice within the commonwealth, so that consumers of prescription drug products may realize cost savings by buying less expensive, safe drug products.
720.002: Citation
105 CMR 720.000 shall be known as the 105 CMR 720.000: Massachusetts List of Interchangeable Drug Products.
720.010: Scope and Application
Note the language that a pharmacist MUST interchange
105 CMR 720.000 establishes the list of interchangeable drug products from which a pharmacist must interchange a
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reasonably available less expensive drug product than that written, when a prescription written by a practitioner indicates
"interchange". 105 CMR 720.000 also establishes criteria and procedures for inclusion of drug products on this list.
720.020: Definitions
The terms used herein shall have the meanings set forth below. Terms defined in M.G.L. c. 112, 12D and c. 94C, 1, and not
defined herein shall have the meanings set forth therein when used in 105 CMR 720.000, unless the context clearly requires a
different interpretation.
Bioequivalent Drug Products means drug products whose rate and extent of absorption do not show a significant difference
when administered at the same molar dose of therapeutic moiety under similar conditions. Some drug products may be
equivalent in the extent of their absorption but not in their rate of absorption and yet may be considered therapeutically
equivalent because such differences in the rate of absorption are not essential to the attainment of effective body drug
concentrations or are considered medically insignificant for the particular drug product studies.
Drug products for which bioequivalence is considered essential are those whose bioinequivalence would have therapeutic
significance, i.e. use of different brands of the same drug product or different batches of the same drug product would result in
therapeutic failure or a hazard to the patient. This is most critical in a drug product that has a narrow therapeutic-toxicity
range which requires careful patient titration and monitoring for safe and effective use.
Commissioner means the commissioner of public health appointed under M.G.L. c. 17, 2.
Department means the Department of Public Health established under M.G.L. c. 17 as an agency within the Executive
Department of the Commonwealth of Massachusetts.
Drug Product means a product which contains an active drug ingredient and is in a dosage form, e.g. tablet, capsule, or
solution, generally, but not necessarily in combination with other substances included in the manufacturing process. An active
drug ingredient is that portion of a drug product intended to produce a therapeutic effect.
FDA means the Food and Drug Administration of the United States Department of Health and Human Services.
Generic name means a non-proprietary (common) name used to identify a drug product as listed by the United States Adopted
Names Council and the United States Pharmacopeia in the USAN/USP Dictionary of Drug Names.
Interchangeable Drug Product means a product containing a drug in the same amounts of the same active ingredients in the
same dosage form as other drug products with the same generic or chemical name.
Pharmaceutically equivalent drug products means drug products which contain the same active ingredients, and are identical
in strength or concentration, dosage form, and route of administration.
Public Health Council means the Department's governing body established under M.G.L. c. 17, 3. See also M.G.L. c. 111,
3.
Therapeutically equivalent drug products means drug products which are pharmaceutically equivalent; meet applicable
standards for strength, quality, purity and identity; are bioequivalent in that:
(a) they do not present a known or potential bioequivalence problem, and they do meet an acceptable in vitro standard; or
(b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standards
matching both rate and extent of absorption; are adequately labeled; and are manufactured in compliance with current Good
Manufacturing Practice regulations.
720.040: Commission Review of Relevant Drug Products

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In preparing the List of Interchangeable Drug Products and amendments thereto, the Drug Formulary Commission shall
determine whether drug products meet the standards set forth in 105 CMR 720.050. In making this determination, the
Commission shall assess and evaluate pertinent data, including, but not limited to, the United States Pharmacopeia and its
supplements, additional pertinent listings of the FDA, other state formularies, formularies of various hospitals of the commonwealth, and data submitted by manufacturers and other interested persons, including chemical and laboratory listing data and
clinical evidence concerning bioequivalence and therapeutic equivalence where available. In reviewing this material, the
Commission shall utilize the pharmaceutical and medical expertise of its members.
720.050: List of Interchangeable Drug Products
The MLID includes drug products that Massachusetts considers to be interchangeable. This list consists of drug products
contained in the FDAs Orange Book plus those on the additional list. The additional list has been excluded here due to its
length. It may be found at: http://www.mass.gov/Eeohhs2/docs/dph/regs/105cmr720.pdf
The introduction to the listexplaining the process by which to determine interchangeability-- is reproduced below under
Appendix A.
The Massachusetts List of Interchangeable Drug Products (MLID) shall consist of:
(1) drug products which are considered by FDA to be therapeutically equivalent to other pharmaceutically equivalent
products listed with the same generic or chemical name according to the most recent edition of "Approved Drug
Products with Therapeutic Equivalence Evaluations" and its supplements as published by the United States Department of Health and Human Services:
(2) drug products specified on a list established by the Department and set forth in 105 CMR 720.200, for which the
Commission has determined that the bioequivalence is not essential, or if the Commission has determined that the
bioequivalence may be essential, bioequivalence has been established. The list may include the following categories of
drug products:
(a) drug products which hold New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs)
approved by the FDA, which FDA does not consider to be therapeutically equivalent to other pharmaceutically
equivalent products listed with the same generic or chemical name; and
(b) drug products exempt from the Food, Drug and Cosmetic Act of 1962, and included in the Drug Efficacy
Study Implementation (DESI) done by the National Academy of Sciences/National Research Council; and
(c) frequently prescribed drug products which were manufactured prior to 1938 and meet the FDA Good
Manufacturing Practices Requirements; and
(d) frequently prescribed over-the-counter drug products which contain the same amounts of active ingredients,
in the same dosage forms, as other drug products with the same general or chemical name.
720.060: Drug Products Excluded
There are currently no drug products on the exception (excluded) list.
The following categories of drug products are excluded from the list of interchangeable drug products:
(a) drug products for which the Commonwealth has determined that bioequivalence may be essential, but for
which bioequivalence has not been established; and
(b) drug products which are the subject matter of patent rights issued by the U.S. Patent Office, for which
provision by other than the patent-holder would violate the patent; and
(c) drug products available from only one manufacturer at one price.
720.070: Amendments to the Massachusetts List of Interchangeable Drugs

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(1) Drug products which meet the criteria specified in 105 CMR 720.050(1) shall be deemed interchangeable and
added to the Massachusetts List of Drugs upon publication by the United States Department of Health and Human
Services of the most recent edition of "Approved Drug Products with Therapeutic Equivalence Evaluations" and its
supplements.
(2) Drug products which meet criteria specified in 105 CMR 720.050(2) shall be deemed interchangeable and added
to the Massachusetts List of Interchangeable Drugs in accordance with procedures set forth in 105 CMR 720.080.

720.080: Procedures for Amending the Massachusetts List of Interchangeable Drugs

The Department, working with the Commission, shall review at least one a year and revise as necessary the list of interchangeable drug products adopted pursuant to 105 CMR 720.050(2), and shall have the authority to review and revise the list of
interchangeable drug products adopted pursuant to 105 CMR 720.050(1) as necessary. The revisions to 105 CMR 720.050(1)
shall be specified on an exception list established by the Department and set forth in 105 CMR 720.200. The revisions will add
and delete drug products, based on current information concerning therapeutic efficacy and interchangeability of drug products.
720.081: Petition to Amend List of Interchangeable Drug Products
Any person who desires a drug product or products to be added to or deleted from the List of Interchangeable Drug Products,
shall file a written petition with the Department to amend the List, pursuant to M.G.L. c. 30A, 4. Each petition shall be in
such form as the Department may require and shall be submitted to the Drug Formulary Commission.
720.082: Commission Review of Petition
Upon receipt of a petition, the Department shall submit the petition and the supporting information to the Commission for
review. The Commission shall make a preliminary determination whether the List of Interchangeable Drug Products should be
amended as proposed.
720.083: Notice of Public Comment Period
Upon completion of the review of all relevant information, including petitions, by the Commission, the Department shall
propose amendments to the List of Interchangeable Drug Products by issuing a Notice of Public Comment Period pursuant to
M.G.L. c. 30A, 2 and 3. The Department shall mail a Notice of Public Comment Period to each person who filed a petition
during the period ending 30 days before the Notice of Public Comment Period is issued. In addition, the Department shall mail
a Notice of the Public Comment Period to each person who has filed a written request therefore with the Department during
December of the previous year pursuant to M.G.L. c. 30A, 2.
720.084: Commission Recommendation of Amendments to Department
Following the comment period Department staff shall review all evidence and commentary concerning the proposed amendments, and shall report its recommendation to the Commission. The Commission shall consider the staff recommendations,
make such revisions as it deems appropriate, and shall recommend Amendments to the List of Interchangeable Drug Products
for adoption by the Commissioner and the Public Health Council.
720.090: Department Adoption of Amendments

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The Commissioner and the Public Health Council shall consider the recommendations of the Drug Formulary Commission,
and shall adopt Amendments to the List of Interchangeable Drug Products.
720.100: Severability
The provisions of 105 CMR 720.000 are severable. If any provision shall be declared invalid by any court, such provision shall
be null and void and such determination shall not affect or impair any of the remaining provisions.
REGULATORY AUTHORITY
105 CMR 720.000: M.G.L. c. 17, 13; c. 112, 12D.

720.200 Appendix A
MASSACHUSETTS
LIST OF
INTERCHANGEABLE DRUGS
Department of Public Health regulation 105 CMR 720.050 describes the Massachusetts List of Interchangeable Drugs.
105 CMR 720.050(a) calls for the automatic adoption of all "A" rated drug products listed in the "Approved Drug Products
with Therapeutic Equivalence Evaluations" and its supplements as published by the U.S. Food and Drug Administration
(FDA), Department of Health and Human Services. This publication is commonly referred to as the "Orange Book". It is
reprinted by the U.S. Pharmacopeial Convention Inc. (USP) as Volume III of the USP DI.
105 CMR 720.050(b) allows for the establishment of the Massachusetts Additional List of Interchangeable Drugs (Additional
List), and provides the criteria upon which these drug products are approved.
All prescriptions written by generic name can be interchanged if the drug is multi-source. To determine if a prescription written
for a brand name drug product is interchangeable in Massachusetts:
1. Look up the drug product by the brand name in the index or by generic name in the "Approved Drug Products with
Therapeutic Equivalence Evaluations" ("Orange Book"). The drug products are arranged alphabetically.
2. Compare the dosage form and strength of the drug product prescribed with the dosage form and strength of the same drug
product in the "Orange Book".
3. If the same drug product, dosage form and strength has been assigned an "A" rating by FDA and is not listed on the
Exception List contained within 105 CMR 720.050, the drug product is interchangeable.
4. If the drug product is not listed in the "Orange Book", refer to 105 CMR 720.050(b), the Massachusetts Additional List of
Interchangeable Drugs (Additional List).
5. Look up the drug product by the generic name in the Additional List. The drug products are arranged alphabetically.

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6. Compare the dosage form and strength of the drug product prescribed with the dosage form and strength of the same drug
product listed on the Additional List.
7. If the same drug product, dosage form and strength are listed, the drug product is interchangeable.
Copies of the "Approved Drug Products with Therapeutic Equivalence Evaluations" and its supplements ("Orange Book") are
available from the:
U.S. Food and Drug Administration
Department of Health and Human Services
Government Printing Office
Washington, D.C. 20402-9371
OPC 6768
(202) 783-3238
and www.fda.gov/cder/drug
Copies of the USP DI (third volume of USP DI is the "Orange Book") are available from:
The United States Pharmacopeial Convention, Inc.,
12601 Twinbrook Parkway
Rockville, MD 20852
(301) 881-0666
Copies of the Massachusetts Additional List of Interchangeable Drug Products (document number 105 CMR 720.000) are
available from:
The State House Bookstore
Room 116
Boston, MA 02133
(617) 727-2834
And www.magnet.state.ma.us/dph/dcp/Drug Formulary/Drug Interchange

FOREWORD
The Massachusetts List of Interchangeable Drugs, is prepared by the Drug Formulary Commission (DFC) and the Department
of Public Health. The DFC is comprised of nine men and women appointed by the Governor for the express purpose of
developing a list of those drug products that are safely interchangeable -- that is, equivalent to each other in all significant
respects. The DFC was established by M.G.L. c. 17, 13. This law was enacted with the intent of saving money for consumers
of prescription drugs, since drug products that are marketed under trademark or proprietary names are often available in the
generic forms from competing manufacturers at substantially lower prices. M.G.L. c. 112, 12D mandates prescription forms
that allow practitioners to prescribe interchangeable drug products by simply signing the signature line. If a practitioner
determines that a brand name drug product should be dispensed, he/she must sign the signature line and write the words
"no substitution" in his/her own handwriting in the space provided below the signature line.
The regulations call for the automatic adoption of "A" rated drug products listed in the "Approved Drug Products with
Therapeutic Equivalence Evaluations" and its supplements (commonly referred to as the "Orange Book") as published by the
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U.S. Food and Drug Administration, Department of Health and Human Services, plus a list of additional drug products, the
Massachusetts Additional List of Interchangeable Drugs ("Additional List"), individually reviewed and approved by the DFC
and the Department. The regulations provide the criteria upon which the drug products listed on the Additional List are
approved for interchange. The regulations also provide the DFC and the Department with the authority to review any "A" rated
drug product listed in the "Orange Book" or drug product approved for interchange on the Additional List and delete it from
the list of interchangeable drug products if deemed appropriate. Drug products assigned an "A" rating by FDA which are
deleted from the Massachusetts List are placed on the Exception List. Drug products listed on the Additional List which are
subsequently deleted are removed from the Additional List.
Of the many factors considered by the Commission in determining which drugs to include on the List, equivalent safety and
effectiveness are paramount. The Commission reviews evidence on bioequivalence and pharmaceutical equivalence and
includes on the List only those drug products determined to be fully interchangeable and whose manufacturers are approved
by the U.S. Food and Drug Administration. Practitioners may prescribe any drug that appears on the List with confidence that
it is as safe and effective as its brand name counterpart.
The efforts of the Commission in the assessment and evaluation of data and the preparation of the List are to be commended.
The Department presents the Massachusetts List of Interchangeable Drugs with pride and with confidence that the List will
greatly benefit consumers throughout the Commonwealth.
INTRODUCTION
INTERCHANGEABLE (GENERIC) DRUG LAW
In 1976 the Massachusetts Legislature passed an Act Further Regulating the Establishment of a Formulary of Interchangeable
Drug Products (St. 1976, c. 470, 13), commonly known as the Generic Drug Law. This law, enacted to promote and regulate
the use of generic drugs, created the Drug Formulary Commission to develop a list of interchangeable drug products and also
required the use of a standard prescription form to encourage practitioners to prescribe generic drugs.
PRESCRIPTION FORM
M.G.L. c. 112, 12D mandates prescription forms with one signature line. If the prescriber signs the prescription form and
writes the words "no substitution" in his/her own handwriting in the space provided below the signature line, the pharmacist
must fill the prescription exactly as indicated, with no interchange permitted. However, if the prescriber signs the prescription
and does not write "no substitution" under his/her signature, the pharmacist is legally required to dispense a less expensive,
equivalent interchangeable drug product listed in the Massachusetts List of Interchangeable Drugs if one is reasonably
available.
MASSACHUSETTS LIST OF INTERCHANGEABLE DRUGS
The Massachusetts List of Interchangeable Drugs (MLID) consists of the "A" rated drug products listed in the "Approved Drug
Products with Therapeutic Equivalence Evaluations" and its supplements as published by the U.S. Food and Drug Administration, Department of Health and Human Services ("Orange Book") and the Massachusetts Additional List of Interchangeable
Drugs (Additional List). The Additional List is developed by the Drug Formulary Commission. The Commission determines
drug products to be interchangeable only when they meet certain criteria:
(a) the drug product is available from more than one source, with the same active ingredient in the same dosage form and
strength;
(b) its manufacturer is approved by the U.S. Food and Drug Administration (FDA); and
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(c) when essential to therapeutic outcome, the manufacturer of the drug has documented clinical evidence of bioequivalence.
The Commission judges that all the drugs included on the MLID meet these standards and are bioequivalent, if essential, based
on assessment and evaluation of the U.S. Pharmacopeia and its supplements, other state and hospital formularies, listings of
the U.S. Department of Health and Human Services of the FDA, and on the expertise of its members.
The List does not include:
(a) drugs that are protected by patent rights or available from only one source;
(b) many controlled-release and enteric coated drug products since they may not consistently deliver the same quantities of
their active ingredients;
(c) those drugs for which the Commission had any significant doubt about safe interchange between manufacturers; and
(d) any drug for which bioequivalence is considered essential but for which bioequivalence has not been demonstrated or an
appropriate standard for bioequivalence has not been established.
Bioequivalence is determined to be necessary for a particular drug when bioinequivalence might result in therapeutic failure
or hazard to the patient. Bioequivalent drug products do not show a significant difference in the rate and extent of absorption
when administered at the same dosage under similar conditions. Drugs that are equivalent in the extent to which they are
absorbed into a patient's body that differ in the rate of absorption may be therapeutically equivalent -- having the same medical
effect -- either because the rate of absorption is not essential to the attainment of effective body concentrations of the drug, or
because the difference in the rate is otherwise considered medically insignificant. Bioequivalence is a primary
consideration for those drug products with a narrow therapeutic/toxic dosage range (when variation in the rate or extent of
absorption could have a critical effect) where careful determination of the correct dosage and monitoring of the patient is
essential to safe and effective use. To determine for which drugs bioequivalence is essential, the Commission relies on expert
medical testimony, studies done by the pharmaceutical industry, the knowledge and expertise of the individual members of the
Commission, and advice from the FDA.
All drug products manufactured by FDA approved firms are considered safe and effective for their intended use, even if the
product has not been included in the MLID. A practitioner may begin a patient's therapy with a drug product from any
manufacturer who has been approved by the FDA, even though interchange of the drug once the dosage has been calculated
for the individual is not advised.
Several generic drug products are manufactured under the same new drug application (NDA) as the brand name drug products.
According to section 1.6 of the Orange Book, drug products with the same NDA are therapeutically equivalent. Massachusetts
regulations allow the interchange of these products. Distributors or repackagers of drug products manufactured under the
same NDA as the brand name product are not identified in the Orange Book. Pharmacists who may not be able to determine
if drug products are interchangeable should contact the manufacturers, distributors or repackagers. In addition the Department maintains an unofficial list of these products.
Information relative to the Interchangeable (Generic) Drug Law may be obtained from the Department of Public Health,
Division of Food and Drugs, 305 South Street, Jamaica Plain, MA 02130, telephone number (617) 727-2670, and from the
Boards of Registration in Medicine, Dentistry and Pharmacy.
DRUG PRODUCT PROBLEM REPORTING INSTRUCTIONS
Since 1971 the United States Pharmacopeia (USP), in cooperation with various professional associations and the Food and

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Drug Administration (FDA), has operated the Drug Product Problem Reporting Program. This program can be utilized by
pharmacists, physicians, or consumers to report any product problems encountered when using drugs interchanged under the
Massachusetts generic drug law. The program is product oriented, and patient identification not requested. Should you prefer
to remain anonymous, so indicate to the USP and your name will be withheld from the manufacturer and the FDA. Your
participation in reporting problems will help to ensure that the drug products prescribed and dispensed in Massachusetts are
of continued high quality.
Reports should be sent to The United States Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD
20852, (301) 881-0666. The USP is an impartial, non-governmental organization concerned with drug standards and quality
control. After USP receives a report, copies are forwarded to the FDA and to the manufacturer of the product involved. Either
the FDA or the manufacturer may act to investigate or correct problems.
EXCEPTION LIST
Orange Book "A" rated drug products not approved for interchange.

105 CMR 721.000:

STANDARDS FOR PRESCRIPTION FORMAT AND SECURITY IN MASSACHUSETTS
Section
721.001: Purpose
721.002: Citation
721.003: Scope and Application
721.010: Definitions
721.020: Prescription Formats
721.030: Security Standards for Prescriptions
721.040: Invalid Prescriptions
721.050: Prescribing More than One Product
721.001: Purpose
The purpose of 105 CMR 721.000 is to specify the requirements for prescription format and security in
Massachusetts.
721.002: Citation
105 CMR 721.000 shall be known as 105 CMR 721.000: Standards for Prescription Format and Security in
Massachusetts.
721.003: Scope and Application
105 CMR 721.000 establishes the standards for format and security in the Commonwealth that all prescriptions issued by practitioners or reduced to writing by pharmacists must meet in order to comply with M.G.L. c.
112, 12D and M.G.L. c. 94C.
721.010: Definitions
The terms used herein shall have the meanings set forth in 105 CMR 721.010. Terms defined in M.G.L. c. 112,
12D and c. 94C, 1 and not defined herein shall have the meanings set forth therein when used in 105 CMR
721.000, unless the context clearly requires a different interpretation.
Authentication means that the identities of the parties sending and receiving electronic prescription data are duly
verified
Confidentiality means that only authorized persons have access to prescription data.
Content Integrity means that the electronic prescription data have not been altered or compromised in transmission.

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Drug Product means the final dosage form of a drug that is marketed under a brand or generic name.
Electronic Signature means an electronic sound, symbol or process attached to or logically associated with a
prescription record and executed or adopted by a practioner with the intent to sign said prescription record.
Technical Non-repudiation means that parties to the generation, transmission, receipt or storage of an electronic
prescription cannot reasonably deny having participated in said activities.
721.020: Prescription Formats
Note that the practitioner must indicate no substitution if he/she prefers that the brand name be dispensed. Note the
requirements for the no substitution phrase.(A) Every prescription written in the Commonwealth must be in a prescription
format that conforms to the following requirements:
(1) a prescription must permit the practitioner to instruct the pharmacist to dispense a brand name drug
product by indicating no substitution, provided that:
(a) the indication of no substitution is not the default indication;
(b) the prescription indicates that Interchange is mandated unless the practitioner indicates no
substitution in accordance with the law; and
(c) the indication of no substitution is a unique element in the prescription and shall not be satisfied
by use of any other element, including the signature;
Hospital and clinic prescriptions require a line below the signature line for the practitioner to print or type his/her name. There
must be a space for practitioner to indicate no substitution then note the language required below that line.
Note other requirements for the prescription format.
(2) if the prescription is paper-based, including but not limited to a prescription that is transmitted via
facsimile or similar technology, or reduced to writing by a pharmacist, the prescription must be on a form
that contains a signature line for the practitioner's signature on the lower portion of the form. Hospital and
clinic prescription forms shall contain a line directly below the signature line for the practitioner to print or
type his/her name. Below the signature line, or in the case of hospital and clinic prescription forms, below
the line provided for the practitioner to print or type his/her name, there shall be a space in which the
practitioner may indicate "no substitution". Below this space shall be printed the words "Interchange is
mandated unless the practitioner indicates 'no substitution' in accordance with the law;
(3) if the prescription is transmitted electronically, the practitioner shall generate and transmit the
prescription in a format that can be read and stored by a pharmacy in a retrievable and readable form;
(4) the name and address of the practitioner shall be clearly indicated on the prescription. A hospital or
clinic prescription shall have the name and address of the hospital or clinic clearly indicated on the
prescription;
(5) the prescription shall contain the following information:
(a) the registration number of the practitioner;
(b) date of issuance of the prescription;
(c) name, dosage, and strength per dosage unit of the controlled substance prescribed, and the quantity
of dosage units;
(d) name and address of the patient, except in a veterinary prescription;
(e) directions for use, including any cautionary statements required; and
(f) a statement indicating the number of times to be refilled.
Prescriptions of practitioners other than physicians must have name of supervising physician.
(B) Prescriptions for certified nurse midwifes, nurse practitioners, psychiatric nurses and physician assistants
shall also contain the name of the supervising physician.
721.030: Security Standards for Prescriptions
(A) A prescription may be transmitted electronically provided that:

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(1) if said prescription is for a controlled substance in Schedules II through V, it is validated and
authenticated in accordance with M.G.L. c. 94C and applicable Department regulations, if any, and 21 CFR
1306 and other applicable federal regulations;
(2) if said prescription is for a controlled substance in Schedule VI it is validated and authenticated in
accordance with requirements in M.G.L. c. 94C and applicable Department regulations for oral prescriptions
or by utilizing a system that includes:
(a) a combination of technical security measures, such as, but not necessarily limited to, those listed in
Security Standards for the Protection of Electronic Protected Health Information (HIPAA), 45 CFR Part
164, Subpart C, 164.312, to ensure a reasonable and appropriate level of:
1. practitioner and dispenser authentication;
2. technical non-repudiation;
3. content integrity; and
4. confidentiality.
(b) an electronic signature that is:
1. unique to an identified practitioner;
2. originated solely by and under the ultimate control of the practitioner; and
3. capable of verification.
(c) reasonable and appropriate security measures to invalidate a prescription if either the electronic
signature or the prescription record to which it is attached or logically associated is altered or compromised; and
(3) said prescription meets any other generally applicable requirements of the federal Health Insurance
Portability and Accountability Act (HIPAA) and related regulations.
(B) An electronic signature that meets the requirements of 105 CMR 721.031 shall have the full force and effect
of a handwritten signature on a paper-based written prescription.
(C) A paper-based written prescription must be written and signed by the practitioner in accordance with M.G.L.
c. 94C, 23 and 105 CMR 721.000.
721.040: Invalid Prescriptions
Note that the language here states that a prescription that does not conform to required Mass. format or security requirements
SHALL not be filled.
(A) A prescription in a format that does not conform to 105 CMR 721.000 is invalid and shall not be filled.
(B) A prescription that does not meet the security requirements of 105 CMR 721.000 is invalid and shall not be
filled.
721.050: Prescribing More Then One Drug Product
No more than one prescribed drug product may be contained on each prescription form.
Practitioners who wish to prescribe more than one drug product, with the same or different dispensing instructions, shall place each prescription on a separate prescription form or record. More than one drug product may be prescribed in the hospital setting on a single form or record provided, however, that the prescription
provides clear directions for use and interchange of each drug product.
REGULATORY AUTHORITY 105 CMR 721.000: M.G.L. c. 30A, 2; c. 94C, 6; c. 111, 3; and c. 112, 12D.
105 CMR 722.000:
DISPENSING PROCEDURES FOR PHARMACISTS
Section
722.001: Purpose
722.002: Citation
722.010: Scope and Application
722.020: Definitions

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722.040:
722.050:
722.060:
722.070:
722.080:
722.090:
722.100:

Medical Emergencies
Oral Prescriptions
Generic Prescriptions
Labeling
Out-Patient Pharmacies
Hospital Pharmacies
Severability

722.001: Purpose
The purpose of 105 CMR 722.001 is to describe procedures which pharmacists must follow when dispensing drug products in accordance with St. 1976, c. 470 and the regulations promulgated thereunder.
722.002: Citation
105 CMR 722.000 shall be known as 105 CMR 722.000: Dispensing Procedures for Pharmacists.
722.010: Scope and Application
105 CMR 722.000 establishes the rules and regulations which a pharmacist must follow to be in accordance
with St. 1976, c. 470, when dispensing drug products.
722.020: Definitions
The terms used herein shall have the meaning set forth below. Terms defined in M.G.L. c. 112, 12D and
c. 94C, 1, and not defined herein shall have the meanings set forth therein when used in 105 CMR 722.000,
unless the context clearly requires a different interpretation.
Discharge Patient. For the purpose of 105 CMR 722.000 only, a discharge patient is a person who has been
released from an inpatient hospital bed and is no longer registered as a hospital patient.
Drug Product means a product which contains an active drug ingredient and is in a dosage form e.g. tablet,
capsule, or solution, generally, but not necessarily in combination with other substances included in the
manufacturing process. An active drug ingredient is that portion of drug product intended to produce a
therapeutic effect.
Drug Purchaser means any individual or third-party payor purchasing prescribed drugs on behalf of himself or
others.
Emergency Room Patient. For the purposes of 105 CMR 722.000 only, an emergency room patient is a person
registered at a hospital for the purpose of receiving emergency services or treatment and who departs from the
hospital immediately after receiving such emergency services or treatment.
Generic Name means a non-proprietary (common) name used to identify a drug product as listed by the United
States Adopted Names Council and the United States Pharmacopeia in the USAN/USP Dictionary of Drug Names.

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Hospital Employees. Employees of the hospital shall include persons currently on the payroll of the hospital and
their spouse and dependents living in the same household, medical staff members, volunteers, students and/or
individuals contracted for employment by the hospital.
Hospital Inpatient. For the purposes of 105 CMR 722.000 only, a hospital inpatient is a person formally admitted
to a hospital bed for the purpose of receiving services or treatment and who remains in the hospital at least
overnight. A person is considered a hospital inpatient if, after formal admission as an inpatient, such person is
later discharged for medical reason or is transferred to another hospital before such person has occasion to
occupy a hospital bed overnight.
Hospital Outpatient. For the purposes of 105 CMR 722.000 only, a hospital outpatient is a person formally
registered on the hospital records as an outpatient and who is currently receiving services or treatments at a
clinic of the hospital (e.g., asthma clinic, arthritis clinic, radiation therapy clinic, etc.). Patients who are seen at
a doctor's private office within or without the hospital shall not be deemed to be hospital outpatients.
Hospital Pharmacy means a hospital's central, satellite or branch pharmacy.
Hospital Premises means, for the purposes of 105 CMR 722.000 only, the buildings and contiguous grounds of a
hospital.
Hospital-based Skilled Nursing Facility means, for the purposes of 105 CMR 722.000 only, a long-term care
facility or unit thereof that is an integral and subordinate part of the hospital, is operated with other departments
of the hospital under common governance and professional supervision such that the skilled nursing facility and
the hospital are subject to the bylaws and operating decisions of a common governing board, is fully integrated
with all other services of the hospital, and is financially integrated with the hospital.
Interchange means the exchange of a less expensive reasonably available drug product selected from the
Massachusetts List of Interchangeable Drugs for a prescribed brand name drug product.
Interchangeable Drug Product means a product containing a drug in the same amounts of the same active
ingredients in the same dosage form as other drug products with the same generic or chemical name.
Less Expensive means that the charge to the drug purchaser in the pharmacy where the sale takes place must be
less for the interchanged drug product, whether brand name or generic, than the selling price for the prescribed
drug product on the day of purchase.
Medical Emergency is a situation which requires immediate drug therapy for a patient in order to alleviate severe
pain or avert disability or loss of life.
Pharmacist means any pharmacist registered in the Commonwealth to dispense controlled substances, and
including any other person authorized to dispense controlled substances under the supervision of a pharmacist
registered in the Commonwealth. Any pharmacist who fills a prescription is responsible for complying with all
requirements of M.G.L. c. 112, 12D, 105 CMR 720.000 et seq., 721.000 et seq., 722.000 et seq., and all
subsequent amendments whether or not that pharmacist orders drugs for the pharmacy.
Reasonably Available Drug Product means any interchangeable drug product which appears on the Massachu-

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setts List of Interchangeable Drugs as long as that product is sold through interstate commerce and is obtainable
by a pharmacist within a time period of 72 hours or less.
722.040: Medical Emergencies
A medical emergency may allow the dispensing of an interchangeable product despite a practitioner marking no substitution on the prescription. Note that the definition of a medical emergency (above) requires IMMEDIATE drug therapy to
alleviate severe pain or to avert disability or death..
In a medical emergency the pharmacist may fill a prescription marked "no substitution" by dispensing a less
expensive interchangeable drug product as allowed by the Massachusetts List of Interchangeable Drugs if the
particular brand is not in stock; similarly, the pharmacist may fill a prescription not marked "no substitution" in
a medical emergency by dispensing the brand name product as written if he has no less expensive interchangeable
drug product in stock to be dispensed.
In such instances, the pharmacist must record the date, hour and nature of the medical emergency on the back
of the prescription and the person purchasing the drug product must indicate acceptance of this deviation from
the law by legibly writing his or her signature on the prescription. All such prescriptions shall be clearly
identifiable and available for review by officials empowered to enforce the laws of the Commonwealth.
722.050: Oral Prescriptions
Note that when receiving an oral prescription the pharmacist must inquire whether the Dr. wishes no substitution.
Upon receiving an oral prescription for a brand name drug product, a pharmacist shall in addition to the
information the pharmacist now requests, ascertain whether or not the prescriber wishes "no substitution" to be
marked on the prescription and record this information with all other required information on his/her prescription log.
722.060: Generic Prescriptions
Upon receiving a prescription for a generic name drug product with no manufacturer specified by the
prescriber, the pharmacist may select, regardless of whether or not the prescriber has marked "no substitution"
on the prescription, any legally marketed drug product whether or not it appears in the Massachusetts List of
Interchangeable Drugs, in accordance with the prescriber's intent and the normal exercise of professional
judgement.
722.070: Labeling
(A) When a less expensive generic drug product has been dispensed, the words "interchange" plus the generic
name and manufacturer of the product shall appear on the label in the following manner:
"Interchange": (Generic name of less expensive drug product dispensed plus manufacturer)
(B) When a less expensive brand name drug product has been dispensed, the words "inter-change" plus either
the generic name and manufacturer of the product or the less expensive brand name dispensed shall appear on
the label in the following manner:
"Interchange": (generic name of less expensive brand drug product plus manufacturer of brand name of less
expensive drug product)

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(C) In addition to the above, the brand name of the prescribed drug product may also appear on the label in the
following manner:
"Interchange": (Name of less expensive generic drug product plus manufacturer or brand name drug product
actually dispensed) for (brand name drug product prescribed)
(D) Abbreviations are permissible as long as they are understandable, e.g., "IC" may be used for "Interchange"
and manufacturer's names may be abbreviated as shown in the Massachusetts List of Interchangeable Drugs.
722.080: Out-Patient Pharmacies
A pharmacist employed by a health care facility as defined in 105 CMR 700.001, other than a hospital, and
who provides outpatient pharmacy services must comply with M.G.L. c. 112, 12D and regulations promulgated
thereunder when filling prescriptions. In particular, no prescription shall be accepted as valid by such a
pharmacist unless it is on a prescription form approved by the Department pursuant to M.G.L. c. 112, 12D.
722.090: Hospital Pharmacies
(A) Hospital pharmacies may fill medication orders for hospital inpatients, prescriptions for hospital outpatients
and employees, and medication orders or prescriptions for inpatients of a hospital-based skilled nursing facility
or a long-term care facility that is solely owned by a hospital that meets the Federal criteria for a sole community
hospital contained at 42 CFR 412.92 and is located on the hospital premises. Patients of such a hospital-based
skilled nursing facility or long-term care facility shall be considered hospital patients for the purposes of
receiving pharmacy services.
Discharge patients may only receive a 14 day supply of medication unless manufacturer packaging does not allow
it.
(B) Notwithstanding the provisions of 105 CMR 722.090(A), hospital pharmacies and their satellites or branches
may fill prescriptions for emergency room patients and discharge patients in an amount not to exceed a 14 day
supply of the prescribed medication.
(1) Prescriptions for emergency room patients and discharge patients may not be refilled by the hospital
pharmacy.
(2) Drug products which are only available from the manufacturer in greater than fourteen day supplies
may be dispensed in larger quantities for emergency room and discharge patients. The quantity dispensed,
however, may not exceed the smallest quantity supplied by the manufacturer.
(C) Notwithstanding 105 CMR 722.090(B), in the case of rare and unusual drugs which generally are not
available in a retail pharmacy, a hospital pharmacist may fill prescriptions for emergency room patients and
discharge patients in the amount prescribed by the practitioner. The Department may establish a list of those
drugs which may be obtained from a hospital pharmacy under 105 CMR 722.090(B).
(D) In filling prescriptions in accordance with 105 CMR 722.090(A), (B) and (C), no prescription shall be
accepted as valid by a pharmacist unless it is on a prescription form approved by the Department pursuant to
M.G.L. c. 112, 12D.

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Note that in the hospital setting, if a practitioner does not indicate no substitution a drug on the hospital formulary shall be
dispensed.
(E) Whenever a practitioner indicates "no substitution" on a prescription form, a hospital pharmacy shall
dispense the drug product prescribed by the practitioner. Whenever a practitioner does not indicate "no
substitution" on a prescription form, a hospital pharmacy shall dispense a less expensive drug product as listed
in the hospital's formulary. A drug listed on the hospital's formulary shall be presumed to be a less expensive
drug product. The hospital's formulary is a continually revised compilation of pharmaceuticals to be dispensed
in the hospital as determined by the medical staff of the hospital. The hospital formulary shall include only those
drugs which have been found to be therapeutically equivalent by the federal Food and Drug Administration.
722.100: Severability
The provisions of 105 CMR 722.000 are severable. If any provision shall be declared invalid by any court,
such provision shall be null and void and such determination shall not affect or impair any of the remaining
provisions.
REGULATORY AUTHORITY 105 CMR 722.000: M.G.L. c. 94, 6; c. 112, 12.
E. Policies of the Massachusetts Board of Registration in Pharmacy
The Board of Registration in Pharmacy publishes the following policies in an attempt to clarify statutes and/or regulations
which may appear unclear, or which may not lend themselves to varying practice settings. Note that these are policies
initiated by the Board of Pharmacy as opposed to statutes or regulations. Policies do NOT have the force and effect of laws
and regulations. However, these policies should be known and followed in the practice of pharmacy in Massachusetts.
Policy 2010-01: Authorizing Transfer of an Original Schedule VI
Prescription Not Dispensed Within One Year of Issue Date
The Massachusetts Board of Registration Pharmacy has established a prescription transfer policy allowing for the transfer of
an original Schedule VI prescription NOT DISPENSED by the initial pharmacy to a receiving pharmacy within one year of the
date of the issuance of the original prescription, upon request of the patient or patients agent, provided that ALL of the below
listed conditions are met by the initial AND receiving pharmacy:
The pharmacist at the initial pharmacy is required to:
record on a written transfer log or by entry into a computerized system, the original prescription (delivered,
telephoned, faxed or electronically transmitted) and maintain the original prescription in a hard copy or computerized
file at the initial pharmacy;
assign a serial number (computer or manually generated) to the prescription (e.g. yyyy/mm/dd/#);
transfer the prescription information to the receiving pharmacist, in accordance with 247 CMR 9.02(3);
document (hard copy or computer record) that the original and refill prescription information was transferred to the
receiving pharmacy and that no quantity of drug was dispensed by the initial pharmacy;
fax the original prescription to the receiving pharmacy to complete the transfer, unless the prescription is otherwise
maintained within a shared system of computerized records; and
maintain a record of the original prescription and transfer, on a written transfer log or by entry into a computerized
system, for a minimum period of two years from the date of transfer, in accordance with 247 CMR 9.02.
The pharmacist at the receiving pharmacy is required to:
record the word TRANSFER on the face of the transferred prescription;
record all information required by state and federal law to be on a prescription, including the initial pharmacys name,
address and DEA number, the original prescription number from which the prescription information was transferred,
and the name of the transferor pharmacist; and
maintain a record of the original prescription and transfer, on a written transfer log or by entry into a computerized

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system, for a minimum period of two years from the date of transfer, in accordance with 247 CMR 9.02.
Authority: Mass. Genl. Laws c. 112, 42A and 247 CMR 9.02
Adopted by the Board of Registration in Pharmacy: January 12, 2010

Joint Policy of the Department of Public Health, Drug Control Program and Board of Registration in Pharmacy
Amendment to DEA Regulation 21 CFR 1306 (Effective Dec. 19, 2007)
On November 19, 2007, the Drug Enforcement Administration (DEA) published a Final Rule on the Issuance of Multiple Prescriptions for Schedule II Controlled Substances [Federal Register: November 19, 2007 (Volume 72, Number 222); Rules
and regulations; Pages 64921-64930]. Effective December 19, 2007, amendments to 21 CFR 1306 allow practitioners to
provide individual patients with multiple prescriptions, to be filled sequentially, for the same Schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90-day
supply of that controlled substance.
Determination that State Law is in Accordance with Amended DEA Regulation
The Massachusetts Department of Public Health, Drug Control Program and the Board of Registration in Pharmacy
have jointly determined that the issuance of multiple Schedule II prescriptions, in accordance with the requirements of the
amended DEA regulation, is permissible under state law.
Note that the prescription becomes invalid 30 days after date of issuance
Date of Issuance
In order to comply with M.G.L. c.94C, 23, and the amended DEA regulation, the Date of Issuance shall be the Do Not
Fill Before date (or similar language) indicated by the prescriber. The Date Written shall be the date that the prescription was written and signed by the prescriber. Thus, in accordance with M.G.L. c.94C, 23, such a written prescription will
become invalid 30 days after the date of issuance.
AUTHORITY: M.G.L. c. 112, ss. 42A and 94C
Board of Registration in Pharmacy Adoption Date: December 11, 2007
Additional Information Regarding Amended DEA Regulation

21 CFR 1306.14(e) states: Where a prescription that has been prepared in accordance with section 1306.12(b)
contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date.

In the DEA response to comments accompanying the Final Rule, the DEA affirmed that no oral modifications may be
made to the earliest date on which the Schedule II prescription may be filled.

For further information on this or any other DEA Regulation, refer to www.deadiversion.usdoj.gov or contact DEA
directly at (617) 557-2191.

Joint Guidelines of the Board of Registration in Pharmacy, Board of Registration in Medicine and Drug Control Program
Pharmacist Dispensing of Emergency Contraception
The Department of Public Health (Department), specifically the Board of Registration in Pharmacy (Pharmacy Board), the
Board of Registration in Medicine and the Drug Control Program under authority of M.G.L. c. 94C, have adopted Guidelines
(Pharmacy

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Board Policy No. 2006-1) that describe the requirements for pharmacists to dispense Emergency Contraception (EC) pursuant
to M.G.L. c. 94C, 19A in accordance with a written standardized procedure or protocol (i.e., Standing Order) developed by
an actively practicing physician registered with the Commissioner to distribute or dispense a controlled substance in the course
of professional practice pursuant to M.G.L. c. 94C, 7. Pursuant to the statute, the Standing Order must be maintained on file
at the participating pharmacy and a copy filed with the Pharmacy Board. In addition to requirements for dispensing, these
Guidelines set forth requirements for training and reporting.
Note that a standing must be maintained on file.o
Physician Orders Are Required to Dispense EC
Prior to the enactment of Chapter 91 of the Acts of 2005, a prescription from an authorized prescriber in compliance with
Department regulations was required to dispense EC (e.g., Plan B).
In accordance with M.G.L. c. 94C, 19A, a pharmacist may now alternatively dispense EC pursuant to a Standing Order
developed by an actively practicing registered physician
(see the Guidelines below). Standing Orders must include written, standardized procedures and protocols, the printed name
and signature of the physician and the entity(ies) authorized by the Physician.
A physician may issue a Standing Order for a pharmacist, pharmacy or group of pharmacies under common ownership or
control of one entity.
GUIDELINES FOR DISPENSING EC PURSUANT TO A STANDING ORDER
Prerequisites
Note requirements.
A pharmacist may dispense EC pursuant to a Standing Order of an actively practicing physician who is registered with the
Commissioner provided that:
the pharmacist is currently licensed by the Pharmacy Board;
the pharmacist has completed training accredited by the Accreditation Council on Pharmacy Education (ACPE) or
offered by an Approved College or School of Pharmacy (247 CMR 2.00), which training shall include instruction
on:
oreferring patient for additional service and follow-up;
oquality assurance; and
oproper documentation.
the Standing Order is maintained on file (readily retrievable) at the pharmacy; and
a copy of the Standing Order has been filed with the Pharmacy Board.
Training
Proof of training must be on file (readily retrievable) at the pharmacy.
Filing
A copy of the Standing Order must be maintained on file (readily retrievable) at each participating pharmacy site.
One copy of the Standing Order must be filed with the Board. Where a Standing Order provided to the participating pharmacy
includes a certification that the Order has been filed with the Board, it is not necessary to make duplicate filings with the Board.
Offer to Provide Medication Counseling
As currently required by M.G.L. c. 94C and Pharmacy Board regulations 247 CMR.
Note that reporting of number of units of E.C. dispensed must be reported annually not later than August 1st for period of July
1 through June 30.
Required Reporting
In accordance with M.G.L. c. 94C, 19A(d), annual reporting of dispensings is required. Where possible, reports shall
aggregate the total number of units of use dispensed pursuant to a Standing Order (not including units of use dispensed
pursuant to a prescription). Reports are not public records and shall not include any patient names or identifiers.
Annual reports must be electronically submitted to the Department not later than August 1 st for the period from July 1 through
June 30 of the prior year.

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Chapter 7: Sample Pharmacy Law Exam
1.

Which of the following is considered an official compendium under the FDCA?

A. The Orange Book.
B. Approved Drug Products with Therapeutic Equivalence Evaluations.
C. The Homeopathic Pharmacopeia.
D. The Physicians Desk Reference.
E. Remingtons Pharmaceutical Sciences.

2.

An article (other than food) that is intended to affect the structure or function of the body of man through chemical
means is classified in what way under the FDCA?
A. Device.
B. Drug.
C. Cosmetic.
D. Dietary Supplement.
E. Dermatological.

3.

An article that is intended to be applied to the human body to alter appearance is classified in what way under the
FDCA?
A. Device.
B. Drug.
C. Cosmetic.
D. Dietary Supplement.
E. Dermatological.

4.

Under the FDCA, the term label refers to which of the following when it is accompanying an article of drug and is
not upon the immediate container of an article of drug?
A. Written matter only.
B. Written or printed matter only.
C. Printed or graphic matter only.
D. Written or graphic matter only.
E. None of the above.

5.

Under the FDCA, by whom must a drug be generally recognized as safe and effective for it to be not
considered a new drug?
A. The FDA.
B. The State Board of Pharmacy.
C. The Physicians Desk Reference.
D. The Innovator Manufacturer.
E. Experts qualified by scientific training and experience.

6.

To avoid being deemed adulterated under the FDCA, the methods used in the packing of a drug must
conform with a specific current standard. By what name is that standard known?
A. Good packing standards.
B. Good laboratory standards.
C. Good clinical standards.
D. Good manufacturing practice.
E. Good distributing practice.

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7.

Under the FDCA, health care economic information must be based on competent and reliable scientific
evidence. To whom may such information be provided under the FDCA misbranding provisions?
A. Practicing physicians.
B. Practicing pharmacists.
C. A formulary committee of a managed care organization.
D. Medical students.
E. Pharmacy students.

8.

Which of the following pieces of information must be included in an NDA?

A. Results of postmarketing programs.
B. Results of postmarketing surveillance.
C. Results of postmarketing investigations.
D. A list of articles used as components of the drug.
E. A list of physicians who will prescribe the drug.

9.

In what way may a prescription-only drug be legally dispensed under the FDCA?
A. Pursuant to a new written prescription only.
B. Pursuant to a new verbal prescription only.
C. Pursuant to either a new written prescription or a new verbal prescription only.
D. Pursuant to either a new written prescription or a new verbal prescription, or an authorized refill of
a written prescription only.
E. Pursuant to either a new written prescription or a new verbal prescription, or an authorized refill of
either a written or verbal prescription.

10.

A pharmacist receives a prescription for an OTC drug. The patient requests that the OTC drug be
dispensed pursuant to a prescription. The pharmacist does so, and prior to dispensing the OTC drug the
pharmacist places on the label of the prescription vial the notation Rx Only. Which of the following statements
is most accurate?
A. The drug is both misbranded and adulterated.
B. The drug is misbranded, but not adulterated.
C. The drug is adulterated, but not misbranded.
D. The drug is neither adulterated nor misbranded.

11.

A pharmacist receives a prescription for an OTC drug. The patient requests that the OTC drug be
dispensed pursuant to a prescription. The pharmacist does so, and after the OTC drug has been dispensed, the
patient places on the label of the prescription vial the notation Rx Only. Which of the following statements is
most accurate?
A. The drug is both misbranded and adulterated.
B. The drug is misbranded, but not adulterated.
C. The drug is adulterated, but not misbranded.
D. The drug is neither adulterated nor misbranded.

12.

According to the FDCA, within what period of time after the filing of an NDA must the NDA be approved
if no grounds for denying approval exist?
A. 180 days.
B. 360 days.
C. 1 year.
D. 2 years.
E. 5 years.

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13.

Under the FDCA, in the absence of confirmatory evidence, what is the minimum number of clinical trials
necessary to provide substantial evidence supportive of an NDA approval?
A. 1
B. 2
C. 3
D. 4
E. 5

14.

The approval of an NDA may be withdrawn without due process under one set of circumstances. What are
those circumstances?
A. Substantial Evidence.
B. Confirmatory Evidence.
C. Imminent Hazard to public health.
D. Lack of efficacy and efficacy.
E. IND exemption.

15.

An unapproved new drug may be legally introduced into interstate commerce under one set of
circumstances. What are those circumstances?
A. Substantial Evidence.
B. Confirmatory Evidence.
C. Imminent Hazard to public health.
D. Lack of efficacy and efficacy.
E. IND exemption.

16.

FDA regulations define a serious adverse drug experience as a life-threatening adverse experience that
occurs at what drug dosage?
A. Any dose.
B. The minimum dose in the package insert.
C. The maximum dose in the package insert.
D. An overdose.
E. An underdose.

17.

The goal of Risk Evaluation and Mitigation Strateigies (REMS) is to ensure the safe use of medications that have
risks if used improperly. The FDA can require REMS before or post-approval. Elements to assure safe use include:
A. Prescribers need specific training or are specially certified.
B. Patient monitoring.
C. Specially certified pharmacies.
D. A and B.
E. A, B, and C.

18.

The distributor of a dietary supplement wishes to make a claim on the label regarding the value of the
supplement for a classical nutrient deficiency disease. Assuming that all other requirements are met, what type of
claim can the distributor make for the dietary supplement?
A. Either a therapeutic claim or a structure/function claim.
B. A therapeutic claim, but not a structure/ function claim.
C. A structure/function claim, but not a therapeutic claim.
D. Neither a therapeutic claim nor a structure/function claim.

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19.

A generic manufacturer wishes to obtain approval of a product believed to be bioequivalent to the FDAapproved
innovator product. Through what mechanism will the generic manufacturer most frequently obtain this
approval?
A. Supplemental NDA.
B. Abbreviated NDA.
C. Additional NDA.
D. Bioequivalency NDA.
E. Full NDA.

20.

Assume that the Orange Book lists two products of the same drug. One product is listed as an A product
(first letter of the two-letter rating) and the other product is listed as a B product (first letter of the two-letter
rating). What do these ratings mean?
A. The two products are bioequivalent.
B. The two products are bioinequivalent.
C. The A rated product is a superior product.
D. The B rated product is not bioavailable.
E. The two products have not been shown to be bioequivalent.

21.

Assume that for a particular drug animal studies have failed to demonstrate a risk to the fetus and there are
no adequate and well controlled studies in pregnant women. In what pregnancy category will this drug be placed?
A. A
B. B
C. C
D. D
E. X

22.

Under FDA regulations, upon what reference must the content of a Medication Guide be based?
A. Goodman and Gilmans Pharmacological Basis of Therapeutics.
B. Remingtons Pharmaceutical Sciences.
C. The package insert.
D. The United States Pharmacopeia.
E. The National Dispensatory.

23.

For which of the following drugs are patient package inserts required?
A. Antihypertensives.
B. Progestational drugs.
C. Oral hypoglycemics.
D. Corticosteroids.
E. Otic drops.

24.

A solid oral dosage form that does not meet the code imprint requirement, and is not exempt from that
requirement, may be considered which of the following?
A. Misbranded only.
B. Adulterated only.
C. Either misbranded or adulterated only.
D. Either misbranded or adulterated or an unapproved new drug.
E. None of the above.

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25.

For OTC drugs there is a document that covers a class of drugs and specifies the ingredients that may be
included, as well as the labeling that may be used. By what name is this document known?
A. Monograph.
B. Official compendium.
C. Package insert.
D. NDA.
E. ANDA.

26.

Under the FDCA, which of the following activities is permissible for drug samples?
A. Sale.
B. Purchase.
C. Trade.
D. Offer to sell.
E. None of the above.

27.

Under the FDCA, which of the following activities is permissible for coupons which may be redeemed for
drugs at a reduced cost?
A. Sale.
B. Purchase.
C. Trade.
D. Offer to sell.
E. None of the above.

28.

Which of the following OTC products is exempt from the requirement of tamper-evident packaging?
A. Dermatological.
B. Dentifrice.
C. Insulin.
D. Lozenge.
E. All of the above.

29.

A patient is not one for whom child-resistant medication vial closures are appropriate. Under the CPSC,
who may request that this patient not receive any medications in child-resistant closures?
A. The prescriber only.
B. The patient only.
C. The pharmacist only.
D. Either the prescriber or the patient only.
E. Either the prescriber or the pharmacist only.

30.

Under the OBRA-90 standards, which of the following publications is listed among the compendia against
which drug use data shall be assessed?
A. American Hospital Formulary Service Drug Information.
B. United States Pharmacopeia-Drug Information.
C. The DRUGDEX Information System.
D. American Medical Association Drug Evaluations.
E. All of the above.

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31.

At the dispenser level, which two controlled substance schedules are treated essentially the same?
A. I and II.
B. II and III.
C. III and IV
D. IV and V.
E. They are all treated essentially the same.

32.

Into what schedule does the DEA place OTC products that are controlled substances?
A. I.
B. II.
C. III.
D. IV.
E. V.

33.

Into what schedule does the DEA place drugs with no currently accepted medical use?
A. I.
B. II.
C. III.
D. IV.
E. V.

34.

In evaluating the DEA number of a distributor named Acme Drug Wholesalers, which of the following
letters would you generally expect to see as the first letter of the DEA number?
A. A.
B. B.
C. C.
D. M.
E. P.

35.

In evaluating the DEA number of a physician named Dr. Bad Chance, which of the following letters
would you generally expect to see as the second letter of the DEA number?
A. A.
B. B.
C. C.
D. M.
E. P.

36.

Which of the following is usually required to register with the DEA?

A. Law enforcement personnel seizing controlled substances as contraband.
B. Stockholders of corporations dispensing controlled substances.
C. Parent corporations of corporations dispensing controlled substances.
D. Pharmacies that dispense controlled substances.
E. Pharmacists that dispense controlled substances.

37.

A pharmacist employed at a pharmacy, who acquires knowledge of the diversion of controlled substances
from the pharmacy, has a responsibility to report this knowledge. To whom must this be reported?
A. The state board of pharmacy.
B. The local police.
C. The DEA.
D. The FDA.
E. A responsible security official of the pharmacy.

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38.

How large must the symbol C-III be, when printed on the label of a schedule III controlled substance
container?
A. At least 1 inch in height.
B. At least 2 inches in height.
C. At least one-half the height of the label itself.
D. The full height of the label itself.
E. None of the above.

39.

Under DEA regulations, a biennial inventory must be done of controlled substances. Assume that a
pharmacy does an initial inventory today. Within what period of time must the next biennial inventory be done.
A. Exactly 2 years from today.
B. At any time between 20 and 24 months from today.
C. At any time between 18 and 24 months from today.
D. At any time between 12 and 24 months from today.
E. At any time within 2 years from today.

40.

A date is chosen on which to conduct a biennial inventory at a pharmacy during a normal business day.
Under DEA regulations, at what time of day must the inventory be officially taken?
A. At the opening of business only.
B. At the close of business only.
C. At either the opening of business or the close of business.
D. At the midpoint of the business day.
E. At any time during the business day.

41.

DEA form 222 may be completed by anyone who has what is referred to as Power of Attorney. Who
must sign the Power of Attorney for it to be effective in authorizing a new pharmacist to sign form 222?
A. The person who signed the most recent application for DEA registration of the pharmacy.
B. The Executive Director of the state board of pharmacy.
C. The Attorney General.
D. Any authorized DEA representative.
E. The Prescription Department Manager.

42.

A physician transmits by facsimile, to a pharmacy, a C-II prescription for a patient who is a resident of a
Long Term Care Facility. Within what period of time must the physician cause a written prescription to be
physically delivered to the pharmacy?
A. 72 hours.
B. 3 days.
C. 7 days.
D. 14 days.
E. None of the above.

43.

A pharmacist is unable to provide the full quantity of a C-II drug prescribed for a patient. The pharmacist
provides a partial filling. Within what period of time must the pharmacist fill the balance without needing to
notify the prescriber?
A. 72 hours.
B. 3 days.
C. 7 days.
D. 14 days.
E. None of the above.

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44.

A pharmacist partially fills a C-II prescription for a patient with a medical diagnosis documenting a
terminal illness. What is the maximum time over which the prescription can be partially filled, assuming that the
quantity prescribed is not exhausted and that the medication is not discontinued?
A. 72 hours.
B. 3 days.
C. 7 days.
D. 14 days.
E. None of the above.

45.

A pharmacist receives a C-II prescription. The pharmacist consults with the prescriber of the C-II
medication. After such consultation, which of the following pieces of information may not be changed on the C-II
prescription even if the prescriber authorizes the change?
A. Patients address.
B. Patients name.
C. Drug strength.
D. Drug quantity.
E. Directions for use.

46.

Partial filling of a C-III prescription is permissible. Assuming that the quantity dispensed does not exceed
the total quantity prescribed, up to how long after a C-III prescription is issued may it be partially filled?
A. 72 hours.
B. 3 days.
C. 7 days.
D. 14 days.
E. None of the above.

47.

Refilling of a C-III prescription is permissible. Assuming that the quantity dispensed does not exceed the
total quantity prescribed, and that the five refill limit is not exceeded, up to how long after a C-III prescription is
issued may it be refilled?
A. 72 hours.
B. 3 days.
C. 7 days.
D. 14 days.
E. None of the above.

48.

Under DEA regulations, a controlled substance that is not a prescription-only drug may be dispensed by a
pharmacist. What is the quantity limit on dispensing of a non-prescription product containing a controlled
substance other than opium?
A. 2 ounces in 24 hours.
B. 2 ounces in 48 hours.
C. 4 ounces in 24 hours.
D. 4 ounces in 48 hours.
E. 4 ounces in 72 hours.

49.

Which of the following requirements applies to the dispensing without a prescription of controlled
substances that are not prescription drugs under the federal CSA?
A. A physician must recommend such drugs in writing.
B. A physician must recommend such drugs either verbally or in writing.
C. The patient must be at least 18 years of age.
D. The purchaser must be known to the pharmacist.
E. Such dispensing must be made by a pharmacist, and not by a nonpharmacist employee.

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50.

Which of the following drugs is approved by the FDA for use in the treatment of opioid addiction in an
opioid treatment program?
A. Methadone only.
B. LAAM only.
C. Buprenorphine only.
D. Methadone and LAAM only.
E. Methadone and Buprenorphine only.

51.

What is the threshold limit on OTC sales of pseudoephedrine in blister packs by retail distributors?
A. 12 grams.
B. 24 grams.
C. 48 grams.
D. 72 grams.
E. There is no such threshold applicable to such sales.

52.

Labeling requirements for C-II controlled substances do not apply when the drug is prescribed for
administration to an institutionalized patient. However, for this relaxed labeling rule to apply, no more than a
specific days supply may be dispensed for such a patient. What is that days supply?
A. 3 days.
B. 5 days.
C. 7 days.
D. 10 days.
E. 21 days.

53.

A pharmacy corporation owns 500 pharmacies at 500 different locations. Each pharmacy dispenses
controlled substances. 100 pharmacies exceed the 5% rule, and are registered as distributors with DEA. 250
pharmacies exceed the 20% rule and are registered as compounders with the DEA. How many total DEA
registrations does the pharmacy corporation have?
A. 250.
B. 350.
C. 500.
D. 850.
E. 1500.

54.

A pharmacy accepts an emergency authorization for dispensing of a C-II medication. This order must be
immediately reduced to writing by the pharmacist. Of the following pieces of information, which may the
pharmacist omit from this writing?
A. The prescribers signature.
B. Address of the prescriber.
C. DEA number of the prescriber.
D. Quantity prescribed.
E. Directions for use.

55.

Interns and some other hospital-based physicians who are licensed to prescribe in their state may, under
DEA rules, not have their own DEA number. What number would they use when prescribing controlled
substances?
A. The hospitals number.
B. The hospitals number with a special internal code number.
C. The dispensing pharmacys number.
D. The dispensing pharmacys number with a special internal code number.
E. The chief of medicines number with a special internal code number.

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56.

A physician issues a controlled substance prescription in order to obtain a supply of controlled substances
for the purpose of general dispensing to patients. What notation must the prescriber place on this prescription to
make it a legitimate prescription that a pharmacist can fill?
A. General Dispensing
B. Office Dispensing
C. General Office Dispensing
D. Office Use
E. None. This is not a prescription and it cannot be filled.

57.

A pharmacist is presented a purported prescription that is not legitimate. The pharmacist fills it. For the
pharmacist to have violated federal law, an important question must be answered about the pharmacist. What is
that question?
A. Did the pharmacist purposefully fill the purported prescription?
B. Did the pharmacist knowingly fill the purported prescription?
C. Did the pharmacist consciously fill the purported prescription?
D. Did the pharmacist intentionally fill the purported prescription?
E. Did the pharmacist willfully fill the purported prescription?

58.

What DEA form is used to acquire the form that is used to order C-II controlled substances?
A. Form 200.
B. Form 202.
C. Form 222.
D. Form 222a.
E. Form 222b.

59.

By whom may a controlled substance prescription be communicated to a pharmacist?

A. The prescriber only.
B. The prescriber or the prescribers agent only.
C. The prescriber or the prescribers employee only.
D. The prescriber or the prescribers agent or the prescribers employee only.
E. Any licensed health care professional.

60.

Within what period of time after informing the DEA Special Agent in Charge of the intent to maintain
controlled substance records on an in-house computer system may the registrant begin maintaining such in-house
computer records?
A. 7 days.
B. 10 days.
C. 14 days.
D. 21 days.
E. There is no such notification requirement and no such time period.

61.

Which of the following statements regarding Continuing Education requirements for Massachusetts
pharmacists when applying for license renewal are not true?
A. A registrant must attach proof (copies of) 30 hours of C.E. in the application for renewal.
B. At least 2 of the 30 hours required over two years must be in the area of pharmacy law.
C. No more than 10 of the 30 hours required over two years shall be done through home study.
D. A and B
E. A, B, and C

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62.

Records of prescription transfers in Massachusetts must be maintained for how many years?
A. 2
B. 4
C. 5
D. 7

63.

How many people serve on the Massachusetts Board of Pharmacy?

A. 5
B. 7
C. 11
D. 10

64.

In Massachusetts, which of the following are true with regard to the storage and handling of Schedule II
controlled substances?
A. A Certified pharmacy technician may handle them with the approval of and under the supervision of the
pharmacist assuming written policies and procedures are in place.
B. A pharmacy technician may transport them with the approval of and under the supervision of the pharmacist assuming written policies and procedures are in place.
C. They must be stored in a locked secured cabinet.
D. A and B
E. None of the above

65.

An authorized Massachusetts practitioner calls in a prescription for alprazolam with 1 refill for a patient on
November 30, 2010. Which of the following is/are true?
A. A pharmacy technician with the approval of and under the supervision of a pharmacist may receive the
new prescription information over the phone.
B. A certified pharmacy technician with the approval and under the supervision of the pharmacist may
transfer the prescription to a different pharmacy on Dec. 31st, 2010.
C. A pharmacy intern under the direct Supervision of the pharmacist may receive the prescription by
phone.
D. A pharmacy intern may transfer the prescription to another pharmacy on April 30, 2011.
E. All of the above
F. B C & D

66.

Which of the following items does the Massachusetts Board of pharmacy require to be in each pharmacy?
A. Current copy of the Massachusetts List of Interchangeable Drugs (MLID) with the Orange Book, Additional List, Exception List and its latest supplements.
B. Current copy of the Board Regulations.
C. A balance capable of weighing quantities as small as 1 mcg.
D. A and B
E. A B & C

67.

What term is used in Massachusetts for the pharmacist responsible for the operation of a pharmacy in con
formance of all laws and regulations pertinent to the practice of pharmacy and the distribution of drugs?
A. Pharmacist in Charge
B. Pharmacist Manager
C. Supervising Pharmacist

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D. Pharmacist Manager of Record
E. Responsible Pharmacist
68.

In Massachusetts which method of filing may a pharmacy utilize for Schedule III controlled substance
prescriptions?
A. Schedule III prescriptions are to be filed alone.
B. Schedule III prescriptions are to be filed with Schedule IV and V prescriptions.
C. Schedule III prescriptions are to be filed with Schedule IV, V and VI prescriptions.
D. Schedule III prescriptions are to be filed with all other prescriptions .
E. B or C

69.

When does the license of a pharmacist in Massachusetts expire?

A. On December 31st, of each year.
B. December 31st of each even-numbered year.
C. December 31st of each odd-numbered year.
D. January 1st of each even-numbered year.
E. None of the above.

70.

Under Massachusetts Law, what language must a practitioner write by hand on a prescription to prevent
generic substitution?
A. Brand Medically Necessary
B. Do Not Substitute or DNS
C. Dispense as Written or DAW
D.No Substitution
E. May not Substitute

71.

In Massachusetts, at what age may a patient receive an Influenza vaccination from a qualifying pharmacist?
A. 21
B. 18
C. 12
D. any age
E. Pharmacists in Massachusetts may not administer influenza vaccines..

72.

In Massachusetts which of the following statements is correct concerning the dispensing of a Schedule II
controlled substance upon an oral or electronically transmitted prescription.
A. Massachusetts does not allow such dispensing of Schedule II drugs.
B. Such dispensing is allowed only pursuant to an Emergency Situation.
C. The pharmacist must verify the prescription by calling back the prescribing practitioner.
D. The prescribing practitioner must cause a written prescription to be delivered to the pharmacy within 72
hours of the dispensing.
E. B, C, and D.

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73.

Under Massachusetts law, which of the following practitioners may have prescriptive authority pursuant to
guidelines mutually agreed upon by the practitioner and a supervising physician?
A. Psychiatric nurse mental health clinical specialists.
B. Certified nurse mid-wives.
C. Opticians
D. A, B & C
E. A and B

74.

Under Massachusetts regulations, which of the following situations would be acceptable regarding
supervision of support personnel?
A. One pharmacist supervising 1 pharmacy intern, 1 certified pharmacy technician and 2 pharmacy technicians.
B. One pharmacist supervising 2 certified pharmacy technicians and 2 pharmacy technicians.
C. One pharmacist supervising 3 pharmacy technicians.
D. A and B
E. A, B and C

75.

In Massachusetts which of the following is NOT true regarding written prescriptions for Schedule II
controlled substances and their dispensing?
A. The pharmacist must sign the face of the prescription.
B. The prescription is invalid 30 days after the date of issuance.
C. A prescription written for a 60 day supply of methylphenidate for the treatment of narcolepsy is invalid.
D. A prescription written for an implantable infusion pump consisting of a Schedule II drug may be filled
for a 90 day supply.
E. C and D

76.

Which of the following statement(s) are NOT true concerning pharmacy interns in Massachusetts?
A. An intern must wear a name tag indicating the interns name and the words pharmacy intern.
B. A pharmacy intern, under the supervision of a registered pharmacy preceptor, may supervise pharmacy
technicians.
C. A pharmacy intern may receive credit of up to 8 hours of pharmacy internship credit per day.
D. An intern must complete 1500 hours of Board approved pharmacy internship experience.
E. B and C

77.

If a registered pharmacist in Massachusetts changes his/her mailing address, he/she must notify the board
of pharmacy:
A. By phone within 10 working days.
B. In writing within 10 working days.
C. In writing within 15 working days.
D. By phone or in writing within 10 working days.
E. In writing within 30 working days.

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78.

Under Massachusetts pharmacy law, which of the following is/are true regarding the improper dispensing
of a prescription drug?
A. All improper dispensing incidents must be reported to the Board within 15 days of the pharmacy
discovering or being informed of the improper dispensing.
B. All improper dispensing incidents that result in serious injury or death must be reported to the Board
within 15 days of the pharmacy discovering or being informed of the improper dispensing.
C. All improper dispensing incidents that result in serious injury or death must be reported to the Board
within 10 days of the pharmacy discovering or being informed of the improper dispensing.
D. Improper dispensing incidents resulting in serious injury or death need to be reported only upon request
by the Board.
E. None of the above.

79.

Which of the following statements is/are true regarding the transfer of prescriptions in Massachusetts?
A. Transfer of prescriptions with refills for Schedule III through V may be transferred on a one-time only
basis.
B. Transfer of prescriptions with refills for Schedule III through V controlled substances may be transferred as many times as refills allow.
C. A certified pharmacy technician may transfer a prescription for Schedule III through V.
D. A and C
E. B and C

80.

Information regarding which Schedule of drugs dispensed must be reported to Massachusetts each month?
A. Schedule II controlled substances
B. Schedule III controlled substances
C. Schedule IV controlled substances
D. A and B
E. A, B and C

81.

Which of the following statements about the practice of pharmacy in Massachusetts is NOT true?
A. A pharmacist may advertise the price of prescription drugs in compliance with specific regulations.
B. A pharmacist must keep a perpetual inventory of Schedule II controlled substances that must be reconciled at least once every 30 days.
C. A pharmacist may dispense emergency contraception in compliance with specific regulations.
D. When a pharmacist is newly hired, the managing pharmacist must report, in writing to the Board, the
commencement of the employment within 10 working days.
E. A and B

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82.

Which of the following would require a Massachusetts pharmacist (or appropriate delegate) to offer to
counsel?
I. New patient with a new prescription.
II. Existing patient receiving the same medication as previously dispensed but a new dose and directions called in by a physicians office.
III. Existing patient with a new prescription.
IV. New patient receiving a transferred prescription.
A. I only
B. I and II only
C. I, II and III
D. I, II, III and IV

83.

What is the maximum number of hours a Massachusetts pharmacist can work each day?
A. 12
B. 8
C. 10
D. 14

84.

Which of the following statements are NOT true concerning the interchangeability of drug products
(generic substitution) in the state of Massachusetts?
A. A prescriber must write the words no substitution on the prescription to prevent generic substitution.
B. The state of Massachusetts incorporates all A rated drug products listed in the FDAs Orange Book on
the Massachusetts List of Interchangeable Drugs (MLID).
C. All prescriptions written by generic name may be interchanged if the drug is multi-source.
D. If a drug product is not listed in the Orange Book it may not be interchanged.
E. C and D

85.

Which of the following statements is NOT true regarding the filling and dispensing of prescriptions in
Massachusetts?
A. In a medical emergency as defined in regulations, the pharmacist may fill a prescription marked no
substitution with a less expensive interchangeable drug if the brand is not in stock.
B. When a less expensive generic drug has been dispensed for a brand name, the words substitute for
must appear on the label.
C. The name of the manufacturer of the drug dispensed must appear on the label.
D. When receiving an oral prescription for a brand name product, a pharmacist must ask whether or not the
prescriber wishes no substitution to be marked on the prescription.
E. A and B

86.

What is the maximum number of hours a pharmacy intern may receive credit for per day?
A. 12
B. 8
C. 10
D. 14

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87.

Which of the following statement(s) is/are NOT true regarding a Quality Related Event (QRE)?
A. It must be documented by the pharmacist who discovered it or was informed of it the same day.
B. The pharmacist must immediately contact the patient or the patients representative.
C. Records of QREs must be maintained for 5 years
D. QRE records may be stored at a site other than the pharmacy where the QRE occurred.
E. C and D

88.

Which statement is correct regarding how a Massachusetts prescriber may/must write a patients
prescriptions for two Schedule III substances and one Schedule VI substance.
A. The prescriber may put all 3 prescriptions on one prescription blank.
B. The prescriber must put the 2 Schedule III substance prescriptions on one blank and the Schedule VI on
a separate blank.
C. The prescriber may put each prescription on a separate prescription blank.
D. The prescriber must put each prescription on a separate prescription blank.
E. A and C

89.

In order for a pharmacist to enter into a collaborative practice agreement in Massachusetts the pharmacist
must:
I. have at least $1,000,000 of professional liability insurance.
II. have earned a doctor of pharmacy degree.
III. agree to devote a portion of his practice to the defined therapy area he/she shall co-manage.
IV. agree to complete 5 additional contact hours of C.E. related to the area of his/her practice therapy.
A. I, II and IV
B. I, III and IV
C. II, II and IV
D. I and IV

90.

A Massachusetts pharmacist may fill a prescription for a Schedule II controlled substance written by a
physician who is licensed to practice medicine out of state (where he lives or practices) and is also
registered under federal law to write prescriptions if:
I. The pharmacist determines the prescription is authentic and valid.
II. The pharmacist must verify the prescription by phone or other means.
III. The prescription has been issued within the last 30 days.
IV. The pharmacist, within 30 days of filling the prescription, sends a copy of the prescription ( w/out identifying the patient) to the Department of Public Health.
A. I, II and III
B. I, III and IV
C. I and IV
D. I, II and IV
E. I, II, III and IV

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Answers
1. C
2. B
3. C
4. E
5. E
6. D
7. C
8. D
9. E
10. B
11. D
12. A
13. B
14. C
15. E
16. A
17. E
18. C
19. B
20. E
21. B
22. C
23. B
24. D
25. A
26. E
27. E
28. E
29. B
30. E
31. C
32. E
33. A
34. E
35. C
36. D
37. E
38. E
39. E
40. C
41. A
42. E
43. A
44. E
45. B
46. E
47. E
48. D
49. E
50. D

51. E
52. C
53. D
54. A
55. B
56. E
57. B
58. D
59. D
60. C
61. E
62. A
63. C
64. D
65. F
66. D
67. D
68. B
69. B
70. D
71. B
72. B
73. E
74. D
75. C
76. C
77. B
78. B
79. D
80. A
81. B
82. C
83. A
84. D
85. B
86. A
87. C
88. D
89. B
90. D

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