Based on the sources and our conversation history, here is a comprehensive study guide for the
Kansas MPJE, focusing on the "unofficial" Kansas Pharmacy Law and Rules provided. Please
remember that this document is provided as a courtesy and is not exhaustive, nor does it
constitute legal advice.
Kansas MPJE Study Guide: Key Concepts from Kansas Pharmacy Law and
Rules
This study guide is derived from the "unofficial" Kansas Pharmacy Law and Rules document.
For official agency laws, refer to Chapter 65 of the Kansas Statutes Annotated (KSAs), published
by the Secretary of State’s Office. For official agency rules, refer to Chapter 68 of the Kansas
Administrative Rules (KARS), also published by the Secretary of State’s Office.
I. General Principles and Administration
Governing Body: The Kansas State Board of Pharmacy (referred to as "the board") is
the primary administrative and enforcement authority for pharmacy practice and
controlled substances within the state.
o The board is comprised of members appointed by the Governor, serving four-year
terms.
o Pharmacist members must be residents and actively practicing pharmacists in
Kansas for at least five years preceding appointment.
o The board organizes annually, electing a president and vice-president, and
appointing a full-time executive secretary.
o The executive secretary is the chief executive officer, responsible for records,
correspondence, and fee collection.
o The board can employ inspectors, chemists, agents, and clerical staff to administer
and enforce the act, and an attorney for prosecutions.
o The board holds at least four meetings annually.
Purpose of Pharmacy Act: The act is officially known as the "pharmacy act of the state
of Kansas".
Unofficial vs. Official Sources: The provided document is "unofficial," while "official"
laws are in Kansas Statutes Annotated (KSAs) and "official" rules in Kansas
Administrative Rules (KARS).
II. Core Definitions (K.S.A. 65-1626, 65-4101)
Understanding these definitions is fundamental to the law:
Administer: Direct application of a drug to a patient or research subject by a practitioner,
pursuant to a practitioner's direction, or by a pharmacist as authorized.
Controlled Substance: Any drug, substance, or immediate precursor included in the
schedules designated in K.S.A. 65-4105, 65-4107, 65-4109, 65-4111, and 65-4113.
Dispense: To deliver a controlled substance to an ultimate user or research subject by or
pursuant to the lawful order of a practitioner or mid-level practitioner, including
packaging, labeling, or compounding.
Distribute: To deliver a controlled substance other than by administering or dispensing.
Drug: Substances recognized in official compendia (USP, NF), or intended for use in
diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the body's
structure/function, or as components of such articles.
Electronic Prescription: Electronically prepared and transmitted from prescriber to
pharmacy.
Institutional Drug Room: A location in a medical care facility where prescription-only
drugs are stored and administered, but it is not a registered pharmacy.
Medical Care Facility: Defined as in K.S.A. 65-425, including psychiatric hospitals and
residential treatment facilities.
Medication Order: A written or oral order by a prescriber for administration of a drug or
device to a patient in a Kansas licensed medical care facility or nursing facility.
Mid-Level Practitioner: Certified nurse-midwife, advanced practice registered nurse
(APRN) with prescribing authority, or physician assistant (PA) with prescribing authority
via written agreement with a supervising physician.
Nonresident Pharmacy: A pharmacy located outside of Kansas.
Outsourcing Facility: A facility at one geographic location engaged in compounding
drugs.
Pharmacist: Any natural person licensed under K.S.A. 65-1625 et seq. to practice
pharmacy.
Pharmacist Intern: A student in an accredited pharmacy program, a graduate serving an
internship, or a foreign graduate who passed equivalency exams approved by the board.
Pharmacy: Premises where drugs are offered for sale, the profession of pharmacy is
practiced, and prescriptions are compounded and dispensed.
Pharmacy Technician: Has a specific definition in the statutes.
Practitioner: Person licensed to practice medicine and surgery, dentist, podiatrist,
veterinarian, optometrist, or scientific investigator authorized to use controlled
substances.
Prescriber: A practitioner or a mid-level practitioner.
Prescription Order: An order for medication dispensed to or for an ultimate user.
Readily Retrievable: Records can be separated from others within 48 hours, or hard
copies have visually identifiable items.
Retail Dealer: Person selling at retail prepackaged nonprescription drugs.
Telepharmacy: Practice of pharmacy by a pharmacist in Kansas using
telecommunications to deliver care to patients at other sites, including dispensing and
counseling, and overseeing telepharmacy outlet operations.
Telepharmacy Outlet: A registered pharmacy site in Kansas owned by a managing
pharmacy, connected via telecommunications, with a pharmacy technician on site under
electronic supervision of a pharmacist.
Wholesale Distribution: Distribution of drugs to persons other than consumers, and does
not include administering or dispensing a product pursuant to a prescription.
III. Pharmacy Practice Act - Statutes (Chapter 65, Article 16)
A. Licensure and Registration
Pharmacist Licensure:
o Applicants must pass an approved examination and a law examination with at
least 75%.
o Reciprocal licensure is possible for those licensed in other states, requiring the
multi-state jurisprudence exam.
o Continuing education is required for renewal.
o Felony convictions are considered but not an automatic bar to licensure.
o Foreign graduates have specific English language and equivalency exam
requirements.
Pharmacy, Manufacturer, Distributor, Logistics Provider, Outsourcing Facility
Registration:
o Required for operation.
o Applications require specific information, and the board may deny applications
not in the public interest.
o Fees are set by the board annually.
o Registrations are not transferable and must be conspicuously displayed.
o Inspections are required.
Pharmacy Technician Registration:
o Required to function as a technician.
o Must pass one or more board-approved certification examinations within a
specified period, typically before first renewal.
o Continuing education is required.
o The ratio of pharmacy technicians to pharmacists shall not exceed four to
one.
o A pharmacist shall not supervise more than two pharmacy technicians who
have not passed a certification examination.
o Pharmacist-in-charge is responsible for training technicians.
Pharmacist Intern Registration:
o Required to function as an intern.
o Must complete 1,740 clock-hours of supervised experience within six years.
o Interns work under the direct supervision and control of a pharmacist, who is
responsible for their acts and omissions.
o Interns must notify the board of new employment or address changes.
B. Pharmacy Operations and Practice
Pharmacist-in-Charge (PIC):
o Every pharmacy must have a PIC.
o PIC is responsible for developing, supervising, and coordinating all
pharmaceutical services, ensuring compliance with laws and regulations.
o PIC must acknowledge review of laws and regulations and be aware of
responsibilities.
o PIC is responsible for developing written procedures for drug distribution,
prepackaging, repackaging, and compounding.
o Must inventory all controlled substances and drugs of concern when starting and
ceasing duties.
Pharmacy Security:
o Pharmacies (except medical care facilities) must be constructed to prevent access
to prescription-only drugs when a pharmacist is not on duty.
o Theft or loss of controlled substances must be reported to the board within one
day.
Recordkeeping:
o Medication profile records must be maintained for at least five years from the last
entry.
o Prescriptions (paper, oral, facsimile) and electronic prescriptions must be retained
for five years.
o Records must be readily retrievable.
o Pharmacies must keep a book or file of every prescription filled.
Dispensing and Prescription Requirements:
o Pharmacist must exercise professional judgment regarding prescription
accuracy, validity, and authenticity.
o Prescriptions require a legitimate medical purpose and a valid patient-prescriber
relationship.
o Refills for non-controlled substances are limited to one year from the date of
origin.
o Patient Counseling: Pharmacists must personally offer to counsel each patient for
new prescriptions, yearly for maintenance medications, and as deemed
appropriate for refills. Specific information must be covered in counseling.
o Brand Exchange: Pharmacist must expressly notify the patient if a brand
exchange occurs.
o Labeling: Labels must include specific information: pharmacy
name/address/phone, prescriber, patient, date, prescription number, drug name,
strength, quantity, directions, cautionary statements, beyond-use date, and
necessary auxiliary labels.
o Prescription Copies: Pharmacists shall not fill a copy of a prescription; reference
copies must be labeled "This prescription copy is issued for reference only".
o Prepackaging: Must be done by or under pharmacist supervision, with
verification and documentation.
o Resale of Dispensed Drugs: Generally prohibited, with exceptions for unit-dose
systems that have not reached the patient and are still intact.
Specific Practice Areas:
o Vaccine Administration: Pharmacists (and supervised interns/techs 18+) may
administer influenza vaccine (6+ years old) and other vaccines (12+ years old)
under a vaccination protocol. Requirements include specific training, CPR
certification, and reporting to the patient's primary care provider (unless refused).
Delegation of vaccine administration is prohibited.
o Institutional Drug Rooms: Must be supervised by a pharmacist or practitioner
responsible for recordkeeping and storage. The board adopts rules for control.
o Automated Dispensing Systems: Must be under pharmacist supervision, who is
responsible for recordkeeping, storage, verification, and documentation of drugs.
The board regulates their control and operation. Specific loading and unloading
personnel are authorized.
o Telepharmacy: Requires specific board rules for application, structural, security,
technology, staffing, training, electronic supervision, inventory, and labeling
requirements. Electronic supervision by a pharmacist of a pharmacy technician in
a medical care facility's pharmacy is permitted, with limitations on the number of
technicians supervised (one technician per pharmacist).
o Collaborative Drug Therapy Management (CDTM): Allows pharmacists to
perform certain patient care functions delegated by a physician through a
collaborative practice agreement. The Collaborative Drug Therapy Management
Advisory Committee establishes protocols. Pharmacists can initiate therapy for
specific conditions (influenza, strep pharyngitis, UTI) within statewide protocols.
o Emergency Opioid Antagonists (Naloxone): Pharmacists may furnish
emergency opioid antagonists (e.g., naloxone) to patients or bystanders under
specific requirements and board rules. Healthcare providers and pharmacists
furnishing these are immune from civil liability if acting in good faith and with
reasonable care.
o Methamphetamine Precursors (Statewide Electronic Logging System): The
board maintains an electronic logging system for sales of pseudoephedrine,
ephedrine, or phenylpropanolamine. Pharmacies must maintain an electronic log
documenting sales, including purchaser, product, quantity, date/time, and
name/initials of seller (pharmacist, technician, or intern). Sales without a lawful
prescription are subject to strict conditions, including identification and logging.
Pharmacies must place these substances behind the counter or in a locked cabinet.
Information collected is confidential but accessible to law enforcement.
o Utilization of Unused Medications Act: Establishes a program for transferring
unused drugs from donating entities (adult care homes, mail service pharmacies,
medical care facilities) to qualifying centers/clinics (indigent health care clinics,
federally qualified health centers, community mental health centers) for
distribution to medically indigent Kansas residents. A pharmacist's verification of
quality and suitability is required before transfer.
o Continuous Quality Improvement (CQI) Program: Each pharmacy must
establish a CQI program to assess dispensing/furnishing errors and prevent
recurrence. Reports and records generated are generally confidential and
privileged peer review documents, not subject to discovery, except in
administrative proceedings initiated by the board.
Pharmacy Owner Responsibilities: Ensure compliance with all applicable state and
federal laws and regulations (Pharmacy Act, Controlled Substances Act, Food, Drug, and
Cosmetic Act, Prescription Monitoring Program Act). Owners shall not prohibit
pharmacy personnel from complying with these laws.
Nonresident Pharmacies: Pharmacies outside Kansas shipping drugs into the state must
register with the board, comply with Kansas laws (especially for controlled substances),
provide a toll-free number for patient consultation, and be subject to inspection (or
provide proof of inspection by another state). Violation is a severity level 10 nonperson
felony.
C. Enforcement and Penalties
Grounds for Disciplinary Action: The board may deny, limit, condition, revoke,
suspend, or place on probation the license/registration of pharmacists, pharmacies,
manufacturers, distributors, or logistics providers for various reasons, including:
o Felony conviction related to controlled substances or moral turpitude.
o Unprofessional conduct.
o Mental or physical incapacity rendering the licensee unfit to practice.
o Violation of the Pharmacy Act, Controlled Substances Act, or any related
rules/regulations adopted by the board.
o Failure to comply with continuing education.
o Knowingly submitting false claims.
o Disciplinary action in another state.
o Self-administration of controlled substances without a prescription.
o Failure to furnish information requested by the board.
o Falsifying or failing to keep required records.
o Refusal to permit inspection.
o Obtaining/renewing registration by false/fraudulent means.
Process:
o The board can compel a licensee to submit to mental/physical examination or
drug screen based on reasonable suspicion.
o The board may temporarily suspend a license if there's an imminent danger to
public health and safety.
o Proceedings are generally subject to the Kansas Administrative Procedure Act.
o Civil fines can be assessed by the board for violations of the Pharmacy Act,
Controlled Substances Act, or board rules.
o Violations of the Pharmacy Act or rules are generally a misdemeanor.
o The board can seek injunctions for repetitious violations.
IV. Controlled Substances Act - Statutes (Chapter 65, Article 41) & Regulations (K.A.R.
68, Article 20)
Board's Authority: The board administers this act and has authority to adopt rules and
regulations for registration and control of controlled substances.
o The board annually reports to the legislature on proposed scheduling changes.
o The board can initiate emergency scheduling of controlled substance analogs.
Registration:
o Mandatory for manufacturers, distributors, or dispensers of controlled substances,
unless exempted.
o Exemptions exist for agents/employees, common carriers, ultimate users,
and persons licensed/registered under the Kansas Pharmacy Act to
manufacture, dispense, or distribute drugs (though manufacturers and
distributors must still file the required application).
o Pharmacists are registered to dispense Schedule I designated prescription
substances and controlled substances in Schedules II through V.
o A separate annual registration is required for each place of business or
professional practice where controlled substances are manufactured, distributed,
or dispensed.
o Registrations expire annually on June 30.
Recordkeeping and Inventory (Building on general recordkeeping):
o Registrants must keep records and maintain inventories conforming to federal
requirements (21 C.F.R. Part 1304).
o Inventories must be legible, hard-copy format, including date, names/signatures of
participants, and whether taken before/after business hours.
o Theft or significant loss must be reported to the board in writing within one
day, and a copy of DEA Form 106 provided upon completion.
Dispensing Requirements:
o Schedule I: Generally, no Schedule I substance may be dispensed, unless
designated by the board as a "Schedule I designated prescription substance".
o Schedule II: Only dispensed pursuant to a signed paper prescription, facsimile,
or digitally signed electronic prescription. Oral prescriptions are allowed only
in emergencies, requiring a written/electronic follow-up within 7 days. No
refills are permitted. Partial filling is permitted for terminally ill or LTCF
patients, up to 60 days.
o Schedules III, IV, V: May be dispensed pursuant to a paper, facsimile,
electronic, or oral prescription(promptly reduced to writing). May be refilled up
to five times within six months of the date issued.
o Prescription Validity: Must be issued for a legitimate medical purpose by a
prescriber acting in their usual professional practice. Responsibility rests with
both the prescriber and the pharmacist.
o Electronic Prescriptions: Must be retained electronically for five years.
Electronic prescription for controlled substances must conform with 21 C.F.R.
Part 1311.
o Prescription Blanks: Cannot be preprinted or rubber-stamped with drug names.
o Intern/Resident Prescriptions: Must include hospital DEA number and special
internal code number, plus the prescriber's name stamped or printed.
o Identity of Patient: Generally confidential and not compelled to be furnished to
the board.
Prescription Monitoring Program (PMP):
o The board maintains a PMP for scheduled substances (Schedules II, III, IV) and
"drugs of concern" (e.g., gabapentin, specific pseudoephedrine/ephedrine
products, promethazine with codeine) dispensed in Kansas or to a Kansas address.
o Dispensers must submit required information electronically to the board,
typically daily.
o Exemptions from reporting may apply to certain low-volume dispensers or
medical care facilities providing interim supplies.
o PMP data is confidential and generally not public record, with specific
authorized access for practitioners, dispensers, delegates, law enforcement, and
licensing agencies.
o Penalties for PMP Violations: Knowingly failing to submit, submitting incorrect
information, or knowingly disclosing/using PMP information in violation of the
act are severity level 10 non-person felonies.
o Practitioners/dispensers are not required to obtain PMP information before
prescribing/dispensing.
o Dispensers must notify patients of PMP access (e.g., by posting a sign).
V. Related Laws and Concepts
Kansas Food, Drug, and Cosmetic Act: Prohibits adulteration and misbranding of
drugs. Pharmacists are responsible for the quality of drugs they sell, compound, or
dispense, unless in original manufacturer packaging. Violations can lead to misdemeanor
charges.
Kansas Chemical Control Act (Sheriff Matt Samuels Chemical Control Act): Aims
to prevent illegal diversion of precursor chemicals. Exemptions exist for pharmacists
selling or furnishing substances upon a valid prescription or order.
Pharmacy Benefits Manager (PBM) Licensure Act: Requires PBMs to be licensed by
the Commissioner of Insurance. Defines PBMs and covered entities. Sets requirements
for licensure, renewal, fees, and includes penalties for violations. Addresses maximum
allowable cost (MAC) pricing.
Healthcare Provider Insurance Availability Act: Defines pharmacists as "healthcare
providers" for the purpose of the Healthcare Stabilization Fund.
Immunity from Liability: Pharmacists are immune from civil liability for good faith
reporting of alleged malpractice incidents to the board. Similarly, healthcare
providers/pharmacists are immune for furnishing emergency opioid antagonists in good
faith.
Electronic Transmission of Prescriptions: Electronic transmission of prescription
orders for controlled substances is generally required, with specific exceptions (e.g.,
temporary technological failures, research protocols, limited prescribing volume, FDA
incompatibilities, waivers).
Fees: Various fees are established by the board for applications, licenses, registrations,
and renewals for pharmacists, technicians, interns, and different types of pharmacy
operations.
This comprehensive overview should provide a solid foundation for your Kansas MPJE study,
focusing on the statutes and regulations provided. Good luck!