96 F.

3d 658

Earl A. HUMPHREYS, M.D., Petitioner,

v.
DRUG ENFORCEMENT ADMINISTRATION, Respondent.
No. 96-3099.

United States Court of Appeals,

Third Circuit.
Argued July 26, 1996.
Decided Sept. 17, 1996.

Robert A. Felkay (argued), John A. Tumolo, Pittsburgh, PA, for Earl A.

Humphreys, M.D.
John C. Keeney, Theresa M.B. Van Vliet, Hope P. McGowan (argued),
Narcotic and Dangerous Drug Section, Criminal Division, Washington,
D.C., for Drug Enforcement Administration.
Before: BECKER, STAPLETON, and MICHEL,* Circuit Judges.
OPINION OF THE COURT
MICHEL, Circuit Judge.

Earl A. Humphreys, M.D. ("Humphreys") appeals from an order of the Drug

Enforcement Administration ("DEA"), dated January 23, 1996, in which the
Deputy Administrator of the DEA ordered that Humphreys' DEA certificate of
registration be revoked and any pending application for renewal of the
registration be denied. Earl A. Humphreys, M.D.; Revocation of Registration,
61 Fed.Reg. 2840 (1996). Because the DEA abused its discretion in failing to
consider Humphreys' privacy defense and, on the present record, arbitrarily
revoked his registration, we vacate and remand.

BACKGROUND
2

Humphreys is a Pittsburgh doctor specializing in gastroenterology and internal

medicine and who, prior to this proceeding, had practiced for over 35 years

without any disciplinary actions being taken against him. On April 12, 1995, a
Deputy Assistant Administrator of the DEA issued to Humphreys an Order to
Show Cause why the DEA should not revoke Humphreys' certificate of
registration under 21 U.S.C. 824(a)(4) and deny any pending application
under 21 U.S.C. 823(f) as being inconsistent with the public interest.
Specifically, the Order to Show Cause alleged that "from the early 1980s to
mid-1993, [Humphreys] prescribed controlled substances to at least four
individuals without a legitimate medical need and with knowledge that these
individuals were not the ultimate recipients of the controlled substances."
3

The DEA's action was precipitated by Humphreys' personal and professional

relationship with former Pennsylvania Supreme Court Justice Rolf Larson
("Larson") and the criminal investigation of Larson. Humphreys acted as
Justice Larson's personal physician for approximately the past 20 years. In
1993, based on the findings and recommendations of a grand jury, Larson was
charged with one count of conspiracy to commit "Acquisition or Obtaining of
Possession of a Controlled Substance by Misrepresentation, Fraud, Forgery,
Deception, or Subterfuge" and numerous other violations of law. Humphreys
was named as an unindicted co-conspirator in the conspiracy count and
received immunity in return for his testimony against Larson.

The criminal conspiracy charge against Larson, and DEA's regulatory

investigation of Humphreys, stemmed from Larson's attempts to keep his
mental health problems out of public sight. Beginning in the 1960's, Larson
visited psychiatrists and psychologists for the treatment of clinical depression
and anxiety. These doctors prescribed various tranquilizers and antidepressants,
which Larson paid for out of his own pocket in order to preserve his privacy.
Beginning in 1981, however, Larson revised his method of assuring his privacy:
he asked Humphreys to prescribe various controlled drugs for Larson in the
name of certain of Larson's employees (secretaries and a law clerk). From the
early 1980's to mid-1993, Humphreys wrote approximately 34 prescriptions for
drugs in this manner, including prescriptions for Valium, Diazepan, Ativan, and
Serax. It is undisputed that the individuals named on the prescriptions always
gave the prescription drugs to Larson and did not take the medications
themselves or resell them. It is also undisputed that Humphreys was aware of
Larson's diagnosed condition, that he believed each medication he prescribed
was for an appropriate medical purpose, and that he prescribed the substances
in appropriate medical dosage amounts and at acceptable time intervals.
Moreover, although Humphreys did not examine Larson each time he
prescribed drugs, Humphreys did examine Larson before the first prescription
and approximately every six months thereafter. Although Humphreys was
aware that Larson was continuing to see other doctors, Humphreys was not

aware of any other medications prescribed by Larson's other doctors and did not
attempt to coordinate his prescriptions with those of these other doctors.
Humphreys received no money for writing these prescriptions.
5

After receiving the Order to Show Cause, Humphreys and his attorney each
filed a response to the Order. Humphreys' primary defense was that, by
prescribing the medication in the names of Larson's close associates, he was
attempting to protect Larson's privacy in a manner common and acceptable in
standard medical practice for famous patients with mental conditions.
Humphreys waived his right to a hearing, as he was recovering from a stroke.

On January 23, 1996, the Deputy Administrator entered his Final Order, based
on the investigative record and Humphreys' written statement. The Deputy
Administrator acknowledged that he could revoke Humphreys' registration only
if continued registration would be inconsistent with the public interest pursuant
to the five factors set forth in 21 U.S.C. 823(f). The Deputy Administrator
considered, discussed and relied upon each of the five factors except for factor
three--Humphreys' conviction record under Federal or State laws relating to
controlled substances, which, because he had none, was not a relevant factor-and, based upon these factors, determined that the public interest would be best
served by revoking Humphreys' registration. The Deputy Administrator did not
discuss, and apparently did not consider, Humphreys' privacy defense.
Humphreys appealed, and this court granted a stay of the Order pending our
disposition of this appeal. We have jurisdiction to hear this appeal under 21
U.S.C. 877 (1994).

ANALYSIS
The Standard of Review
7

Agency decisions, such as the Deputy Administrator's Order, may be set aside
only if arbitrary, capricious, an abuse of discretion or otherwise not in
accordance with the law. 5 U.S.C. 706(2)(A) (1994). "As a reviewing court,
we must accord proper deference to the DEA's expertise but must nonetheless
make a 'searching and careful inquiry' of the record to determine whether the
agency's decision was based on a consideration of the relevant factors and
whether there was a clear error of judgment." Trawick v. DEA, 861 F.2d 72, 76
(4th Cir.1988) (affirming revocation of registration) (citation omitted).

The Regulatory Framework

8

The Controlled Substances Act, as amended by the Dangerous Drug Diversion

Control Act of 1984, Pub.L. No. 98-473, Title II, 511, 98 Stat.2073, requires
that any person who dispenses controlled substances must first obtain a
certificate of registration from the Attorney General. 21 U.S.C. 822(a),
823(f) (1994). The Attorney General has delegated the authority to deny,
revoke or suspend registrations to the Administrator of the DEA. 21 U.S.C.
824 (1994); 28 C.F.R. 0.100(b).1
9

Prior to 1984, the DEA could revoke a registration for only three reasons: (1)
falsification of an application; (2) felony conviction related to controlled
substances; and (3) suspension, revocation or denial of a state license. In 1984,
with the enactment of the Dangerous Drug Diversion Control Act, Congress
added a fourth reason for which a registration could be revoked, namely, a
finding that the physician had committed "such acts as would render his
registration under section 823 of this title inconsistent with the public interest as
determined under such section...." 21 U.S.C. 824(a) (1994). In determining
whether registration would be inconsistent with the public interest, the DEA
must consider the following factors:

10

(1) The recommendation of the appropriate State licensing board or disciplinary

authority.

11

(2) The applicant's experience in dispensing, or conducting research with

respect to controlled substances.

12

(3) The applicant's conviction record under Federal or State laws relating to the
manufacture, distribution, or dispensing of controlled substances.

13

(4) Compliance with applicable State, Federal, or local laws relating to

controlled substances.

14

(5) Such other conduct which may threaten the public health and safety.

15

21 U.S.C. 823(f) (1994). The five factors are independent, and the Deputy
Administrator may revoke a registration based on one factor or a combination
of several factors. Henry J. Schwartz, M.D., 54 Fed.Reg. 16,422, 16,424
(1989).

16

The DEA bears the burden of proving that registration would not be in the
public interest. See Shatz v. United States Dep't of Justice, 873 F.2d 1089, 1091
(8th Cir.1989) ("We think the burden of persuasion and production on the issue

whether registration would be in the public interest was correctly placed on the
Administrator as an initial matter. Once the Administrator produced evidence
of the state medical board's actions, the DEA investigation and the drug-related
felony conviction, the burden of production only then shifted to Shatz to rebut
this evidence.").
Applicability of the Statute to Humphreys and its Application
17
18

Humphreys raises two primary issues on appeal: whether 21 U.S.C. 824(a)

can apply to the facts of this case and, if so, whether the DEA properly applied
the five public interest factors to his case and properly considered his privacy
defense.

19

Initially, we may easily dispose of Humphreys' contention that 21 U.S.C.

824(a) was never meant to apply to physicians in his circumstances. Citing
Trawick, 861 F.2d at 76, Humphreys argues that the legislative history of the
1984 amendment indicates it was meant to apply only in egregious cases and
was specifically directed to those physicians who prescribed controlled
substances to addicts, who then could either use the drugs themselves or resell
them in order to purchase different drugs, such as heroin. Humphreys argues
that his actions did not fall within the category of egregious cases. Certainly,
there is no allegation here of sales to addicts.

20

However, Humphreys, while relying on selected language in the Trawick

opinion, has ignored not only the holding of the Trawick decision, but other
language as well. In Trawick, a dentist was indicted on state felony drug
charges, including conspiracy to distribute and distribution of cocaine, based on
acts not related to his patients. 861 F.2d at 73-74. The dentist pled guilty only to
misdemeanor possession of cocaine as part of a plea bargain. Id. at 74.
Following his conviction, the DEA revoked his registration as being
inconsistent with the public interest. Id. The Court of Appeals noted that the
legislative history of the public interest standard was much as Humphreys now
suggests, but concluded that the dentist there could not "avoid the plain
statutory language of the amendment merely by showing that Congress, in
enacting it was largely concerned with a situation different from the instant
case." Id. at 76. Reasoning that a court must uphold any reasonable agency
construction of a statute it is entrusted to enforce, the court concluded it was
reasonable to interpret the statute to authorize revocation based on a
misdemeanor drug conviction. Id. at 75-76. Likewise, here there is nothing
unreasonable about the DEA's interpretation of the statute as authorizing
revocation based on Humphreys' allegedly unlawful and irregular prescription
of controlled substances in the names of individuals other than his patient,

Larson. As discussed below, however, the DEA's application of the statute to

the precise situation facing Humphreys is so deficient as to be an abuse of
discretion.
The Privacy Defense
21

In a combined discussion of factors two and four under 21 U.S.C. 823(f), the
two factors upon which the Deputy Administrator relied most heavily, the
Deputy Administrator emphasized that Humphreys had engaged in a course of
conduct during approximately a 12-year period that clearly violated federal
drug prescribing regulations. Specifically, the Deputy Administrator concluded
that Humphreys' conduct violated 21 C.F.R. 1306.04(a), which provides that
a prescription for a controlled substance "must be issued for a legitimate
medical purpose by an individual practitioner acting in the usual course of his
professional practice." The Deputy Administrator concluded that these factors
weighed in favor of revoking Humphreys' registration, as Humphreys' long
practice of issuing prescriptions in the names of individuals unknown to him
and not under his care would not meet this criterion.

22

The central deficiency in the Deputy Administrator's decision is his complete

failure to discuss the one and only defense raised by Humphreys: that
prescribing antidepressants and other such drugs for a famous patient in the
name of another individual in order to preserve the privacy of the patient was,
in fact, the "usual course" of medical practice in circumstances such as these
and that, therefore, Humphreys did not violate the federal regulation.
Humphreys squarely and intelligibly raised this defense before the Deputy
Administrator, as before us.

23

Specifically, Humphreys, too ill to appear in person, wrote in a letter

responding to the DEA Order to Show Cause that "[t]he psychiatrist and the
neurologist at the trial for Justice Larson testified that they probably would
have done the same thing and might have even used the same medications.
They indicated that it is common practice, especially in psychiatric patients, to
do this." Additionally, Humphreys' attorney wrote the following:

24
Separate
and apart from Dr. Humphrey's [sic] opinion is the sworn testimony of
Gerald Sandson, M.D. given in the case of Commonwealth of Pennsylvania v. Rolf
Larson at # 9313844, in which this psychiatrist completely concurred with the need
for privacy in the treatment of Justice Larson.... Testimony at trial showed that
psychiatric patients suffer a stigma in society, and that public figures bear even
greater burden.

25
During
the case of Commonwealth of Pennsylvania vs. [sic] Larson, it was
established without contradiction, that on a daily basis, psychiatrists on the staffs of
at least Allegheny General Hospital and the Western Psychiatric Institute prescribed
drugs in names of people for whom the prescriptions were not intended because
privacy was an essential part of the treatment of the patient. No prosecutions were
ever brought for any of these doctors or hospitals.
26

Humphreys' attorney also asserted that the sworn testimony at the Larson trial
also established that privacy was an essential part of Larson's treatment, that
privacy was the reason the drugs were prescribed in the names of others, and
that the manner and method of Larson's treatment were not inconsistent with
generally accepted medical standards.

27

The Deputy Administrator apparently failed to consider any of this evidence,

stating instead only that "the trial transcript from Justice Larson's trial was not a
part of the investigative record, and the Respondent did not attach a copy of the
referenced sections to his Reply." It is true that Humphreys failed to include the
Larson trial transcripts he cited in the DEA record. Humphreys should have
submitted these transcripts to the DEA for inclusion in the record. However,
while the record did not contain these trial transcripts, the Deputy
Administrator was clearly aware of the trial and referred specifically to
Humphreys' testimony at a pre-trial hearing in the Larson case. Thus, the
Deputy Administrator did have before him, and took notice of, Humphreys'
sworn testimony, observing that

28
beginning
in 1981 and continuing until 1993, [Humphreys] had issued prescriptions
for Schedule IV controlled substances intended for Justice Larson's use, but he had
issued the prescriptions in the name of third-parties.... [Humphreys] had never met
these individuals, and they were not his patients.... [Humphreys] testified that he
examined Justice Larson about every six months, but not necessarily prior to issuing
each of the prescriptions. Rather, Justice Larson would telephone [Humphreys] and
tell him what substances he wanted and in whose name to issue the prescription....
[Humphreys] was aware of Justice Larson's diagnosed condition ... and that it was
[his] belief that every medication he prescribed for Justice Larson was for a
legitimate medical purpose. [Humphreys] testified that he had prescribed the
substances in legitimate medical dosage amounts and at appropriate time intervals.
He states that he prescribed these controlled substances in this manner in order to
preserve his patient's privacy....
29

Indeed, nearly the entirety of the administrative record consists of items from
Larson's criminal trial, including hearing transcripts and a copy of the
complaint, and newspaper reports regarding the trial.

30

We are troubled by the fact that the Deputy Administrator went outside the
papers submitted by Humphreys for evidence supporting his decision, such as
Humphreys' pre-trial testimony--evidence that actually indicated that
Humphreys acted out of concern for Larson's privacy--yet failed to obtain the
public trial transcripts of Dr. Sandson and others from the very same trial,
which were cited by Humphreys in his support, or to otherwise consider
Humphreys' privacy defense. Such failure is especially egregious where, as
here, the record is devoid of any evidence, in the form of affidavits, medical
treatises or anything else, that would support a conclusion that doctors do not
prescribe drugs in the name of proxies for famous patients with mental
disorders in the "usual course" of their medical practice. Nor have we been able
to locate any previous published DEA or court decision in which such privacy
concerns were raised and rejected. Indeed, at oral argument the DEA
representative acknowledged that she was unaware of any other proceeding in
which such a privacy defense had been raised.

31

An agency's action is arbitrary and capricious if the agency "entirely failed to

consider an important aspect of the problem, offered an explanation for its
decision that runs counter to the evidence before the agency, or is so
implausible that it could not be ascribed to a difference in view or the product
of agency expertise." Natural Resources Defense Council, Inc. v. United States
Envtl. Protection Agency, 790 F.2d 289, 297-98 (3rd Cir.1986)(quoting Motor
Vehicle Mfrs. Ass'n. v. State Farm Mutual, 463 U.S. 29, 43, 103 S.Ct. 2856,
2867, 77 L.Ed.2d 443 (1983)) (emphasis added), cert. denied sub nom. Chicago
Ass'n. of Commerce & Indus. v. Natural Resources Defense Council, Inc., 479
U.S. 1084, 107 S.Ct. 1285, 94 L.Ed.2d 143 (1987); see also Shane Meat Co. v.
United States Dep't of Defense, 800 F.2d 334, 336 (3d Cir.1986) ("Failure of
the agency to address an important aspect of the issue under consideration may
be fatal to its conclusion."). Here, the decision of the Deputy Administrator,
lacking any analysis of Humphreys' privacy defense, is arbitrary and
capricious.

32

In short, the Deputy Administrator both failed to evaluate and address

Humphreys' defense and to resolve the conflict created by the arguments and
evidence before him. See Kent v. Schweiker, 710 F.2d 110, 114 (3d Cir.1983)
(stating, in reference to the substantial evidence test, that "[a] single piece of
evidence will not satisfy the substantiality test if the Secretary ignores, or fails
to resolve, a conflict created by countervailing evidence."). Humphreys and
other trial witnesses asserted that such prescribing occurred in the "usual
course," and there is no contrary evidence in the record. Thus, there is a conflict
between the record evidence and the Deputy Administrator's tacit assumption
about the "usual course" of medical practice. The Deputy Administrator

nevertheless failed to resolve or even acknowledge this conflict. He neither

gave any reasons for rejecting Humphreys' assertions about the "usual course,"
nor cited any evidence supporting the conclusion that Humphreys did not act in
the "usual course." That he avoided this conflict is all the worse given his
failure to review the public testimony that Humphreys and his attorney
specifically cited, summarized and asserted would corroborate Humphreys'
position.
33

It may well be that the testimony referred to by Humphreys and his attorney
does not, in fact, establish that Humphreys was merely engaging in the "usual
course" of practice. Here, however, the Deputy Administrator improperly failed
to consider Humphreys' privacy concerns and failed to determine whether
Humphreys' privacy concerns brought his otherwise allegedly improper
prescribing conduct within the "usual course." Failing to analyze the privacy
defense was an abuse of discretion. Absent such analysis, it was arbitrary and
capricious to revoke Humphreys' registration in reliance on the second and
fourth factors of 21 U.S.C. 823(f).2

34

We neither disregard nor minimize the substantial deference to which such

agency decisions are always entitled. See Pennsylvania Funeral Directors Ass'n.
v. Federal Trade Comm'n., 41 F.3d 81, 85 (3d Cir.1994) ("The arbitrary and
capricious standard is very deferential."). We also recognize that we must not
simply substitute our judgment for that of the agency. Shane Meat Co., 800
F.2d at 336. However, this is not simply a case where we disagree with the
Deputy Administrator's application of relevant mitigating aspects of the
statutory factors to settled facts. See Id. (reversing district court decision
finding an administrative decision arbitrary and capricious where the agency
decision gave consideration to the relevant mitigating factors). Rather, here the
agency improperly failed even to consider the defense put forth by Humphreys.
The case must be remanded for proper consideration of that defense.3

Proceedings on Remand
35

In addition to the Deputy Administrator's improper reliance on factors two and

four in the absence of a consideration of Humphreys' privacy defense, the
Deputy Administrator's remaining discussion of the 21 U.S.C. 823(f) factors
contains several additional inconsistencies and problems which should be
addressed and corrected on remand.

36

First, as to factor one, the "recommendation" of the appropriate state licensing

board or professional disciplinary authority, section 823(f)(1), the Deputy
Administrator noted that the Pennsylvania Bureau of Professional and

Occupational Affairs had issued a Show Cause order alleging that Humphreys
had engaged in a 12-year pattern of issuing prescriptions to individuals who
were not his patients that, if proven, would violate state law and might justify
revoking his medical license. At the time of DEA's decision, however, the only
evidence in the record pertaining to the state investigation indicated merely that
the Show Cause order had issued and that Pennsylvania bore the burden of
proving the charges by a preponderance of the evidence. We have no indication
whether Humphreys advanced the same defense there as here or what ruling, if
any, Pennsylvania made on any such defense. On remand, the DEA should
determine whether Pennsylvania, in fact, met its burden and what actions, if
any, have actually been taken against Humphreys. If none, then the Deputy
Administrator should consider whether, by merely issuing the Order to Show
Cause, Pennsylvania authorities have made any "recommendation" within the
meaning of section 823(f)(1). Only if the Deputy Administrator properly
concludes Pennsylvania has made a "recommendation" of revocation or other
punitive action may any weight adverse to Humphreys be given under factor
one. Although in this decision the Deputy Administrator only gave limited
weight to factor one, it is not clear any weight at all is appropriate.
37

Second, we note that, as applied by the Deputy Administrator, any weight

under factor two, which concerns "experience with dispensing ... controlled
substances," is entirely dependent on the violation of a federal regulation found
by the Deputy Administrator under factor four. That is, if Humphreys violated
the federal regulation, that he did so for over 12 years is an aggravating factor.
However, if his conduct was indeed in the "usual course," its duration is
irrelevant.

38

Third, the DEA found that Humphreys' "prescribing of controlled substances to

Justice Larson merely upon his request, without seeing him, examining him, or
otherwise making a medical evaluation prior to issuing the prescription,
demonstrated behavior such that the patient's demands seemed to replace the
physician's judgment.... Such uncontroverted actions on the part of the
Respondent are preponderating evidence that he has dispensed controlled
substances in violation of federal law." We have reviewed the administrative
record and see nothing in the current record that would support this particular
finding. While there is some evidence indicating Larson would call Humphreys
and request prescriptions for certain drugs or request a change in his
prescription, there is absolutely no testimony indicating Humphreys failed to
exercise his own medical judgment when prescribing medication for Larson.
We do not mean to say that the DEA might not be able to prove this fact at a
later date upon an expanded record--only that it has not done so on this record.
Indeed, if anything, the current record indicates Humphreys, in fact, was

exercising independent medical judgment. Specifically, Humphreys stated that

he would have adjusted the drugs accordingly had he become aware that other
drugs were being prescribed to Larson by other doctors. Humphreys also
testified that it was his belief that every medication he prescribed for Larson
was medically appropriate.4 In addition, the testimony of Larson himself
indicates Humphreys exercised his own judgment. Specifically, Larson testified
Humphreys performed a full physical evaluation before prescribing drugs for
the first time, that the drugs were later changed due to side effects, and that
Humphreys was the "ultimate decider" of what particular drugs to prescribe.
Thus, it remains unclear how factor four can weigh against Humphreys in this
regard.
39

Fourth, the Deputy Administrator found, under factor five, that the public was
at risk from the potential diversion of controlled substances by both Larson,
who could have received duplicative prescriptions for controlled substances,
and the employees named on the prescriptions, who were prescribed
medication they did not intend to ingest and for which they themselves lacked a
medical need. The Deputy Administrator's inferences of a threat of public harm
are overly broad and only weakly, if at all, supported by the present record.
Indeed, the Deputy Administrator admitted that no such diversion in fact
occurred. The conclusion that substantial risk for diversion existed because
Larson or the secretaries and the law clerk might resell the drugs, under these
circumstances, is so unlikely as to be unsustainable. The secretaries and law
clerk in whose names the prescriptions were written were, after all, trusted
employees and responsible adults. They obtained the drugs at Larson's specific
requests and under his instruction. Moreover, Larson was aware of what drugs
he should receive from each of these individuals and when he should receive
them, having contacted Humphreys each time to tell Humphreys which name to
use for a particular prescription. Any deviation would have been quickly
noticed and, presumably, dealt with appropriately. That such trusted employees
were at risk because they might take the drugs themselves or endangered others
because they might attempt to resell them, rather than turn them over to Larson,
is "implausible". See Natural Resources Defense Council, 790 F.2d at 297-98.

40

It is true, as the Deputy Administrator noted, that the pharmacist filling a

prescription could not have checked any available computer data bank for
conflicting prescriptions for Larson, since the prescriptions for Larson were not
in his name. However, the DEA did not establish that the pharmacy or
pharmacies patronized by Larson had such a system in place during the relevant
time period. Moreover, if Larson frequented more than one pharmacy, the DEA
has not shown that problems would have been detected even if all of Larson's
prescriptions had been written in his own name.

41

Our discussion of the need on remand to correct the deficiencies in the decision
under review should not be construed in any way as suggesting that Humphreys
either is or is not entitled to retain his DEA registration. We intimate no view
on that issue. Rather, we hold only that the Deputy Administrator failed to
properly analyze the evidence and decide the issues and must do so on remand.

CONCLUSION
42

Because the DEA utterly failed to consider Humphreys' defense and improperly
analyzed some of the evidence, its analysis was so inadequate and prejudicial to
Humphreys as to constitute an abuse of discretion and render the revocation
order an arbitrary and capricious agency action. Therefore, we vacate and
remand.

Hon. Paul R. Michel, United States Circuit Judge for the Federal Circuit, sitting
by designation

That the Deputy Administrator may exercise this authority delegated by the
Attorney General to the DEA Administrator is not in dispute

We note that Humphreys' privacy defense goes directly to factor four and a
determination of whether Humphreys acted in the "usual course." However, if
the testimony referred to by Humphreys actually is found to demonstrate that
Humphreys was indeed acting in the usual course and, hence, did not violate
any federal, state or local laws, we also do not believe the very same actions,
once found to be lawful, can be held against Humphreys under factor two. The
Deputy Administrator's discussion of these factors as if they were one and the
same supports our view

We note that, although not cited by the Deputy Administrator, another

regulation, 21 C.F.R. 1306.05(a), requires that all prescriptions for controlled
substances shall bear the full name and address of the patient. To the extent, if
any, an alleged violation of this regulation is relevant under factors two and
four, we believe Humphreys' privacy defense, if proven, is as equally
applicable to the effect of a violation of this regulation as it is to 21 C.F.R.
1306.04. While Humphreys' privacy defense may not prevent a finding that he
violated this regulation, it may impact upon the appropriate punishment for
violating the regulation and such a violation, by itself, would not necessarily
support revocation. In any event, as this argument was apparently not raised
before the Deputy Administrator and was not the basis of the Deputy
Administrator's revocation decision, the decision cannot be affirmed on this

ground. This regulation may be addressed on remand

4

Nor does the government dispute their medical appropriateness