[Federal Register Volume 75, Number 157 (Monday, August 16, 2010)]
[Notices]
[Pages 49995-50004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20243]


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 DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 09-22]


Robert F. Hunt, D.O. Revocation of Registration

    On November 25, 2008, I, the Deputy Administrator of the Drug 
Enforcement Administration (DEA), issued an Order to Show Cause and 
Immediate Suspension of Registration to Robert F. Hunt, D.O. 
(Respondent), of Fort Lauderdale, Florida. The Show Cause Order 
proposed the revocation of Respondent's Certificate of Registration, 
BH1292642, which authorizes him to dispense schedule II through V 
controlled substances as a practitioner, on the ground that his 
``continued registration is inconsistent with the public interest, as 
that term is defined in 21 U.S.C. 823(f).'' Order to Show Cause at 1. 
The Order immediately suspended Respondent's registration based on my 
conclusion that his continued registration during the pendency of the 
proceeding would ``constitute[] an imminent danger to the public health 
and safety.'' Id. at 2 (citing 21 U.S.C. 824(d)).
    More specifically, the Show Cause Order alleged that on April 10, 
2008, Respondent ``issued a prescription for an anabolic steroid, a 
Schedule III controlled substance,'' to a patient without referring 
``to the patient's medical file or conduct[ing] a medical examination 
of this patient.'' Id. at 1. The Order further alleged that Respondent 
``issued the prescription solely because [this] patient requested 
anabolic steroids,'' that he had ``previously issued numerous 
prescriptions for controlled substances to this patient,'' and that 
``in some instances,'' he had ``accepted illicit drugs as payment for 
these prescriptions.'' Id. at 1-2. The Order thus alleged that 
Respondent's conduct violated 21 U.S.C. 841(a)(1) and 844. Id. at 2.
    Next, the Show Cause Order alleged that, on April 24, 2008, 
Respondent ``issued two prescriptions for two brands of anabolic 
steroids to another patient,'' who was ``a police detective acting in 
an undercover capacity,'' and who ``presented no legitimate medical 
reason to justify the * * * prescriptions.'' Id. at 2. The Order 
alleged that neither Respondent, nor his staff, ``perform[ed] any 
medical tests or exams on this patient'' and that Respondent ``stated 
that [he] would list a fictitious ailment in [the patient's] medical 
record to justify [his] prescribing of anabolic steroids.'' Id. The 
Order alleged that ``[t]hese prescriptions were not for a legitimate 
medical purpose in the usual course of professional practice'' and that 
in issuing them, Respondent violated Florida Statute Sec.  
893.13(8)(a)(1), which ``prohibits a prescribing practitioner from 
knowingly assisting a patient in obtaining a controlled substance 
through deceptive, untrue, or fraudulent representations in or related 
to the

[[Page 49996]]

practice of the prescribing practitioner's professional practice,'' as 
well as 21 U.S.C. 841(a)(1). Id.
    Additionally, the Show Cause Order alleged that at the same visit, 
Respondent also prescribed hydrocodone to this undercover detective 
again without ``obtain[ing] a medical history, conduct[ing] a physical 
examination, or otherwise conduct[ing] an evaluation of the patient in 
violation of Florida Administrative Code Sec. Sec.  64B15-14.005(3)(a) 
and (f).'' Id. The Order further alleged that the hydrocodone 
prescription ``was not for a legitimate medical purpose'' and was not 
issued ``in the usual course of professional practice,'' and thus 
violated both Federal law and Florida Statute Sec.  458.33(1)(q) & (t). 
Id.
    Finally, the Show Cause Order alleged that on July 24, 2008, the 
Broward County Sheriff's Office arrested Respondent on two felony 
counts of assisting persons in obtaining controlled substances through 
deceptive, untrue, or fraudulent representations, a violation of 
Florida Statute Sec.  893.13-8(a)(1), and one felony count of 
trafficking by issuing prescriptions in excessive quantities, a 
violation of Florida Statute Sec.  893.13(8)(d). Id. The Order further 
alleged that Respondent is ``currently on pre-trial release.'' Id.
    By letter of December 15, 2008, Respondent, through his counsel, 
requested a hearing on the allegations. ALJ Ex. 3. The matter was 
placed on the docket of the Agency's Administrative Law Judges (ALJ) 
and set for a hearing on January 6, 2009. Id. Thereafter, Respondent's 
counsel sought and was granted several continuances; \1\ the hearing 
was finally held on April 28 and 29, 2009, in Fort Lauderdale, Florida. 
ALJ Exs. 4-6; ALJ at 4.
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    \1\ In his letter which requested a hearing, Respondent's 
counsel also requested a continuance from the scheduled date of the 
hearing of January 6, 2009. ALJ Ex. 3, at 1. The hearing was then 
rescheduled for February 23, 2009. See ALJ Ex. 4, at 2. On January 
28, 2009, Respondent's counsel requested a second continuance on the 
grounds that he sought the actual recordings of the transcribed 
undercover visits at issue, that he sought to depose the 
confidential informant, and that he was ``interviewing prospective 
expert witnesses to testify on the doctor's behalf.'' Id. at 1-2. In 
ruling on the second request for continuance, the ALJ noted that 
``Respondent argued that any prejudice stemming from an additional 
continuance is suffered only by the Respondent.'' ALJ Ex. 6, at 2. 
The ALJ therein canceled the February 23, 2009 hearing. Id. at 3. In 
her Prehearing Ruling of February 27, 2009, the ALJ rescheduled the 
hearing for April 28 and 29, 2009. ALJ Ex. 7, at 4; see also ALJ Ex. 
8 (Notice of Hearing; Instructions (April 8, 2009)).
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    At the hearing, both parties called witnesses to testify and 
introduced documentary evidence. Thereafter, both parties filed 
proposed findings of facts, conclusions of law, and argument.
    On July 2, 2009, the ALJ issued her Recommended Decision (also 
ALJ). Therein, the ALJ, upon analyzing the public interest factors, see 
21 U.S.C. 823(f), concluded that the ``continuation of [Respondent's] 
registration would not be in the public interest,'' and ``that the 
preponderance of the evidence * * * favors revocation.'' ALJ at 33.
    With respect to the first factor--the recommendation of the 
appropriate state licensing board--the ALJ found that the record 
contained ``no information of any action being taken by the Florida 
Medical Board * * * against the Respondent's medical license'' or ``any 
recommendation from the [Florida Medical] Board regarding the outcome 
of this proceeding.'' Id. at 27. Likewise, with respect to the third 
factor--Respondent's record of convictions for offenses related to 
controlled substances--the ALJ found that the ``record contains no 
evidence that the Respondent has a conviction record related to his 
handling of controlled substances.'' Id. at 30.
    As to the second and fourth factors--Respondent's experience in 
dispensing controlled substances and his compliance with applicable 
laws--the ALJ made several findings. First, she found that Respondent 
``prescribed controlled substances to [the undercover detective (UC)] 
to assist in pain management for his joint pain,'' but that his 
``[medical] records fail to identify this diagnosis, and do not include 
the amount, strength, and number of refills of the controlled 
substances he prescribed,'' in violation of Florida Statute Sec.  
458.331(1)(m).\2\ Id. at 27.
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    \2\ This statute provides for disciplinary action against a 
medical doctor for ``[f]ailing to keep legible * * * medical records 
that * * * justify the course of the treatment of the patient, 
including, but not limited to, patient histories; examination 
results; test results; records of drugs prescribed, dispensed, or 
administered; and reports of consultations and hospitalizations.'' 
Fla. Stat. Sec.  458.331(1)(m). However, as discussed below, 
Respondent is a doctor of osteopathy; his license is subject to the 
provisions of Florida Statutes Chapter 459, which provide grounds 
for disciplinary action against an osteopath's license in Fla. Stat. 
Sec.  459.015.
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    Next, the ALJ found that Respondent's ``medical record for [the UC] 
fails to have any of [the] elements,'' such as ``[a] complete medical 
history and physical examination * * * [and documentation of] the 
nature and intensity of the pain,'' as required by Florida 
Administrative Code r. 64B15-14.005(3)(a). Id. at 27-28. The ALJ 
reasoned that even if this provision, which is part of Florida Board of 
Osteopathic Medicine's [hereinafter, the Board] guidelines for the 
treatment of pain with controlled substances, does ``not have the force 
of law in Florida, the fact that the Respondent's medical record for 
[the UC] fails to have any of these elements to justify the prescribing 
of controlled substances for pain supports a finding that * * * 
Respondent is not handling controlled substance prescriptions and 
records in a responsible manner.'' Id. at 28. The ALJ also noted that 
the transcript of the UC's ``April 24, 2008 visit does not contain any 
conversation between * * * Respondent and [the UC] that would support a 
finding that [he] attempted to ascertain the `nature and intensity of 
the pain,' or any other factor listed in Section 64B15-14.005(3)(a), in 
order to justify the prescribing of 100 dosage units of Vicodin with 
three refills.'' Id.
    The ALJ further found that ``Respondent recorded a history of 
osteoporosis in [the UC's] medical record, while simultaneously stating 
that it was not true,'' and that ``[t]his chart notation was used to 
justify issuing prescriptions for two anabolic steroids to'' the UC. 
Id. Based on this finding, the ALJ concluded that Respondent violated 
Florida Statute Sec.  893.13(8)(a)(1), which prohibits ``a prescribing 
practitioner'' from ``knowingly assist[ing] a patient * * * in 
obtaining a controlled substance through deceptive, untrue, or 
fraudulent representations in or related to the practice of the 
prescribing practitioner's professional practice.'' Id.
    Having found that ``Respondent's asserted belief that [the UC] had 
HIV and osteoporosis is not credible, and his purported diagnoses 
false,'' the ALJ further concluded that Respondent ``knew or should 
have known that [the UC] was seeing him to obtain anabolic steroids for 
the purpose of body building,'' and thus, in issuing the steroid 
prescriptions to the UC, he also violated the prescription requirement 
of 21 CFR 1306.04(a). Id. (citing Edmund Chein, M.D., 72 FR 6580, 6590 
(2007) (``prescribing anabolic steroids for body building or strength 
enhancement under a false diagnosis is not [prescribing] for a 
legitimate medical purpose'')).
    The ALJ further found that Respondent ``prescribed Subutex'' 
(buprenorphine), ``a Schedule III controlled substance * * * approved 
by the FDA for use by authorized practitioners for detoxification or 
maintenance treatment,'' \3\ to a patient ``on multiple occasions to 
treat him for the effects of the other controlled substances [the 
patient] was consuming.'' Id. at 28-29. Because Respondent did not hold 
a separate registration to prescribe ``this drug for narcotic abuse 
treatment'' as required by

[[Page 49997]]

21 U.S.C. 823(g), and ``was admittedly not authorized by the DEA to 
prescribe this substance for this purpose,'' the ALJ concluded that 
Respondent ``clearly violated the Controlled Substances Act.'' Id. at 
29. Ultimately, the ALJ concluded that under these two factors, ``the 
preponderance of the evidence weighs against allowing Respondent to 
maintain his DEA registration.'' Id. at 29-30.
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    \3\ See 21 CFR 1308.13(c)(2)(i).
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    As to the final factor--such other conduct which may threaten the 
public health and safety--the ALJ explained that ``[t]he gravamen of 
this case is the Respondent's lack of candor, in both his recordkeeping 
and in his testimony before this tribunal, as well as his apparent lack 
of appreciation for the serious responsibilities of a DEA registrant.'' 
Id. at 30. Noting that ``Respondent falsely entered `osteoporosis' as a 
diagnosis in [the UC's] medical record,'' and ``then testified under 
oath that he genuinely believed his diagnosis to be true,'' the ALJ 
found--based on the transcript of the April 24 undercover visit--that 
``this testimony lacked credibility.'' Id. The ALJ thus concluded that 
this ``lack of candor further supports [the] conclusion that revocation 
of Respondent's registration is appropriate.'' Id.
    The ALJ further noted that Respondent had ``issued the 
prescriptions for anabolic steroids notwithstanding the fact that he 
had no test results to support his purported diagnosis of osteoporosis, 
and despite his admission that such test results would determine 
whether or not his basis for issuing the prescriptions was valid.'' Id. 
at 31. The ALJ thus concluded that ``Respondent's attitude toward 
prescribing controlled substances under these circumstances * * * was 
so cavalier as to create a substantial risk of diversion'' and that 
``Respondent's conduct therefore falls below the level of 
responsibility expected of a DEA registrant.'' Id. Thus, under the 
fifth factor, the ALJ found that ``the preponderance of the evidence * 
* * supports a conclusion that continuation of [Respondent's] DEA 
registration would not be in the public interest.'' Id.
    Having concluded that the Government had made out a prima facie 
case for revocation, the ALJ turned to whether Respondent had 
``accept[ed] responsibility for his misconduct'' and demonstrated that 
his misconduct would not recur. Id. at 32. The ALJ noted that 
Respondent had refused the UC's request for a prescription for HGH and 
had declined the UC's request to refer other persons, stating that he 
would not ``usually'' prescribe to men who were seeking anabolic 
steroids for body building. Id. However, the ALJ also found that 
``[i]nstead of admitting his mistake in prescribing steroids for [the 
UC] and presenting evidence to reassure [the Agency] that he would 
cease this practice, * * * Respondent chose to build upon the 
falsifications.'' Id. at 33. Concluding that Respondent had failed ``to 
take responsibility for his past misconduct, and [had] fail[ed] to 
provide assurances regarding his future conduct,'' the ALJ concluded 
that Respondent's registration should be revoked. Id.
    Neither party timely filed exceptions to the ALJ's decision, which 
were due no later than July 27, 2009. On July 30, 2009, the ALJ 
forwarded the record to me for final agency action. Thereafter, on 
September 3, 2009, Respondent filed exceptions. However, because 
Respondent's exceptions were filed out-of-time, I have not considered 
them.
    However, I have considered the rest of the record in its entirety 
including Respondent's brief containing his proposed findings of fact 
and conclusions of law. Having done so, I adopt the ALJ's findings of 
fact and conclusions of law except as specifically noted herein. I 
further adopt both her ultimate conclusion that Respondent's continued 
registration is inconsistent with the public interest and her 
recommendation that Respondent's registration be revoked. I make the 
following findings.

Findings of Fact

    Respondent is a doctor of osteopathic medicine, and is board-
certified in family practice. Tr. 408-09. At the time of the hearing, 
Respondent had practiced as a general practitioner in Broward County, 
Florida for approximately 21\1/2\; years.\4\ Tr. 408-09.
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    \4\ Respondent has been ``involved with'' two organizations, 
Community Healthcare Center One and Broward House, which are 
community resource centers for patients with HIV in Broward County. 
Id.f at 413, 417-18. At the Children's Medical Services Program, he 
helped create Broward County's clinic for infectious diseases for 
the pediatric HIV population; at the Children's Diagnostic and 
Treatment Center, he has volunteered one afternoon a week seeing HIV 
patients and waiving payment. Id. at 421. He has also been 
``involved with'' the Gay and Lesbian Community Center, where he has 
given free lectures on topics ``related to living with HIV.'' Id. at 
416.
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    Respondent is also the holder of DEA Certificate of Registration, 
BH1292642, which authorizes him to dispense controlled substances as a 
practitioner in schedules II through V. GX 1. According to the 
certificate, Respondent's registration was to expire on October 31, 
2008. Id. However, on September 18, 2008, Respondent filed a renewal 
application. GX 2. In accordance with the Administrative Procedure Act 
and DEA regulations, I find that Respondent's registration remains in 
effect (albeit in suspended status) pending the issuance of the Final 
Order in this matter. See 5 U.S.C. 558(c); 21 CFR 1301.36(i).
    In February of either 2006 or 2007, one of Respondent's patients 
was arrested by an officer with the Hollywood, Florida police 
department and charged with the state law offense of trafficking in 
hydrocodone. Tr. 123. At the time of his arrest, the patient had in his 
possession 150 tablets of a controlled substance containing 
hydrocodone, which he had obtained through a prescription issued by 
Respondent.\5\ Id. at 23, 25, 75. In either December 2007 or January 
2008, the patient, who was facing a lengthy prison sentence, accepted a 
plea bargain under which he entered into a ``substantial assistance 
agreement'' with the Broward County, Florida Sheriff's Office and 
became a confidential informant (CI). Id. 23, 27, 87, 364.
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    \5\ The patient had been treated by Respondent since at least 
January 2002, GX 7A, at 70; and initially saw Respondent for anxiety 
and a heart palpitations and explained that he was concerned that 
his heart problems were caused by his prior use of steroids. Tr. 31. 
The CI maintained that Respondent had told him that ``if I wanted to 
do it the right way under [a] doctor's care[,] to come see him. Id.
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    Thereafter, the CI told the authorities that Respondent had 
prescribed hydrocodone,\6\ testosterone,\7\ Deca-Durabolin,\8\ and 
Xanax \9\ for him. Id. at 27. While the CI testified that Respondent 
had legitimately treated him for anxiety and had referred him to 
several specialists for heart and joint issues, Respondent also gave 
him prescriptions for anabolic steroids. Id. at 28-29. According to the 
CI, he initially obtained the steroid prescriptions ``just because I 
asked him for them,'' id. at 29, and did so at either the second or 
third visit after his initial visit. Id. at 31. However, ``after awhile 
[the CI's] body was [not] producing enough testosterone'' and ``it 
became medically necessary to have some testosterone.'' Id.

[[Page 49998]]

at 29. According to the CI, when he asked for the steroid 
prescriptions, Respondent did not hesitate to prescribe them. Id. at 
30.
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    \6\ Hydrocodone in combination with another active 
pharmaceutical ingredient is a Schedule III narcotic controlled 
substance. 21 CFR 1308.13(e)(iv). Stipulated Facts, ALJ at 5.
    \7\ Androgen 1% is an injectable brand of testosterone, an 
anabolic steroid, a Schedule III controlled substance. 21 CFR 
1300.01(b)(4)(lvii), 21 CFR 1308.13(f); Stipulated Facts, ALJ at 5. 
Delatestryl is a brand of testosterone, and Testim 1% is a brand of 
testosterone gel. ALJ at 5.
    \8\ A brand of nandrolone decanoate, an anabolic steroid. Tr. 
170; 21 CFR 1300.01(b)(4)(xl); 21 CFR 1308.13(f).
    \9\ Xanax, or alprazolam, which is a Schedule IV depressant 
controlled substance. 21 CFR 1308.14(c)(1); Stipulated Facts, ALJ at 
5.
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    According to the CI, Respondent prescribed the anabolic steroids 
``off and on,'' and the CI made the decision as to when to cycle on, 
and off of, the drugs. Id. at 32, 34. The CI also testified that 
Respondent wrote him a prescription for Human Growth Hormone (HGH) 
because he asked for it, id. at 35, as well as prescriptions for 
Percocet \10\ for his knees; Respondent subsequently referred the CI to 
an orthopedist who diagnosed him as having ``a slight torn meniscus.'' 
Id. at 34-35. Finally, the record also establishes that Respondent 
wrote the CI at least twenty-six prescriptions for Subutex 
(buprenorphine), a schedule III controlled substance, as well as 
prescriptions for both Testim and Androgel, which are gel forms of 
testosterone and also a schedule III controlled substance. See GX 7C, 
at 1-3, 5-6, 9-10, 14-15, 18-19, 22-23, 30-32, 37, 61-62, 64, 66, 71, 
78, 83-84, 87-90, 95-96, 105-06 (Subutex Rxs); id. at 2, 24, 31, 33, 
62, 67, 81, 82 (Testim and Androgel Rxs).
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    \10\ Percocet is a combination oxycodone product. Oxycodone is a 
Schedule II narcotic controlled substance. 21 CFR 
1308.12(b)(1)(xiii); Stipulated Facts, ALJ at 5.
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    The CI's medical record (GXs 7A & 7D) contains various documents 
including blood tests, radiology reports, as well as evaluations by 
specialists including an orthopedist, cardiologist, and 
endocrinologist. See GX 7A, at 60 (orthopedist's report); 65-69 
(cardiologist's report); GX 7D, at 13-14 (endocrinologist's report). 
The medical record contains ample evidence (including blood tests and 
endocrinologist's report) establishing that the CI had low testosterone 
levels and had been diagnosed with hypogonadism, which was caused by 
the presence of a small tumor (adenoma) on his pituitary gland. Id. at 
444-455; GX 7A, at 9, 13-14; GX 7D, at 1, 3-4, 7-12, 16-18, 21, 25, 39-
41, 43-49, 54-57; GX 7D, at 13-14. In its brief, the Government does 
not challenge the medical appropriateness of any of the controlled 
substance prescriptions Respondent wrote for the CI with the exception 
of an April 10, 2008 prescription for Testim, and his prescribing of 
Subutex. See Gov. Br. at 8-9; 31-35.
    As for the Subutex prescriptions, Respondent testified that after 
the CI told him that he had also been going to a pain clinic (run by a 
Dr. Weed) to obtain additional quantities of narcotics and ``had 
actually been taking much higher quantities of narcotics that I had 
suspected [and] had been doing this for quite some time,'' he 
recommended that the CI ``see a psychiatrist who specializes in detox 
patients.'' Tr. 486. While Respondent was ``not sure'' as to whether 
the CI went to this doctor ``or another detox specialist,'' the CI went 
back to Respondent, showed him the Subutex prescription and apparently 
other documents showing that he had seen the detox specialist ``a 
couple of times.'' Tr. 486, 488. The CI told Respondent said that the 
Subutex ``was working well for him,'' but complained that the detox 
specialist charged ``$250 or $275 a visit, insisted on seeing [the CI] 
every month, and would not accept his'' insurance. Id. at 488. 
Respondent then agreed to write Subutex prescriptions for the CI. Id. 
As found above, the CI's patient file indicates that between November 
16, 2004, and April 10, 2008, Respondent authorized at least twenty six 
prescriptions for Subutex. See generally GX 7C, at 1-3, 5-6, 9-10, 14-
15, 18-19, 22-23, 30-33, 37, 61-62, 64, 66, 71, 78, 83-84, 87-90, 95-
96, 105-06; GX 7D, at 19 & 33.
    In his testimony, Respondent maintained that he was unaware until 
``only recently'' that there was a special course that he had to take 
to prescribe Subutex, that he did know exactly when this requirement 
``went into effect,'' and that he was unsure as to whether the course 
was required at the time he wrote the CI's prescriptions. Id. at 488-
89. He also maintained that no pharmacist had told him that he needed a 
special registration to prescribe Subutex for detoxification. Id. at 
488-89.
    The ALJ observed that ``the Government presented no expert medical 
testimony to suggest that the Respondent's treatment of [the CI] was 
inappropriate.'' ALJ at 9. She therefore ``decline[d] to make any 
specific findings concerning the legitimacy of Respondent's treatment 
decisions in [the CI's] case.'' Id. at 9 n. 5. As noted above, the ALJ 
did, however, find that Respondent violated Federal law by prescribing 
Subutex to the CI. ALJ at 28-29.
    Pursuant to his substantial assistance agreement, the CI agreed to 
introduce a Detective from the Broward County Sheriff's Office to 
Respondent. Tr. 39. Accordingly, the CI phoned Respondent and left a 
message in the latter's personal voicemail indicating that he would be 
dropping by Respondent's office and bringing a friend that he wanted to 
refer to him. Id. at 38, 39, 40. The CI testified that he did not make 
any further phone calls to Respondent. Id. at 40. Furthermore, 
according to the Detective, the CI was required to report any contact 
he had with Respondent, and the Detective stated that he believed the 
CI would have reported any such contact. Tr. 374. Moreover, had the CI 
otherwise contacted Respondent and not reported it, the CI would have 
violated the substantial assistance agreement. Id. at 371.
    In his testimony, Respondent asserted that either ``a few days,'' 
or ``a few weeks'' before April 10, 2008, Respondent and the CI talked 
on the phone for some five to ten minutes regarding the friend's 
alleged medical issues. Id. at 493-94, 531. However, on cross-
examination, Respondent testified that the call could have taken place 
on April 10, 2008. Tr. 530. Respondent's recollection was that the 
conversation occurred when he answered the CI's phone call. Id. at 531.
    Respondent maintained that during this conversation, the CI told 
him that his friend experienced problems with fatigue and that he had a 
``history of * * * joint pain, shoulder problems with surgery, 
fractures in his back, etc., and that he was, his workout partner * * * 
and that he felt he would benefit from the same testosterone therapy 
and the steroids that he was taking.'' Id. at 494.
    In his testimony, Respondent claimed that he told the CI that there 
was a ``difference'' between him and his friend because ``You [the CI] 
have a medical reason * * * to be on testosterone replacement therapy 
[and] I can't just prescribe this for a patient who wants it.'' Id. at 
494-95. According to Respondent, the CI ``continued to badger me,'' and 
asked: ``Well, couldn't we put down something else as a diagnosis?'' 
Id. Respondent maintained that he answered: ``No, that's not the way 
this works. This is a controlled substance and I need to document why 
it's being used.'' Id.
    Respondent asserted that the CI then told him that his friend was 
HIV positive, that he ``had a serious problem maintaining [his] weight 
[and] with fatigue and weakness,'' and that he was in paramedic 
training and needed to ``beef up'' to complete it. Id. Respondent 
testified that he thought it ``was admirable'' that the CI's friend had 
decided not to go on disability and collect Medicaid or work under the 
table. Id. at 495-96. On cross-examination, however, Respondent 
acknowledged that the CI had not said when his friend was diagnosed 
with HIV or by whom. Id. at 532. Nor did he discuss what treatment the 
CI's friend was receiving for HIV. Id. at 533.
    According to Respondent, he ``felt a little bit of compassion'' on 
hearing that

[[Page 49999]]

the CI's friend ``was HIV positive,'' but he ``reiterated'' that 
``[a]nabolic steroids are out of the question unless there is a medical 
reason.'' Id. at 496. Respondent further claimed that the CI told him 
that his friend was ``really touchy about'' his being HIV positive and 
did not want anyone to know because they would think that he was either 
gay or an ``IV drug addict.'' Id. Respondent next asserted that the CI 
had said that he [Respondent] could not tell his friend that the CI had 
told him about the friend's HIV positive status. Id.
    Respondent then testified that he asked the CI to ``tell [him] more 
about these fractures [the friend] had'' and that the CI related that 
his friend had fractured his shoulder and two vertebrae. Id. at 497. 
Respondent maintained that based on this information he concluded that 
the CI's friend ``may have some bone loss'' and ``some osteoporosis.'' 
Id. Respondent then asserted that he told the CI that if he could 
``establish that as a diagnosis, then I can at least justify giving him 
a prescription and then when he comes back to see me for [a] follow 
up[,] I will try to get him to admit that he knows that he's HIV 
positive and proceed with the appropriate testing.'' Id. Finally, 
Respondent asserted that he discussed with the CI that the latter's 
friend did not have insurance and that there would be ``cost issues'' 
as to whether he ``could do all the testing on him like the bone 
density study to show that he had osteoporosis.'' Id.
    The ALJ found it unnecessary to make a specific finding as to 
whether the phone conversation--as testified to by Respondent--took 
place. ALJ at 12 n.12. However, as ultimate factfinder, I reject 
Respondent's testimony pertaining to the conversation in its entirety. 
See 5 U.S.C. 557(b); Reckitt & Colman, Ltd., v. DEA, 788 F.2d 22, 26 
(DC Cir. 1986). I do so for the following reasons: (1) I accept the 
CI's testimony that the only call he made involved his leaving a voice 
mail message noting that the Detectives testified that the CI made only 
one call and that if the CI had made another a call and had not 
notified the Detectives, he would have violated the assistance 
agreement and could have received substantial prison time; (2) in his 
testimony, Respondent gave three possible dates (or ranges of) for when 
the conversation took place including a few weeks before, a few days 
before, or on the day that the visit actually occurred; (3) other 
evidence in the case (which is discussed below) showed that Respondent 
falsified medical records, thus casting serious doubt on his 
truthfulness as a witness; (4) much of Respondent's testimony regarding 
the phone call is patently self-serving and implausible;\11\ and (5) 
during the Detective's two visits, Respondent never questioned the 
Detective (despite his elaborate story regarding his reason for 
diagnosing the Detective as having osteoporosis) about the purported 
fractures of the Detective's shoulder and two back vertebrae.\12\ See 
ALJ at 31; see also GXs 9 & 10.
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    \11\ See, e.g., Tr. 495 (``I can't just prescribe this 
[testosterone] for a patient who wants it.''); (``This is a 
controlled substance and I need to document why it's being used.'')
    \12\ At the second visit, Respondent, after looking at charts 
filled out by the Detective, asked: ``what was the shoulder, rotator 
cuff?'' GX 10, at 8. He then asked the Detective: ``Any other 
problems other than the shoulder?'' Id. at 10. Notably, he did not 
ask the Detective any questions about the purported fractures.
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    On April 10, 2008, the CI and the Detective, who used the name 
``Bill Rix,'' [hereinafter, either ``Rix'' or ``UC''] went to 
Respondent's office; the UC wore a wire, and the entire visit was tape-
recorded and transcribed. Id. at 132; see GX 9. The CI introduced Bill 
Rix to Respondent, and indicated that Rix was looking for a doctor. Tr. 
39, 125.
    At the visit, the CI complained of a swollen gland. GX 9, at 2. 
Respondent examined his neck and wrote him a prescription for an 
antibiotic, Augmentin. Id. at 2-3; GX 5, at 1. The CI then asked 
whether Respondent had ``any more samples * * * of Andro Gel.'' GX 9, 
at 4. Respondent asked the CI ``[w]hich one'' he took? The CI 
responded: ``Testim.'' Id. at 4. Respondent then gave the CI a coupon 
for a debit card that gave a $40 discount off of each monthly co-pay 
for the drug for a year, id. at 4-5, and wrote him a prescription for 
Testim 1%, a brand of testosterone gel, which is an anabolic steroid 
and schedule III controlled substance. GX 5, at 2; Stipulated Facts, 
ALJ at 5. Respondent did not document the April 10, 2008 visit in the 
CI's medical record.\13\ Tr. 181-82; GX 7A-D.
---------------------------------------------------------------------------

    \13\ On July 24, 2008, the Broward County Sheriff's Office 
executed a search warrant at Respondent's office and seized the 
medical records. Tr. 321-22.
---------------------------------------------------------------------------

    At the April 10 visit, the UC (after indicating that he did not 
have insurance) stated that he had ``had shoulder surgery,'' that his 
joints were ``shot,'' that ``everything'' hurt, that he was ``just 
losing strength and * * * getting older,'' and that he wanted to ``get 
the physical done * * * and just see what [his] body's doing.'' GX 9, 
at 9-10. When Respondent mentioned getting blood tests done, the UC 
indicated that he did not want blood work done, asked if it ``that 
[was] necessary,'' and stated that he was ``just worried about [his] 
joints.'' Id. at 10. Respondent then asked the UC if he thought 
``anything is bad like you're going to need x-rays or an MRI scan or 
anything like that?'' Id. The UC answered ``no,'' and that he did not 
``think so.'' Id.
    In his testimony regarding the April 10 visit, Respondent alleged 
that he made his diagnosis in part that day because Bill Rix had ``a 
slight figure'' and ``ha[d] very deep lines on either side of his face. 
That to me is a sign of lipodystrophy * * * when he smiled and I saw 
these deep indentations in either side of his face, it just 
corroborated for me that this guy * * * not only is * * * definitely 
HIV positive but that he's had some problems with muscle wasting and 
fat loss and muscle loss.'' \14\ Tr. 499, 571.
---------------------------------------------------------------------------

    \14\ The ALJ found credible Respondent's testimony that 
lipodystrophy is a sign of HIV status. ALJ at 16. However, the 
record contains no evidence establishing whether the UC actually has 
deep lines on his face. Moreover, according to the UC's patient 
file, on April 24, 2008, the UC was measured as being 5 feet, 10 
inches tall and weighing 182 pounds. The UC's height and weight do 
not appear consistent with that of a person who has a slight build.
---------------------------------------------------------------------------

    Regarding the April 10 visit, Respondent also testified that the 
fatigue and joint pain of which the UC complained would be consistent 
with osteoporosis. Tr. 510; RX 13. While Respondent testified that in 
normally evaluating a patient's complaint of fatigue he would conduct 
blood tests to check a patient's testosterone level, Tr. 510, at 
neither of the UC's visits did Respondent require the UC to undergo a 
blood test. See GXs 9 & 10. According to Respondent, this was because 
the UC had indicated he did not want them. Tr. 510.
    At the April 24th visit, the UC first completed several forms for 
the patient file, including one in which he provided his ``Patient 
Information,'' one for his ``Adult Health History,'' and one in which 
he provided his consent ``to undergo all necessary tests * * * and any 
other procedure required in the course of study, diagnosis, and 
treatment of'' his condition. GX 8, at 6-7, 9-11, 13-14; GX 10, at 1; 
Tr. 184-188. On the ``Patient Information'' form, the UC indicated that 
he was ``self-employed'' and not that he was training to become a 
paramedic. GX 8, at 6. On the medical history form, the UC indicated 
that he was sexually active with more than one female partner, that he 
drank four to five times per week, and that he smoked marijuana 
``socially.'' GX 8, at 11. He also indicated that the purpose of his 
visit was ``Fatigue/Muscle Loss,'' and that he had undergone shoulder 
surgery in ``02.'' Id. at 10. The UC did not, however, indicate that he 
had a history of any other

[[Page 50000]]

conditions such as the purported fractures of his shoulder or 
vertebrae. Id.
    On cross-examination, Respondent testified that he does not usually 
read the ``demographic'' portion of the forms his patients complete 
(where the UC had indicated that he was self-employed), and that he 
reads only the medical history. Tr. 560. Respondent further maintained 
that he was ``operating on the assumption that this man w[i]ll be 
trying to use my medical records to reflect a normal physical within 
reason so that he could get a job as a paramedic,'' notwithstanding 
that at no time during the visit did the UC indicate that he was in 
training for a paramedic position. Id. at 559, 564-65. He also 
maintained that he believed that Bill Rix had been infected with HIV 
since 2002. Id. at 561-62.
    Upon entering the exam room, Respondent recognized the UC and asked 
him if he had been with the CI ``the other week, right?'' GX 10, at 8. 
After the UC answered affirmatively, Respondent asked him: ``What was 
the shoulder, rotator cuff?'' Id. The UC mentioned ``Mumford,'' an 
apparent reference to a surgical procedure, but then stated that he had 
no problems other than aging, losing strength, and aching joints. Id. 
at 9-10.
    The UC then complained that things were different when he could get 
Winstrol and Testosterone Enthanate, which are both anabolic steroids, 
through Powermedica, a pharmacy which arranged for persons to get 
prescriptions which were written by doctors who never saw the persons 
for whom they prescribed.\15\ Id. The UC also related that he had gone 
to Powermedica ``one day to pick up my order and there were cops 
everywhere.'' Id.
---------------------------------------------------------------------------

    \15\ On June 20, 2005, the Florida Department of Health ordered 
the emergency suspension of Powermedica's state pharmacy permit 
following a joint investigation by the Food and Drug Administration 
and the Broward County Sheriff's Office. Powermedica eventually 
surrendered its state permit and DEA registration. See Wonderyears, 
Inc., 74 FR 457458 (2008).
---------------------------------------------------------------------------

    After discussing the side effects of HGH, the UC told Respondent 
that he had used Deca Durabolin ``back in college'' when he ``played 
college baseball.'' Id. at 12. Respondent stated it was ``too bad they 
stopped making'' Deca. Id. When the UC expressed surprise at this, 
Respondent indicated that ``we can still get [Deca] at Comcare 
Pharmacy[.] [T]hey're compounding their own.'' Id.
    After discussing some of the side effects of using anabolic 
steroids and how these substances are metabolized, Respondent noted 
that Deca provided ``more bang for your buck'' than other steroids. Id. 
at 12-14. Respondent advised the UC that while there was an 
``association'' between Deca and necrosis of the hip, he ``would have 
no problem prescribing it for anybody'' and that necrosis was caused by 
using too much. Id. at 14.
    Respondent then advised the CI that Deca was the ``safest one as 
far as your liver is concerned,'' and ``you get good results with it 
especially when you combine it with testosterone,'' but that ``you just 
have to combine it with testosterone cause if you just start using the 
Deca[,] [its] chemical structure is very similar to testosterone so 
your body sees it as testosterone.'' Id. ``So if you start injecting 
all that extra Deca[,] your own testosterone production is going to 
drop.'' Id. at 15. Respondent then told the CI that ``you really have 
to combine the two together,'' (Deca and testosterone) and ``that's not 
a problem cause'' ``injectable testosterone is cheap and they're both 
oil base[d] so you can put it in the same syringe and you're done.'' 
Id. Respondent did advise the UC that he would need to get a liver 
function test ``every two to three months'' that he took the steroids. 
Id.
    The CI then told Respondent that ``all I'm concerned with'' is ``I 
need to get strong again.'' Id. at 16. Respondent then asked the CI: 
``What was the blood work that you last had done or anything?'' Id. The 
CI answered: ``it was about two years ago.'' Id. Upon being asked by 
Respondent if he ever ``had any liver enzyme problems?,'' the CI 
answered ``No,'' and added that ``actually,'' his ``testosterone levels 
[were] high.'' Id.
    After discussing the relative effects of testosterone (which would 
improve his strength) and Deca (which would give him more size), 
Respondent declared: ``Just to cover my ass I'm going to put down you 
got a history of osteoporosis.'' Id. at 17. Respondent then explained 
that ``[i]t's just brittle bones, it's common actually * * * in women 
after menopause but men do get it who have low testosterone levels.'' 
Id. The UC then asked Respondent: ``Do you want me to say my Mom or Dad 
had it?'' Id. Respondent answered ``No,'' and the UC stated: ``Okay.'' 
Id.
    Respondent then stated: ``Just so that you know when I write 
osteoporosis it has nothing to do with you[,] it just has to do if the 
State ever comes in to monitor my charts that I have a reason for 
prescribing you testosterone and Deca.'' \16\ Id. at 18. After 
discussing osteoporosis, Respondent advised the UC that ``at some point 
down the road you should get your liver enzymes checked[,] not now 
because you know you haven't been on anything.'' Id. Respondent then 
advised the UC how often he should get his liver enzymes tested, how to 
cycle on and off of the testosterone, and how to come off of it without 
losing his strength gains. Id. at 19-20. Respondent added: ``we're 
looking to get you to the upper limits of normal[,] not Lyle Alzado[']s 
brain tumor.'' Id. at 21.
---------------------------------------------------------------------------

    \16\ In his testimony, Respondent asserted that his comment that 
he was ``using this diagnosis [of osteoporosis] to cover my ass'' 
was just a flippant and stupid comment which he made to try to get 
the UC to trust him so that he would admit that he had HIV. Tr. 515. 
The ALJ did not find Respondent's story persuasive. See ALJ at 17. 
Nor do I given that the comment was not some offhand remark but a 
prelude to Respondent's further explanation that he was going to 
write down the osteoporosis diagnosis in the UC's chart so that if 
``the State ever comes in to monitor my charts * * * I have a reason 
for prescribing you testosterone and Deca.'' GX 10, at 18. Moreover, 
while the comment may have been flippant and stupid, in that it was 
made to an undercover officer who was wearing a wire, it is 
nonetheless probative of Respondent's intent.
---------------------------------------------------------------------------

    Respondent and the UC next discussed what drug he could take for 
joint pain. Id. at 21-23. Respondent recommended several drugs 
including anti-inflammatories such as Ibuprofen and Naproxen, narcotics 
such as Vicodin or Percocet, and Celebrex (if he had a sensitive 
stomach, but which cost $240 for thirty pills). Id. at 24. The UC then 
noted that a Vicodin prescription cost only $13 dollars at a local 
pharmacy while ``everyone [is] talking about how much OxyContin is.'' 
Id.
    Respondent then apparently wrote out various prescriptions as the 
UC asked if there was ``[a]ny particular place you want me to give 
these to?'' Id. at 25. Respondent recommended Comcare, the same 
pharmacy he had referred to earlier as compounding Deca Durabolin, and 
indicated that they had three offices. Id. at 25-26. Respondent further 
noted that ``most of the pharmacists'' at Comcare knew him, and added: 
``they're nice guys so you won't have a problem.'' Id. at 27.\17\
---------------------------------------------------------------------------

    \17\ Following a discussion of the counterfeiting of 
prescription drugs and the implementation of a drug tracking system 
to protect consumers, Respondent started discussing the ordering of 
drugs from Canada. GX 10, at 32. Respondent stated that he did not 
``know how that works,'' and ``that's why I ask whoever comes [in] 
how did you get the stuff you're getting before without a 
prescription.'' Id. Respondent then noted that a patient ``had a 
doctor who was pulling a little scam.'' Id. at 33. After the UC 
interjected: ``Oh, I don't know where it's coming from,'' Respondent 
stated: ``He [the doctor] was treating you and giving it to you 
without ever actually meeting you or examining you.'' Id. Respondent 
then added: ``Which is not really appropriate[.] I'm sure he lost 
his license in the process.'' Id.
---------------------------------------------------------------------------

    Later, the UC asked whether he could refer ``a couple close 
friends.'' Id. at 34. Respondent initially responded that he

[[Page 50001]]

didn't ``normally'' take on such persons, and while he would ``do 
this'' for the CI, ``this is not my thing.'' Id. Respondent stated that 
he knew ``a lot about steroids cause [he] did them in college'' and had 
``learned the hard way how to do them.'' Id. at 34-35. Respondent then 
added that the CI ``has a deficiency where he doesn't make enough * * * 
of a certain hormone'' and thus had a ``medical reasons for doing it.'' 
Id. at 35. After the UC stated, ``That's why I asked you,'' Respondent 
replied: ``That's not a problem but it's not my thing to do this.'' Id. 
Respondent then said that he would be willing to prescribe to the UC's 
friends if they were HIV positive because ``three quarters of men with 
HIV disease are low in testosterone'' and there is research showing 
that ``normal or elevated testosterone levels actually help the immune 
system.'' Id. at 36. Respondent added that while he was willing to help 
HIV patients, ``for guys who are just looking for body building and 
stuff like that I don't usually do.'' Id. at 36.
    The record shows that during the visit, Respondent wrote Bill Rix 
five prescriptions, including three for controlled substances. 
Specifically, Respondent wrote for: 100 tablets of Vicodin ES, with 
three refills; \18\ 5 cc's of nandrolone decanoate, with three refills; 
and 10 cc's of testosterone cipionate, with three refills. GX 6. 
Respondent also wrote Rix a prescription for 30 syringes with five 
refills and one for ibuprofen. GX 6; Stipulated Facts, ALJ at 5.
---------------------------------------------------------------------------

    \18\ The ALJ reasoned that because ``the record contains no 
expert medical testimony or any other evidence which demonstrates 
that the Respondent's treatment of [the UC] in this area was not for 
a legitimate medical reason or outside the course of professional 
practice,'' the preponderance of the evidence did not indicate that 
this prescription was invalid. ALJ at 22. For reasons explained in 
the discussion section of this decision, I conclude otherwise.
---------------------------------------------------------------------------

    As the ALJ noted, ``[t]he assessment notes in [the UC's] medical 
chart were incomplete, and did not include the specific prescriptions 
the Respondent issued to [the UC].'' ALJ at 14; see also GX 8, at 5 
(sheet for listing prescriptions for both legend and over-the-counter 
drugs which is blank). More specifically, while the form Respondent 
used to indicate the patient's complaint, history, physical exam, 
assessment and treatment plan, indicates that he diagnosed Rix with 
``osteoporosis''; consistent with the transcript of the visit, there 
are no findings to support the diagnosis. Likewise, there are no 
findings to support a diagnosis of joint pain or low testosterone and 
neither condition is documented in the ``assessment'' section of the 
form.
    The ALJ also noted that Respondent did not ask ``for a copy of the 
results of any of [the UC's] prior blood tests or order[] new blood 
tests prior to prescribing testosterone.'' ALJ at 15. And, as the 
transcript of the visit make clear, at no point did the UC indicate 
that he had a history of shoulder and vertebral fractures, and 
Respondent did not question the UC regarding the purported condition. 
See id. at 18-19.
    In his testimony, Respondent nonetheless maintained that he did a 
full physical exam on the UC (except for checking his prostate), Tr. 
570, and that he had actually ``found signs of lipodystrophy'' even 
though there is no such documentation in UC's chart. Id. at 580. In his 
testimony, Respondent stated that the form was incomplete because his 
nurse came in to the exam room and said ``that a patient was about to 
leave if I didn't get in there right away.'' Id. However, he intended 
to write down ``history of osteoporosis second to hypogonadism [low 
testosterone]'' at the ``little pound sign [which] is [his] indication 
for a diagnosis.'' Id.
    Respondent may well have intended to write this down. However, 
given that: (1) The transcript of the visit clearly shows that 
Respondent told the UC that he was writing down osteoporosis simply to 
``cover my ass'' in the event the State inspected his records; (2) he 
never questioned the UC about any of the purported fractures; (3) he 
had been told by the UC that when he was last tested he had high 
testosterone levels; and (4) he had been told by the UC that he had 
previously obtained steroids illegally, writing down the additional 
information would not make the diagnosis any less fraudulent.
    Regarding his ``diagnosis'' of the UC, Respondent testified that 
``[i]n [his] mind, Bill Rix had osteoporosis.'' Id. at 597. Thus, ``in 
[his] mind, that was not a false diagnosis.'' Id. at 593. On cross-
examination, Respondent admitted, however, that he would not ``find out 
whether this [sic] testosterone prescriptions that [he] issued were 
medically valid'' until three months later, after the UC underwent a 
blood test. Id. at 604. Moreover, the ALJ specifically found incredible 
Respondent's testimony that he genuinely believed that the UC had 
osteoporosis, noting his statement during the UC's April 24 visit. ALJ 
at 19 (quoting GX 10, at 17-18) (``Just to cover my ass I'm going to 
put down you got a history of osteoporosis. * * * [W]hen I write 
osteoporosis it has nothing to do with you[.] [I]t just has to do if 
the State ever comes in to monitor my charts that I have a reason for 
prescribing you testosterone and * * * [Deca].'') I agree with the 
ALJ's credibility determination.
    Finally, in his testimony, Respondent stated that ``[i]n [his] 
mind, everything [the UC] said was legitimate because I had already the 
knowledge that he was HIV and he did show signs of it.'' Tr. 503. 
Furthermore, he was ``trying to develop a rapport with this man. I was 
trying to get him to trust me * * * to get him to eventually admit to 
me that he knew he was HIV positive.'' Id. at 505. Respondent 
maintained that he had lied to the UC about having used steroids in 
college because he ``wanted to develop a rapport that `Hey, he's a cool 
guy.' [The UC] was telling me he used steroids in the past, I wanted 
him to think I was a sympathetic ear.'' Id. at 511.
    The ALJ did not address whether she found this testimony credible. 
However, I note that this testimony flows from Respondent's claim, 
which I find is not credible, that the CI had told him in a telephone 
call prior to the UC's visit that the UC was HIV positive. Moreover, at 
no point did Respondent order a blood test to verify the UC's purported 
condition. Finally, while Respondent testified that he believed that 
the UC had been infected with HIV since 2002, id. at 562, Respondent 
did not discuss with the UC what doctors he had previously seen and 
offered no evidence that he had attempted to obtain the UC's medical 
records. In short, he did nothing to verify whether the UC was HIV 
positive. Thus, I find this testimony disingenuous.

Discussion

    Section 304(a) of the Controlled Substances Act (CSA) provides that 
a registration to ``dispense a controlled substance * * * may be 
suspended or revoked by the Attorney General upon a finding that the 
registrant * * * has 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)(4). In making the public interest determination, the CSA 
requires that the following factors be considered:

    (1) The recommendation of the appropriate state licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing * * * controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.


[[Page 50002]]


21 U.S.C. 823(f).
    These factors are considered in the disjunctive. Robert A. Leslie, 
M.D., 68 FR 15227, 15230 (2003). I may rely on any one or a combination 
of factors, and I may give each factor the weight I deem appropriate in 
determining whether to revoke an existing registration. Id. Moreover, I 
am ``not required to make findings as to all the factors.'' Hoxie v. 
DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 
F.3d 165, 173-74 (DC Cir. 2005).
    The Government bears the burden of proof. 21 CFR 1316.56. However, 
where the Government makes out a prima facie case that a registrant's 
continued registration is inconsistent with the public interest, the 
burden shifts to the registrant to demonstrate why he can be entrusted 
with a registration.
    Having considered all of the factors, I acknowledge that the record 
contains no evidence that the State of Florida has taken action against 
Respondent's medical license (factor one) or that Respondent has been 
convicted of an offense related to controlled substances (factor 
three).\19\ However, with respect to Respondent's experience in 
dispensing controlled substances (factor two) and his record of 
compliance with applicable Federal and state laws (factor four), the 
record establishes that Respondent violated the CSA's prescription 
requirement, see 21 CFR 1306.04(a), and Federal law when he prescribed 
anabolic steroids and narcotics to the UC in that he acted outside of 
the usual course of professional practice and/or lacked a legitimate 
medical purpose. See 21 U.S.C. 841; 21 CFR 1306.04(a). The record also 
demonstrates that Respondent violated the prescription requirement and 
Federal law on numerous occasions by prescribing Subutex to the CI for 
detoxification purposes when he was not qualified to treat and manage 
opiate-dependent patients. 21 U.S.C. 823(g); 21 CFR 1306.04(c). 
Finally, I agree with the ALJ that Respondent has failed to rebut the 
Government's prima facie case. Accordingly, Respondent's registration 
will be revoked and his pending application to renew his registration 
will be denied.
---------------------------------------------------------------------------

    \19\ This Agency has long held that a State's failure to take 
action against a practitioner's authority to dispense controlled 
substances is not dispositive in determining whether the 
continuation of a registration would be consistent with the public 
interest. See Mortimer B. Levin, 55 FR 8209, 8210 (1990). Likewise, 
the absence of a criminal conviction is not dispositive of the 
public interest inquiry. See, e.g., Edmund Chein, 72 FR 6580, 6593 
n.22 (2007).
---------------------------------------------------------------------------

Factors Two and Four--Respondent's Experience in Dispensing Controlled 
Substances and Compliance With Applicable Laws.

    Under a longstanding DEA regulation, a prescription for a 
controlled substance is not ``effective'' unless it is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). This 
regulation further provides that ``an order purporting to be a 
prescription issued not in the usual course of professional treatment * 
* * is not a prescription within the meaning and intent of [21 U.S.C. 
829] and * * * the person issuing it, shall be subject to the penalties 
provided for violations of the provisions of law related to controlled 
substances.'' Id. See also 21 U.S.C. 802(10) (defining the term 
``dispense'' as meaning ``to deliver a controlled substance to an 
ultimate user by, or pursuant to the lawful order of, a practitioner, 
including the prescribing and administering of a controlled 
substance'') (emphasis added).
    As the Supreme Court recently explained, ``the prescription 
requirement * * * ensures patients use controlled substances under the 
supervision of a doctor so as to prevent addiction and recreational 
abuse. As a corollary, [it] also bars doctors from peddling to patients 
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon, 
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 
135, 143 (1975)). Under the CSA, it is fundamental that a practitioner 
must establish and maintain a bonafide doctor-patient relationship in 
order to act ``in the usual course of * * * professional practice'' and 
to issue a prescription for a ``legitimate medical purpose.'' Laurence 
T. McKinney, 73 FR 43260, 43265 n.22 (2008); see also Moore, 423 U.S. 
at 142-43 (noting that evidence established that physician ``exceeded 
the bounds of `professional practice,' '' when ``he gave inadequate 
physical examinations or none at all,'' ``ignored the results of the 
tests he did make,'' and ``took no precautions against * * * misuse and 
diversion''). The CSA, however, generally looks to state law to 
determine whether a doctor and patient have established a bonafide 
doctor-patient relationship. See Kamir Garces-Mejias, 72 FR 54931, 
54935 (2007); United Prescription Services, Inc., 72 FR 50397, 50407-08 
(2007).
    Under the standards adopted by the Florida Board of Osteopathic 
Medicine, to evaluate a patient:

    [a] complete medical history and physical examination must be 
conducted and documented in the medical record. The medical record 
should document the nature and intensity of the pain, current and 
past treatments for pain, underlying or coexisting diseases or 
conditions, the effect of the pain on physical and psychological 
function, and history of substance abuse. The medical record also 
should document the presence of one or more recognized medical 
indications for the use of a controlled substance.

Fla. Admin Code Ann. r. 64B15-14.005(3)(a). The Board's standard 
further states that ``[t]he osteopathic physician should discuss the 
risks and benefits of the use of controlled substances with the 
patient.'' Id. para. (3)(c). Moreover, as relevant here, an

ostheopathic physician is required to keep accurate and complete 
records to include, but not be limited to:
    1. The medical history and physical examination;
    2. Diagnostic, therapeutic, and laboratory results;
    3. Evaluations and consultations;
    4. Treatment objectives;
    5. Discussion of risks and benefits;
    6. Treatments; [and]
    7. Medications (including date, type, dosage, and quantity 
prescribed)[.]
Id. para (3)(f).

    As found above, during the UC's April 24 visit, Respondent issued 
him a prescription for 100 tablets of Vicodin ES, with three refills, a 
schedule III controlled substance which contains hydrocodone. ALJ at 5 
(stipulated facts). While the prescription was purportedly issued to 
address the UC's joint pain, Respondent did not physically examine the 
UC. Moreover, although the UC made an oblique reference to pain in his 
knees while performing squats, Respondent did not further question the 
UC as to the nature and intensity of the pain or the pain's effect on 
the UC's physical and psychological function. Furthermore, Respondent 
did not discuss the risks and benefits of using controlled substances. 
Finally, Respondent did not document any past or current treatments for 
the purported pain and did not document the presence of a medical 
condition for which the use of controlled substances was indicated. 
Therefore, in accordance with the standards of the Florida Board, I 
conclude that Respondent acted outside of the usual course of 
professional practice and lacked a legitimate medical purpose in 
issuing the Vicodin prescription (with three refills) to the UC and 
violated Federal law. See 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a).
    I further conclude that Respondent violated both state and Federal 
law when he prescribed to the UC two anabolic steroids, which are 
schedule III

[[Page 50003]]

controlled substances: 15 cc's of nandralone decanoate (with three 
refills), and 10 cc's of testosterone cipionate (also with three 
refills). Under Florida law, ``prescribing * * * testosterone or its 
analogs * * * for the purpose of muscle building or to enhance athletic 
performance'' is unlawful.\20\ See Fla. Stat. Ann. Sec.  
458.331(1)(ee). As found above, during the April 24 visit, the UC was 
clearly seeking the anabolic steroid prescriptions for muscle building 
purposes, which is not a legitimate medical purpose under Florida law 
(and therefore Federal law as well).
---------------------------------------------------------------------------

    \20\ It is acknowledged that for the purpose of this provision, 
``the term `muscle building' does not include the treatment of 
injured muscle.'' Fla. Stat. Ann. Sec.  458.331(ee).
---------------------------------------------------------------------------

    Moreover, the transcript of the visit further establishes that 
Respondent clearly knew that the UC was seeking the steroids for this 
purpose. Specifically, the UC did not complain of any problem other 
than that he was aging and losing strength; related that he had 
obtained steroids through a pharmacy, which arranged for doctors, who 
never saw patients, to write the prescriptions lawfully required to 
dispense the steroids; that he had gone to the pharmacy one day only to 
find that it had been raided by the police; and that when he had last 
undergone a blood test, his testosterone levels were high.
    Respondent's statements during the undercover visit further support 
the conclusion that he knew the UC was seeking the steroids for other 
than a legitimate medical purpose. As found above, Respondent stated 
that ``just to cover my ass,'' he was going to ``put down'' in the UC's 
chart that he had ``a history of osteoporosis,'' and that ``when I 
write osteoporosis it has nothing to do with you[,] it just has to do 
if the State ever comes in to monitor my charts that I have a reason 
for prescribing you testosterone and Deca.'' GX 10, at 17-18. Thus, it 
is clear that Respondent knew that he lacked a legitimate medical 
purpose for prescribing steroids to the UC.\21\
---------------------------------------------------------------------------

    \21\ To similar effect, upon being asked by the UC whether he 
would accept referrals of ``a couple [of] close friends,'' 
Respondent answered that while he was willing to prescribe steroids 
to the UC as a favor to Jimmy (the CI), ``this is not my thing'' and 
that I ``know a lot about steroids cause I did them in college.'' GX 
10, at 34. He then added that Jimmy (unlike the UC) ``actually has a 
deficiency where he doesn't make enough of a certain hormone so * * 
* he has medical reasons for doing'' steroids. Id. at 35. Respondent 
then told the UC that ``it's not my thing to do this.'' Id.
---------------------------------------------------------------------------

    Respondent therefore violated the prescription requirement of 
Federal law when he wrote the UC prescriptions for nandralone and 
testosterone. I further hold that Respondent's issuance of the Vicodin 
and anabolic steroid prescriptions to the UC each provide an 
independent and adequate basis to satisfy the Government's prima facie 
case that Respondent's continued registration is inconsistent with the 
public interest.
    Respondent also repeatedly violated Federal law by prescribing 
Subutex to the CI. According to the record, Respondent had initially 
referred the CI to a psychiatrist who specialized in detoxification of 
opiate-dependent patients and from whom the CI received prescriptions 
of Subutex for this purpose. When, however, the CI complained that the 
detox specialist charged too much and insisted on seeing him every 
month, Respondent agreed to write Subutex prescriptions for the CI and 
wrote him numerous prescriptions (as well as authorized refills) over 
the course of nearly three and a half years. Respondent did not dispute 
that the Subutex prescriptions were written for this purpose.
    Under Federal law, a physician who dispenses (which includes 
prescribing) narcotic drugs in schedules III through V to a person for 
maintenance or detoxification treatment need not necessarily obtain a 
separate registration for this purpose. However, the physician must 
satisfy extensive conditions to prescribe these drugs for these 
purposes. See 21 U.S.C. 823(g)(2)(A) & (B). These conditions include 
that the practitioner must, ``before the initial dispensing of narcotic 
drugs in schedule III, IV or V'' for these purposes, notify the 
Secretary of the Department of Health and Human Services (HHS) of his 
intent ``to begin dispensing the drugs * * * for such purpose.'' Id. 
Sec.  823(g)(2)(B). And as part of the notification, the physician must 
make three certifications.
    More specifically, the practitioner must certify that: (1) He ``is 
a qualifying physician''; (2) he ``has the capacity to refer the 
patients for appropriate counseling and other appropriate ancillary 
services''; and (3) ``[t]he total number of patient of the practitioner 
at any one time will not exceed the applicable number.''\22\ Id. With 
respect to the first requirement, a physician must hold (in addition to 
a state license) either board certification in addiction, addiction 
medicine, or addiction psychiatry; or have completed ``not less than 
eight hours of training'' in the ``treatment and management of opiate-
dependent patients'' provided by various professional 
organizations,\23\ or have other training or experience as either the 
Secretary of HHS or a State medical board has determined 
``demonstrate[s] the ability of the physician to treat and manage 
opiate-dependent patients.'' Id. Sec.  823(g)(2)(G).
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    \22\ Initially, a practitioner may only treat thirty patients. 
21 U.S.C. 823(g)(2)(B)(iii).
    \23\ The organizations include ``the American Society of 
Addiction Medicine, the American Academy of Addiction Psychiatry, 
the American Medical Associations, the American Ostheopathic 
Association, and the American Psychiatric Association.'' 21 U.S.C. 
823(g)(2)(G)(IV).
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    Although Respondent holds a valid state license, he did not meet 
any of the conditions necessary to demonstrate that he is qualified as 
a physician to treat and manage opiate-dependent patients such as the 
CI. Nor did he satisfy any of the statute's other requirements for 
dispensing narcotics drugs for the purpose of maintenance or 
detoxification treatment.
    While Respondent asserted that he did not know when these 
requirements went into effect and was unsure as to whether ``the 
course'' was required at the time he wrote the prescriptions, they have 
been in effect since the year 2000.\24\ See Drug Addiction Treatment 
Act of 2000, Public Law 106-310, Sec.  3502, 114 Stat. 1222, 1225 
(2000). As for his contention that no pharmacist ever told him he 
needed a special registration to prescribe narcotics for this purpose, 
Respondent is responsible for knowing the law. Cf. Patrick W. Stodola, 
M.D., 74 FR 20727 20734 (2009) (quoting Hageseth v. Superior Court, 59 
Cal. Rptr.3d 385, 403 (Ct. App. 2007) (``[T]he proscription of the 
unlicensed practice of medicine is neither an obscure nor an unusual 
state prohibition of which ignorance can reasonably be claimed, and 
certainly not by persons * * * who are licensed health care 
providers.'').
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    \24\ Since 1974, Federal law has required that a practitioner 
obtain a separate registration and meet various standards imposed by 
the Secretary to dispense narcotic drugs for maintenance or 
detoxification treatment. See Narcotic Treatment Act of 1974, Public 
Law 93-281, 88 Stat. 137-38 (1974). While a practitioner who seeks 
to dispense schedule III through V controlled substances for 
maintenance or detoxification treatment may obtain a waiver of the 
registration requirement, as explained above, he must still meet 
various requirements including having either board- certification or 
suitable experience and/or training in treating and managing opiate-
dependent patients.
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    These are serious violations of Federal law. Congress made this 
clear in the Drug Addiction Treatment Act, where it specifically 
provided that if a practitioner, ``in violation of the conditions 
specified in subparagraph[] B * * * dispenses narcotic drugs in 
schedule III, IV, or V * * * for maintenance treatment or 
detoxification treatment, the Attorney General may, for

[[Page 50004]]

purposes of [21 U.S.C. 824(a)(4)], consider the practitioner to have 
committed an act that renders the registration of the practitioner 
pursuant to subsection (f) to be inconsistent with the public 
interest.'' 21 U.S.C. 823(g)(2)(E)(i). Accordingly, I further hold that 
Respondent's prescribing of Subutex to the CI for detoxification 
purposes provides an additional and independent basis to support the 
Government's prima facie case.

Sanction

    Under Agency precedent, where, as here, ``the Government has proved 
that a registrant has committed acts inconsistent with the public 
interest, a registrant must `present[] sufficient mitigating evidence 
to assure the Administrator that [he] can be entrusted with the 
responsibility carried by such a registration.' '' Medicine Shoppe-
Jonesborough, 73 FR 363, 387 (2008) (quoting Samuel S. Jackson, 72 FR 
23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988)). 
Moreover, because ``past performance is the best predictor of future 
performance, ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995), 
[DEA] has repeatedly held that where a registrant has committed acts 
inconsistent with the public interest, the registrant must accept 
responsibility for [his] actions and demonstrate that [he] will not 
engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also 
Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); 
Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. 
DEA, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]'' 
by DEA to be an ``important factor[]'' in the public interest 
determination).
    As part of this determination, this Agency also places great weight 
on a registrant's candor, both during an investigation and in any 
subsequent proceeding. See, e.g., The Lawsons, Inc., t/a The Medicine 
Shoppe Pharmacy, 72 FR 74334, 74338 (2007) (quoting Hoxie, 419 F.3d at 
483) (``Candor during DEA investigations properly is considered by the 
DEA to be an important factor when assessing whether a * * * 
registration is consistent with the public interest.''). See also Rose 
Mary Jacinta Lewis, M.D., 72 FR 4035, 4042 (2007) (holding that lying 
under oath in proceeding to downplay responsibility supports conclusion 
that physician ``cannot be entrusted with a registration'').
    Here, as the ALJ found, the evidence supports the conclusions that 
Respondent has failed to accept responsibility for his misconduct and 
gave false testimony in the proceeding. ALJ at 30. More specifically, 
based on the transcript of the April 24 visit, which clearly shows that 
Respondent falsely documented that the UC had osteoporosis, the ALJ 
found not credible Respondent's testimony that he genuinely believed 
the UC had osteoporosis. I agree.
    Moreover, while the ALJ expressly declined to make any findings as 
to whether she found credible Respondent's testimony that the CI had 
phoned him and related that the UC had various conditions such as HIV 
and a history of bone fractures (which was offered to provide some 
medical justification for the steroid prescriptions), as explained 
above, as ultimate factfinder, I have rejected his testimony as not 
credible for multiple reasons. In short, the entirety of the evidence 
convincingly demonstrates that Respondent's testimony regarding the 
purported phone call was patently self-serving and disingenuous.
    Respondent further argues that he refused to prescribe HGH to the 
UC and also refused the UC's request to accept the latter's friends as 
``patients.'' As for Respondent's refusal to prescribe HGH (which is 
not a controlled substance), it is far from clear that the UC was 
seeking HGH as he noted that it's ``the most expensive stuff on earth'' 
and that it had caused an acquaintance's head to swell.\26\ GX 10, at 
11. While it is true that Respondent told the UC of other serious side 
effects caused by HGH, this no more mitigates his misconduct in issuing 
the steroid prescriptions than would an argument that one had 
prescribed a slightly less dangerous narcotic rather than a more 
dangerous one sought by a drug abuser (for example OxyContin instead of 
Fentanyl), when there was no legitimate medical purpose for any such 
prescription. Put another way, the fact that a controlled substance 
causes less dangerous side effects than another drug which a drug 
abuser may have sought does not make a prescription for a controlled 
substance, which lacks a legitimate medical purpose, any less illegal.
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    \26\ In her opinion, the ALJ found that the UC had ``hinted that 
he would like a prescription for'' HGH. ALJ at 22. This does not 
seem to be an accurate reading of the evidence in light of the UC's 
complaint that HGH is ``the most expensive stuff on earth.'' GX 10, 
at 39.
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    As for Respondent's declining the UC's offer to refer his friends 
because he ``usually'' did not do ``guys who are just looking for 
bodybuilding and stuff like that,'' he nonetheless was willing to issue 
illegal prescriptions to the UC. Moreover, that Respondent did not 
``usually'' write steroid prescriptions for those into bodybuilding 
implies that, in some other instances, he did. See ALJ at 32.
    In short, even were I to view the evidence as supporting both 
Respondent's contention that the UC sought HGH but he refused to 
prescribe it and that he declined the UC's offer to refer his friends, 
these circumstances are not sufficient to rebut the Government's prima 
facie case and demonstrate that he can be entrusted with a 
registration. Moreover, regarding his extensive violations of Federal 
law in prescribing Subutex for detoxification treatment, Respondent did 
not accept responsibility, but rather blamed his misconduct on the fact 
that no pharmacist told him that he needed a separate registration to 
do so.\27\
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    \27\ I have also considered Respondent's evidence regarding his 
volunteer activities related to persons with HIV. While his 
activities are laudable, they do not negate the fact that Respondent 
knowingly diverted steroids and repeatedly violated Federal law in 
prescribing Subutex. Nor are his activities relevant in determining 
whether Respondent has accepted responsibility for his misconduct.
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    In conclusion, because Respondent has failed to accept 
responsibility for his misconduct and provided less than candid 
testimony in the proceeding, it is clear that his continued 
registration ``would be inconsistent with the public interest.'' 21 
U.S.C. 823(f). Accordingly, Respondent's registration will be revoked 
and his pending application to renew his registration will be denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 
824(a), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA 
Certificate of Registration, BH1292642, issued to Robert F. Hunt, D.O., 
be, and it hereby is, revoked. I further order that Respondent's 
pending application to renew his registration be, and it hereby is, 
denied. This Order is effective immediately.

    Dated: July 30, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-20243 Filed 8-13-10; 8:45 am]
BILLING CODE 4410-09-P