Tony T. Bui, M.D.; Revocation of Registration, 49979-49991 [2010-20242]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 75, Number 157 (Monday, August 16, 2010)]
[Notices]
[Pages 49979-49991]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20242]


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 DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 09-8]


Tony T. Bui, M.D.; Revocation of Registration

    On September 15, 2008, the Deputy Assistant Administrator, Office 
of Diversion Control, issued an Order to Show Cause to Tony T. Bui, 
M.D. (Respondent), of Bedford, Texas. The Show Cause Order proposed the 
revocation of Respondent's DEA Certificate of Registration, BB8997857, 
which authorizes him to dispense controlled substances as a 
practitioner, and the denial of any pending applications to renew or 
modify his registration, on the ground that his ``continued 
registration is inconsistent

[[Page 49980]]

with the public interest.'' ALJ Ex. 1, at 1 (citing 21 U.S.C. 823(f) & 
824(a)(4)).
    More specifically, the Show Cause Order alleged that Respondent has 
``a history of cocaine abuse'' and that on, or about, December 13, 
2007, the Texas Medical Board ordered Respondent to provide a urine 
sample. Id. The Order alleged that the sample ``tested positive for 
cocaine metabolites'' and that ``[a] retest of the same sample 
reconfirmed'' this result. Id.
    The Show Cause Order also alleged that Respondent has failed to 
keep his registered address current with the Agency as required by 21 
CFR 1301.51. Id. Next, the Show Cause Order alleged that Respondent was 
``dispensing narcotic drugs for narcotic treatment without the 
necessary authorization.'' Id. at 2 (citing 21 U.S.C. 823(g) and 21 CFR 
101.13). Finally, the Show Cause Order alleged that Respondent had 
``written prescriptions for Jintropin, a human growth hormone, which 
the Food and Drug Administration has not approved for use in the United 
States.'' Id.
    Respondent's request for a hearing was not received by Agency until 
October 29, 2008, and was thus beyond the thirty-day period for 
requesting a hearing. See 21 CFR 1301.43(a). Respondent's counsel 
explained that he had sent the request on October 14, but that one of 
his staff had typed an incomplete address on the envelope which was 
used for mailing the request, and that as a result, the mailing was 
returned. ALJ Ex. 11, at 1. Respondent's counsel promptly refiled the 
hearing request. ALJ Ex. 2. Finding that the Government had not 
objected to Respondent's hearing request, and reasoning that ``the law 
seeks to avoid a result where a blameless party suffers because of the 
errors or neglect of his attorney,'' the ALJ concluded that Respondent 
had shown ``good cause'' for his untimely filing. ALJ Ex.12, at 1-2; 
see also 21 CFR 1301.43(d).
    Following pre-hearing procedures, the ALJ conducted a hearing in 
Dallas, Texas on August 4-5, 2009. At the hearing, both parties 
elicited testimony and submitted various documents for the record. 
Thereafter, both parties filed briefs containing their proposed 
findings of fact, conclusions of law, and arguments.
    On September 16, 2009, the ALJ issued his recommended decision 
(hereinafter, also ALJ). Therein, the ALJ concluded that the Government 
had proved that ``Respondent ha[d] committed acts that are inconsistent 
with the public interest.'' ALJ at 37. The ALJ further concluded that 
``Respondent has not accepted responsibility for his actions, expressed 
remorse for his conduct at any level, or presented evidence that could 
reasonably support a finding that'' his registration should be 
continued. Id.
    With respect to factor one--the recommendation of the state 
licensing board--the ALJ noted that ``Respondent has had a somewhat 
storied history with the Texas Medical Board'' and that ``[t]here has 
been a repeated pattern of the Board meting out sanctions that are 
followed by additional misconduct,'' but that the Board ``has 
authorized the Respondent to continue to practice medicine.'' Id. at 
23-34. However, based on the extensive precedent which holds that the 
Agency has an ``independent responsibility to determine whether a 
registration is in the public interest,'' and that possessing ``a state 
license is a necessary, but not a sufficient condition for 
registration,'' the ALJ concluded that while Respondent is currently 
authorized to practice medicine in Texas, this factor ``does not weigh 
for or against a determination as to whether [the] continuation of [his 
registration] is consistent with the public interest.'' Id. at 24.
    The ALJ then turned to factor three--Respondent's conviction record 
for offenses relating to the manufacture, distribution and dispensing 
of controlled substances. While noting that Respondent had been 
indicted and received a deferred adjudication under Texas law for the 
felony offense of possession of a controlled substance, the ALJ, after 
noting the confused state of agency precedent, concluded that his 
offense did not implicate this factor because it was not an offense 
which ``relat[es] to the manufacturing, distribution, or dispensing of 
controlled substances.'' Id. at 25. Thus, the ALJ held that ``this 
factor does not weigh against * * * Respondent.'' Id. at 26.
    Next, the ALJ considered together factors two (Respondent's 
experience in dispensing controlled substances), four (compliance with 
applicable laws related to controlled substances) and five (such other 
conduct which may threaten public health and safety). With respect to 
Respondent's prescribing practices, the ALJ concluded that the 
Government had not proven that Respondent violated Federal law by 
prescribing narcotic controlled substances for maintenance or 
detoxification purposes. Id. at 29.
    With respect to Respondent's prescribing of human growth hormone 
including Jintropin, a substance which has not been approved by the 
Food and Drug Administration for any medical indication, the ALJ 
acknowledged that ``human growth hormone is not a controlled substance 
with the meaning of the'' Controlled Substances Act and that 
``Respondent's issuance of a prescription for the substance for 
purposes other than FDA-approved uses does not fall squarely within the 
purview of the criminal statute.'' Id. at 30. The ALJ reasoned, 
however, that ``because he issued prescriptions for human growth 
hormone for unauthorized uses and for Jintropin for any use, he 
violated federal law by issuing prescriptions outside the usual course 
of professional practice.'' Id. (citing 21 CFR 1306.04(a)). The ALJ 
also concluded that this conduct was relevant under factor five, 
reasoning that ``[i]t would be difficult to conceive of a scenario that 
hits closer to the mark of a dangerous prescribing practice than the 
prescribing of substances for purposes that have not been approved by 
the FDA and the prescribing of a substance not approved for any purpose 
by the FDA.'' Id. at 31.
    Next, the ALJ considered the evidence pertaining to Respondent's 
use of cocaine and alcohol. The ALJ noted that within two months of his 
entering into an agreed order with the Texas Medical Board, which 
required him to undergo treatment and urinalysis, Respondent used 
cocaine and then ``fabricated a tale about innocent ingestion'' and 
``procured a false letter from a former girlfriend admitting to a soft-
drink adulteration that never occurred.'' Id. at 32. Moreover, even 
after the Texas Board restored his license (following a suspension), 
Respondent failed to check in for testing and then tested positive for 
alcohol, a result he claimed was caused by his use of an 
antiperspirant. Id. The ALJ further noted that while the Texas Board 
gave him ``yet another chance,'' Respondent subsequently tested 
positive for cocaine. Id. The ALJ further found that ``Respondent has 
met every objective indication of his continued substance abuse issues 
with denials and fabrications.'' Id. at 32-33.
    Noting the ``settled Agency precedent that a registrant's 
continuing substance abuse and/or unsuccessful rehabilitation efforts 
are contrary to the public safety and militate against entrusting such 
a person with the responsibilities attendant upon a registration,'' the 
ALJ concluded that because ``Respondent is not being currently 
monitored for substance abuse, there is no way to accurately gauge 
whether he has subsequently taken definitive, successful steps to 
overcome his substance abuse issues * * * [and] [t]he evidence 
regarding the continued episodes of cocaine use weighs in favor of 
revocation.'' Id. at 33.
    The ALJ also observed that Respondent had changed his practice

[[Page 49981]]

address at least four different times without updating his registered 
location. Id. at 34 (citing 21 CFR 1301.12(a) & (b)(3)). While noting 
that ``the nature of his practice at each practice address was not 
demonstrated with crystal clarity at the hearing,'' the ALJ concluded 
that the record showed that Respondent had administered testosterone 
injections to at least one person at an unregistered address. Id. at 
34. Moreover, the ALJ noted that Respondent was apparently no longer 
practicing at the address listed on his renewal application and thus 
his renewal application could be denied on this basis alone. Id. at 35. 
The ALJ also did not find persuasive Respondent's explanation that he 
had failed to update his addresses because ``he had difficulty 
remembering to fulfill this obligation.'' Id. at 36. The ALJ thus 
concluded that factors two, four, and five ``weigh strongly in favor of 
revocation'' of Respondent's registration. Id.
    The ALJ thus held that ``Respondent has committed acts that are 
inconsistent with the public interest.'' Id. at 37. Moreover, the ALJ 
found that ``Respondent has not accepted responsibility for his 
actions, expressed remorse for his conduct at any level, or presented 
evidence that could reasonably support a finding that'' he can be 
entrusted with a registration. Id. The ALJ thus recommended that 
Respondent's registration be revoked and any pending applications be 
denied. Id.
    Thereafter, Respondent filed exceptions to the ALJ's recommended 
decision. More specifically, Respondent excepted to the ALJ's finding 
that he had ingested cocaine in the days before his positive urine 
test, contending that the ALJ had disregarded several significant 
inconsistencies in the testimony of the Government's expert regarding 
the sensitivity of hair testing. Resp. Exceptions at 1-3. Respondent 
also maintained that an Agency Investigator had violated his right to 
procedural due process when she told Respondent that he could not 
prescribe controlled substances until further notice from the Agency. 
Id. at 3-4. Finally, Respondent excepted to the ALJ's recommendation 
that his registration be revoked, contending that he provided 
``sufficient mitigating evidence'' to support his being granted ``a 
restricted registration.'' Id. at 5.\1\
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    \1\ Respondent also excepted to the ALJ's finding that the 
Diversion Investigator who investigated him was not biased. Id. at 
3.
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    On October 13, 2009, the record was forwarded to me for Final 
Agency Action. Having considered the entire record, I hereby issue this 
Decision and Final Order. I agree with the ALJ that the Government has 
not proved that Respondent prescribed methadone for maintenance or 
detoxification purposes in violation of 21 U.S.C. 823(g), and that 
substantial evidence supports the conclusion that Respondent ingested 
cocaine in December 2007. I reject the ALJ's conclusion that 
Respondent's prescribing of human growth hormone (including Jintropin) 
violated 21 CFR 1306.04(a), and further hold that the allegation is 
beyond the Agency's authority to adjudicate under 21 U.S.C. 823(f). I 
also reject the ALJ's finding that Respondent violated Federal law by 
administering controlled substances at a non-registered location. 
However, I agree with the ALJ that Respondent has failed to accept 
responsibility with respect to his ingestion of cocaine in December 
2007. Accordingly, I make the following findings.

Findings of Fact

    Respondent is a doctor of medicine with training in physical 
medicine and rehabilitation who currently practices geriatric medicine 
in Dallas, Texas. Tr. 261 & 265; GX 3, at 1. Respondent has been 
licensed by the Texas Medical Board since May 10, 1997. GX 3, at 1.
    Respondent previously held DEA Certificate of Registration, 
BB5278141, which authorized him to dispense controlled substances as a 
practitioner. GX 11, at 5. However, as discussed more fully below, on 
November 7, 2003, the Texas Medical Board suspended Respondent's 
medical license for a period of six months, GX 4, at 3-4; and on 
January 15, 2004, Respondent surrendered this registration. GX 11, at 
2.
    On October 28, 2004, after the State restored Respondent's medical 
license, Respondent obtained a new practitioner's registration, 
BB8997857, for the location of 4300 MacArthur Ave., Suite 265, Dallas, 
Texas. Id. at 2. On July 24, 2007, Respondent applied to both renew and 
modify the registration by changing his registered location to 1901 
Central Drive, Suite 805, Bedford, Texas. Id. While Respondent was 
issued a new certificate for the Bedford address, the Agency did not 
renew his registration. GX 1. On January 8, 2009, Respondent submitted 
a new request to modify his registration by changing the address to 
2735 Villa Creek Drive, Suite 110C, Dallas, Texas. GX 11, at 2.

The State Investigations

    On April 16, 2002, Respondent was stopped by a police officer for 
driving with a defective brake light. GX 2. During the stop, the 
officer determined that Respondent's driver's license was suspended and 
arrested him. Id. While being processed at the jail, Respondent was 
found to have in his possession a small quantity of cocaine. GX 3, at 
2. Respondent also ``admitted to a history of recreational cocaine 
abuse.'' Id.
    Respondent was subsequently indicted for the offense of possession 
of a controlled substance, in the amount of less than one gram, a 
felony under Texas law. Id. On November 27, 2002, the state court 
placed Respondent on deferred adjudication. Id.
    Thereafter, on August 15, 2003, Respondent entered into an Agreed 
Order with the Texas Medical Board. Id. at 1. The order noted that on 
October 8, 2002, Respondent met with the Physician's Health and 
Rehabilitation Committee of Medical City Hospital, Dallas, and entered 
into a recovery contract, the terms of which included ``an evaluation 
by an addictionologist and treatment, if recommended[;] abstention from 
drugs and alcohol; limitation of [his] prescribing authority; and 
random urine testing through the Texas Medical Association.'' Id. at 2.
    The Board imposed various terms and conditions for a period of five 
years. As relevant here, the terms included that: (1) Respondent 
abstain from consuming ``alcohol, dangerous drugs, or controlled 
substances in any form unless prescribed by another physician to [him] 
for a legitimate and documented therapeutic purpose''; (2) Respondent 
submit to random testing for alcohol or drug use ``either through a 
urine, blood, or hair specimen, at the request of'' the Board, 
``without prior notice,'' and at his own expense; (3) either a positive 
test result or his refusal to submit to a test would constitute a 
violation of the order and subject his license to an immediate 
suspension without a hearing; (4) Respondent submit to a psychiatric 
evaluation, and if recommended, undergo psychiatric care and treatment; 
(5) Respondent participate in either a program of Narcotics Anonymous 
or a substantially similar program; and (6) Respondent ``participate in 
the activities of a county or state medical society committee on 
physician health and rehabilitation, including participation in weekly 
meetings, if any''; and (7) Respondent pay an administrative penalty of 
$5,000 within sixty days of the order. Id. at 4-8.
    Pursuant to the Agreed Order, on October 14, 2003, Respondent 
provided a specimen, which ``tested positive for cocaine.'' GX 4, at 2. 
On November 7, 2003, the Board found that Respondent had ``failed to 
abstain from the consumption of dangerous drugs or

[[Page 49982]]

controlled substances'' and had violated the Agreed Order. Id. 
Moreover, during a show cause proceeding before the Texas Board, 
Respondent admitted that he had not paid the administrative penalty. 
Id.
    During the state proceeding, Respondent asserted that his positive 
test result was caused by his ex-girlfriend's having spiked a soft 
drink without his knowledge. Id. In support of his claim, Respondent 
submitted a ``hand-written statement,'' which he claimed was from his 
ex-girlfriend.\2\ Id. The Board apparently did not buy his story as it 
determined that he had violated the Agreed Order and suspended his 
state license ``for a minimum period of six months'' while continuing 
in effect the terms of the Agreed Order. Id. at 3. The suspension 
remained in effect until October 8, 2004, when the Board terminated it 
upon finding that Respondent was in compliance with the terms of the 
Agreed Order. GX 5, at 2-3.
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    \2\ At the instant hearing, Respondent admitted repeatedly that 
he had lied to the Board about this incident. Tr. 311-12. Explaining 
his conduct, Respondent testified that he was in denial, and that 
when ``you're up against a wall * * * you're going to lie. You're 
going to try to pull the wool over people's eyes.'' Id. at 312. He 
insisted, however, that he is not on cocaine. Id. at 315.
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    On August 3, 2005, the Board filed a Complaint against Respondent 
based on violations of the Texas Medical Practice Act. GX 6, at 1. 
Therein, the Board alleged that on February 8, 2005, Respondent 
consumed alcohol and thereby violated the Agreed Order, and that he 
also failed to report this incident as required by the Agreed Order. 
Id. at 2. The Board further alleged that on March 2, 2005, Respondent 
failed to call in to determine whether he was required to submit a 
sample for drug testing, and that the next day, Respondent provided a 
sample, which tested positive for EtG (Ethyl Glucoronide), a marker for 
alcohol use. Id.
    On February 3, 2006, the Board and Respondent entered into a 
Mediated Agreed Order. GX 7, at 1. Therein, the Board found that 
``Respondent did report an unintentional ingestion of alcohol,'' but 
that ``the report was late.'' Id. at 2. The Board further found that 
Respondent ``tested negative for alcohol.'' Id. While the Board also 
found that ``Respondent was late for a call-in * * * he submitted a 
sample two days later that was negative.'' Id. Finally, the Board found 
that Respondent's ``compliance officer reports he is currently in 
compliance with his Order.'' Id. The Board reprimanded Respondent and 
imposed a $5,000 administrative penalty on him. Id. at 3.
    On December 13, 2007, Respondent was subjected to a random urine 
drug screen. The specimen, which was analyzed using an initial test and 
confirmed through the Gas Chromatography and Mass Spectrometry methods, 
was positive for cocaine metabolites at the level of 627 ng./ml., an 
amount more than four times the 150 ng./ml. level which confirms a 
positive test result. GX 8, at 2 & 4. The result was confirmed by a 
retest of Respondent's specimen, which was conducted by a second 
laboratory. Id. at 5.
    On December 19, before the retest of his urine sample was 
completed, Respondent submitted a hair specimen, which represented 
three to four months of growth, for screening by another laboratory. RX 
2, at 1. Respondent's specimen tested negative for prohibited 
substances including cocaine and its metabolites. Id. On January 10, 
2008, Respondent submitted an additional hair specimen for screening. 
RX 3, at 1. This specimen also tested negative for cocaine and its 
metabolites. Id.
    To address these conflicting test results, the Government called 
Dr. Angela Springfield as an expert witness. Tr. 22. Dr. Springfield 
holds a PhD in Pharmacology and Toxicology, has served as Chief 
Toxicologist for Tarrant County, Texas for more than twenty-five years, 
and was an Assistant Professor at the University of North Texas Health 
Science Center. GX 12. Dr. Springfield is a member of the Society of 
Forensic Toxicology and of the American Academy of Forensic Sciences, 
and holds a diploma from the latter organization. Id. at 2; Tr. 22. Dr. 
Springfield was qualified as an expert in toxicology.
    Dr. Springfield testified that urine drug screening uses an 
``enzyme mechanism'' which looks for various ``classes of drugs'' such 
as cocaine by causing a ``reaction above a given cut off point.'' Id. 
at 24. The sample is then tested using the gas chromatography-mass 
spectrometry method, ``which identifies the component in the urine, and 
then quantitates the * * * amount of drug that may be present in the 
sample.'' Id. Dr. Springfield further testified that urine drugs tests 
are ``very reliable'' and will detect cocaine usage within 36 to 48 
hours of ingestion. Id. at 25.
    Dr. Springfield testified that hair testing uses a similar process 
in which the specimen is ground up into a powder or other form and 
subjected to a preliminary test and, if a positive result is returned, 
is then tested using gas chromatography-mass spectrometry. Id. at 27-
29. Dr. Springfield stated that hair testing is also ``very reliable'' 
and that the drug binds itself to melanin in the hair and will stay 
there until it has been cut. Id. at 28-29. However, because the drug 
enters the hair in the bulb, it ``takes four or five days before the 
hair'' containing the drug ``extrude[s] from the scalp.'' Id. at 30.
    With respect to the first urine drug screen, Dr. Springfield 
testified that the report indicated that a ``Quantitative Result'' of 
Cocaine Metabolite in the amount of 627 ng./ml. When asked by the ALJ 
if that was the result of the ``GC-mass spec test?,'' Dr. Springfield 
answered: ``I'm assuming that is a mass spec test. They have GC here.'' 
Tr. 33. Apparently, this was a reference to a notation on the lab 
report: ``Test confirmed by GC.'' GX 8, at 4. Dr. Springfield then 
explained: ``A GC and a GC-mass spec are two different instruments. I 
would have thought they would put GC-mass spec on there.'' Tr. 34. Dr. 
Springfield testified that she assumed that the reference to GC on page 
4 of the lab report was to ``GC-mass spec'' based on the first page of 
the report which indicated Respondent's positive test result for 
cocaine metabolites and that the quantitative levels for a positive 
result under both the initial test (300 ng./ml.) and the GC/MS 
Confirmation (150 ng./ml.). Id. at 35. Dr. Springfield testified, 
however, that based on this report, this particular [urine] sample 
contained the presence of benzoylecgonine and by inference, cocaine. 
Id. at 38.
    Dr. Springfield further testified that the second report confirmed 
the findings of the first test. Id. at 40. While there is no indication 
on the report form as to what procedures were followed in conducting 
the test, GX 8, at 5; and no evidence was adduced showing what 
procedure the lab follows for a retest, Respondent did not challenge 
the adequacy of the procedures used in conducting the retest.
    In any event, Dr. Springfield testified that there was no way to 
tell whether the cocaine was ingested by snorting it or drinking it. 
Id. at 41. She further testified that if a person ``took small doses, 
[he] might not be aware if [he was] in a party situation. If [he] were 
having a good time, [he] might not notice whether [he is] ingesting 
that or not.'' Id. at 42.
    Dr. Springfield then testified that the negative hair test results 
could support either of two conclusions. Id. First, that Respondent did 
not use drugs. Id. at 44. Second, that the drug used was ``outside of 
the limitations of the hair.'' Id. at 45. With respect to the first 
sample, Dr.

[[Page 49983]]

Springfield explained that ``there's a possibility that hair had not 
been extruded'' from Respondent's scalp between the time of ingestion 
and the taking of the sample. Id. at 46.
    As for the second sample, Dr. Springfield testified that the other 
possibility is that ``the amount of the drug that was used was small 
enough to not be detected'' by the testing process. Id. at 45. Dr. 
Springfield further testified that while the 600 nanograms of 
metabolite which were detected in the urine screen were above the cut-
off, this number does not indicate ``that somebody is a binge user.'' 
Id. Continuing, Dr. Springfield added that ``it may well be that the 
dose was not high enough to sequester in sufficient amount to be 
detected in this second process.'' Id.
    However, Dr. Springfield acknowledged ``that sufficient time had 
elapsed'' for ingested drug to be present in the hair which was tested 
in the second sample and that she ``would have expected to have seen 
benzoylecgonine [cocaine metabolite] in that sample.'' Id. at 46. Dr. 
Springfield explained that there might well have been drug present but 
that the drug was below the cutoff level and was not reported as a 
positive test. Id. She thus concluded that Respondent's negative hair 
tests neither confirmed nor refuted the urine test. Id. at 47.
    On cross-examination, Dr. Springfield testified that she could not 
say whether or not 627 nanograms per milliliter is a lot of cocaine 
because it would depend on how soon the sample was taken after 
ingestion. Id. at 53. However, she reiterated that this level could 
``very well * * * be under the detection limits'' and that hair testing 
is not ``sensitive enough to see low doses of cocaine'' and probably 
would not pick up either ``[a] small one-time use or a two-time use of 
a small amount.'' Id. at 61. Dr. Springfield also stated that this is 
widely accepted in the scientific community. Id. at 53-54. Respondent 
did not refute this testimony.
    On cross-examination, Respondent questioned Dr. Springfield about 
research she had performed which involved hair testing on Peruvian 
mummies to determine the presence of cocaine. Id. at 72. In her 
testimony, Dr. Springfield explained that the testing had found the 
presence of cocaine metabolites in the mummies after many years. More 
specifically, Dr. Springfield stated that while the Peruvians ``were 
chronic users [of] cocaine,'' the ``levels were low'' and were ``not in 
the 600 nanogram range.'' Id. at 72-74.
    In his Exceptions, Respondent contends that Dr. Springfield's 
testimony regarding the level of cocaine metabolites found in the 
mummies contradicted her earlier testimony that the level of 600 
nanograms in urine would be under the detection limits of the hair 
test. Exceptions at 2-3. Respondent, however, produced no evidence that 
the ingestion of an amount of cocaine would result in the presence of 
cocaine metabolites in hair at similar levels as would be found in 
urine. Notably, hair testing results are typically expressed in 
picograms per milligram, a unit which is one one-thousandth of a 
nanogram. As Respondent's hair test results indicate, a positive test 
for benzoylecgonine would be triggered by a level of 300 picograms per 
milligram, a level which is one two-thousandth of 600 nanograms. See RX 
2-3. This suggests that the absolute amounts of cocaine metabolites 
that are found in hair are three orders of magnitude lower than the 
amounts which are found in urine. It thus also suggests that there was 
no inconsistency in Dr. Springfield's testimony.
    I thus conclude that Respondent's hair test results do not refute 
the results of the December 13, 2007 urine sample. I therefore find 
that sometime shortly before December 13, Respondent ingested cocaine.
    Following his positive test for cocaine, Respondent, who had 
apparently been summoned to appear before the Texas Medical Board, 
obtained three letters to support his continued licensure. The first of 
these (dated February 1, 2008) was from J. Douglas Crowder, M.D., a 
general and forensic psychiatrist who has treated him since July 22, 
2005. RX 9. Therein, Dr. Crowder stated that he has treated Respondent 
eleven times and had ``never noted any evidence of substances abuse, 
intoxication or withdrawal on mental status examination.'' Id. Dr. 
Crowder further noted that Respondent ``has always seem dedicated to 
his recovery program and quite focused on setting his life aright again 
after having used cocaine in the past.'' Id. While acknowledging that 
he could not ``know whether [Respondent] has been honest with me or 
returned to cocaine use,'' Dr. Crowder wrote that ``my clinical 
impression is that he has been honest and straightforward with me, 
having freely admitted his past problems.'' Id. Dr. Crowder admitted 
that he was speaking from a ``limited perspective'' but then claimed 
that ``all the data available to me indicate that [his] trace positive 
result in December was a false positive result rather than due to 
renewed cocaine use.'' Id. Dr. Crowder further stated that ``I would 
consider him fully rehabilitated.'' Id. Of note, however, nowhere in 
his letter did Dr. Crowder indicate that he had examined Respondent 
following his positive test.
    The second letter (dated February 11, 2008) which Respondent 
produced was from Rahn K. Bailey, M.D., a board certified psychiatrist, 
and was addressed to the Texas Board of Medical Examiners. RX 10. 
Therein, Dr. Bailey stated that he had been seeing Respondent since 
February 7, 2007, and had done a psychiatric evaluation of him on 
February 11, 2008. Id. According to Dr. Bailey, Respondent's ``mental 
status is within normal limits,'' ``there is no current impairment,'' 
and his ``[c]ocaine dependence [is] in remission.'' Id. Dr. Bailey 
further stated that he planned to release Respondent from his care. Id. 
However, Dr. Bailey's letter contains no indication that he was aware 
that Respondent had failed a drug test just two months earlier. See id.
    Finally, Respondent produced a letter from Vella V. Chancellor, 
M.D., the Chair of the Physician's Recovery Committee of the Dallas 
County Medical Society. RX 11. Dr. Chancellor wrote that Respondent 
``has been actively seeing our committee since April 2005'' and that 
``[s]ince that time he has complied with every aspect of our 
committee's goals.'' Id. Dr. Chancellor also stated that in the 
committee's opinion, Respondent ``takes his recovery very seriously and 
he remains committed to maintaining both his recovery and a healthy 
medical practice for his patients.'' Id.
    On August 15, 2008, the conditions imposed by the August 15, 2003 
Agreed Order expired. RX 4. By letter dated August 18, 2008, the Texas 
Medical Board notified Respondent that ``all restrictions and 
conditions imposed by the Agreed Orders are removed by the expiration 
of the terms of the Order'' and that Respondent's license status was 
changed to ``CL--Board Order Cleared.'' Id.
    In his testimony, Respondent testified that when he was notified by 
the Board of his positive test result, his ``jaw dropped to the 
floor.'' Tr. 282. Recognizing that the test result ``was a death 
sentence'' professionally, Respondent underwent both the hair tests and 
a polygraph (the latter is not, however, in evidence). Id. at 282-83, 
313. He further testified that he had ``taken almost 400 urine tests'' 
during the period in which he was subject to the Agreed Order and had 
gone to hundreds of meetings and the Twelve Step Program. Id. at 281. 
He also testified that at the time of the positive test, he was ``only 
eight months away'' from completing the Agreed Order, and it would not 
``make sense for somebody to

[[Page 49984]]

relapse'' at that point. Id. at 283. He then maintained that just as 
there is ``no such thing as one potato chip * * * [t]here's no such 
thing as one beer, one line,'' the latter presumably being a reference 
to cocaine. Id.
    Later, in response to the ALJ's question as to why his testimony 
should be believed when he had previously lied to the State Board and 
submitted a false letter, Respondent acknowledged that he had lied to 
the Board. Id. at 314. Continuing his testimony, he stated:

    Today, I mean, we're talking about not a letter from my ex-
girlfriend. We're talking about a letter from specialists that work 
with the Medical Board, two of them, and a whole panel of 
physicians.
    Are you telling me that I pulled the wool over their eyes and 
faked them out? Are you telling me that I somehow faked out two hair 
tests and passed a polygraph test? I must be damned good. I'm that 
good? And, no. I'm not that good. I'm just being honest. * * * I 
know what I did, and I'll admit to it. I know what I didn't do, and 
I'm going to fight for my right.

Id. at 314-15.

The Federal Investigation

Allegations Pertaining to HGH

    In June 2006, a U.S. Postal Inspector intercepted a package 
containing human growth hormone (HGH) which was addressed to R.G., a 
resident of Fort Worth, Texas, and which had been mailed from an 
address in Vancouver, Canada. GX 10; Tr. 137. The Postal Inspector 
contacted R.G., who stated that Respondent was his doctor and that he 
had obtained a prescription for HGH from him. Id. at 137-38.
    At the hearing, R.G. testified that sometime in either later 2003 
or early 2004, he had heard Respondent discuss testosterone treatment 
on a radio program. Id. at 103-04. Because of his age (45) and the fact 
that his workouts were not ``going well,'' R.G. thought that he 
possibly had a low testosterone count and went to see Respondent. Id. 
at 104-05. At R.G.'s first visit, he completed a questionnaire and 
Respondent performed a physical exam on him and ordered a blood test. 
Id. at 105-06; 125. According to R.G., the blood test showed that he 
``did have low testosterone.'' Id. at 106. Respondent reviewed the 
physical exam findings and various treatment options with R.G. Id.
    After obtaining the blood test results, Respondent put R.G. on 
testosterone and HGH. Id. at 107-08. According to R.G.'s memory, 
Respondent recommended HGH basically as an ``anti-aging'' treatment. 
Id. at 108. The record established that Respondent issued R.G. three 
prescriptions for HGH (on April 23, August 30 and October 7, 2005), the 
latter one being for Jintropin,\3\ and one prescription for 
testosterone cypionate (on May 10, 2005). See GX 9. R.G. also testified 
as to obtaining additional prescriptions. Tr. 127. However, R.G. 
testified that Respondent performed blood tests ``every six months,'' 
and that each time the tests were done, he had a testosterone 
deficiency. Id.
---------------------------------------------------------------------------

    \3\ The parties stipulated that Jintropin is a form of HGH, 
which has not been approved by the FDA for use in the United States. 
ALJ Ex. 8, at 2. According to an FDA Special Agent, Jintropin is 
manufactured in China. Tr. 90. According to the DI, during an 
interview Respondent stated that he had prescribed Jintropin because 
``it was cheaper.'' Id. at 153. The DI further testified that 
Respondent ``was unaware'' that Jintropin ``was not DEA approved.'' 
Id. DEA does not, however, approve drug products. The DI also 
testified that she did not know whether Respondent knew that 
Jintropin was made in China. Id.
     In his testimony, Respondent stated that he did not know that 
Jintropin was not FDA approved and ``apologized for that.'' Id. at 
316. Respondent explained that it was his understanding that 
``Jintropin was a generic type of HGH.'' Id. Respondent then 
testified: ``I understand ignorance is not an excuse, but that's the 
truth.'' Id. He maintained, however, that ``[t]he only reason I 
prescribed the Jintropin in a few circumstances * * * was because it 
was less expensive.'' Id. at 317. Respondent then stated that he was 
no longer practicing anti-aging medicine, and had stopped doing so 
in ``early 2007.'' Id. at 319 & 326-27.
---------------------------------------------------------------------------

    On some date which is not clearly established in the record, R.G. 
expressed his concern about the cost of the HGH and Respondent provided 
him with the name of a Web site which could fill his prescriptions and 
which was located in Vancouver, Canada. GX 9, at 5; Tr. 116-17. R.G. 
acknowledged that he had ordered HGH from the Web site including the 
package which was intercepted by the Postal Inspector. Id. at 119, 121. 
R.G. also testified that he had to take the testosterone to Respondent, 
who was then practicing at the Spa 02, to have it administered. Id. at 
114. This happened either once a month or every two weeks at most. Id. 
However, as noted above, the record contains but a single testosterone 
prescription. Nor did the Government introduce R.G.'s patient file to 
show the duration of Respondent's administration of testosterone to 
him.
    According to an FDA Special Agent, human growth hormone is approved 
for ``short stature for children, AIDS-wasting patients, short bowel 
syndrome in adults, and there's several other that are pertaining to 
children's growth.'' Id. at 89-90. More precisely, Genotropin has been 
approved for: (1) ``[l]ong-term treatment of pediatric patients who 
have growth failure due to an inadequate secretion of endogenous growth 
hormone''; (2) ``[l]ong-term treatment of pediatric patients who have 
growth failure due to Prader-Willi syndrome''; (3) ``[l]ong-term 
treatment of growth failure in children born small for gestational age 
* * * who fail to manifest catch-up growth by age 2''; and (4) 
``[l]ong-term replacement therapy in adults with growth hormone 
deficiency * * * of either childhood--or adult onset etiology.'' 
Physicians' Desk Reference 2738-39 (59th ed. 2005). See also United 
States ex rel. Rost v. Pfizer, Inc., 507 F.3d 720, 723 (1st Cir. 2007).
    As noted above, the Government did not introduce into evidence 
R.G.'s patient file. Nor did it call any expert witness to testify as 
to whether Respondent had a legitimate medical purpose and acted within 
the usual course of professional practice in prescribing testosterone 
to R.G.
    As for his prescribing of human growth hormone, Respondent 
maintained that, while the drug is not approved for anti-aging, it ``is 
approved for adult growth hormone deficiency syndrome,'' and that his 
diagnoses of this condition in his patients were ``based on a 
combination of factors'' including ``clinical symptoms and examination 
and blood work.'' Tr. 332. He also testified that R.G.'s blood work and 
clinical manifestations supported a diagnosis of ``somatopause, which 
is adult growth hormone deficiency syndrome.'' Id. at 337. Here again, 
to the extent Respondent's prescribing of human growth hormone is even 
within the authority of this Agency to adjudicate, the Government did 
not call a medical expert to refute his testimony.
    The Government also introduced a document showing additional 
prescriptions written by Respondent for Genotropin and testosterone 
cypionate for several other patients and which were dispensed by a Las 
Vegas, Nevada pharmacy. See GX 16. According to a Diversion 
Investigator, she contacted the five patients whose names were not 
redacted in the exhibit and ``some of them'' said that they had 
received HGH for anti-aging purposes, but she could not recall which 
ones. Tr. 201-02. Moreover, the Government did not produce any evidence 
that the prescriptions for testosterone were unlawful. Finally, when 
asked with respect to these five patients, whether there is anything 
``illegal * * * about these drugs,'' the DI testified that ``there 
[was] nothing illegal about'' Respondent's prescribing them ``[i]f he 
has a doctor-patient relationship with these patients'' and that she 
had verified that he did. Id. at 245. See also id. at 164 (testimony of 
another DI that she could not testify as to the legality of 
Respondent's prescribing of Somatropin, another HGH product).

[[Page 49985]]

    On some date not established by the record, the Texas Medical Board 
(``Board'') also commenced an investigation into Respondent's 
prescribing of Jintropin. See RX 7. On February 9, 2009, Respondent 
entered into an Agreed Order with the Board. See RX 12, at 9. Therein, 
the Board found that ``respondent prescribed Jinotropin, a non-FDA-
approved human growth hormone * * * to a single patient without 
verifying the substance was FDA approved.'' Id. at 2. The Board did 
not, however, find that Respondent's prescribing of HGH for anti-aging 
purposes was a violation of the Texas Medical Practice Act and the 
Board's rules. See id. at 1-3.
    The Board ordered that Respondent ``take and pass'' the ``Medical 
Jurisprudence Examination'' which is administered by the Board, and 
that his failure to do so within one year of the order would subject 
his state license to an immediate suspension without a hearing. Id. at 
3. The Board also ordered that Respondent ``successfully complete 10 
hours of Continuing Medical Education * * * in the area of ethics,'' 
and that his practice be monitored by a physician approved by the 
Board's Compliance Division, who is to review selected medical and 
billing records. Id. at 4. The Board further ordered that Respondent 
``pay an administrative penalty in the amount of $4000.'' Id. at 5.

Allegations Pertaining to Respondent's Controlled Substance Prescribing 
and Failure To Update His Registered Location

    The Government also alleged that Respondent dispensed narcotics for 
narcotic treatment purposes without holding the authorization required 
by 21 U.S.C. 823(g) and 21 CFR 1301.13. In support of the allegation, 
the Government introduced into evidence several prescriptions which 
Respondent issued to D.M. for methadone (10 mg.), a schedule II control 
substance. See GX 11, at Tab E; see also 21 CFR 1308.12(c). According 
to a DEA Diversion Investigator, D.M. told her that before Respondent 
agreed to treat him, he had gone to several other doctors who wrote him 
prescriptions for OxyContin in ``enormous amounts,'' and that 
Respondent agreed to prescribe methadone and ``told him that eventually 
he would be able to lower his doses, because he was so addicted to the 
OxyContin.'' Tr. 188-89. However, D.M. told the DI that he had 
previously injured his back and suffered back pain. Id. at 188 & 232.
    According to the DI, upon being questioned about his treatment of 
D.M., Respondent ``told us that he weaned patients'' off of narcotics. 
Id. at 251. She further testified that she understood this statement to 
mean that Respondent was treating drug addicts. Id. at 252. Respondent 
does not hold a registration to conduct a narcotic treatment program, 
and is not authorized to treat and detoxify patients with Suboxone. Id. 
at 190-91.
    On cross-examination, the DI testified that when she interviewed 
D.M., she could not determine that he was addicted and that he had told 
her that Respondent was prescribing methadone to him for pain and that 
D.M. ``felt like he was functioning.'' Id. at 232-33. The DI also 
testified that she subpoenaed D.M.'s records, and that she believed 
D.M.'s statement that the methadone was being prescribed for legitimate 
pain management. Id. at 233. The DI then admitted that she does not 
``have the expertise to determine'' whether D.M. was a legitimate 
chronic pain patient. Id. at 254-55.
    D.M. testified as a witness for Respondent. D.M. stated that he had 
undergone three back surgeries and that another physician had been 
prescribing methadone to him for pain management for several years when 
he met Respondent.\4\ Id. at 490-91. While D.M. testified that 
Respondent did not ask him to provide his medical records, he further 
stated that Respondent performed a physical examination on him which 
included checking his blood pressure and lungs, having him touch his 
toes, and feeling the area where either a TENS unit or a stimulator had 
been placed in his back. Id. at 504, 506, 508. D.M. also stated that 
Respondent had successfully tapered his methadone dosage from 160 mg. 
to 60 mg. and that he was now ``able to do a lot of things'' that he 
could not do previously. Id. at 492-93.
---------------------------------------------------------------------------

    \4\ D.M. worked at a halfway house for probationers where 
Respondent had performed community service and then volunteered.
---------------------------------------------------------------------------

    Respondent likewise testified that D.M. was being treated with 
methadone ``for chronic pain'' and ``not for heroin addiction.'' Id. at 
343. While he acknowledged having used ``the word `wean' '' in 
discussing his treatment of D.M., he maintained that he was not 
``running a methadone clinic,'' id., that D.M. was already on methadone 
(160 mg.) when he first saw him, and that he had tried to find the 
right balance between controlling D.M.'s pain and maximizing his 
ability to function. Id. at 341.
    The Government did not introduce into evidence D.M.'s medical 
records. Nor did it elicit any expert testimony probative of whether 
Respondent's prescribing to D.M. was lawful under Federal law. Based on 
the record as a whole, I find that Respondent issued the methadone 
prescriptions to treat D.M.'s chronic pain and not to provide either 
maintenance or detoxification treatment for him.
    The Government also elicited testimony regarding Respondent's 
prescribing of hydrocodone, a schedule III controlled substance, to 
D.C., and clonazepam, a schedule IV controlled substance, to R.S. Id. 
at 194-96; see also GX 18. A DI asserted that both of these individuals 
were residents of Seidler House, a halfway house which forbids its 
residents from being prescribed controlled substances. Tr. 196.
    While J.S., the assistant director of Seidler House, testified that 
it does not accept persons who are ``not clean and sober,'' id. at 516, 
he further stated that Respondent had ``never'' prescribed a controlled 
substance to a resident. Id. at 524-25. J.S. also testified that D.C., 
who had received a single hydrocodone prescription from Respondent, 
``was a full-time staff member,'' and that he believed that the script 
was to treat pain caused by a staph infection which D.C. developed and 
for which he was hospitalized for thirty days.\5\ Id. at 525. J.S. 
testified that R.S. had become an employee a month or so before he saw 
Respondent, and that in any event, it was standard procedure that ``a 
staff member could not get anything from [Respondent] without the 
director knowing and having it locked'' up and monitored to ``make sure 
it was dispensed according to the prescription.'' Id. at 530. J.S. 
reiterated that to his knowledge, Respondent never violated the halfway 
house's policy by prescribing controlled substance to a resident. Id. 
at 530-31. According to Respondent, he prescribed the clonazepam to 
R.S. for anxiety, the prescription was documented in a medical record, 
and the drug was ``put in a lock box'' at Seidler House. Id. at 349.
---------------------------------------------------------------------------

    \5\ Respondent had earlier testified that he had prescribed 
fifteen tablets of hydrocodone to D.C. for acute back pain caused by 
a disk problem, which was kept in a lock box at Seidler House. Tr. 
347. Respondent's testimony regarding the size of the prescription 
is corroborated by the actual prescription. GX 18. Respondent also 
stated that he had prescribed antibiotics to D.C. Tr. 347. He also 
testified that he discussed any controlled substance prescriptions 
with the owner of Seidler House. Id. at 348.
---------------------------------------------------------------------------

    Here again, there is no evidence that Respondent's controlled 
substance prescriptions to either D.C. or R.S. were unlawful. Finally, 
J.S. testified that Respondent was awarded several plaques for his 
service to Seidler House.

[[Page 49986]]

    The Government also alleged that Respondent failed to keep his 
registered address current. ALJ Ex. 1, at 1. As found above, Respondent 
was registered at 4300 MacArthur Ave, Suite 265, Dallas, Texas from 
October 28, 2004, through July 24, 2007, when his registered location 
was changed to 1901 Central Drive, Suite 805, Bedford, Texas. GX 11, at 
5. There is evidence that Respondent wrote controlled substance 
prescriptions while he was practicing at other addresses. See id. at 
Tab B (prescriptions using address of 1032 West Pioneer Parkway, 
Arlington, Texas); id. at Tab D (prescriptions using address 1701 
Legacy Drive, Suite 100, Frisco, Texas)\6\; id. at Tab E (prescriptions 
using address of 2735 Villa Creek, Suite 110 C, Dallas, Texas). There 
was also testimony that Respondent administered testosterone to R.G. at 
the Spa O2 clinic because R.G. had difficulty injecting himself. Tr. 
114. However, the evidence shows that R.G. obtained the testosterone 
through a prescription, which suggests that he brought it with him to 
the clinic, and in any event, there is no evidence that Respondent 
ordered controlled substances which were delivered to, and stored at, 
the clinic.
---------------------------------------------------------------------------

    \6\ This was the address of the Spa O2 clinic. Tr. 145.
---------------------------------------------------------------------------

    The evidence also established that Respondent did not own the Spa 
O2 clinic, but was merely associated with it. Id. at 94. There is, 
however, no evidence establishing who owned this clinic and whether the 
clinic was owned by a registered practitioner.
    During an interview with a DI, Respondent admitted to practicing at 
these locations. Id. at 153-55. While he had no explanation for why he 
had not kept his practice locations current, he ``apologized for not 
having done so.'' Id. at 155. Moreover, at the hearing, Respondent 
testified that while he mainly practiced at the MacArthur address, 
having previously lost his medical license, he was ``in the process of 
rebuilding'' his practice and ``moonlighted'' at ``multiple places.'' 
Id. at 270. He further testified that he had notified the Texas 
authorities whenever he changed his practice location, and had ``simply 
overlooked'' the DEA registration. Id. at 271. Respondent then 
testified: ``I apologize for it, and it will never happen again.'' Id.

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). Moreover, ``the Attorney General may deny an application for 
[a practitioner's] registration if he determines that the issuance of 
such registration would be inconsistent with the public interest.'' Id. 
Sec.  823(f). With respect to a practitioner, the Act requires the 
consideration of the following factors in making the public interest 
determination:

    (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.

Id. Sec.  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 may give each factor the weight [I] deem [ 
] appropriate in determining whether a registration should be 
revoked.'' Id. Moreover, I am ``not required to make findings as to all 
of 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).
    As explained below, having considered all of the factors, I adopt 
the ALJ's ultimate conclusion that Respondent's continued registration 
is inconsistent with the public interest and that his registration 
should be revoked. However, the only misconduct proved on this record 
involves Respondent's self-abuse of a controlled substance. 
Accordingly, while I conclude that the revocation of Respondent's 
registration is necessary to protect the public interest, I further 
order that in the event Respondent undergoes and successfully completes 
in-patient treatment as well as additional random drug testing, which 
shall be at his own expense, the Agency shall give favorable 
consideration to a new application after a period of one year from the 
effective date of this Order.\7\
---------------------------------------------------------------------------

    \7\ In his Exceptions, Respondent argues that the ALJ erred in 
finding that an Agency DI was not biased against him. Exceptions at 
3. He also maintains that the DI violated his rights to procedural 
due process because she told his counsel that he ``could not 
prescribe controlled substances until further notice from the'' 
Agency. Id.
    In light of my rejection of all the allegations with the 
exception of those pertaining to Respondent's failed drug test, 
there is no need to address the contention that the DI was biased 
against him. As for the second contention, the DI's advice was not a 
formal order of the Agency and does not rise to the level of a 
constitutionally significant deprivation of a property interest.
---------------------------------------------------------------------------

Factor One--The Recommendation of the State Licensing Board

    At the outset, it should be noted that the Texas Medical Board has 
not made a formal recommendation as to what action this Agency should 
take in this matter. However, DEA precedents have typically taken a 
broader view as to the scope of this factor. See Edmund Chein, 72 FR 
6580, 6590 (2007).
    As the record demonstrates, Respondent is no stranger to the 
disciplinary proceedings conducted by the Texas Medical Board. As found 
above, Respondent and the Board have entered into several agreed orders 
which have imposed extensive conditions on him. The Board, however, has 
allowed the 2003 Agreed Order to expire notwithstanding Respondent's 
failed drug test and Respondent is currently authorized to practice 
medicine in Texas and presumably is authorized to handle controlled 
substances.\8\
---------------------------------------------------------------------------

    \8\ Texas requires that a practitioner obtain a state-issued 
controlled substances registration. There is no evidence in the 
record as to the status of Respondent's registration.
---------------------------------------------------------------------------

    Although Respondent's licensure status satisfies an essential 
requirement for holding a registration under CSA, this Agency has 
repeatedly held that possessing a valid state license is not 
dispositive of the public interest inquiry. See Patrick W. Stodola, 74 
FR 20727, 20730 (2009); Robert A. Leslie, 68 FR 15227, 15230 (2003). 
While the Board has allowed the 2003 Agreed Order to expire, as 
explained more fully below, the evidence presented in this case shows 
that Respondent still has a cocaine problem. Accordingly, I decline to 
treat the Board's action as a recommendation to continue Respondent's 
registration. I therefore adopt the ALJ's conclusion that this factor 
neither ``weigh[s] for or against [the] determination'' that 
Respondent's continued registration is consistent with the public 
interest. ALJ at 24.

[[Page 49987]]

Factors Two, Four, and Five--Respondent's Experience in Dispensing 
Controlled Substances, Record of Compliance With Laws Relating to 
Controlled Substances and Such Other Conduct Which May Threaten Public 
Health and Safety

    Reasoning that ``[m]any of the Respondent's controlled substance 
prescribing practices impact not only Factor 2 * * *, but also Factors 
4 * * * and 5[,] '' the ALJ combined these three factors in his 
analysis of the Government's case. ALJ at 28. While the ALJ correctly 
rejected the Government's allegation pertaining to Respondent's 
prescribing of methadone, he erroneously concluded that Respondent's 
prescribing of human growth hormone violated the CSA's prescription 
requirement. See ALJ at 30. His further conclusion that Respondent's 
prescribing of human growth hormone could be considered under factor 
five is not supported by Agency precedent, has been previously 
rejected--at least implicitly--by the Agency, and would require this 
Agency to exercise authority which the Supreme Court has made clear it 
does not possess.
    The ALJ did, however, correctly conclude that Respondent's history 
of cocaine abuse should be considered under factor five. Moreover, I 
also concur with the ALJ's conclusion that Respondent still does not 
accept responsibility for his cocaine addiction.

Respondent's Prescribing Practices

    As noted above, at the hearing, the Government put on evidence 
regarding three different aspects of Respondent's prescribing 
practices: (1) His prescribing of controlled substances to two persons 
who allegedly were residents of Seidler house; (2) his prescribing of 
methadone to D.M., which it alleges constituted ``dispensing narcotic 
drugs for narcotic treatment without the'' authorization required by 21 
U.S.C. 823(g) and 21 CFR 1301.13; and (3) his prescribing of human 
growth hormone for anti-aging purposes.
    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 
(2007).
    The Government put on evidence (which included both testimony and 
documentary evidence) establishing that Respondent prescribed 
hydrocodone (totaling 15 tablets) to D.C., and clonazepam to R.S., both 
of whom it alleged were residents of Seidler House. Apparently, the 
Government found this inappropriate because Seidler House has a policy 
which forbids its residents from being prescribed controlled 
substances. Yet the Government produced no evidence that either 
prescription lacked a legitimate medical purpose or that Respondent 
acted outside of the usual course of professional practice in 
prescribing to these individuals. 21 CFR 1306.04(a). Thus, the 
Government has failed to show that Respondent violated Federal law in 
issuing the prescriptions.\9\
---------------------------------------------------------------------------

    \9\ It is noted that this conduct was not alleged in the Show 
Cause Order and that the Government did not disclose that it 
intended to pursue these allegations in either of its pre-hearing 
statements. See CBS Wholesale Distributors, 74 FR 36746, 36750 
(2009). Respondent did not, however, object to this line of inquiry.
---------------------------------------------------------------------------

    Having failed to put on any evidence relevant to whether these 
prescriptions violated Federal law, perhaps the Government's theory was 
(as notwithstanding the evidence it introduced on the issue, its brief 
sets forth no legal theory) that Respondent's prescribing to these 
persons is actionable as ``other conduct which may threaten public 
health and safety'' because Seidler House's policy forbade its 
residents from being prescribed controlled substances. 21 U.S.C. 
823(f)(5). However, even assuming that this conduct is properly 
considered under this factor, I would still reject the contention 
because the Government failed to show that either person was a resident 
of Seidler House at the time Respondent prescribed to them.
    The Government also put on evidence regarding Respondent's 
methadone prescriptions to D.M. Apparently, this evidence was the basis 
of the Show Cause Order's allegation that Respondent was engaging in 
narcotic treatment without the authorization required under 21 U.S.C. 
823(g) and 21 CFR 1301.13. ALJ Ex. 1, at 2. As noted above, the ALJ 
properly rejected this allegation as unsupported by substantial 
evidence.
    Under Federal law, ``practitioners who dispense narcotic drugs [in 
schedule II] to individuals for maintenance treatment or detoxification 
treatment shall obtain annually a separate registration for that 
purpose.'' 21 U.S.C. 823(g)(1)(A) (emphasis added).\10\ While this 
provision requires a separate registration when a practitioner seeks to 
dispense methadone for the purpose of providing maintenance or 
detoxification treatment for a patient, a practitioner may nonetheless 
lawfully prescribe

[[Page 49988]]

methadone to a patient for pain management purposes under his 
practitioner's registration. Id. Sec.  823(f).
---------------------------------------------------------------------------

    \10\ To obtain this registration, a practitioner must meet three 
main requirements. First, the Secretary of the Department of Health 
and Human Services must determine that he is ``qualified (under 
standards established by the Secretary) to engage in'' either 
maintenance or detoxification treatment. 21 U.S.C. 823(g)(1)(A). 
Second, the Attorney General must determine that he ``will comply 
with standards established by the Attorney General respecting (i) 
security of stocks of narcotic drugs for such treatment, and (ii) 
the maintenance of records (in accordance with [21 U.S.C. 827]) on 
such drugs.'' Id. Sec.  823(g)(1)(B). Third, the Secretary must 
``determine[] that the applicant will comply with standards * * * 
respecting the quantities of narcotic drugs which may be provided 
for unsupervised use by individuals in such treatment.'' Id. Sec.  
823(g)(1)(C).
---------------------------------------------------------------------------

    Notwithstanding the DI's testimony that D.M. had told her that he 
was addicted to OxyContin, there is no expert evidence establishing 
that D.M. was a drug addict (as opposed to a patient who, over time, 
developed opioid tolerance and required greater doses). Moreover, 
notwithstanding that Respondent used the word ``wean'' to describe his 
treatment of D.M., even the DI testified that she believed that D.M., 
who had undergone three back surgeries, was a legiti