Bill Alexander, M.D.; Decision and Order, 35028-35031 [2012-14316]
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Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices
applicant ever surrendered (for cause) or
had a federal controlled substance
registration revoked, suspended,
restricted, or denied, or is any such
action pending?’’ Mr. Arna marked
‘‘NO,’’ and in the area provided for
explaining any ‘‘YES’’ answer, wrote
‘‘None.’’ Id.
On February 17, 2012, following a
hearing before a state Administrative
Law Judge (ALJ), the Secretary of the
Illinois Department of Human Services
issued a Final Order on Applicant’s
application for state licensure. See In
´
the Matter of Serenity Cafe at 1, 11
DASA 001 (Ill. Dep’t Hum. Servs., Feb.
17, 2012). Adopting the ALJ’s findings
and report, the Final Order denied
Applicant’s application for a state
license to provide both Level I Adult
and Adolescent Outpatient Treatment
and Level II Adult and Adolescent
Intensive Outpatient Treatment, DUI
Evaluation, DUI Risk Education, and
Methadone as Adjunct Services. Id.
Accordingly, because Applicant does
not possess a valid Illinois license to
provide substance abuse treatment, I
find that Applicant is not currently
authorized to dispense controlled
substances in the State of Illinois, the
State in which it seeks registration. See
20 Ill. Comp. Stat. 301/15–5 (it is
‘‘unlawful for any person to provide
treatment for alcoholism and other drug
abuse or dependency . . . unless the
person is licensed to do so by the
Department’’); Ill. Admin. Code tit. 77,
2060.201 (‘‘Substance abuse treatment
and intervention services * * * shall be
licensed by the Department.’’).
srobinson on DSK4SPTVN1PROD with NOTICES
Discussion
Under section 303(g) of the Controlled
Substances Act (CSA), ‘‘practitioners
who dispense narcotic drugs [in
schedule II] to individuals for
maintenance treatment * * * shall
obtain annually a separate registration
for that purpose.’’ 21 U.S.C. 823(g)(1)
(emphasis added). Moreover, this
provision imposes as a requirement of
registration, that the applicant meet
three conditions, including that ‘‘the
applicant is a practitioner who is
determined by the Secretary to be
qualified * * * to engage in the
treatment with respect to which
registration is sought.’’ Id. 823(g)(1)(A)
(emphasis added). Thus, it is clear that
in order to obtain a registration
authorizing the dispensing of schedule
II narcotics such as methadone for
maintenance treatment, the applicant
must be (among other things), a
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practitioner within the meaning of the
CSA.1
The CSA defines the term
‘‘practitioner’ to mean ‘‘a physician
* * * pharmacy, hospital or other
person licensed, registered, or otherwise
permitted, by * * * the jurisdiction in
which he practices * * * to distribute,
dispense, [or] administer * * * a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). Likewise, in the case of
practitioners, the CSA imposes, as a
condition of registration, that it be
currently authorized to dispense
controlled substances under the laws of
the State in which it engages in
professional practice. See id. 823(f)
(‘‘The Attorney General shall register
practitioners * * * if the applicant is
authorized to dispense * * * controlled
substances under the laws of the State
in which he practices.’’). Thus, DEA has
long held that the possession of
authority under state law to dispense
controlled substances is an essential
condition for obtaining and maintaining
a DEA registration. See David W. Wang,
72 FR 54297, 54298 (2007); Sheran
Arden Yeates, 71 FR 39130, 39131
(2006); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR
11919, 11920 (1988).
As found above, the Illinois
Department of Human Services has
issued a final order denying Applicant’s
application for the state licenses
required to dispense controlled
substances for the purpose of providing
maintenance treatment. Therefore,
Applicant is not a ‘‘practitioner’’ within
the meaning of the CSA, and thus, it is
not entitled to be registered. See 21
U.S.C. 802(21); 823(f); 823(g).
Accordingly, its application will be
denied.2
1 Likewise, the requirements of section 303(g)(1)
‘‘are waived in the case of the dispensing (including
the prescribing), by a practitioner, of narcotic drugs
in schedule III, IV, or V or combinations of such
drugs if the practitioner meets the conditions
specified in subparagraph (B). 21 U.S.C.
823(g)(2)(A) (emphasis added). This provision
requires that the ‘‘the practitioner submit to the
Secretary [of HHS] a notification of the intent of the
practitioner to begin dispensing the drugs or
combinations for’’ maintenance or detoxification
treatment, ‘‘as well as to certify that ‘‘[t]he
practitioner is a qualifying physician,’’ that ‘‘the
practitioner has the capacity to refer the patients for
appropriate counseling and other appropriate
ancillary services,’’ and that ‘‘[t]he total number of
such patients of the practitioner at any one time
will not exceed the applicable number.’’ Id.
823(g)(2)(B) (emphasis added). Moreover, a
practitioner’s notification to the Secretary must
‘‘identif[y] the registration issued for the
practitioner pursuant to subsection (f) of this
section.’’ Id. 823(g)(2)(D)(i)(II). See also 21 CFR
1301.28.
2 Because it is clear that Applicant is not entitled
to be registered, it is not necessary to decide
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Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 823(g)(1) & (2),
as well as 28 CFR 0.100(b), I order that
´
the application of Serenity Cafe for a
DEA Certificate of Registration as a
Narcotic Treatment Program, be, and it
hereby is, denied. This Order is effective
July 12, 2012.
Dated: June 4, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–14291 Filed 6–11–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Bill Alexander, M.D.; Decision and
Order
On September 22, 2011, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order To
Show Cause to Bill Alexander, M.D.
(Applicant), of Porter, Texas. The Show
Cause Order proposed the denial of
Applicant’s application for a DEA
Certificate of Registration as a
practitioner in schedules II through V,
on the ground that his ‘‘registration
would be inconsistent with the public
interest.’’ Show Cause Order at 1 (citing
21 U.S.C. 823(f) and 824(a)(4)).
The Show Cause Order alleged that on
December 3, 2010, Applicant applied for
a practitioner’s registration in schedules
II–V at the location of 24420 FM 1314,
Suite 101, Porter, Texas. Id. The Show
Cause Order then alleged that on or
about June 18, 2009, Applicant
unlawfully possessed 64 kilograms of
marijuana, a schedule I controlled
substance, in violation of both federal
and state law. Id. at 2 (citing 21 U.S.C.
841(a)(1) and Texas Health & Safety
Code Ann. 481.121(b)(5)).
Next, the Show Cause Order alleged
that on or about June 18, 2009,
Applicant told law enforcement agents
that he was transporting the marijuana
for a drug dealer, and that he had
transported over a dozen such loads of
marijuana in the past. Id. The Order
further alleged that Applicant told the
agents that he was addicted to and used
crack cocaine, a schedule I controlled
substance.1 Id.
The Show Cause Order also alleged
that on or about February 4, 2011, the
Texas Medical Board entered a
Corrective Order against Applicant’s
medical license. Id. According to the
whether denial of its application is warranted under
the public interest standard of 21 U.S.C. 823(f).
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allegations, the Texas Board found that
Applicant prescribed controlled
substances to individuals without
holding a valid Texas Controlled
Substances Registration, in violation of
state law. Id. (citing Tex. Health &
Safety Code Ann. 481.061(a)).
The Show Cause Order further alleged
that during various interviews with DEA
Investigators, Applicant stated his
desire to open a pain management clinic
in order to make money. Id. According
to the allegations, Applicant stated his
‘‘belief that the purpose of a pain
management clinic was to give addicts
their prescriptions because other
doctors won’t do it.’’ Id.
The Show Cause Order, which also
notified Applicant of his right to request
a hearing on the allegations or to submit
a written statement in lieu of a hearing,
the procedure for doing either, and the
consequence for failing to do either, id.
at 2 (citing 21 CFR 1301.43), was served
on Applicant by registered mail
addressed to him at the address he
provided on his application. While the
return receipt card did not include a
delivery date, Applicant subsequently
confirmed to Government Counsel that
he received the Order on September 26,
2011. GX 4; Request for Final Action, at
2.
Since the date of service of the Order,
thirty days have now passed and neither
Applicant, nor anyone purporting to
represent him, has requested a hearing
or submitted a written statement in lieu
of a hearing. I therefore find that
Applicant has waived his right to a
hearing or to submit a written statement
in lieu of a hearing, and issue this
Decision and Final Order based on
relevant evidence contained in the
record submitted by the Government.
21 CFR 1301.43(d) and (e). I make the
following additional findings of fact.
srobinson on DSK4SPTVN1PROD with NOTICES
Findings
Applicant’s Licensure and Registration
Status
Applicant is a physician licensed by
the Texas Medical Board (hereinafter,
the Board). GX 6. On February 4, 2011,
a Quality Assurance Panel of the Board
issued a Corrective Order to Applicant.
Id. Therein, the Board found that
notwithstanding that Applicant had
allowed his Texas Controlled Substance
Registration to expire on October 31,
2008, he had continued to write
prescriptions for controlled substances
through October 21, 2009, when his
state license was renewed. Id. The Order
imposed an administrative penalty in
the amount of $500 against Applicant.
Id. at 1–2 (citing Tex. Occ. Code Ann.
164.002(a) and (d), and 164.053(a)(1)).
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Applicant previously held DEA
Certificate of Registration BA0549177,
which authorized him to dispense
controlled substances in schedules II
through V, as a practitioner, at the
registered location of 1406 Wilson Road,
Conroe, TX 77304. GX 2. This
registration expired by its terms on June
30, 2003. Id.
On March 30, 2004, Applicant was
granted Certificate of Registration
BA8721765, which also authorized him
to dispense controlled substances in
schedules II through V, as a practitioner,
at the registered location of 350 South
Adams, Eagle Pass, TX 78852. This
registration expired by its terms on June
30, 2010. Id.
On December 3, 2010, Applicant
submitted a new application for a
practitioner’s registration in schedules II
through V, through the Office of
Diversion Control’s Web site. It is this
application which is at issue in this
proceeding.
Evidence Regarding the Substantive
Allegations
On June 18, 2009, following a traffic
stop, Applicant was arrested by a Texas
Highway Patrol Officer for possession of
marijuana, a schedule I controlled
substance. GX 5. At the time of his
arrest, the Trooper conducted a
consensual search of Applicant’s
vehicle, during which he found two
large black suitcases which contained
marijuana and a small black toiletry bag
which contained several homemade
smoking pipes. Id. at 4–5. Regarding the
pipes, which the Trooper identified as
drug paraphernalia, the Trooper asked
Applicant what he used them for;
Applicant stated: ‘‘To smoke.’’ Id. The
Trooper then asked Applicant what he
smoked; Applicant replied: ‘‘Crack,’’
which is a schedule II controlled
substance. Id. Respondent was then
arrested; however, he was not
criminally charged.
On December 6, 2010, a DEA
Diversion Investigator (DI) began an
investigation of Applicant’s December 3,
2010 application for a DEA registration.
GX 7 (DI’s affidavit). According to the
DI’s affidavit, because Applicant
cooperated with another ongoing law
enforcement investigation, he was never
criminally charged in connection with
his arrest for possession of marijuana on
June 18, 2009. Id.
The DI stated that during a phone
conversation on January 11, 2011,
Applicant admitted that at the time of
his June 2009 arrest, which he
characterized as a mistake, he was
transporting marijuana for a drug
trafficking organization because he
needed the money. Id. at 2. Applicant
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35029
told the DI he planned to open a
medical clinic, with other practitioners,
which would specialize in orthopedic
surgery and pain management. Id. He
stated that his desire to open a pain
management clinic was only because he
wanted to make money and that he
would ‘‘do anything to make money.’’
Id.
During a subsequent in-person
interview, Applicant told the DIs that he
closed his last medical practice, an
orthopedic surgery center, in 2008. Id.
He also admitted that he had abused
crack cocaine in the past, but had
stopped using crack cocaine in 2009
after having a heart attack. Id. However,
Applicant never underwent a drug
treatment program. Id.
Applicant told the DIs that after
closing his medical practice in late
2008, he agreed to transport marijuana
for a drug organization. Id. Applicant
admitted to having driven loads of
marijuana from Eagle Creek or Del Rio,
Texas to either San Antonio or Austin
because he was having financial
problems and he would ‘‘ ‘do anything
not to lose [his] property.’ ’’ Id. He also
admitted that he transported such loads
approximately every other weekend
from the end of 2008 until he was
arrested in June 2009, but he was
uncertain as to the exact number of
loads he had delivered. Id. at 2–3.
Applicant stated that he was paid $50
per pound, and that he usually received
$3,000 to $5,000 per load of marijuana.
Id. at 3.
Applicant told the DIs that he only
wanted to open a pain clinic to share
the overhead costs of a medical clinic
with other practitioners, that he did not
have any formal pain management
training, and that he ‘‘ ‘hated those
kinds of patients.’ ’’ Id. at 3. Moreover,
he then stated that pain management
clinics were good because they served
individuals who were addicted to pain
medication without ‘‘ ‘bogging down
other clinics asking for pain pills.’ ’’ Id.
When asked by the DIs what he would
do when he had twenty patients waiting
for their prescriptions, Applicant
responded that ‘‘ ‘if their doctors gave
them a prescription and they’re hooked,
if they’re a functioning patient, probably
give it to them. What else are you gonna
[sic] do with them?’ ’’ Id.
Upon being told by the DI that she
was recommending the denial of his
application based on his previous
involvement with transporting large
quantities of marijuana and his
intention to open a pain clinic,
Applicant asked the DI if she thought
that ‘‘ ‘there’s a proper way’ ’’ to manage
a pain clinic and make sure everything
was done correctly. Id. When the DI said
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that she did not think it was proper to
provide prescriptions to addicts,
Applicant replied: ‘‘ ‘What do you think
pain management clinics are for? They
give addicts their prescriptions because
other doctors won’t do it!’ ’’ Id. at 3–4.
Discussion
srobinson on DSK4SPTVN1PROD with NOTICES
Section 303(f) of the Controlled
Substances Act (CSA) provides that an
application for a practitioner’s
registration may be denied upon a
determination ‘‘that the issuance of such
registration would be inconsistent with
the public interest.’’ 21 U.S.C. 823(f). In
making the public interest
determination in the case of a
practitioner, Congress directed 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.
Id.
‘‘[T]hese factors are considered in the
disjunctive.’’ Robert A. Leslie, 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
* * * to deny an application.’’ Id.; see
also Volkman v. DEA, 567 F.3d 215, 222
(6th Cir. 2009). While I must consider
each factor, I am ‘‘not required to make
findings as to all of the factors.’’ MacKay
v. DEA, 664 F.3d 808, 816 (10th Cir.
2011); Hoxie v. DEA, 419 F.3d 477, 482
(6th Cir. 2005).
With respect to a practitioner’s
registration, the Government has the
burden of proving by substantial
evidence that granting a registration
would be inconsistent with the public
interest. See 21 CFR 1301.44(d).2 As no
DEA regulation provides that the entry
of a default is a consequence of the
waiver of the right to a hearing, the
Government must therefore support its
2 As found above, Applicant neither requested a
hearing nor submitted a written statement
explaining his position on the matters of fact and
law asserted. By contrast, in a contested case, where
the Government satisfies its prima facie burden, as
for example, by showing that an applicant has
committed acts which are inconsistent with the
public interest, the burden then shifts to the
Applicant to demonstrate why he can be entrusted
with a registration. Medicine Shoppe-Jonesborough,
73 FR 363, 387 (2008).
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proposed action with substantial
evidence.
In this matter, I have considered all of
the factors and conclude that the
evidence relevant to Respondent’s
experience in dispensing controlled
substances (factor two), his compliance
with applicable laws related to
controlled substances (factor four), and
his having engaged in other conduct
which may threaten the public health
and safety (factor five), conclusively
establishes that granting his application
would be ‘‘inconsistent with the public
interest.’’ 21 U.S.C. 823(f).
Factors One and Three—The
Recommendation of the State Licensing
Board and the Applicant’s Conviction
Record Under Federal or State Laws
Relating to the Manufacture,
Distribution or Dispensing of Controlled
Substances
As found above, the Board found that
Applicant dispensed controlled
substances for nearly a year without the
requisite State controlled substance
registration. However, the Board took no
action against Applicant’s medical
license other than to impose a $500
administrative penalty and he thus
retains an active State medical license.
Also, Applicant apparently still holds a
valid Texas Controlled Substance
Registration.
However, while the CSA makes
holding authority to dispense controlled
substances a condition of obtaining a
DEA registration, it is not dispositive of
the public interest inquiry. Rather, in
enacting the public interest
amendments to the CSA, Congress
vested this Agency with ‘‘a separate
oversight responsibility [apart from that
which exists in State authorities] with
respect to the handling of controlled
substances.’’ Mortimer B. Levin, 55 FR
8209, 8210 (1990). DEA has therefore
long recognized that it has ‘‘a statutory
obligation to make its independent
determination as to whether the
granting of [a registration] would be in
the public interest.’’ Id. Accordingly,
‘‘DEA has long held * * * that a State’s
failure to take action against an
Applicant’s medical license [or State
controlled substance registration] is not
dispositive in determining whether the
continuation of a registration is in the
public interest.’’ Jayam Krishna-Iyer, 74
FR 459, 461 (2009); see also Levin, 55
FR at 8210 (holding that practitioner’s
reinstatement by state board ‘‘is not
dispositive’’ in public interest inquiry).
Thus, that neither the Texas Medical
Board nor Texas Department of Public
Safety has suspended or revoked
Applicant’s medical license or
controlled substance registration is of no
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consequence in determining whether
his continued registration is consistent
with the public interest.
Likewise, the fact that Applicant has
not been convicted of an offense falling
within factor three, notwithstanding his
arrest and admission that on numerous
occasions he transported large
quantities of marijuana for a drug
trafficking organization, is not
dispositive. As previously explained,
and as this case demonstrates, there are
a variety of reasons why a person who
has engaged in criminal conduct may
not have been convicted, let alone
charged with a criminal offense. See
Dewey C. MacKay, 75 FR 49956, 49973
(2010). Accordingly, I find that factor
three is not dispositive of whether
granting Applicant’s application would
be consistent with the public interest.
Factors Two and Four—Applicant’s
Experience in Dispensing Controlled
Substances and Record of Compliance
With Applicable Controlled Substance
Laws
The Texas Board found that Applicant
allowed his Texas Controlled Substance
Registration to expire on October 31,
2008, and yet continued to write
controlled substance prescriptions in
violation of Texas law until he renewed
his license on October 21, 2009. GX 6,
at 1–2. This was also a violation of
federal law.
Under a DEA regulation, ‘‘[a]
prescription for a controlled substance
may be issued only by an individual
practitioner who is * * * authorized to
prescribe controlled substances by the
jurisdiction in which he is licensed to
practice his profession.’’ 21 CFR
1306.03(a)(1). By issuing prescriptions
when he did not possess state authority,
Respondent thus violated the CSA as
well. See 21 U.S.C. 841(a)(1) (‘‘Except as
authorized by this subchapter, it shall
be unlawful for any person knowingly
or intentionally * * * to * * *
dispense * * * a controlled
substance[.]’’).
In addition, Applicant admitted to the
DIs that on numerous occasions, he
illegally transported large quantities of
marijuana for a drug trafficking
organization and was paid to do so. GX
7, at 2–3. This conduct also violated 21
U.S.C. 841(a)(1), which prohibits both
the knowing or intentional distribution
of a controlled substance, as well as the
possession of a controlled substance
with the intent to distribute.
Finally, Applicant admitted that he
abused crack cocaine. GX 7, at 2. This
conduct violated 21 U.S.C. 844(a),
which makes it ‘‘unlawful for any
person knowingly or intentionally to
possess a controlled substances unless
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such substance was obtained directly, or
pursuant to a valid prescription or
order, from a practitioner, while acting
in the course of his professional
practice, or except as authorized by’’ the
CSA or the Controlled Substances
Import Export Act. In addition,
Respondent’s conduct violated various
provisions of state law. See Tex. Health
& Safety Code 481.115(a) and
481.121(b)(5). Thus, the evidence with
respect to factors two and four provides
ample reason to deny Applicant’s
application.3
srobinson on DSK4SPTVN1PROD with NOTICES
Factor Five—Such Other Conduct
Which May Threaten the Public Health
and Safety
As found above, during the
consensual search of Applicant’s
vehicle, a Texas Highway Patrol Officer
found several home-made pipes, and
upon being questioned as to what he
used them for, Applicant admitted that
he smoked crack cocaine. Also,
Applicant admitted to DEA Investigators
that he had previously abused crack
cocaine. While Applicant later claimed
that he had stopped using crack after
suffering a heart attack, he also stated
that he never underwent drug
rehabilitation treatment.
DEA has ‘‘long held that a
practitioner’s self-abuse of a controlled
substance can be considered under
Factor Five even if there is no evidence
that [he] abused his prescription-writing
authority or otherwise engaged in an
unlawful distribution to others.’’ See
Scott D. Fedosky, 76 FR 71375, 71378
(2011). See also Tony T. Bui, 75 FR
49979, 49989–90 (2010) (collecting
cases); David E. Trawick, 53 FR 5326,
5327 (1988). Thus, even if there was no
other evidence of misconduct on the
part of Applicant, his self-abuse of crack
cocaine would by, itself, constitute
conduct which threatens public health
and safety and renders his proposed
3 As evidence of his likely non-compliance with
applicable laws related to controlled substances, I
note that during his interviews with DEA
Investigators regarding the purpose of his proposed
registration, Applicant stated that he wanted to
open a pain clinic ‘‘only because he wanted to make
money, and that he would do anything to make
money.’’ Id. at 2. Moreover, Applicant expressed
the view that pain clinics were good because they
served individuals who were addicted to pain
medication without ‘‘bogging down other clinics
asking for pain pills.’’ GX 7, at 3. Subsequently,
Applicant stated ‘‘what do you think pain
management clinics are for? They give addicts their
prescriptions because other doctors won’t do it!’’ Id.
at 3–4. Putting aside the misconduct proven on this
record, Applicant’s comments do not inspire
confidence that he would comply with federal
requirements such as 21 CFR 1306.04(a), which
requires that a prescription for a controlled
substance be issued only for a legitimate medical
purpose by a practitioner acting in the usual course
of professional practice.
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registration ‘‘inconsistent with the
public interest.’’ Id. 823(f).
Conclusion
Based on Applicant’s misconduct in
issuing prescriptions without the
requisite state authority, see 21 CFR
1306.03(a), his admitted transportation
of marijuana for a drug trafficking
organization, see 21 U.S.C. 841(a)(1),
and his self-abuse of crack cocaine, I
conclude that Applicant’s registration
would be ‘‘inconsistent with the public
interest.’’ Id. 823(f). Accordingly, his
application will be denied.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as 28 CFR
0.100(b), I order that the application of
Bill Alexander, M.D., for a DEA
Certificate of Registration, be, and it
hereby is, denied. This Order is effective
immediately.
Dated: June 2, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–14316 Filed 6–11–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10–51]
4 OTC, Inc.; Decision and Order
On September 22, 2011,
Administrative Law Judge (ALJ) Gail A.
Randall issued the attached
Recommended Decision. Therein, the
ALJ recommended that I deny
Respondent’s application for a
Certificate of Registration as an importer
of ephedrine, a list I chemical. Neither
party filed exceptions to the decision.1
Having considered the record as a
whole, including the parties’ briefs, I
have decided to adopt the ALJ’s findings
of fact and conclusions of law except as
explained below. Because I agree with
the ALJ’s conclusion that Respondent
has failed to prove that the proposed
importation of its combination
ephedrine products is ‘‘necessary to
provide for medical, scientific, or other
legitimate purposes’’ and thus, it is not
1 The ALJ initially issued a decision on July 22,
2011, to which both parties filed exceptions.
However, after the record was forwarded to this
Office, the ALJ requested that the record be
returned. Subsequently, the ALJ re-issued her
decision. Neither party filed exceptions to this
decision. However, I have considered the
exceptions which the parties submitted following
the ALJ’s issuance of her first opinion.
All citations to the ALJ’s decision are to the slip
opinion as originally issued by her which includes
a cover page and table of contents.
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Sfmt 4703
35031
entitled to the issuance of a rule under
21 U.S.C. 952(a)(1) authorizing the
importation of such products, this alone
is reason to adopt the ALJ’s
recommendation. ALJ at 54–57. I further
agree with the ALJ’s ultimate conclusion
that Respondent’s registration would be
‘‘inconsistent with the public interest.’’
21 U.S.C. 958(c)(2)(A); ALJ at 80–81.
Accordingly, Respondent’s application
will be denied.
The Section 952 Analysis
As the ALJ noted, in 2006, Congress
enacted the Combat Methamphetamine
Epidemic Act of 2005 (CMEA), Public
Law 109–177, 120 Stat. 256. Among the
CMEA’s provisions was section 715, 120
Stat. 264–65, which amended 21 U.S.C.
952(a) by adding the listed chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine to those
substances (i.e., narcotic raw materials
and coca leaves) for which importation
is not authorized unless the Attorney
General finds the amount ‘‘to be
necessary to provide for medical,
scientific, or other legitimate purposes.’’
21 U.S.C. 952(a)(1). Upon such a
finding, the controlled substance or
listed chemical ‘‘may be so imported
under such regulations as the Attorney
General shall prescribe.’’ Id. 952(a).
In multiple cases involving
applications for a registration to import
a substance subject to section 952(a)(1),
DEA has held that an applicant ‘‘cannot
be registered as an importer of [such
substance] unless the [Agency] finds
that [it] will be allowed to import [the
substance] pursuant to 21 U.S.C.
952(a)(1).’’ Johnson Matthey, Inc., 67 FR
39041, 39042 (2002); see also Chattem
Chemicals, Inc., 71 FR 9834, 9835
(2006); Penick Corp., Inc., 68 FR 6947,
6948 (2003). As previously explained, a
finding that the proposed importation
complies with section 952(a) is ‘‘a
prerequisite to [an applicant’s]
registration as an importer’’ of a
substance subject to this provision.
Roxane Laboratories, Inc., 63 FR 55891,
55892 (1998). Moreover, it is settled that
because the applicant is the proponent
of the rule authorizing a proposed
importation of a substance subject to
section 952(a)(1), ‘‘it must establish by
a preponderance of the evidence that
such a rule can be issued.’’ Johnson
Matthey, 67 FR at 39042; see also
Chattem, 71 FR at 9835; Penick, 68 FR
at 6948.
As the ALJ concluded, Respondent
failed to establish by a preponderance of
the evidence that its proposed
importation of its combination
ephedrine/guaifenesin product is
‘‘necessary to provide for medical,
scientific, or other legitimate purposes.’’
E:\FR\FM\12JNN1.SGM
12JNN1
Agencies
[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 35028-35031]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14316]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Bill Alexander, M.D.; Decision and Order
On September 22, 2011, the Deputy Assistant Administrator, Office
of Diversion Control, Drug Enforcement Administration, issued an Order
To Show Cause to Bill Alexander, M.D. (Applicant), of Porter, Texas.
The Show Cause Order proposed the denial of Applicant's application for
a DEA Certificate of Registration as a practitioner in schedules II
through V, on the ground that his ``registration would be inconsistent
with the public interest.'' Show Cause Order at 1 (citing 21 U.S.C.
823(f) and 824(a)(4)).
The Show Cause Order alleged that on December 3, 2010, Applicant
applied for a practitioner's registration in schedules II-V at the
location of 24420 FM 1314, Suite 101, Porter, Texas. Id. The Show Cause
Order then alleged that on or about June 18, 2009, Applicant unlawfully
possessed 64 kilograms of marijuana, a schedule I controlled substance,
in violation of both federal and state law. Id. at 2 (citing 21 U.S.C.
841(a)(1) and Texas Health & Safety Code Ann. 481.121(b)(5)).
Next, the Show Cause Order alleged that on or about June 18, 2009,
Applicant told law enforcement agents that he was transporting the
marijuana for a drug dealer, and that he had transported over a dozen
such loads of marijuana in the past. Id. The Order further alleged that
Applicant told the agents that he was addicted to and used crack
cocaine, a schedule I controlled substance.\1\ Id.
---------------------------------------------------------------------------
\1\ Under federal law, crack cocaine is a schedule II controlled
substance. 21 CFR 1308.12(b)(4).
---------------------------------------------------------------------------
The Show Cause Order also alleged that on or about February 4,
2011, the Texas Medical Board entered a Corrective Order against
Applicant's medical license. Id. According to the
[[Page 35029]]
allegations, the Texas Board found that Applicant prescribed controlled
substances to individuals without holding a valid Texas Controlled
Substances Registration, in violation of state law. Id. (citing Tex.
Health & Safety Code Ann. 481.061(a)).
The Show Cause Order further alleged that during various interviews
with DEA Investigators, Applicant stated his desire to open a pain
management clinic in order to make money. Id. According to the
allegations, Applicant stated his ``belief that the purpose of a pain
management clinic was to give addicts their prescriptions because other
doctors won't do it.'' Id.
The Show Cause Order, which also notified Applicant of his right to
request a hearing on the allegations or to submit a written statement
in lieu of a hearing, the procedure for doing either, and the
consequence for failing to do either, id. at 2 (citing 21 CFR 1301.43),
was served on Applicant by registered mail addressed to him at the
address he provided on his application. While the return receipt card
did not include a delivery date, Applicant subsequently confirmed to
Government Counsel that he received the Order on September 26, 2011. GX
4; Request for Final Action, at 2.
Since the date of service of the Order, thirty days have now passed
and neither Applicant, nor anyone purporting to represent him, has
requested a hearing or submitted a written statement in lieu of a
hearing. I therefore find that Applicant has waived his right to a
hearing or to submit a written statement in lieu of a hearing, and
issue this Decision and Final Order based on relevant evidence
contained in the record submitted by the Government. 21 CFR 1301.43(d)
and (e). I make the following additional findings of fact.
Findings
Applicant's Licensure and Registration Status
Applicant is a physician licensed by the Texas Medical Board
(hereinafter, the Board). GX 6. On February 4, 2011, a Quality
Assurance Panel of the Board issued a Corrective Order to Applicant.
Id. Therein, the Board found that notwithstanding that Applicant had
allowed his Texas Controlled Substance Registration to expire on
October 31, 2008, he had continued to write prescriptions for
controlled substances through October 21, 2009, when his state license
was renewed. Id. The Order imposed an administrative penalty in the
amount of $500 against Applicant. Id. at 1-2 (citing Tex. Occ. Code
Ann. 164.002(a) and (d), and 164.053(a)(1)).
Applicant previously held DEA Certificate of Registration
BA0549177, which authorized him to dispense controlled substances in
schedules II through V, as a practitioner, at the registered location
of 1406 Wilson Road, Conroe, TX 77304. GX 2. This registration expired
by its terms on June 30, 2003. Id.
On March 30, 2004, Applicant was granted Certificate of
Registration BA8721765, which also authorized him to dispense
controlled substances in schedules II through V, as a practitioner, at
the registered location of 350 South Adams, Eagle Pass, TX 78852. This
registration expired by its terms on June 30, 2010. Id.
On December 3, 2010, Applicant submitted a new application for a
practitioner's registration in schedules II through V, through the
Office of Diversion Control's Web site. It is this application which is
at issue in this proceeding.
Evidence Regarding the Substantive Allegations
On June 18, 2009, following a traffic stop, Applicant was arrested
by a Texas Highway Patrol Officer for possession of marijuana, a
schedule I controlled substance. GX 5. At the time of his arrest, the
Trooper conducted a consensual search of Applicant's vehicle, during
which he found two large black suitcases which contained marijuana and
a small black toiletry bag which contained several homemade smoking
pipes. Id. at 4-5. Regarding the pipes, which the Trooper identified as
drug paraphernalia, the Trooper asked Applicant what he used them for;
Applicant stated: ``To smoke.'' Id. The Trooper then asked Applicant
what he smoked; Applicant replied: ``Crack,'' which is a schedule II
controlled substance. Id. Respondent was then arrested; however, he was
not criminally charged.
On December 6, 2010, a DEA Diversion Investigator (DI) began an
investigation of Applicant's December 3, 2010 application for a DEA
registration. GX 7 (DI's affidavit). According to the DI's affidavit,
because Applicant cooperated with another ongoing law enforcement
investigation, he was never criminally charged in connection with his
arrest for possession of marijuana on June 18, 2009. Id.
The DI stated that during a phone conversation on January 11, 2011,
Applicant admitted that at the time of his June 2009 arrest, which he
characterized as a mistake, he was transporting marijuana for a drug
trafficking organization because he needed the money. Id. at 2.
Applicant told the DI he planned to open a medical clinic, with other
practitioners, which would specialize in orthopedic surgery and pain
management. Id. He stated that his desire to open a pain management
clinic was only because he wanted to make money and that he would ``do
anything to make money.'' Id.
During a subsequent in-person interview, Applicant told the DIs
that he closed his last medical practice, an orthopedic surgery center,
in 2008. Id. He also admitted that he had abused crack cocaine in the
past, but had stopped using crack cocaine in 2009 after having a heart
attack. Id. However, Applicant never underwent a drug treatment
program. Id.
Applicant told the DIs that after closing his medical practice in
late 2008, he agreed to transport marijuana for a drug organization.
Id. Applicant admitted to having driven loads of marijuana from Eagle
Creek or Del Rio, Texas to either San Antonio or Austin because he was
having financial problems and he would `` `do anything not to lose
[his] property.' '' Id. He also admitted that he transported such loads
approximately every other weekend from the end of 2008 until he was
arrested in June 2009, but he was uncertain as to the exact number of
loads he had delivered. Id. at 2-3. Applicant stated that he was paid
$50 per pound, and that he usually received $3,000 to $5,000 per load
of marijuana. Id. at 3.
Applicant told the DIs that he only wanted to open a pain clinic to
share the overhead costs of a medical clinic with other practitioners,
that he did not have any formal pain management training, and that he
`` `hated those kinds of patients.' '' Id. at 3. Moreover, he then
stated that pain management clinics were good because they served
individuals who were addicted to pain medication without `` `bogging
down other clinics asking for pain pills.' '' Id. When asked by the DIs
what he would do when he had twenty patients waiting for their
prescriptions, Applicant responded that `` `if their doctors gave them
a prescription and they're hooked, if they're a functioning patient,
probably give it to them. What else are you gonna [sic] do with them?'
'' Id.
Upon being told by the DI that she was recommending the denial of
his application based on his previous involvement with transporting
large quantities of marijuana and his intention to open a pain clinic,
Applicant asked the DI if she thought that `` `there's a proper way' ''
to manage a pain clinic and make sure everything was done correctly.
Id. When the DI said
[[Page 35030]]
that she did not think it was proper to provide prescriptions to
addicts, Applicant replied: `` `What do you think pain management
clinics are for? They give addicts their prescriptions because other
doctors won't do it!' '' Id. at 3-4.
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
an application for a practitioner's registration may be denied upon a
determination ``that the issuance of such registration would be
inconsistent with the public interest.'' 21 U.S.C. 823(f). In making
the public interest determination in the case of a practitioner,
Congress directed 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.
Id.
``[T]hese factors are considered in the disjunctive.'' Robert A.
Leslie, 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 * * * to deny an application.'' Id.;
see also Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009). While I
must consider each factor, I am ``not required to make findings as to
all of the factors.'' MacKay v. DEA, 664 F.3d 808, 816 (10th Cir.
2011); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005).
With respect to a practitioner's registration, the Government has
the burden of proving by substantial evidence that granting a
registration would be inconsistent with the public interest. See 21 CFR
1301.44(d).\2\ As no DEA regulation provides that the entry of a
default is a consequence of the waiver of the right to a hearing, the
Government must therefore support its proposed action with substantial
evidence.
---------------------------------------------------------------------------
\2\ As found above, Applicant neither requested a hearing nor
submitted a written statement explaining his position on the matters
of fact and law asserted. By contrast, in a contested case, where
the Government satisfies its prima facie burden, as for example, by
showing that an applicant has committed acts which are inconsistent
with the public interest, the burden then shifts to the Applicant to
demonstrate why he can be entrusted with a registration. Medicine
Shoppe-Jonesborough, 73 FR 363, 387 (2008).
---------------------------------------------------------------------------
In this matter, I have considered all of the factors and conclude
that the evidence relevant to Respondent's experience in dispensing
controlled substances (factor two), his compliance with applicable laws
related to controlled substances (factor four), and his having engaged
in other conduct which may threaten the public health and safety
(factor five), conclusively establishes that granting his application
would be ``inconsistent with the public interest.'' 21 U.S.C. 823(f).
Factors One and Three--The Recommendation of the State Licensing Board
and the Applicant's Conviction Record Under Federal or State Laws
Relating to the Manufacture, Distribution or Dispensing of Controlled
Substances
As found above, the Board found that Applicant dispensed controlled
substances for nearly a year without the requisite State controlled
substance registration. However, the Board took no action against
Applicant's medical license other than to impose a $500 administrative
penalty and he thus retains an active State medical license. Also,
Applicant apparently still holds a valid Texas Controlled Substance
Registration.
However, while the CSA makes holding authority to dispense
controlled substances a condition of obtaining a DEA registration, it
is not dispositive of the public interest inquiry. Rather, in enacting
the public interest amendments to the CSA, Congress vested this Agency
with ``a separate oversight responsibility [apart from that which
exists in State authorities] with respect to the handling of controlled
substances.'' Mortimer B. Levin, 55 FR 8209, 8210 (1990). DEA has
therefore long recognized that it has ``a statutory obligation to make
its independent determination as to whether the granting of [a
registration] would be in the public interest.'' Id. Accordingly, ``DEA
has long held * * * that a State's failure to take action against an
Applicant's medical license [or State controlled substance
registration] is not dispositive in determining whether the
continuation of a registration is in the public interest.'' Jayam
Krishna-Iyer, 74 FR 459, 461 (2009); see also Levin, 55 FR at 8210
(holding that practitioner's reinstatement by state board ``is not
dispositive'' in public interest inquiry). Thus, that neither the Texas
Medical Board nor Texas Department of Public Safety has suspended or
revoked Applicant's medical license or controlled substance
registration is of no consequence in determining whether his continued
registration is consistent with the public interest.
Likewise, the fact that Applicant has not been convicted of an
offense falling within factor three, notwithstanding his arrest and
admission that on numerous occasions he transported large quantities of
marijuana for a drug trafficking organization, is not dispositive. As
previously explained, and as this case demonstrates, there are a
variety of reasons why a person who has engaged in criminal conduct may
not have been convicted, let alone charged with a criminal offense. See
Dewey C. MacKay, 75 FR 49956, 49973 (2010). Accordingly, I find that
factor three is not dispositive of whether granting Applicant's
application would be consistent with the public interest.
Factors Two and Four--Applicant's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Controlled
Substance Laws
The Texas Board found that Applicant allowed his Texas Controlled
Substance Registration to expire on October 31, 2008, and yet continued
to write controlled substance prescriptions in violation of Texas law
until he renewed his license on October 21, 2009. GX 6, at 1-2. This
was also a violation of federal law.
Under a DEA regulation, ``[a] prescription for a controlled
substance may be issued only by an individual practitioner who is * * *
authorized to prescribe controlled substances by the jurisdiction in
which he is licensed to practice his profession.'' 21 CFR
1306.03(a)(1). By issuing prescriptions when he did not possess state
authority, Respondent thus violated the CSA as well. See 21 U.S.C.
841(a)(1) (``Except as authorized by this subchapter, it shall be
unlawful for any person knowingly or intentionally * * * to * * *
dispense * * * a controlled substance[.]'').
In addition, Applicant admitted to the DIs that on numerous
occasions, he illegally transported large quantities of marijuana for a
drug trafficking organization and was paid to do so. GX 7, at 2-3. This
conduct also violated 21 U.S.C. 841(a)(1), which prohibits both the
knowing or intentional distribution of a controlled substance, as well
as the possession of a controlled substance with the intent to
distribute.
Finally, Applicant admitted that he abused crack cocaine. GX 7, at
2. This conduct violated 21 U.S.C. 844(a), which makes it ``unlawful
for any person knowingly or intentionally to possess a controlled
substances unless
[[Page 35031]]
such substance was obtained directly, or pursuant to a valid
prescription or order, from a practitioner, while acting in the course
of his professional practice, or except as authorized by'' the CSA or
the Controlled Substances Import Export Act. In addition, Respondent's
conduct violated various provisions of state law. See Tex. Health &
Safety Code 481.115(a) and 481.121(b)(5). Thus, the evidence with
respect to factors two and four provides ample reason to deny
Applicant's application.\3\
---------------------------------------------------------------------------
\3\ As evidence of his likely non-compliance with applicable
laws related to controlled substances, I note that during his
interviews with DEA Investigators regarding the purpose of his
proposed registration, Applicant stated that he wanted to open a
pain clinic ``only because he wanted to make money, and that he
would do anything to make money.'' Id. at 2. Moreover, Applicant
expressed the view that pain clinics were good because they served
individuals who were addicted to pain medication without ``bogging
down other clinics asking for pain pills.'' GX 7, at 3.
Subsequently, Applicant stated ``what do you think pain management
clinics are for? They give addicts their prescriptions because other
doctors won't do it!'' Id. at 3-4. Putting aside the misconduct
proven on this record, Applicant's comments do not inspire
confidence that he would comply with federal requirements such as 21
CFR 1306.04(a), which requires that a prescription for a controlled
substance be issued only for a legitimate medical purpose by a
practitioner acting in the usual course of professional practice.
---------------------------------------------------------------------------
Factor Five--Such Other Conduct Which May Threaten the Public Health
and Safety
As found above, during the consensual search of Applicant's
vehicle, a Texas Highway Patrol Officer found several home-made pipes,
and upon being questioned as to what he used them for, Applicant
admitted that he smoked crack cocaine. Also, Applicant admitted to DEA
Investigators that he had previously abused crack cocaine. While
Applicant later claimed that he had stopped using crack after suffering
a heart attack, he also stated that he never underwent drug
rehabilitation treatment.
DEA has ``long held that a practitioner's self-abuse of a
controlled substance can be considered under Factor Five even if there
is no evidence that [he] abused his prescription-writing authority or
otherwise engaged in an unlawful distribution to others.'' See Scott D.
Fedosky, 76 FR 71375, 71378 (2011). See also Tony T. Bui, 75 FR 49979,
49989-90 (2010) (collecting cases); David E. Trawick, 53 FR 5326, 5327
(1988). Thus, even if there was no other evidence of misconduct on the
part of Applicant, his self-abuse of crack cocaine would by, itself,
constitute conduct which threatens public health and safety and renders
his proposed registration ``inconsistent with the public interest.''
Id. 823(f).
Conclusion
Based on Applicant's misconduct in issuing prescriptions without
the requisite state authority, see 21 CFR 1306.03(a), his admitted
transportation of marijuana for a drug trafficking organization, see 21
U.S.C. 841(a)(1), and his self-abuse of crack cocaine, I conclude that
Applicant's registration would be ``inconsistent with the public
interest.'' Id. 823(f). Accordingly, his application will be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b), I order that the application of Bill Alexander,
M.D., for a DEA Certificate of Registration, be, and it hereby is,
denied. This Order is effective immediately.
Dated: June 2, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-14316 Filed 6-11-12; 8:45 am]
BILLING CODE 4410-09-P