Steven B. Brown, M.D.; Revocation of Registration, 65660-65663 [2010-27031]
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Federal Register / Vol. 75, No. 206 / Tuesday, October 26, 2010 / Notices
by renewal to the Drug Enforcement
Administration (DEA) as a bulk
manufacturer of Cocaine (9041), a basic
class of controlled substance listed in
schedule II.
The company plans to manufacture
small quantities of the above listed
controlled substance for distribution to
its customers for the purpose of
research.
Any other such applicant, and any
person who is presently registered with
DEA to manufacture such substance,
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than December 27, 2010.
Dated: October 14, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–27037 Filed 10–25–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
emcdonald on DSK2BSOYB1PROD with NOTICES
Pursuant to 21 U.S.C. 958(i), the
Attorney General shall, prior to issuing
a registration under this Section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2) authorizing the importation of
such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on July 9,
2010, Noramco, Inc., 1440 Olympic
Drive, Athens, Georgia 30601, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the basic
classes of controlled substances listed in
schedule II:
Drug
Schedule
Thebaine (9333) ...........................
Tapentadol (9780) ........................
II
II
The company plans to import
Thebaine (9333) analytical reference
standards for distribution to its
customers. The company plans to
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18:09 Oct 25, 2010
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import an intermediate form of
Tapentadol (9780) to bulk manufacture
Tapentadol for distribution to its
customers.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic class of controlled substance
may file comments or objections to the
issuance of the proposed registration,
and may, at the same time, file a written
request for a hearing on such
application pursuant to 21 CFR 1301.43,
and in such form as prescribed by 21
CFR 1316.47.
Any such comments or objections
should be addressed, in quintuplicate,
to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than November 26, 2010.
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
in a previous notice published in the
Federal Register on September 23, 1975,
(40 FR 43745–46), all applicants for
registration to import a basic class of
any controlled substance in schedule I
or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Dated: October 15, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–27032 Filed 10–25–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration
By Notice dated October 21, 2009 and
published in the Federal Register on
October 28, 2009, (74 FR 55586),
Archimica, Inc., 2460 W. Bennett Street,
Springfield, Missouri 65807–1229, made
application by letter to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
Tapentadol (9780, a basic class of
controlled substance listed in schedule
II.
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The company plans to manufacture
the listed controlled substance in bulk
for distribution to its customers.
One comment objecting to the
granting of registration as a bulk
manufacturer of the basic class of
controlled substance listed to this
applicant was received. However, after
a thorough review of this matter, DEA
has concluded that the issues raised in
the comment and objection do not
warrant the denial of this application.
DEA has considered the factors in 21
U.S.C. 823(a) and determined that the
registration of Archimica, Inc. to
manufacture the listed basic class of
controlled substance is consistent with
the public interest at this time. DEA has
investigated Archimica, Inc. to ensure
that the company’s registration is
consistent with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 823(a),
and in accordance with 21 CFR 1301.33,
the above named company is granted
registration as a bulk manufacturer of
the basic class of controlled substance
listed.
Dated: October 19, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–27035 Filed 10–26–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Steven B. Brown, M.D.; Revocation of
Registration
On May 13, 2010, I, the Deputy
Administrator of the Drug Enforcement
Administration, issued an Order to
Show Cause and Immediate Suspension
of Registration (‘‘Order’’) to Steven B.
Brown, M.D. (‘‘Registrant’’), of Wilton
Manors and Pompano Beach, Florida.
The Order proposed the revocation of
Registrant’s DEA Certificates of
Registration, BB2972140 and
FB1490349, as well as the denial of any
pending applications for the renewal or
modification of both registrations, on
the ground that his ‘‘continued
registrations are inconsistent with the
public interest, as that term is defined
in 21 U.S.C. 823(f).’’ Order, at 1.
The Order alleged that Registrant
‘‘issued illegal prescriptions for
oxycodone, a Schedule II controlled
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substance, for no legitimate medical
purpose and outside the course of [his]
professional practice.’’ Id. at 1–2 (citing
21 U.S.C. 841(a) and 21 CFR 1306.04(a)).
More specifically, the Order alleged that
Registrant ‘‘prescribed oxycodone 30
mg. tablets in amounts as high as 180
dosage units to patients’’ and that he
‘‘received half the dosage units back
from the patients after the illegal
prescription was filled and dispensed.’’
Id. at 2. The Order also alleged that on
March 27, 2010, ‘‘[a]s a result of
[Registrant’s] illegal prescribing and
[his] illegal possession of controlled
substances,’’ Registrant ‘‘was arrested by
the Broward County Sheriff’s Office.’’ Id.
Moreover, the Order alleged that on
April 28, 2010, Registrant ‘‘illegally
possessed amphetamine, a Schedule II
controlled substance’’ and was ‘‘arrested
by the Broward County Sheriff’s Office
during an Administrative Inspection by
the Florida Department of Health’’ at one
of his registered locations. Id. Finally,
the Order alleged that ‘‘[a]s a result of
actions by the State of Florida
Department of Health,’’ Registrant is
‘‘currently without authority to handle
controlled substances in the State of
Florida,’’ the State in which he is
registered with DEA. Id.
Based on the above, I concluded ‘‘that
[Registrant’s] continued registrations,
while these proceedings are pending,
constitute an imminent danger to the
public health and safety.’’ Id. (citing 21
U.S.C. 824(d) and 21 CFR 1301.36(e)). I,
therefore, ordered the immediate
suspension of both of Registrant’s
registrations. Id.
On May 17, 2010, the Order, which
also notified Registrant 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, was served on him. See
Order, at 3 (citing 21 CFR 1301.43);
Gov’t Not. of Svc. of Order. Since the
date of service of the Order, 30 days
have passed and neither Respondent,
nor anyone purporting to represent him,
has requested a hearing or submitted a
written statement in lieu of a hearing. I,
therefore, hold that Respondent has
waived his right to a hearing or to
submit a written statement and issue
this Decision and Final Order based on
relevant evidence contained in the
record submitted by the government. 21
CFR 1301.43(d) & (e). I make the
following findings of fact.
Findings
Registrant is a physician licensed by
the State of Florida. He is the holder of
two DEA Certificates of Registration: (1)
BB2972140 (as well as XB2972140), at
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the registered address of 1749 N.E. 26th
Street, Suite A, Wilton Manors, Florida;
and (2) FB1490349, at the registered
address of 605 East Atlantic Blvd,
Pompano Beach, Florida. Both
registrations do not expire until July 31,
2012.
Registrant practiced pain management
at his Pompano Beach registered
location. Order of Emergency
Suspension of License, at 2, In re:
Steven Barry Brown, M.D., (Fla. Dep’t of
Health, Nos. 2010–06419, 2010–07923)
(hereinafter, State Susp. Order). He is
also registered under Florida law as a
dispensing practitioner; this authorizes
him to order and dispense controlled
substances in the State.
In March 2010, DEA and the Broward
County Sheriff’s Office (‘‘BSO’’) received
information from a confidential source
(‘‘CS’’) that Registrant was issuing
prescriptions for oxycodone 1 30 mg. to
the CS and providing her with money to
fill the prescriptions; in exchange, the
CS gave Registrant half of the pills she
obtained. Declaration of Diversion
Investigator (DI), at 1–2. According to
the CS, Registrant had been treating her
for chronic pain for the last four years.
However, after two years, Registrant
proposed that he would write her
prescriptions for 160 tablets of
oxycodone 30 mg. and give her the
money to pay for them ‘‘if the CS would
give half the pills back to’’ him. Id.; see
also Stat. Susp. Order, at 2. The CS
agreed to the arrangement. Id.
Each month for two years, Registrant
wrote the CS prescriptions for up to 180
tablets of oxycodone 30 mg. and gave
her the money to fill them; the CS
would then provide Registrant with half
of the pills she obtained. Declaration, at
2. Registrant told the CS to fill the
prescriptions at local pharmacies and
not at his clinic. Id. The CS also related
to the Investigator that Registrant was
abusing oxycodone and Dilaudid. Id. at
2.
At about 6:16 p.m. on March 27, 2010,
the CS, under the direction of a BSO
officer and a DI, made a consensually
recorded telephone call to Registrant to
arrange a delivery of oxycodone to him.
During the call, Registrant twice asked
the CS if she had split the oxycodone
up; the CS answered affirmatively. The
CS and Registrant then agreed to meet
in the parking lot of a local fast food
restaurant.
During the delivery, which was
observed by several law enforcement
officers, the CS wore a recording device.
Id. Upon meeting, Registrant asked the
CS if she ‘‘want[ed] one of these hits?’’
1 Oxycodone is a schedule II controlled
substance. 21 CFR 1308.12(b)(1)(xiii).
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65661
and stated: ‘‘Oh their good.’’ The CS
replied ‘‘Yeah’’ and Registrant then said:
‘‘You know what I’m talking about right?
It’s Percocet liquid.’’ The CS replied that
she knew ‘‘that’s the Oxyfast’’ but added
that she did not want any because it
would upset her stomach.
Acknowledging that the drug would do
so, Registrant stated: ‘‘You know what I
do? To make it taste better I put Wyler’s
Raspberry in it.’’ Registrant then added:
‘‘It’s so good.’’ The CS, however, again
said that she did not want any of the
drug. The CS then gave the oxycodone
to Registrant, who gave her eighty
dollars. The CS left, and shortly
thereafter, Registrant was arrested and
charged with trafficking in oxycodone.
On May 5, 2010, the State Surgeon
General, Florida Department of Health
(DOH), issued an Order of Emergency
Suspension of License which
immediately suspended Registrant’s
physician’s license. State Suspension
Order, at 1, 12. The Order alleged that
Registrant ‘‘violated Section
458.331(1)(q)’’ of the Florida Statutes
‘‘by prescribing medications to [three
individuals] with no medical records
justifying why the prescriptions were
being written,’’ Id. at 10, as well as ‘‘by
prescribing * * * a legend drug,
including any controlled substance,
other than in the course of the
physician’s professional practice.’’ Id. at
11.
The State Suspension Order further
alleged ‘‘that [Registrant] has shown a
disregard for the safety of the public
with his practice of prescribing
medications to patients with no medical
records to justify why the prescriptions
were being written’’ and that his
‘‘practice was especially egregious in
that he was using his relationship as a
physician with a patient to divert
medication for his own use.’’ Id.
Accordingly, the State Suspension
Order concluded that Registrant’s
‘‘actions clearly constitute prescribing
outside the practice of medicine and
present such an immediate, serious
danger to the public health, safety or
welfare that nothing short of the
immediate suspension of his license to
practice medicine will protect the
public from this danger.’’ Id.
Discussion
Section 304(a) of the Controlled
Substances Act (‘‘CSA’’) provides that a
‘‘registration pursuant to section 823 of
this title to * * * dispense a controlled
substance * * * may be suspended or
revoked by the Attorney General upon
a finding that the registrant * * * has
had his State license suspended,
revoked, or denied by competent State
authority and is no longer authorized by
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State law to engage in the * * *
dispensing of controlled substances,’’ 21
U.S.C. 824(a)(3), or ‘‘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.’’ Id.
§ 824(a)(4). With respect to the latter
ground for revocation, the CSA directs
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.
21 U.S.C. 823(f).
The public interest ‘‘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 revoke an
existing registration or to deny an
application. 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 (D.C. Cir. 2005).
As explained below, the investigative
record clearly shows that Registrant’s
experience in dispensing controlled
substances and compliance with
applicable laws is characterized by his
unlawful use of his prescribing
authority to obtain controlled
substances for his personal use.
Moreover, the record also shows that by
virtue of the State Suspension Order,
Registrant no longer has authority under
Florida law to dispense controlled
substances and thus, he no longer meets
an essential requirement for holding a
DEA registration. I will therefore order
that Registrant’s Certificates of
Registration be revoked.
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The Public Interest Grounds
Factors Two, Four, and Five:
Registrant’s Experience in Dispensing
Controlled Substances, Record of
Compliance With Applicable Controlled
Substance Laws, and Such Other
Conduct Which May Threaten Public
Health and Safety
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
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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
relating 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.’’)
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)).
As found above, in order to obtain
drugs for his own use, Registrant
entered into an agreement with the CS
to provide her with monthly
prescriptions for 160 to 180 tablets of
oxycodone 30 mg. Registrant paid for
the prescriptions in exchange for the
CS’s providing him with half of the
pills. Registrant wrote the prescriptions
on a monthly basis for a two-year
period.
While during this period, Registrant
may have been treating the CS for
legitimate chronic pain (although with
another drug), it is clear that Registrant’s
primary purpose in writing these
prescriptions was to obtain drugs that
he then abused. Each of the
prescriptions Registrant wrote thus
violated 21 CFR 1306.04(a) and
constituted an unlawful distribution of
a controlled substance. 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 manufacture, distribute, or
dispense, or possess with intent to
manufacture, distribute, or dispense, a
controlled substance.’’). See also
Michael F. Myers, 72 FR 36464, 36486
(2007) (finding Respondent ‘‘engaged in
the criminal distribution of controlled
substances in violation of 21 U.S.C. 841’’
where Respondent ‘‘issued [a] person
prescriptions for hydrocodone on a
monthly basis * * * [and the] person
admitted * * * that he took very few
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hydrocodone tablets and regularly
provided Respondent with 60 of them’’).
Under the CSA, it is also ‘‘unlawful
for any person knowingly or
intentionally * * * to acquire or obtain
possession of a controlled substance by
misrepresentation, fraud, forgery,
deception, or subterfuge.’’ 21 U.S.C.
843(a)(3). Even assuming that the CS
required her share of the oxycodone to
treat a legitimate medical condition, by
writing prescriptions in excess of the
CS’s legitimate medical needs and for
the purpose of obtaining the drugs for
his own use, Registrant obtained
possession of controlled substances by
‘‘deception[] or subterfuge’’ and violated
Federal law.
Moreover, Florida prohibits the
prescribing of ‘‘inappropriate quantities’’
of legend drugs, including controlled
substances. Fla. Stat. 458.331(1)(q).
Again, even assuming that the CS had
a legitimate medical need for her share
of the oxycodone, Registrant violated
Florida law because the prescriptions he
issued to her clearly exceeded the
quantity necessary to treat her condition
and were issued in those quantities so
that he could obtain drugs for his own
use.
Additionally, DEA has long held that
a practitioner’s self-abuse of controlled
substances constitutes ‘‘conduct which
may threaten public health and safety.’’
21 U.S.C. 823(f)(5). See Tony T. Bui, 75
FR 49979, 49990 (2010); Kenneth Wayne
Green, Jr., 59 FR 51453 (1994); David E.
Trawick, 53 FR 5326 (1988). In addition
to the evidence showing that Registrant
issued prescriptions to the CS to obtain
controlled substances for his own use,
the evidence also shows that during the
March 27, 2010 meeting with the CS, he
offered her a hit of liquid oxycodone,
stating ‘‘Oh their good,’’ and then
explained how he made it more
palatable to ingest. Thus, it is clear that
Registrant is a drug abuser and a threat
to public health and safety.2
I, therefore, conclude that the
evidence pertinent to Registrant’s
experience in dispensing controlled
substances (factor two), his record of
compliance with Federal and State laws
related to controlled substances (factor
2 I conclude that it is not necessary to make
findings under factor one because Registrant’s loss
of his State authority will be considered separately
in this Decision.
As for factor three, while there is evidence that
Registrant was arrested on drug charges, there is no
evidence as to the disposition of the charges. Nor
is there any evidence establishing that Registrant
has otherwise been convicted of any offenses within
the purview of factor three. However, DEA has
repeatedly held that the absence of any convictions
under factor three is not dispositive of the public
interest inquiry. See, e.g., Edmund Chein, 72 FR
6580, 6593 n.22 (2007).
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four), and such other conduct which
may threaten public health and safety
(factor five), establishes that he has
committed acts which render his
continued registration ‘‘inconsistent
with the public interest.’’ 21 U.S.C.
824(a)(4). This finding provides reason
alone to revoke Registrant’s registrations
and to deny any pending applications to
renew or modify his registrations.
The Loss of State Authority Ground
Under the CSA, a practitioner must
possess authority to dispense controlled
substances under the laws of the State
in which he engages in his professional
practice in order to obtain and maintain
a DEA registration. See 21 U.S.C.
802(21) (defining the term ‘‘practitioner’’
as a person ‘‘licensed, registered, or
otherwise permitted, by the United
States or the jurisdiction in which he
practices * * * to distribute, dispense
* * * [or] administer * * * a
controlled substance’’), id. § 823(f) (‘‘The
Attorney General shall register
practitioners * * * to dispense * * *
controlled substances * * * if the
applicant is authorized to dispense
* * * controlled substances under the
laws of the State in which he
practices.’’). As these provisions make
plain, possessing authority under State
law to handle controlled substances is
an essential condition for holding a DEA
registration. See John B. Freitas, 74 FR
17524, 17525 (2009); Dominick A. Ricci,
58 FR 51104, 51105 (1993); Bobby
Watts, 53 FR 11919, 11920 (1988).
DEA, has therefore, held repeatedly
that the CSA requires the revocation of
a registration issued to a practitioner
whose State authority has been
suspended or revoked. 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). See also id.
§ 824(a)(3) (a ‘‘registration pursuant to
section 823 of this title to * * *
dispense a controlled substance * * *
may be suspended or revoked by the
Attorney General upon a finding that
the registrant * * * has had his State
license suspended, revoked, or denied
by competent State authority and is no
longer authorized by State law to engage
in the * * * dispensing of controlled
substances’’). DEA has further held that
revocation is warranted even where a
practitioner’s State authority has been
summarily suspended and the State has
yet to provide the practitioner with a
hearing to challenge the State’s action.
See Robert Wayne Mosier, 75 FR 49950
(2010) (‘‘revocation is warranted * * *
even in those instances where a
practitioner’s State license has only
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been suspended, and there is the
possibility of reinstatement’’); accord
Bourne Pharmacy, 72 FR 18273, 18274
(2007).
As found above, on May 5, 2010, the
Florida Surgeon General immediately
suspended Registrant’s State medical
license. Registrant is therefore without
authority to dispense controlled
substances in the State where he holds
his DEA registrations. Registrant’s loss
of his State authority thus provides an
additional basis for revoking his
registrations. Accordingly, his
registrations will be revoked and any
pending application will be denied.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as 28 CFR 0.100(b) and 0.104, I order
that DEA Certificates of Registration
BB2972140, XB2972140, and
FB1490349, issued to Stephen B.
Brown, M.D., be, and they hereby are,
revoked. I further order that any
pending application of Stephen B.
Brown, M.D., to renew or modify such
registrations, be, and it hereby is,
denied. This order is effective
immediately.3
Dated: October 15, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010–27031 Filed 10–25–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Gilbert Eugene Johnson, M.D.;
Revocation of Registration
On November 20, 2008, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Gilbert Eugene Johnson,
M.D. (Respondent), of Idabel,
Oklahoma. The Show Cause Order
proposed the revocation of
Respondent’s DEA Certificate of
Registration, AJ6783535, as a
practitioner, and the denial of any
pending applications to renew or
modify his registration, on the ground
that Respondent’s ‘‘continued
registration is inconsistent with the
public interest, as that term is used in
21 U.S.C. 823(f).’’ Show Cause Order at
1.
3 For the same reason that I ordered the
immediate suspension of Registrant’s DEA
registrations, I conclude that the public interest
requires that this Order shall be effective
immediately.
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65663
The Show Cause Order alleged that
the Oklahoma State Board of Medical
Licensure had found that: (1)
Respondent ‘‘prescribed or administered
a drug (i.e., meperidine, a schedule II
controlled substance, and hydrocodone,
a schedule III controlled substance) or
treatment without sufficient
examination or the establishment of a
valid physician patient relationship’’; (2)
Respondent ‘‘engaged in indiscriminate
or excessive prescribing, dispensing or
administering of controlled or narcotic
drugs’’; and (3) Respondent ‘‘prescribed,
dispensed or administered controlled
substances or narcotic drugs in excess of
the amount considered good medical
practice or prescribed, dispensed or
administered controlled substances or
narcotic drugs without medical need.’’
Id. at 1–2.
Next, the Show Cause Order alleged
that on June 23, 2008, based on the
Oklahoma Board’s action, the Medical
Board of California ‘‘ordered the
revocation of [Respondent’s] license to
practice medicine in that state, effective
July 23, 2008.’’ Id. at 2. Finally, the
Order alleged that on July 7, 2008,
Respondent ‘‘falsified’’ his application
for renewal of his DEA registration ‘‘by
answering ‘no’ to the question
concerning whether [Respondent] had
ever had a state professional license
revoked or placed on probation or
whether any such action was pending.’’
Id.
On December 16, 2008, the Show
Cause Order was served on Respondent
by certified mail to him at the address
which he had recently given the Agency
as his new registered location on his
application to modify his registration.
On January 29, 2009, Respondent’s
counsel filed a request for a hearing and
the matter was placed on the docket of
the Agency’s Administrative Law Judges
(ALJs).
Thereafter, the ALJ requested that the
parties address whether Respondent had
timely requested a hearing. See
Corrected Order Cancelling Hearing and
Terminating Proceedings, at 1.
Following receipt of the parties’
submissions, the ALJ found that
Respondent’s request was not timely
because it was not filed within 30 days
of service of the Show Cause Order as
required by 21 CFR 1301.43(a). Id. at 2.
Because Respondent had not
‘‘provide[d] a basis upon which to find
good cause,’’ the ALJ held that his
failure to file a timely request
constituted a waiver of his right to a
hearing. Id. (citing 21 CFR 1301.43(d)
and Brinton D. Glisson, 72 FR 54296
(2007)). Accordingly, the ALJ canceled
the scheduled hearing, terminated the
proceedings, and directed that the
E:\FR\FM\26OCN1.SGM
26OCN1
Agencies
[Federal Register Volume 75, Number 206 (Tuesday, October 26, 2010)]
[Notices]
[Pages 65660-65663]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27031]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Steven B. Brown, M.D.; Revocation of Registration
On May 13, 2010, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration (``Order'') to Steven B. Brown, M.D.
(``Registrant''), of Wilton Manors and Pompano Beach, Florida. The
Order proposed the revocation of Registrant's DEA Certificates of
Registration, BB2972140 and FB1490349, as well as the denial of any
pending applications for the renewal or modification of both
registrations, on the ground that his ``continued registrations are
inconsistent with the public interest, as that term is defined in 21
U.S.C. 823(f).'' Order, at 1.
The Order alleged that Registrant ``issued illegal prescriptions
for oxycodone, a Schedule II controlled
[[Page 65661]]
substance, for no legitimate medical purpose and outside the course of
[his] professional practice.'' Id. at 1-2 (citing 21 U.S.C. 841(a) and
21 CFR 1306.04(a)). More specifically, the Order alleged that
Registrant ``prescribed oxycodone 30 mg. tablets in amounts as high as
180 dosage units to patients'' and that he ``received half the dosage
units back from the patients after the illegal prescription was filled
and dispensed.'' Id. at 2. The Order also alleged that on March 27,
2010, ``[a]s a result of [Registrant's] illegal prescribing and [his]
illegal possession of controlled substances,'' Registrant ``was
arrested by the Broward County Sheriff's Office.'' Id. Moreover, the
Order alleged that on April 28, 2010, Registrant ``illegally possessed
amphetamine, a Schedule II controlled substance'' and was ``arrested by
the Broward County Sheriff's Office during an Administrative Inspection
by the Florida Department of Health'' at one of his registered
locations. Id. Finally, the Order alleged that ``[a]s a result of
actions by the State of Florida Department of Health,'' Registrant is
``currently without authority to handle controlled substances in the
State of Florida,'' the State in which he is registered with DEA. Id.
Based on the above, I concluded ``that [Registrant's] continued
registrations, while these proceedings are pending, constitute an
imminent danger to the public health and safety.'' Id. (citing 21
U.S.C. 824(d) and 21 CFR 1301.36(e)). I, therefore, ordered the
immediate suspension of both of Registrant's registrations. Id.
On May 17, 2010, the Order, which also notified Registrant 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, was served on him. See Order, at
3 (citing 21 CFR 1301.43); Gov't Not. of Svc. of Order. Since the date
of service of the Order, 30 days have passed and neither Respondent,
nor anyone purporting to represent him, has requested a hearing or
submitted a written statement in lieu of a hearing. I, therefore, hold
that Respondent has waived his right to a hearing or to submit a
written statement and issue this Decision and Final Order based on
relevant evidence contained in the record submitted by the government.
21 CFR 1301.43(d) & (e). I make the following findings of fact.
Findings
Registrant is a physician licensed by the State of Florida. He is
the holder of two DEA Certificates of Registration: (1) BB2972140 (as
well as XB2972140), at the registered address of 1749 N.E. 26th Street,
Suite A, Wilton Manors, Florida; and (2) FB1490349, at the registered
address of 605 East Atlantic Blvd, Pompano Beach, Florida. Both
registrations do not expire until July 31, 2012.
Registrant practiced pain management at his Pompano Beach
registered location. Order of Emergency Suspension of License, at 2, In
re: Steven Barry Brown, M.D., (Fla. Dep't of Health, Nos. 2010-06419,
2010-07923) (hereinafter, State Susp. Order). He is also registered
under Florida law as a dispensing practitioner; this authorizes him to
order and dispense controlled substances in the State.
In March 2010, DEA and the Broward County Sheriff's Office
(``BSO'') received information from a confidential source (``CS'') that
Registrant was issuing prescriptions for oxycodone \1\ 30 mg. to the CS
and providing her with money to fill the prescriptions; in exchange,
the CS gave Registrant half of the pills she obtained. Declaration of
Diversion Investigator (DI), at 1-2. According to the CS, Registrant
had been treating her for chronic pain for the last four years.
However, after two years, Registrant proposed that he would write her
prescriptions for 160 tablets of oxycodone 30 mg. and give her the
money to pay for them ``if the CS would give half the pills back to''
him. Id.; see also Stat. Susp. Order, at 2. The CS agreed to the
arrangement. Id.
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\1\ Oxycodone is a schedule II controlled substance. 21 CFR
1308.12(b)(1)(xiii).
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Each month for two years, Registrant wrote the CS prescriptions for
up to 180 tablets of oxycodone 30 mg. and gave her the money to fill
them; the CS would then provide Registrant with half of the pills she
obtained. Declaration, at 2. Registrant told the CS to fill the
prescriptions at local pharmacies and not at his clinic. Id. The CS
also related to the Investigator that Registrant was abusing oxycodone
and Dilaudid. Id. at 2.
At about 6:16 p.m. on March 27, 2010, the CS, under the direction
of a BSO officer and a DI, made a consensually recorded telephone call
to Registrant to arrange a delivery of oxycodone to him. During the
call, Registrant twice asked the CS if she had split the oxycodone up;
the CS answered affirmatively. The CS and Registrant then agreed to
meet in the parking lot of a local fast food restaurant.
During the delivery, which was observed by several law enforcement
officers, the CS wore a recording device. Id. Upon meeting, Registrant
asked the CS if she ``want[ed] one of these hits?'' and stated: ``Oh
their good.'' The CS replied ``Yeah'' and Registrant then said: ``You
know what I'm talking about right? It's Percocet liquid.'' The CS
replied that she knew ``that's the Oxyfast'' but added that she did not
want any because it would upset her stomach. Acknowledging that the
drug would do so, Registrant stated: ``You know what I do? To make it
taste better I put Wyler's Raspberry in it.'' Registrant then added:
``It's so good.'' The CS, however, again said that she did not want any
of the drug. The CS then gave the oxycodone to Registrant, who gave her
eighty dollars. The CS left, and shortly thereafter, Registrant was
arrested and charged with trafficking in oxycodone.
On May 5, 2010, the State Surgeon General, Florida Department of
Health (DOH), issued an Order of Emergency Suspension of License which
immediately suspended Registrant's physician's license. State
Suspension Order, at 1, 12. The Order alleged that Registrant
``violated Section 458.331(1)(q)'' of the Florida Statutes ``by
prescribing medications to [three individuals] with no medical records
justifying why the prescriptions were being written,'' Id. at 10, as
well as ``by prescribing * * * a legend drug, including any controlled
substance, other than in the course of the physician's professional
practice.'' Id. at 11.
The State Suspension Order further alleged ``that [Registrant] has
shown a disregard for the safety of the public with his practice of
prescribing medications to patients with no medical records to justify
why the prescriptions were being written'' and that his ``practice was
especially egregious in that he was using his relationship as a
physician with a patient to divert medication for his own use.'' Id.
Accordingly, the State Suspension Order concluded that Registrant's
``actions clearly constitute prescribing outside the practice of
medicine and present such an immediate, serious danger to the public
health, safety or welfare that nothing short of the immediate
suspension of his license to practice medicine will protect the public
from this danger.'' Id.
Discussion
Section 304(a) of the Controlled Substances Act (``CSA'') provides
that a ``registration pursuant to section 823 of this title to * * *
dispense a controlled substance * * * may be suspended or revoked by
the Attorney General upon a finding that the registrant * * * has had
his State license suspended, revoked, or denied by competent State
authority and is no longer authorized by
[[Page 65662]]
State law to engage in the * * * dispensing of controlled substances,''
21 U.S.C. 824(a)(3), or ``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.'' Id. Sec.
824(a)(4). With respect to the latter ground for revocation, the CSA
directs 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.
21 U.S.C. 823(f).
The public interest ``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 revoke an existing
registration or to deny an application. 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 (D.C. Cir. 2005).
As explained below, the investigative record clearly shows that
Registrant's experience in dispensing controlled substances and
compliance with applicable laws is characterized by his unlawful use of
his prescribing authority to obtain controlled substances for his
personal use. Moreover, the record also shows that by virtue of the
State Suspension Order, Registrant no longer has authority under
Florida law to dispense controlled substances and thus, he no longer
meets an essential requirement for holding a DEA registration. I will
therefore order that Registrant's Certificates of Registration be
revoked.
The Public Interest Grounds
Factors Two, Four, and Five: Registrant's Experience in Dispensing
Controlled Substances, Record of Compliance With Applicable Controlled
Substance Laws, and Such Other Conduct Which May Threaten Public Health
and Safety
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 relating
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.'')
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)).
As found above, in order to obtain drugs for his own use,
Registrant entered into an agreement with the CS to provide her with
monthly prescriptions for 160 to 180 tablets of oxycodone 30 mg.
Registrant paid for the prescriptions in exchange for the CS's
providing him with half of the pills. Registrant wrote the
prescriptions on a monthly basis for a two-year period.
While during this period, Registrant may have been treating the CS
for legitimate chronic pain (although with another drug), it is clear
that Registrant's primary purpose in writing these prescriptions was to
obtain drugs that he then abused. Each of the prescriptions Registrant
wrote thus violated 21 CFR 1306.04(a) and constituted an unlawful
distribution of a controlled substance. 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 manufacture, distribute,
or dispense, or possess with intent to manufacture, distribute, or
dispense, a controlled substance.''). See also Michael F. Myers, 72 FR
36464, 36486 (2007) (finding Respondent ``engaged in the criminal
distribution of controlled substances in violation of 21 U.S.C. 841''
where Respondent ``issued [a] person prescriptions for hydrocodone on a
monthly basis * * * [and the] person admitted * * * that he took very
few hydrocodone tablets and regularly provided Respondent with 60 of
them'').
Under the CSA, it is also ``unlawful for any person knowingly or
intentionally * * * to acquire or obtain possession of a controlled
substance by misrepresentation, fraud, forgery, deception, or
subterfuge.'' 21 U.S.C. 843(a)(3). Even assuming that the CS required
her share of the oxycodone to treat a legitimate medical condition, by
writing prescriptions in excess of the CS's legitimate medical needs
and for the purpose of obtaining the drugs for his own use, Registrant
obtained possession of controlled substances by ``deception[] or
subterfuge'' and violated Federal law.
Moreover, Florida prohibits the prescribing of ``inappropriate
quantities'' of legend drugs, including controlled substances. Fla.
Stat. 458.331(1)(q). Again, even assuming that the CS had a legitimate
medical need for her share of the oxycodone, Registrant violated
Florida law because the prescriptions he issued to her clearly exceeded
the quantity necessary to treat her condition and were issued in those
quantities so that he could obtain drugs for his own use.
Additionally, DEA has long held that a practitioner's self-abuse of
controlled substances constitutes ``conduct which may threaten public
health and safety.'' 21 U.S.C. 823(f)(5). See Tony T. Bui, 75 FR 49979,
49990 (2010); Kenneth Wayne Green, Jr., 59 FR 51453 (1994); David E.
Trawick, 53 FR 5326 (1988). In addition to the evidence showing that
Registrant issued prescriptions to the CS to obtain controlled
substances for his own use, the evidence also shows that during the
March 27, 2010 meeting with the CS, he offered her a hit of liquid
oxycodone, stating ``Oh their good,'' and then explained how he made it
more palatable to ingest. Thus, it is clear that Registrant is a drug
abuser and a threat to public health and safety.\2\
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\2\ I conclude that it is not necessary to make findings under
factor one because Registrant's loss of his State authority will be
considered separately in this Decision.
As for factor three, while there is evidence that Registrant
was arrested on drug charges, there is no evidence as to the
disposition of the charges. Nor is there any evidence establishing
that Registrant has otherwise been convicted of any offenses within
the purview of factor three. However, DEA has repeatedly held that
the absence of any convictions under factor three is not dispositive
of the public interest inquiry. See, e.g., Edmund Chein, 72 FR 6580,
6593 n.22 (2007).
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I, therefore, conclude that the evidence pertinent to Registrant's
experience in dispensing controlled substances (factor two), his record
of compliance with Federal and State laws related to controlled
substances (factor
[[Page 65663]]
four), and such other conduct which may threaten public health and
safety (factor five), establishes that he has committed acts which
render his continued registration ``inconsistent with the public
interest.'' 21 U.S.C. 824(a)(4). This finding provides reason alone to
revoke Registrant's registrations and to deny any pending applications
to renew or modify his registrations.
The Loss of State Authority Ground
Under the CSA, a practitioner must possess authority to dispense
controlled substances under the laws of the State in which he engages
in his professional practice in order to obtain and maintain a DEA
registration. See 21 U.S.C. 802(21) (defining the term ``practitioner''
as a person ``licensed, registered, or otherwise permitted, by the
United States or the jurisdiction in which he practices * * * to
distribute, dispense * * * [or] administer * * * a controlled
substance''), id. Sec. 823(f) (``The Attorney General shall register
practitioners * * * to dispense * * * controlled substances * * * if
the applicant is authorized to dispense * * * controlled substances
under the laws of the State in which he practices.''). As these
provisions make plain, possessing authority under State law to handle
controlled substances is an essential condition for holding a DEA
registration. See John B. Freitas, 74 FR 17524, 17525 (2009); Dominick
A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920
(1988).
DEA, has therefore, held repeatedly that the CSA requires the
revocation of a registration issued to a practitioner whose State
authority has been suspended or revoked. 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). See also id. Sec. 824(a)(3) (a ``registration pursuant to
section 823 of this title to * * * dispense a controlled substance * *
* may be suspended or revoked by the Attorney General upon a finding
that the registrant * * * has had his State license suspended, revoked,
or denied by competent State authority and is no longer authorized by
State law to engage in the * * * dispensing of controlled
substances''). DEA has further held that revocation is warranted even
where a practitioner's State authority has been summarily suspended and
the State has yet to provide the practitioner with a hearing to
challenge the State's action. See Robert Wayne Mosier, 75 FR 49950
(2010) (``revocation is warranted * * * even in those instances where a
practitioner's State license has only been suspended, and there is the
possibility of reinstatement''); accord Bourne Pharmacy, 72 FR 18273,
18274 (2007).
As found above, on May 5, 2010, the Florida Surgeon General
immediately suspended Registrant's State medical license. Registrant is
therefore without authority to dispense controlled substances in the
State where he holds his DEA registrations. Registrant's loss of his
State authority thus provides an additional basis for revoking his
registrations. Accordingly, his registrations will be revoked and any
pending application will be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b) and 0.104, I order that DEA
Certificates of Registration BB2972140, XB2972140, and FB1490349,
issued to Stephen B. Brown, M.D., be, and they hereby are, revoked. I
further order that any pending application of Stephen B. Brown, M.D.,
to renew or modify such registrations, be, and it hereby is, denied.
This order is effective immediately.\3\
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\3\ For the same reason that I ordered the immediate suspension
of Registrant's DEA registrations, I conclude that the public
interest requires that this Order shall be effective immediately.
Dated: October 15, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-27031 Filed 10-25-10; 8:45 am]
BILLING CODE 4410-09-P