Registrant Actions - 2011
[Federal Register Volume 76, Number 209 (Friday, October 28, 2011)]
[Notices]
[Pages 66969-66972]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28011]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Aaron Gloskowski, D.O.; Decision and Order
On March 17, 2011, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Aaron Gloskowski, D.O. (Registrant), of Kearny, Arizona.
The Show Cause Order proposed the revocation of Registrant's DEA
Certificate of Registration BG6908757, as a practitioner in Schedules
II through V, and the denial of any pending applications to renew or
modify his registration, pursuant to 21 U.S.C. 824(a)(3) & (4) and
823(f). Show Cause Order at 1.
[[Page 66970]]
More specifically, the Show Cause Order alleged that as a result of
action by the Arizona Board of Osteopathic Examiners in Medicine and
Surgery (hereinafter, the Board), Registrant is without authority to
practice medicine or handle controlled substances in the State of
Arizona, the State in which he is registered with DEA, and therefore is
not entitled to hold a DEA registration. Id. at 1-2.
The Show Cause Order also alleged that pursuant to Registrant's
consent agreements with the Board, on two occasions, Registrant
provided urine samples for drug testing, which tested positive for
methamphetamine, a Schedule I \1\ controlled substance. Id. at 2. The
Order further alleged that Registrant has a history of drug abuse
dating to at least November 2008, when he entered into a Rehabilitation
Agreement with the Board, and that his self-abuse of a controlled
substance is also a ground for revocation of his DEA registration. Id.
The Order 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. Id. at 2. (citing 21 CFR 1301.43).
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\1\ In fact, methamphetamine is a schedule II controlled
substance. See 21 CFR 1308.l2(d).
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The Government initially attempted to serve the Show Cause Order by
certified mail addressed to Registrant at his registered address.
However, the mailing was returned to the Government marked: "Moved,
Left no Address" and "Unable to Forward." Government Request for
Final Agency Action (Request), at 1.
Registrant was then located by a DEA Diversion Investigator (DI),
who then resent the Show Cause Order to him by certified mail;
according to a certified mail receipt, on April 4, 2011, Registrant was
served with the Order. Request at 1-2. On March 21, 2011, the
Government also emailed the Order to Registrant; the DI confirmed that
Registrant had received the email and had opened the attachment
containing the Order. Id. at 2.
Since the date of service of the Show Cause Order, thirty days have
now passed and neither Registrant, nor anyone purporting to represent
him, has requested a hearing or submitted a written statement in lieu
of a hearing. I therefore find that Registrant 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)
& (e). I make the following findings of fact.
Findings
Registrant is the holder of DEA Certificate of Registration
BG6908757, which authorizes him to handle controlled substances in
Schedules II through V as a practitioner, at the registered address of
100 Tilbury Drive, Kearny, Arizona. His registration does not expire
until September 30, 2012.
Registrant was formerly licensed as an osteopathic physician in
Arizona. On November 21, 2008, Registrant entered into a Stipulated
Rehabilitation Agreement with the Arizona Board of Osteopathic
Examiners in Medicine and Surgery, under which he was allowed to
participate in the Board's confidential program for the treatment and
rehabilitation of doctors of medicine who are impaired by alcohol or
drug abuse, pursuant to A.R.S. Sec. 32-1861. See GX E, at 1
(Stipulated Rehabilitation Agreement). The Rehabilitation Agreement was
to remain in effect for 5 years. Id. at 3.
The Rehabilitation Agreement stipulated that any violation of its
terms constituted unprofessional conduct as defined in A.R.S. Sec. 32-
1854,\2\ and may have resulted in disciplinary action pursuant to
A.R.S. Sec. 32-1855. Id. at 1. Therein, Registrant agreed to various
conditions, including that he take only those medications prescribed to
him by his primary care physician; that he submit to biological fluid
collection for testing, id. at 4-5; and that in the event of a relapse,
he would enter into an Interim Consent Agreement for Practice
Restriction that required, among other things, that he not practice
medicine until such time as he successfully completed a long-term
inpatient or residential treatment program designated by the Board. Id.
at 7.
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\2\ Under Arizona law, "unprofessional conduct" includes,
inter alia: "[p]racticing medicine while under the influence of
alcohol, narcotic or hypnotic drugs or any substance that impairs or
may impair the licensee's ability to safely and skillfully practice
medicine"; "[e]ngaging in the practice of medicine in a manner
that harms or may harm a patient or that the Board determines falls
below the community standard"; "[v]iolating a formal order,
probation or a stipulation issued by the Board under this chapter;"
"[a]ny conduct or practice that endangers a patient's or the
public's health or may reasonably be expected to do so"; and
"[a]ny conduct or practice that impairs the licensee's ability to
safely and skillfully practice medicine or that may reasonably be
expected to do so." Ariz. Rev. Stat. Sec. 32-1854 (3), (6), (25),
(38), and (39).
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On February 25, 2009, the Board was notified that Registrant had
provided a biological fluid sample which tested positive for
methamphetamine. GX F, at 3 (Consent Agreement and Order For Probation,
June 29, 2009). Upon notice from the Executive Director of the Board,
Registrant voluntarily refrained from practicing medicine, successfully
completed an inpatient treatment program, and entered an outpatient
program. Id. at 3.
On June 29, 2009, the Board issued an Interim Order placing
Registrant on probation for five years. The Board imposed extensive
conditions on Registrant, including that he participate in the Board's
monitored aftercare program and participate in the intensive outpatient
program until the program's medical director approved his discharge
from it. Id. at 4. The Board also ordered that he attend a 12-step
program or self-help group; obtain psychological counseling; take no
medication unless prescribed by his primary care physician or in an
emergency; consume no alcohol or poppy seeds; and submit biological
fluid samples upon the Board's request with the further provision that
his failure to cooperate in the collection of such samples "may be
considered [a] failure to comply with th[e] Order." Id. at 4-7.
Finally, the Order provided that "the positive finding in
[Registrant's] biological fluid of a drug or medication not prescribed
to [him] in accordance with this Order shall be considered proof of a
relapse," and that in the event of a relapse, his "license to
practice medicine shall be summarily suspended pending a formal
administrative hearing for revocation." Id. at 7-8.
On June 9, 2010, Registrant submitted a biological fluid sample for
testing pursuant to the 2009 Order. GX H, at 5-6. As a result of
irregularities found in the sample, Registrant was directed by the
Board to submit an observed urine test and hair test for sampling. Id.
at 6. Registrant submitted the biological fluid testing sample;
however, the collected sample had not been "observed" and the chain
of custody form did not indicate "observed" but "monitored." Id. at
7. The Board then informed Registrant by letter that all future
biological testing fluid samples must be observed. Id. at 8.
On July 27, 2010, the day after meeting with Board staff to discuss
his compliance with the 2009 Order, Registrant submitted to another
urine test, which tested positive for amphetamines and methamphetamine.
Based in part on this test result, the Board summarily suspended
Registrant's license to practice osteopathic medicine. GX G, at 3-4.
Following a hearing before a State Administrative Law Judge (ALJ),
the Board made extensive findings regarding Registrant's compliance
with the Consent Order. GX H. Regarding
[[Page 66971]]
Registrant's July 27, 2010 drug test, the Board found that while the
positive result for amphetamines could be explained by a legitimate
prescription Registrant had for Vyvanse, the methamphetamine result
revealed a high concentration of an isomer which "marks the
biologically active ingredient in the street drug methamphetamine that
is not normally prescribed." Id. at 9. While Respondent argued that he
was also taking Claritin-D at the time of the test, the director of the
laboratory that performs biological fluid testing for the Board, and
who holds a Ph.D. in toxicology, id. at 4, "testified that he had no
doubt whatsoever that [Registrant's] July 27, 2010 specimen tested
positive for methamphetamine." Id. at 9, 12. The Board thus found that
Registrant had "relapsed to substance abuse and violated the Consent
Agreement" and that "[t]hese acts constitute unprofessional conduct
as defined by" Arizona law. Id. at 12 (citing Ariz. Rev. Stat. Sec.
32-1854(25), (38), and (39)). The Board further found that Registrant
had failed to accept responsibility "for his repeated failures to
comply with the Consent Agreement and his relapse," and revoked his
state osteopathic license. Id. at 12-13.
I therefore find that Registrant is currently without authority to
handle controlled substances under the laws of the State of Arizona,
the State in which he is registered with DEA.
Discussion
The Loss of State Authority Ground
Under the Controlled Substances Act (CSA), a practitioner must be
currently authorized to handle controlled substances in the
"jurisdiction in which he practices" in order to maintain a DEA
registration. See 21 U.S.C. 802(21) ("[t]he term 'practitioner' means
a physician * * * 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"). See also id. Sec. 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."). As these provisions make plain,
possessing authority under state law to handle controlled substances is
an essential condition for obtaining and maintaining a DEA
registration.
Accordingly, DEA has held that revocation of a registration is
warranted whenever a practitioner's state authority to dispense
controlled substances 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 21 U.S.C. 824(a)(3) (authorizing revocation of a
registration "upon a finding that the registrant * * * has had his
State license or registration suspended [or] revoked * * * and is no
longer authorized by State law to engage in the * * * distribution [or]
dispensing of controlled substances").
As found above, on March 22, 2011, the Arizona Board revoked
Registrant's state osteopathic medicine license. Accordingly,
Registrant is without authority to dispense controlled substances in
the State where he practices medicine and holds his DEA registration,
and is therefore no longer entitled to hold his registration. See 21
U.S.C. 802 (21), 823(f), 824(a)(3). Therefore, pursuant to the
authority granted under 21 U.S.C. 824(a)(3), his registration will be
revoked.
The Public Interest Ground
The Government further argues that Registrant's abuse of
methamphetamine is an additional ground for revoking his registration
because he has committed acts that render his registration inconsistent
with the public interest. Request for Final Agency Action, at 3 (citing
21 U.S.C. 824(a)(4)). I agree.
Section 304(a) of the Controlled Substances Act 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 committed
such acts as would render his registration under section 823 of this
title inconsistent with the public interest as determined under such
section." 21 U.S.C. 824(a)(4). With respect to a practitioner, the Act
requires the consideration of the following factors in making the
public interest determination:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
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 for a registration. Id. Moreover, I am "not
required to make findings as to all of the factors." Hoxie v. DEA, 419
F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165,
173-74 (DC Cir. 2005).
In this matter, while I have considered all of the factors, I
conclude that it is not necessary to make findings with respect to
factors one \3\ through four. However, I conclude that factor five,
which authorizes the Agency to consider "other such conduct which may
threaten public health and safety," 21 U.S.C. 823(f)(5), supports a
finding that Respondent has committed acts which render his continued
"registration inconsistent with the public interest." 21 U.S.C.
824(a)(4).
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\3\ For the same reason that supports revocation under 21 U.S.C.
824(a)(3), factor one would also support revocation.
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Under longstanding Agency precedent, factor five encompasses
"wrongful acts relating to controlled substances committed by a
registrant outside of his professional practice but which relate to
controlled substances." David E. Trawick, 53 FR 5326, 5327 (1988).
More recently, I explained that "DEA has long held that a
practitioner's self-abuse of a controlled substance is a relevant
consideration under factor five and has done so even when there is no
evidence that the registrant abused his prescription writing authority.
Moreover, DEA has revoked registrations and/or denied applications for
a registration even where there is no evidence that the practitioner
committed acts involving unlawful distribution to others." Tony T.
Bui, M.D., 75 FR 49979, 49989 (2010) (citations omitted.)
As found above, in 2008, Registrant self-reported to the Arizona
Board that he was beginning in-patient treatment for substance abuse.
GX H, at 3. Moreover, on two subsequent occasions (February 25, 2009
and July 27, 2010), Registrant provided biological specimens which
tested positive for methamphetamine, in violation of his agreements
with the Board. Of further significance, the Board found that
Registrant's July 2010 test sample had a 90% concentration of an isomer
which is the biologically active ingredient in methamphetamine which is
sold on the street. Id. at 9.
Thus, substantial evidence supports the conclusion that Registrant
has
[[Page 66972]]
repeatedly engaged in the self-abuse of a Schedule II controlled
substance, and done so notwithstanding the attempts by the Arizona
Board to assist Registrant to rehabilitate himself. I therefore hold
that Registrant has engaged in "such other conduct which may threaten
public health or safety," 21 U.S.C. 823(f)(5), and that he has
committed acts which render his registration "inconsistent with the
public interest." Id. Sec. 824(a)(4). This conclusion provides a
further reason to revoke Registrant's registration and to deny any
pending applications.
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), I order that DEA Certificate of
Registration BG6908757, issued to Aaron Gloskowski, D.O., be, and it
hereby is, revoked. I further order that any pending application of
Aaron Gloskowski, D.O., to renew or modify his registration, be, and it
hereby is, denied. This Order is effective immediately.
Dated: October 7, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-28011 Filed 10-27-11; 8:45 am]
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