Decisions and Orders:

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).

\1\ In fact, methamphetamine is a schedule II controlled substance. See 21 CFR 1308.l2(d).

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.

\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).

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).

\3\ For the same reason that supports revocation under 21 U.S.C. 824(a)(3), factor one would also support revocation.

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

BILLING CODE 4410-09-P