[Federal Register Volume 76, Number 209 (Friday, October 28, 2011)]
[Notices]
[Pages 66965-66968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27927]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 11-68]


Treasure Coast Specialty Pharmacy Decision and Order

    On September 14, 2011, Administrative Law Judge (ALJ) Gail A. 
Randall issued the attached recommended decision. There were no 
exceptions filed to the ALJ's decision.
    Having reviewed the record in its entirety including the ALJ's

[[Page 66966]]

recommended decision, I have decided to adopt the ALJ's rulings, 
findings of fact, conclusions of law, and recommended decision to grant 
the Government's Motion for Summary Decision.

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, BT9856002, issued to Treasure Coast Specialty Pharmacy, 
be, and it hereby is, revoked. I further order that any pending 
application of Treasure Coast Specialty Pharmacy, 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.

Scott Lawson, Esq., for the Government
Richard K. Alan, II, Esq., for the Respondents

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge

I. Facts

    Gail A. Randall, Administrative Law Judge. On June 27, 2011, the 
Administrator, Drug Enforcement Administration (``DEA'' or 
``Government''), issued an Order to Show Cause and an Immediate 
Suspension of Registration (``Order''), immediately suspending the DEA 
Certificate of Registration, No. BT9856002, of Treasure Coast Specialty 
Pharmacy (``Treasure Coast''), as a retail pharmacy pursuant to 21 
U.S.C. 824(d) (2006), because Treasure Coast's continued registration 
constitutes an imminent danger to the public health and safety. The 
Order also proposed to deny any pending DEA registration applications 
by Treasure Coast and to deny the pending application for DEA 
registration by Pappy's Drugs d/b/a Prima Vista Pharmacy (``Pappy's 
Drugs'') because their registrations would be inconsistent with the 
public interest, as that term is used in 21 U.S.C. 823(f).
    Specifically, the Order alleged that Treasure Coast ``has dispensed 
and continues to dispense controlled substances, primarily Schedule III 
anabolic steroids and Schedule II narcotics under circumstances 
demonstrating that [Treasure Coast] knew or should have known'' that 
those prescriptions were not issued for a legitimate medical purpose. 
[Order at 2]. The Order explains that this knowledge must be inferred 
from Treasure Coast's association with and filling of prescriptions 
issued by physicians who have pled guilty in federal court to 
unlawfully distributing steroids, and who market themselves as 
providing ``hormone replacement therapy'' and ``anti-aging'' services. 
[Id.]. In addition, the Order alleges that Treasure Coast dispensed 
controlled substances based on invalid prescriptions where the 
prescribing practitioners were not licensed to prescribe controlled 
substances in the various states where their patients were located.'' 
[Id.]. Further, the Government alleges that despite Treasure Coast 
being apprised that it is illegal for it to practice in North Carolina 
without a license, the pharmacy continued to ship anabolic steroids to 
customers located in that state. [Id. at 3-4].
    Next, the Government alleged that Treasure Coast filled 
prescriptions for Schedule II controlled substances prescriptions 
``under circumstances indicating that the drugs are diverted from 
legitimate channels, misused, or abused.'' [Id. at 4].
    On July 28, 2011, counsel for Treasure Coast and Pappy's Drugs 
(collectively, ``Respondents'') timely filed a request for a hearing in 
the above-captioned matter.
    On July 29, 2011, the Government filed its Motion For Summary 
Disposition And Motion to Stay Proceedings (``Government's Motion''). 
Therein, the Government moved for summary disposition of the portion of 
these proceedings that relate to Treasure Coast's registration. The 
Government based its motion on the fact that the State of Florida 
suspended Treasure Coast's registration as a community pharmacy and, 
therefore, Treasure Coast currently lacks state authority to handle 
controlled substances.
    On August 1, 2011, I ordered the Respondents to file a response to 
the Government's Motion, if any, on or before August 5, 2011.
    On August 5, 2011, counsel for the Respondents filed their 
Respondents' Response to DEA's Motion For Summary Disposition And 
Motion To Stay Proceedings (``Respondents' Response''). Therein, the 
Respondents argued that the Government is precluded from using Treasure 
Coast Pharmacy's lack of state licensure as a basis for revocation of 
its DEA registration, through summary disposition or otherwise, as the 
Government failed to state those grounds in its Order to Show Cause. 
Consequently, the Respondents' aver that Treasure Coast's due process 
rights require the Government ``to serve an Order to Show Cause * * * 
stating the DEA's new or substituted basis for revocation and calling 
upon [Treasure Coast] to appear at the time and place stated in the 
Order to Show Cause, but in no event less than thirty days after the 
date of receipt of this order.'' [Resp. Response at 2]. In addition, 
the Respondents argue that under applicable Florida law the owner of a 
pharmacy need not be licensed as such, yet must designate a managerial 
pharmacist that is so licensed. Further, citing Federgo v. Department 
of Professional Regulation, 452 So.2d 1063 (Fla. 3rd DCA 1984), the 
Respondents state that alleged wrongdoing of a pharmacist does not 
trigger nor support the suspension of the pharmacy's state license. 
[Id. at 3].
    On August 5, 2011, I ordered the Government to reply to the 
Respondents' Response no later than August 12, 2011.
    On August 9, 2011, counsel for Treasure Coast filed its 
Respondents' Supplemental Response to DEA's Motion For Summary 
Disposition And Motion To Stay Proceedings. Therein, the Respondents 
argue that Treasure Coast has a valid Florida retail pharmacy drug 
wholesale distribution license, and on that basis summary disposition 
is inappropriate.
    On August 12, 2011, counsel for the Government filed its 
Government's Reply To Respondent's Initial And Supplemental Responses 
To Government's Motion For Summary Disposition (``Government's 
Reply''). In its Reply the Government argues that its Motion for 
Summary Disposition remains valid. First, the Government addresses the 
Respondents' due process argument in stating

    The Administrative Procedures Act (APA), 5 U.S.C. 551 et seq, 
does not * * * mandate * * * an inelastic application of the 
strictures of administrative due process: ``[p]leadings in 
administrative proceedings are not judged by the standards applied 
to an indictment at common law.'' Citizens State Bank of Marshfield 
v. FDIC, 751 F.2d 209, 213 (8th Cir. 1984) (quoting Aloha Airlines 
v. Civil Aeronautics Bd., 598 F.2d 250, 262 (DC Cir. 1979), cited in 
Liddy's Pharmacy, L.L.C., 76 FR 48887, 48896, fn 15. As noted in 
Liddy's, ``the failure of the Government to disclose an allegation 
in the Order to Show Cause is not dispositive, and an issue can be 
litigated if the Government otherwise timely notifies a respondent 
of its intent to litigate the issue.'' Id. Due process is 
traditionally measured by the notice accorded respondents not by the 
contents of the OTSC but by subsequent prehearing statements. Id. 
citing Darrell Risner, DMD, 61 FR 728, 730 (1996); Nicholas A. 
Sychak, d/b/a Medicap Pharmacy, 65 FR 75959, 75961 (2000); John 
Stafford Noell, 59 FR 47359, 47361 (1994).

[Government's Reply at 3-4]. Therefore, the Government argues that it 
accorded

[[Page 66967]]

the Respondent due process when it notified Treasure Coast of its basis 
for summary disposition in the Government's prehearing Motion for 
Summary Disposition [Id. at 4].
    Next, the Government addresses the substantive basis for its 
Motion. Specifically, the Government argues that Treasure Coast's 
possession of a wholesale distributor permit is meaningless, as the 
loss of its community pharmacy license renders that permit useless. 
[Id. at 5-6]. The Government points to Florida Statute Sections 
499.01(2)(f) and 499.003(51) for the proposition that a pharmacy's 
possession of a wholesale distributor permit is conditioned on that 
pharmacy's maintenance of a community pharmacy license. [Id. at 5]. The 
Government buttresses this argument via provision of a letter from the 
Chief Legal Counsel for the Emergency Action Unit of the Florida 
Department of Health, stating ``[b]ecause Treasure Coast's community 
pharmacy permit is presently suspended, Treasure Coast may not operate 
under either its community pharmacy permit or its wholesale distributor 
permit.'' [Id.]. Hence, the Government argues that the Respondent 
currently lacks state authority to handle controlled substances and, 
therefore, summary revocation of its DEA registration is appropriate.
    For the reasons set forth below, I will grant the Government's 
Motion and recommend that the Deputy Administrator revoke Treasure 
Coast's DEA Certificate of Registration and deny any currently pending 
applications to renew its registration.

II. Discussion

a. Procedural Due Process

    First, I reject Treasure Coast's argument that it will not be 
afforded procedural due process if its registration is revoked due to 
its lack of state licensure, as that basis was not noticed in the 
Government's Order. As correctly stated by the Government, the confines 
of this administrative proceeding are not defined by the Government's 
Order to Show Cause, but rather the Government's prehearing 
disclosures, in toto. [See George Mathew, M.D., 75 FR 66,138, 66146 
(DEA 2010)]. Further, the DEA has consistently followed Goldberg v. 
Kelly, 397 U.S. 254, 270 (1970), by writing: ``In Goldberg, the Supreme 
Court held that `where governmental action seriously injures an 
individual, and the reasonableness of the action depends on fact 
findings, the evidence used to prove the Government's case must be 
disclosed to the individual so that he has an opportunity to show that 
it is untrue.' '' [Beau Boshers, M.D., 76 FR 19,401, 19,403 (DEA 2011) 
(citing Goldberg, 397 U.S. at 270 (quoting Greene v. McElroy, 360 U.S. 
474, 496 (1959))]. The Court has further explained that ``[a] party is 
entitled * * * to know the issues on which [the] decision will turn and 
to be apprised of the factual material on which the agency relies for 
decision so that he may rebut it. Indeed, the Due Process Clause 
forbids an agency to use evidence in a way that forecloses an 
opportunity to offer a contrary presentation.'' [Id. (citing Bowman 
Transp., Inc. v. Arkansas-Best Freight System, Inc., 419 U.S. 281, 288 
n.4 (1974))].''
    Here, the Government put the Respondent on notice through its 
Motion for Summary Disposition. Accordingly, Treasure Coast's due 
process rights are not violated because the Government, through its 
prehearing Motion, timely notified Treasure Coast of its intent to 
pursue revocation of its registration on the basis of the pharmacy's 
lack of state licensure. In its Response, Treasure Coast had the 
opportunity to rebut the factual basis upon which the Government based 
its Motion. For this reason, Treasure Coast's due process argument 
fails.

b. Wholesale Distribution Permit and State Authority

    The DEA will not maintain a controlled substances registration if 
the registrant is without state authority to handle controlled 
substances. The Controlled Substances Act (``CSA'') provides that 
obtaining a DEA registration is conditional on holding a state license 
to handle controlled substances. [See 21 U.S.C. 823(f) (``the Attorney 
General shall register practitioners (including pharmacies * * *) * * * 
if the applicant is authorized to dispense * * * controlled substances 
under the laws of the State in which he practices''). See also 
824(a)(3) (stating ``a registration may be suspended or revoked by the 
Attorney General upon a finding that the registrant has had his State 
license or registration suspended, revoked or denied by competent State 
authority'')]. The DEA, therefore, has consistently held that the CSA 
requires the DEA to revoke the registration of a registrant who no 
longer possesses a state license to handle controlled substances. [See 
e.g. Joseph Baumstarck, 74 FR 17,525, 17,527 (DEA 2009) (stating the 
``ALJ applied the Agency's long-settled ruled [sic] that a practitioner 
may not maintain his DEA registration if he lacks authority to handle 
controlled substances under the laws of the state in which he 
practices''); Roy Chi Lung, M.D., 74 FR 20,346 (DEA 2009); Gabriel 
Sagun Orzame, M.D., 69 FR 58,959 (DEA 2004); Alton E. Ingram, Jr., 
M.D., 69 FR 22,562 (DEA 2004); Graham Travers Schuler, M.D., 65 FR 
50,570 (DEA 2000); Dominick A. Ricci, M.D., 58 FR 51,104 (DEA 1993)].
    The parties do not dispute that the State of Florida suspended 
Treasure Coast's retail pharmacy registration. Therefore, Treasure 
Coast no longer possesses authority under that license to handle 
controlled substances. However, Treasure Coast argues that it currently 
possesses other state authority to handle controlled substances, 
through its maintenance of a wholesale distributor permit.
    Nevertheless, I am persuaded by the Government's argument that the 
State of Florida did not intend a pharmacy, who lacks authority to 
handle controlled substances under a retail pharmacy registration, to 
be permitted to handle controlled substances under a wholesale 
distribution permit. Not only is the alternative plainly inconsistent 
with Florida law, it renders an absurd interpretation of those laws. 
[See Fla. Stat. 499.01(2)(f) (2010) (only permitting a retail pharmacy 
to obtain a wholesale distribution permit); 499.003(51) (defining 
``retail pharmacy'' as ``a community pharmacy licensed under chapter 
465''); Durr v. Shinseki, 638 F.3d 1342, 1348 (11th Cir. 2011) 
(``[b]ecause the legislature is presumed to act with sensible and 
reasonable purpose, statute should, if at all possible, be read so as 
to avoid unjust or absurd conclusion.'')].
    This interpretation is consistent with the letter from the Chief 
Legal Counsel, Emergency Action Unit, Florida Department of Health, who 
wrote that, ``[b]ecause Treasure Coast's community pharmacy permit is 
presently suspended, Treasure Coast may not operate under either its 
community pharmacy permit or its wholesale distributor permit.'' 
[Government's Reply, attachment 3]. Therefore, because, as a matter of 
law, Treasure Coast no longer possesses state authority to handle 
controlled substances, its DEA registration must be revoked.

c. Respondents' Other Arguments

    Treasure Coast's other arguments for denial of the Government's 
Motion are irrelevant to this proceeding. First, the Respondent's 
argument that Florida law does not require the owner of a retail 
pharmacy to be registered as a pharmacist, but instead permits a 
pharmacy to designate managerial authority to a registered pharmacist, 
is irrelevant because despite the truth or

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falsity of that assertion, the DEA registers pharmacies, not 
pharmacists,\1\ and Treasure Coast as a retail pharmacy currently lacks 
state authority to operate.
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    \1\ 21 U.S.C. 823(f).
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    In addition, the Respondents' argument that the State of Florida 
may not revoke a pharmacy's registration on the basis of its 
pharmacist's wrongdoing is equally irrelevant. Upon a motion for 
summary disposition due to lack of state licensure, the DEA will not 
consider whether the State has a valid basis for revoking the 
Respondent's registration; it will only consider whether the Respondent 
currently possesses state authority. As Treasure Coast does not, its 
registration must be revoked.

III. Conclusion, Order, and Recommendation

    It is well-settled that when no question of fact is involved, or 
when the material facts are agreed upon, a plenary, adversarial 
administrative proceeding is not required under the rationale that 
Congress does not intend administrative agencies to perform meaningless 
tasks. [See Layfe Robert Anthony, M.D., 67 FR 35,582 (DEA 2002); 
Michael G. Dolin, M.D., 65 FR 5,661 (DEA 2000); see also Philip E. 
Kirk, M.D., 48 FR 32,887 (DEA 1983), aff'd sub nom. Kirk v. Mullen, 749 
F.2d 297 (6th Cir. 1984); Puerto Rico Acqueduct & Sewer Auth. v. EPA, 
35 F.3d 600, 605 (1st Cir. 1994)]. Consequently, there is no genuine 
dispute of material fact as the Respondent currently lacks state 
authority to handle controlled substances. Therefore, summary 
disposition for the Government is appropriate.\2\
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    \2\ This opinion does not reach the other factual issues made in 
the Order to Show Cause. Rather, this opinion solely addresses 
Treasure Coast's loss of ability to handle controlled substances in 
the State of Florida, and, thus, ability to maintain a DEA 
registration.
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    Accordingly, I hereby grant the Government's Motion for Summary 
Disposition.
    I also forward the portion of this case that relates to Treasure 
Coast's registration to the Deputy Administrator for final disposition. 
I recommend that Treasure Coast's DEA Certificate of Registration, 
Number BT9856002, be revoked and any pending renewal applications for 
this registration be denied.

    Dated: August 16, 2011.
Gail A. Randall,
Administrative Law Judge.
[FR Doc. 2011-27927 Filed 10-27-11; 8:45 am]
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