83 FR 7220 - Trinity Pharmacy I; Order Terminating Registration

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 34 (February 20, 2018)

[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Page 7220]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03297]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 15-27]


Trinity Pharmacy I; Order Terminating Registration

    On July 10, 2015, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Trinity Pharmacy I (hereinafter ``Trinity I'' or 
Respondent), which proposed the revocation of its DEA Certificate of 
Registration BT9848170, pursuant to which it is authorized to dispense 
controlled substances in schedules II through V as a retail pharmacy, 
at the registered location of 11130 Seminole Boulevard, Seminole, 
Florida. Administrative Law Judge Exhibit (ALJ Ex.) 1a, at 1. As 
grounds for the proposed action, the Show Cause Order alleged that 
Respondent's ``continued registration is inconsistent with the public 
interest.'' Id. (citing 21 U.S.C. 823(f) and 824(a)(4)). The Show Cause 
Order notified Respondent of its right to request a hearing on the 
allegations or to submit a written statement in lieu of a hearing, the 
procedure for electing either option, and the consequence for failing 
to elect either option. Id. at 15.
    In a letter from its counsel dated August 12, 2015, Trinity I 
requested a hearing on the allegations. ALJ Ex. 2a. The matter was 
placed on the docket of the Office of Administrative Law Judges and 
assigned to Chief Administrative Law Judge John J. Mulrooney, II 
(hereinafter, CALJ), who conducted a hearing on the allegations on 
January 4-8, 2016, in Arlington, Virginia, and on January 11-12, 2016, 
in Tampa, Florida. On May 12, 2016, the CALJ issued and served his 
Recommended Decision, which included the CALJ's recommendation that I 
revoke Respondent's registration and deny any pending applications for 
renewal. Recommended Decision (R.D.), at 66.\1\ On June 2, 2016, the 
Government and Respondent each filed Exceptions to the CALJ's 
Recommended Decision. Thereafter, the record was forwarded to me for 
final agency action.
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    \1\ Trinity Pharmacy II (``Trinity II''), located in Clearwater, 
Florida, was served with a separate July 10, 2015 Order to Show 
Cause by the Government. ALJ Ex. 1b. Although the CALJ eventually 
ordered the consolidation of the evidentiary hearings for Trinity I 
and Trinity II, see ALJ Ex. 10 at 2, the CALJ wrote separate 
recommendations regarding each Respondent, and I therefore will 
issue a separate Order regarding the disposition of the Show Cause 
Order directed at Trinity II.
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    On March 22, 2017, during the course of reviewing the record, my 
office received a ``Notice of Trinity Pharmacy I Change of Business 
Status'' (hereinafter, ``Notice'') from the Government. In its Notice, 
the Government ``informs the Acting Administrator of the change of 
business status for'' Trinity I. Notice, at 1. Specifically, the 
Government states that, on March 17, 2017, counsel for Trinity I sent 
an email to the Group Supervisor of the Agency's Tampa, Florida 
District Office, which in turn attached a copy of a February 27, 2017 
letter to the DEA's Registration Unit stating that Trinity I ``desires 
to discontinue business activities'' and enclosed ``the original DEA 
Certificate of Registration for Cancellation.'' Feb. 27, 2017 Letter to 
DEA Registration Unit from Dale R. Sisco, Counsel for Trinity I, 
attached as Exhibit B to Notice, at 1. The Government attached to its 
Notice a copy of the email, the letter, and a copy of Trinity I's 
``original DEA Certificate of Registration'' sent to the Agency. Notice 
at 1; Exhibits A-B to Notice. It is undisputed that Trinity I 
surrendered its ``original DEA Certificate of Registration'' to the 
Agency.
    Based on these facts, I find that Respondent has surrendered its 
DEA registration certificate. Pursuant to 21 CFR 1301.52(a), ``the 
registration of any person . . . shall terminate, without any further 
action by the Administration, if and when such person . . . surrenders 
a registration.'' As a result, I find that Respondent's registration 
terminated upon its surrender to the Agency, and accordingly, that the 
Show Cause proceeding is now moot.\2\
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    \2\ In its Notice, the Government stated that it forwarded the 
February 27, 2017 correspondence from Trinity I's counsel for my 
consideration because it is ``unsure of how Trinity `disposed of' 
the `controlled substances in the possession of the pharmacy,' when 
it disposed of them, and if applicable, to whom the controlled 
substances were provided.'' Notice at 2 (quoting Ex. B to Notice, at 
1). This uncertainty, in turn, is based solely on the Government's 
observation that Trinity I's counsel cited to federal regulations in 
his letter that ``do[ ] not exist.'' Id. Specifically, Trinity I's 
counsel stated that Trinity I ``desires to discontinue business 
activities.'' Ex. B to Notice, at 1. As a result, he enclosed 
Trinity I's ``original DEA Certificate of Registration'' ``as 
required by 21 CFR Section 1307.14'' and stated that Trinity I 
``does not possess any unexecuted Order forms,'' and ``[a]ll 
controlled substances in the possession of the pharmacy have been 
disposed of in accordance with 21 CFR Section 1307.21.'' Id.
     The Government observed, correctly, that ``21 CFR Section 
1307.14'' and ``21 CFR Section 1307.21'' ``do[ ] not exist,'' and 
that the federal regulation setting forth the procedures a DEA 
registrant must follow when it desires to discontinue business 
activities altogether is 21 CFR 1301.52(c). Notice, at 2. However, 
the Government failed to note that the provision cited by Trinity 
I's counsel related to the disposal of controlled substances (21 CFR 
1307.21) did exist until it was re-codified and amended on September 
9, 2014 to what is now 21 CFR 1301.52(c) and part 1317 of Title 21 
of the Code of Federal Regulations. See generally Disposal of 
Controlled Substances Final Rule, 79 FR 53520 (Sept. 9, 2014). Most 
importantly, the Government offered no factual basis for why it is 
``unsure'' of how Trinity I disposed of its controlled substances 
when Trinity I discontinued its business activities. Nevertheless, 
if the Government has a factual basis to believe that Trinity I 
violated the Controlled Substances Act when it disposed of its 
controlled substances as a result of its discontinued business 
activities, then I direct the Government to investigate such 
violations immediately.
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    Pursuant to the authority vested in me under 5 U.S.C. 554(e) and 28 
CFR 0.100(b), I declare that DEA Certificate of Registration BT9848170, 
issued to Trinity I, terminated upon its surrender to the Agency. 
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 further order that the Order to Show 
Cause issued to Trinity I be, and it hereby is, dismissed. This Order 
is effective immediately.

    Dated: February 6, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-03297 Filed 2-16-18; 8:45 am]
 BILLING CODE 4410-09-P