83_FR_7254 83 FR 7220 - Trinity Pharmacy I; Order Terminating Registration

83 FR 7220 - Trinity Pharmacy I; Order Terminating Registration

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

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

Page Range7220-7220
FR Document2018-03297

Federal Register, Volume 83 Issue 34 (Tuesday, 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

7220 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices New Hampshire, the State in which he either option, and the consequence for person . . . shall terminate, without any is registered with the Agency and, failing to elect either option. Id. at 15. further action by the Administration, if therefore, he is not entitled to maintain In a letter from its counsel dated and when such person . . . surrenders his DEA registration. Hooper, 76 FR at August 12, 2015, Trinity I requested a a registration.’’ As a result, I find that 71,371–72; Blanton, 43 FR at 27,617. hearing on the allegations. ALJ Ex. 2a. Respondent’s registration terminated Accordingly, I will order that The matter was placed on the docket of upon its surrender to the Agency, and Respondent’s registration be revoked the Office of Administrative Law Judges accordingly, that the Show Cause and that any pending application for the and assigned to Chief Administrative proceeding is now moot.2 renewal or modification of his Law Judge John J. Mulrooney, II registration be denied. 21 U.S.C. (hereinafter, CALJ), who conducted a Pursuant to the authority vested in me 824(a)(3), id. § 823(f). hearing on the allegations on January 4– under 5 U.S.C. 554(e) and 28 CFR 8, 2016, in Arlington, Virginia, and on 0.100(b), I declare that DEA Certificate Order January 11–12, 2016, in Tampa, Florida. of Registration BT9848170, issued to Pursuant to the authority vested in me On May 12, 2016, the CALJ issued and Trinity I, terminated upon its surrender by 21 U.S.C. 824(a), as well as 28 CFR served his Recommended Decision, to the Agency. Pursuant to the authority 0.100(b), I order that DEA Certificate of which included the CALJ’s vested in me by 21 U.S.C. 823(f) and Registration FV0660565 issued to Robert recommendation that I revoke 824(a), as well as 28 CFR 0.100(b), I C. Vidaver, M.D., be, and it hereby is, Respondent’s registration and deny any further order that the Order to Show revoked. Pursuant to the authority pending applications for renewal. Cause issued to Trinity I be, and it vested in me by 21 U.S.C. 823(f), as well Recommended Decision (R.D.), at 66.1 hereby is, dismissed. This Order is as 28 CFR 0.100(b), I further order that On June 2, 2016, the Government and effective immediately. any pending application of Robert C. Respondent each filed Exceptions to the CALJ’s Recommended Decision. Dated: February 6, 2018. Vidaver, M.D., to renew or modify this registration, as well as any other Thereafter, the record was forwarded to Robert W. Patterson, pending application by him for me for final agency action. Acting Administrator. registration in the State of New On March 22, 2017, during the course [FR Doc. 2018–03297 Filed 2–16–18; 8:45 am] Hampshire, be, and it hereby is, denied. of reviewing the record, my office BILLING CODE 4410–09–P This order is effective March 22, 2018. received a ‘‘Notice of Trinity Pharmacy I Change of Business Status’’ Dated: February 6, 2018. (hereinafter, ‘‘Notice’’) from the 2 In its Notice, the Government stated that it Robert W. Patterson, forwarded the February 27, 2017 correspondence Government. In its Notice, the from Trinity I’s counsel for my consideration Acting Administrator. Government ‘‘informs the Acting because it is ‘‘unsure of how Trinity ‘disposed of’ [FR Doc. 2018–03303 Filed 2–16–18; 8:45 am] Administrator of the change of business the ‘controlled substances in the possession of the BILLING CODE 4410–09–P status for’’ Trinity I. Notice, at 1. pharmacy,’ when it disposed of them, and if Specifically, the Government states that, applicable, to whom the controlled substances were on March 17, 2017, counsel for Trinity provided.’’ Notice at 2 (quoting Ex. B to Notice, at DEPARTMENT OF JUSTICE 1). This uncertainty, in turn, is based solely on the I sent an email to the Group Supervisor Government’s observation that Trinity I’s counsel of the Agency’s Tampa, Florida District cited to federal regulations in his letter that ‘‘do[ ] Drug Enforcement Administration Office, which in turn attached a copy of not exist.’’ Id. Specifically, Trinity I’s counsel stated [Docket No. 15–27] a February 27, 2017 letter to the DEA’s that Trinity I ‘‘desires to discontinue business Registration Unit stating that Trinity I activities.’’ Ex. B to Notice, at 1. As a result, he Trinity Pharmacy I; Order Terminating ‘‘desires to discontinue business enclosed Trinity I’s ‘‘original DEA Certificate of activities’’ and enclosed ‘‘the original Registration’’ ‘‘as required by 21 CFR Section Registration 1307.14’’ and stated that Trinity I ‘‘does not possess DEA Certificate of Registration for On July 10, 2015, the Deputy any unexecuted Order forms,’’ and ‘‘[a]ll controlled Cancellation.’’ Feb. 27, 2017 Letter to substances in the possession of the pharmacy have Assistant Administrator, Office of DEA Registration Unit from Dale R. been disposed of in accordance with 21 CFR Diversion Control, Drug Enforcement Sisco, Counsel for Trinity I, attached as Section 1307.21.’’ Id. Administration, issued an Order to Exhibit B to Notice, at 1. The The Government observed, correctly, that ‘‘21 Show Cause to Trinity Pharmacy I Government attached to its Notice a CFR Section 1307.14’’ and ‘‘21 CFR Section (hereinafter ‘‘Trinity I’’ or Respondent), copy of the email, the letter, and a copy 1307.21’’ ‘‘do[ ] not exist,’’ and that the federal which proposed the revocation of its of Trinity I’s ‘‘original DEA Certificate of regulation setting forth the procedures a DEA DEA Certificate of Registration registrant must follow when it desires to Registration’’ sent to the Agency. Notice BT9848170, pursuant to which it is discontinue business activities altogether is 21 CFR at 1; Exhibits A–B to Notice. It is 1301.52(c). Notice, at 2. However, the Government authorized to dispense controlled undisputed that Trinity I surrendered its failed to note that the provision cited by Trinity I’s substances in schedules II through V as ‘‘original DEA Certificate of counsel related to the disposal of controlled a retail pharmacy, at the registered Registration’’ to the Agency. substances (21 CFR 1307.21) did exist until it was location of 11130 Seminole Boulevard, Based on these facts, I find that re-codified and amended on September 9, 2014 to Seminole, Florida. Administrative Law Respondent has surrendered its DEA what is now 21 CFR 1301.52(c) and part 1317 of Judge Exhibit (ALJ Ex.) 1a, at 1. As registration certificate. Pursuant to 21 Title 21 of the Code of Federal Regulations. See generally Disposal of Controlled Substances Final grounds for the proposed action, the CFR 1301.52(a), ‘‘the registration of any Rule, 79 FR 53520 (Sept. 9, 2014). Most Show Cause Order alleged that importantly, the Government offered no factual Respondent’s ‘‘continued registration is sradovich on DSK3GMQ082PROD with NOTICES 1 Trinity Pharmacy II (‘‘Trinity II’’), located in basis for why it is ‘‘unsure’’ of how Trinity I inconsistent with the public interest.’’ Clearwater, Florida, was served with a separate July disposed of its controlled substances when Trinity 10, 2015 Order to Show Cause by the Government. I discontinued its business activities. Nevertheless, Id. (citing 21 U.S.C. 823(f) and ALJ Ex. 1b. Although the CALJ eventually ordered 824(a)(4)). The Show Cause Order if the Government has a factual basis to believe that the consolidation of the evidentiary hearings for Trinity I and Trinity II, see ALJ Ex. 10 at 2, the CALJ Trinity I violated the Controlled Substances Act notified Respondent of its right to when it disposed of its controlled substances as a wrote separate recommendations regarding each request a hearing on the allegations or Respondent, and I therefore will issue a separate result of its discontinued business activities, then to submit a written statement in lieu of Order regarding the disposition of the Show Cause I direct the Government to investigate such a hearing, the procedure for electing Order directed at Trinity II. violations immediately. VerDate Sep<11>2014 17:55 Feb 16, 2018 Jkt 244001 PO 00000 Frm 00085 Fmt 4703 Sfmt 9990 E:\FR\FM\20FEN1.SGM 20FEN1


Document Created: 2018-02-17 02:29:37
Document Modified: 2018-02-17 02:29:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation83 FR 7220 
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