[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2904-2905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00956]



[[Page 2904]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Tel-Pharmacy; Decision and Order

    On August 3, 2017, the then Acting Assistant Administrator, 
Diversion Control Division, Drug Enforcement Administration 
(hereinafter, Government), issued an Order to Show Cause (hereinafter, 
OSC) to Tel-Pharmacy (hereinafter, Applicant) of Coconut Creek, 
Florida. OSC, at 1. The OSC proposed the denial of Applicant's 
application for DEA Certificate of Registration No. W16006664A. It 
alleged that Applicant ``does not have authority to operate a pharmacy 
in Florida, the state for which it seeks a [DEA registration].'' Id. 
(citing 21 U.S.C. 823(f)). Specifically, the OSC alleged that 
Applicant's Florida pharmacy permit expired on February 28, 2017, and 
was not renewed. Id. at 2.
    The OSC notified Applicant of the right to request a hearing on the 
allegations or to submit a written statement, while waiving the right 
to a hearing, the procedures for electing each option, and the 
consequences for failing to elect either option. Id. at 2 (citing 21 
CFR 1301.43). The OSC also notified Applicant of the opportunity to 
submit a corrective action plan. Id. at 2-3 (citing 21 U.S.C. 
824(c)(2)(C)).

Adequacy of Service

    In a Declaration dated December 6, 2021, a Diversion Investigator 
(hereinafter, the DI) assigned to the DEA's Miami Field Division stated 
that on August 4, 2017, a Special Agent and Task Force Officer from 
DEA's Miami Field Division hand-delivered a copy of the OSC to 
Applicant's agent at the agent's residence. Request for Final Agency 
Action (hereinafter, RFAA), Exhibit (hereinafter, RFAAX) 1, at 1-2; see 
also RFAAX 1, Appendix (hereinafter, App.) B.
    The Government forwarded its RFAA, along with the evidentiary 
record, to this office on December 8, 2021. In its RFAA, the Government 
represents that ``neither [Applicant] nor any attorney representing 
[Applicant] has requested a hearing'' nor ``has [Applicant] nor any 
attorney for [Applicant] submitted a written statement.'' RFAA, at 2. 
The Government ``seeks to deny [Applicant's] application for a [DEA 
registration] because [Applicant] lacks authority to handle controlled 
substances in [Florida], the state in which it seeks registration with 
DEA.'' Id. at 1. Accordingly, the Government requests that the 
Administrator deny Applicant's application. Id. at 5.
    Based on the DI's Declaration, the Government's written 
representations, and my review of the record, I find that the 
Government accomplished service of the OSC on Applicant on August 4, 
2017. I also find that more than thirty days have now passed since the 
Government accomplished service of the OSC. Further, based on the 
Government's written representations, I find that neither Applicant, 
nor anyone purporting to represent the Applicant, requested a hearing, 
submitted a written statement while waiving Applicant's right to a 
hearing, or submitted a corrective action plan. Accordingly, I find 
that Applicant has waived the right to a hearing and the right to 
submit a written statement and corrective action plan. 21 CFR 
1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this 
Decision and Order based on the record submitted by the Government, 
which constitutes the entire record before me. 21 CFR 1301.43(e).

Findings of Fact

Applicant's Application for DEA Registration

    On or about January 27, 2016, Applicant submitted an application 
for a DEA Certificate of Registration as a retail pharmacy in Schedules 
II through V with a proposed registered address at 5489 Wiles Rd. 302, 
Coconut Creek, FL 33073. RFAAX 1, App. A, at 1. Applicant's application 
was assigned Control No. W16006664A.\1\ Id.
---------------------------------------------------------------------------

    \1\ In spite of Applicant's discontinuance of business, its 
application remains pending and I will continue to assess the 
application under 21 U.S.C. 823. See Lawrence E. Stewart, M.D., 86 
FR 15,257 (2021).
---------------------------------------------------------------------------

The Status of Applicant's State License

    In her Declaration, the DI stated that as of December 6, 2021, 
Applicant's state license was listed as ``null and void'' on the 
Florida Department of Health website. RFAAX 1, at 2; see also RFAAX 1, 
App. C. According to the Florida Department of Health's online records, 
of which I take official notice, Applicant's state pharmacy 
registration PH29813 is ``null and void.'' \2\ Florida Department of 
Health's License Verification, https://mqa-internet.doh.state.fl.us/MQASearchServices/Home (last visited date of signature of this Order).
---------------------------------------------------------------------------

    \2\ Under the Administrative Procedure Act, an agency ``may take 
official notice of facts at any stage in a proceeding--even in the 
final decision.'' United States Department of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), 
``[w]hen an agency decision rests on official notice of a material 
fact not appearing in the evidence in the record, a party is 
entitled, on timely request, to an opportunity to show the 
contrary.'' Accordingly, Applicant may dispute my finding by filing 
a properly supported motion for reconsideration of finding of fact 
within fifteen calendar days of the date of this Order. Any such 
motion and response shall be filed and served by email to the other 
party and to Office of the Administrator, Drug Enforcement 
Administration at [email protected].
---------------------------------------------------------------------------

    Accordingly, I find that Applicant is not currently licensed to 
engage in the practice of pharmacy in Florida, the state in which 
Applicant applied for registration with the DEA.

Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823 of the 
Controlled Substances Act (hereinafter, CSA) ``upon a finding that the 
registrant . . . has had [its] State license or registration suspended 
. . . [or] revoked . . . by competent State authority and is no longer 
authorized by State law to engage in the . . . dispensing of controlled 
substances.'' With respect to a practitioner, the DEA has also long 
held that the possession of authority to dispense controlled substances 
under the laws of the state in which a practitioner engages in 
professional practice is a fundamental condition for obtaining and 
maintaining a practitioner's registration. See, e.g., James L. Hooper, 
M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 F. App'x 826 (4th 
Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 (1978).
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined the term ``practitioner'' to mean ``a pharmacy 
. . . or other person 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.'' 21 U.S.C. 802(21). Second, in 
setting the requirements for obtaining a practitioner's registration, 
Congress directed that ``[t]he Attorney General shall register 
practitioners . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated 
that a practitioner possess state authority in order to be deemed a 
practitioner under the CSA, the DEA has held repeatedly that revocation 
of a practitioner's registration is the appropriate sanction whenever 
he is no longer authorized to dispense controlled substances under the 
laws of the state in which he practices. See, e.g.,

[[Page 2905]]

James L. Hooper, 76 FR 71,371-72; Sheran Arden Yeates, M.D., 71 FR 
39,130, 39,131 (2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 
(1993); Bobby Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh 
Blanton, 43 FR 27,617.
    According to Florida statute, ``It is unlawful for any person to 
own, operate, maintain, open, establish, conduct, or have charge of, 
either alone or with another person or persons, a pharmacy: (a) Which 
is not registered under the provisions of this chapter.'' Fla. Stat. 
Ann. 465.015(1). Further, ``the practice of the profession of 
pharmacy'' definition ``includes compounding, dispensing, and 
consulting concerning contents, therapeutic values, and uses of any 
medicinal drug \3\ . . . .'' Fla. Stat. Ann. 465.003(13) (West, 2021).
---------------------------------------------------------------------------

    \3\ ``Medicinal Drugs'' or ``Drugs'' means ``those substances or 
preparations commonly known as `prescription' or `legend' drugs 
which are required by federal or state law to be dispensed only on a 
prescription . . . .'' Fla. Stat. Ann. 465.003(8).
---------------------------------------------------------------------------

    Here, the undisputed evidence in the record is that Applicant 
currently lacks authority to operate a pharmacy in Florida. As already 
discussed, a pharmacy must be a licensed to dispense a medicinal drug, 
including a controlled substance, in Florida. Thus, because Applicant 
lacks authority to practice pharmacy in Florida and, therefore, is not 
authorized to dispense controlled substances in Florida, Applicant is 
not eligible to receive a DEA registration. Accordingly, I will order 
that Applicant's application for a DEA registration be denied.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 823(f), I hereby order that the pending application for a 
Certificate of Registration, Control Number W16006664A, submitted by 
Tel-Pharmacy, is denied, as well as any other pending application of 
Tel-Pharmacy for additional registration in Florida. This Order is 
effective February 18, 2022.

Anne Milgram,
Administrator.
[FR Doc. 2022-00956 Filed 1-18-22; 8:45 am]
BILLING CODE 4410-09-P