Notice2022-00956
Tel-Pharmacy; Decision and Order
Primary source
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Published
January 19, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 87 Issue 12 (Wednesday, January 19, 2022)</title>
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[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2904-2905]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00956]
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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.
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\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).
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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, <a href="https://mqa-internet.doh.state.fl.us/MQASearchServices/Home">https://mqa-internet.doh.state.fl.us/MQASearchServices/Home</a> (last visited date of signature of this Order).
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\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 <a href="/cdn-cgi/l/email-protection#c3a7a6a2eda2a7a7aceda2b7b7acb1ada6bab083a7a6a2edb6b0a7aca9eda4acb5"><span class="__cf_email__" data-cfemail="b7d3d2d699d6d3d3d899d6c3c3d8c5d9d2cec4f7d3d2d699c2c4d3d8dd99d0d8c1">[email protected]</span></a>.
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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.,
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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).
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\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).
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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
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.