Notice2023-17389
Weise Prescription Shop Inc.; Decision and Order
Primary source
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Published
August 14, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 88 Issue 155 (Monday, August 14, 2023)</title>
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[Federal Register Volume 88, Number 155 (Monday, August 14, 2023)]
[Notices]
[Pages 55070-55071]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17389]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22-43]
Weise Prescription Shop Inc.; Decision and Order
I. Introduction
On July 7, 2022, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Weise Prescription
Shop Inc. (Respondent).\1\ OSC, at 1-4. Citing 21 U.S.C. 824(a)(2), the
OSC proposes the revocation of Respondent's registration, and the
denial of ``any applications for renewal or modification of such
registration and any applications for any other DEA registration,''
``because Mr. Gilbert Weise, Jr. has been convicted of a felony offense
relating to federal controlled substance laws.'' \2\ Id. at 1.
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\1\ Certificate of Registration No. AW0201474 at the registered
address of 4343 Colonial Avenue, Jacksonville, Florida 32210. OSC,
at 1.
\2\ According to the OSC, Mr. Gilbert Weise, Jr. is an owner of
Respondent. OSC, at 2. The OSC alleges that a ``corporate
registrant's registration `may be revoked upon a finding that a
natural person who is an owner, officer, key employee, or an
individual who has some responsibility for the operation of the
registrant's controlled substance business, has been convicted of a
felony offense relating to controlled substances.' '' Id.
In its Prehearing Statement, Respondent named Mr. Weise, Jr. as
a proposed hearing witness and stated that he ``has retained counsel
to seek to withdraw his [guilty] plea and further seek collateral
relief'' due to the Supreme Court's opinion in Ruan v. United
States, 142 S. Ct. 2370 (2022). Resp. Prehearing, at 4; see also
Weise v. United States of America, No. 2:22-cv-00106 (S.D. Ga. filed
Oct. 7, 2022).
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II. Summary of Proceedings
Respondent timely requested a hearing. In due course, the
Government submitted a Motion for Summary Disposition (MSD).
Government's Notice of Filing of Evidence and Motion for Summary
Disposition (October 28, 2022) (First MSD). Respondent opposed the MSD.
Respondent's Response in Opposition to Government's Motion for Summary
Disposition (November 2, 2022) (Resp Opp. to First MSD). Respondent,
among other things, argued that the Government's First MSD was
meritless because there are ``questions of fact involved,'' there are
``material facts in dispute,'' and there is disagreement as to
``material facts.'' \3\ Resp Opp. to First MSD, at 4.
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\3\ For example, Respondent's opposition argues that (1) Mr.
Weise, Jr.'s ``alleged criminal conviction . . . related to events
occurring from on or about October 9, 2014 to and including June 13,
2017,'' (2) Mr. Weise, Jr. ``did not have an ownership interest'' in
Respondent ``between October 9, 2014 to and including June 13,
2017,'' (3) the OSC ``seeks revocation . . . because . . . [Mr.
Weise, Jr.] `was a co-owner of Weise and the Pharmacist in Charge at
the time of his illegal activity,' '' and (4) the Exhibits filed
with the Government's First MSD are unauthenticated, uncertified, or
otherwise inadmissible. Resp Opp. to First MSD, at 2-3.
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The Administrative Law Judge (ALJ) issued her Recommended Rulings,
Findings of Fact, Conclusions of Law, and Decision granting the
Government's First MSD on November 16, 2022 (First RD) and transmitted
the record to the Office of the Administrator on December 12, 2022. Her
transmittal letter states that no evidentiary hearing was held, no
factual issues were involved, and neither party filed Exceptions to the
First RD.\4\
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\4\ Though Respondent never filed exceptions, it did file a
``Motion for Extension of Time to File Motion for Reconsideration''
stating that it ``intend[ed] to seek reconsideration or other relief
related to this Order.'' That motion was denied, but in so doing,
the ALJ pointed out that the deadline for filing exceptions was
after the date through which Respondent requested an extension.
Order Denying Respondent's Motion for Extension to File a Motion for
Reconsideration, at n.1.
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While it was appropriate for the ALJ to adjudicate the First MSD,
the granting of the First MSD should not have ended the proceedings.
See, e.g., Garrett Howard Smith, M.D., 83 FR 18882, 18910 (2018).
Accordingly, the Agency remanded the matter for further proceedings,
encouraging the ALJ to exercise her discretion and to develop the
record to allow for the determination of an appropriate sanction. E.g.,
21 CFR 1316.50, 1316.65.
On remand, the Government filed another MSD, a Request for Official
Notice, and a Request to File a Supplemental Prehearing Statement. The
basis of the Government's second MSD (Second MSD) is Respondent's lack
of legal authority to operate as a pharmacy in Florida.\5\ It is
Respondent's
[[Page 55071]]
lack of state authority that this Decision adjudicates.
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\5\ The ALJ granted the Second MSD. Order Granting the
Government's Second Motion for Summary Disposition, and Recommended
Rulings, Findings of Fact, Conclusions of Law, and Decision of the
Administrative Law Judge (May 4, 2023) (Second RD), at 2, 5.
According to the record transmitted to the Office of the
Administrator after remand, Respondent did not oppose the Second
MSD. Second RD, at n.3.
The Government's filings included material concerning its First
MSD, particularly Mr. Weise, Jr.'s felony conviction.
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Findings of Fact
The record contains uncontroverted evidence that, on February 28,
2023, Respondent's Florida pharmacy license expired. See, e.g., Second
MSD, at 1. According to Florida online records, of which the Agency
takes official notice, Respondent's pharmacy license is ``delinquent.''
\6\ <a href="https://mqa-internet.doh.state.fl.us/MQASearchServices/HealthCareProviders">https://mqa-internet.doh.state.fl.us/MQASearchServices/HealthCareProviders</a> (last visited date of signature of this Order).
Respondent, therefore, ``is not authorized to practice in the state of
Florida.'' Id.
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\6\ 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, Respondent may dispute the Agency's finding
by filing a properly supported motion for reconsideration of
findings 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#026667632c6366666d2c6376766d706c677b71426667632c656d74"><span class="__cf_email__" data-cfemail="610504004f0005050e4f0015150e130f041812210504004f060e17">[email protected]</span></a>.
``Delinquent,'' according to the website, means that, pursuant
to ``Chapter 456 F.S.--the licensed practitioner who held a CLEAR
ACTIVE or CLEAR INACTIVE license, but failed to renew the license by
the expiration date. The licensed practitioner is not authorized to
practice in the state of Florida. The practitioner is obligated to
update his/her profile data.''
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Accordingly, the Agency finds that Respondent is currently without
authority to operate as a pharmacy in Florida. See supra n.6.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under 21 U.S.C. 823 ``upon a
finding that the registrant . . . has had his 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, 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 71371 (2011), pet. for rev.
denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh Blanton,
M.D., 43 FR 27616, 27617 (1978).\7\
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\7\ This rule derives from the text of two provisions of the
Controlled Substances Act (CSA). First, Congress defined the term
``practitioner'' to mean ``a physician . . . 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(g)(1) (this section, formerly section 823(f), was
redesignated as part of the Medical Marijuana and Cannabidiol
Research Expansion Act, Pub. L. 117-215, 136 Stat. 2257 (2022)).
Because Congress has clearly mandated that a practitioner possess
state authority in order to be deemed a practitioner under the CSA,
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., James L. Hooper, 76 FR
71371-72; Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006);
Dominick A. Ricci, M.D., 58 FR 51104, 51105 (1993); Bobby Watts,
M.D., 53 FR 11919, 11920 (1988); Frederick Marsh Blanton, 43 FR
27617.
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Here, the undisputed record evidence is that Respondent currently
lacks authority to operate a pharmacy in Florida. Respondent,
therefore, is not a ``practitioner'' under federal law. 21 U.S.C.
802(21) (``The term ``practitioner'' means a . . . pharmacy''). The CSA
provides for the issuance of a registration to ``practitioners.'' 21
U.S.C. 823(g). It explicitly provides for the revocation of a
registration issued to an entity whose ``State license'' has been
``suspended, revoked, or denied by competent State authority.'' 21
U.S.C. 824(a)(3). For these reasons, Respondent is not eligible under
the CSA to maintain a DEA registration in Florida. Accordingly, the
Agency orders that Respondent's DEA registration be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
AW0201474 issued to Weise Pharmacy Shop Inc. Further, pursuant to 28
CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Weise Pharmacy Shop Inc. to
renew or modify this registration, as well as any other pending
application of Weise Pharmacy Shop Inc. for additional registration in
Florida. This Order is effective September 13, 2023.
Signing Authority
This document of the Drug Enforcement Administration was signed on
August 7, 2023, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-17389 Filed 8-11-23; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on August 14, 2023.
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