Notice2023-23957
Fares F. Yasin, M.D.; Decision and Order
Primary source
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Published
October 31, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 88 Issue 209 (Tuesday, October 31, 2023)</title>
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[Federal Register Volume 88, Number 209 (Tuesday, October 31, 2023)]
[Notices]
[Pages 74523-74525]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-23957]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Fares F. Yasin, M.D.; Decision and Order
On June 30, 2021, the Drug Enforcement Administration (hereinafter,
DEA or Government) issued an Order to Show Cause (hereinafter, OSC) to
Fares F. Yasin, M.D. (hereinafter, Applicant). Request for Final Agency
Action (hereinafter, RFAA), Exhibit (hereinafter, RFAAX) 2, at 1, 4;
RFAAX 4, at 1. The OSC proposed the denial of Applicant's application
for a DEA Certificate of Registration, Control No. W19137777C, with the
proposed registered address of
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11 Calle Central, Coto Laurel, Puerto Rico 00780. RFAAX 2, at 1. The
OSC alleged that Applicant's application should be denied because
Applicant materially falsified his application and because Applicant's
registration would be inconsistent with the public interest. Id.
(citing 21 U.S.C. 824(a)(1), 823(g)(1) \1\).
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\1\ Effective December 2, 2022, the Medical Marijuana and
Cannabidiol Research Expansion Act, Public Law 117-215, 136 Stat.
2257 (2022) (Marijuana Research Amendments or MRA), amended the
Controlled Substances Act (CSA) and other statutes. Relevant to this
matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC, as
21 U.S.C. 823(g)(1). This Decision cites to the current designation,
21 U.S.C. 823(g)(1), and to the MRA-amended CSA throughout.
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By letter dated August 31, 2021, Applicant requested that DEA
``[f]ormally withdraw [his] DEA registration application and cancel the
hearing.'' RFAAX 3.\2\ On May 25, 2023, the Government submitted its
RFAA, alleging that Applicant's Puerto Rico controlled substance
license had been suspended and proposing the denial of Applicant's
application on the grounds that Applicant lacks authority to handle
controlled substances in Puerto Rico, the territory in which he seeks
registration with DEA. RFAA, at 1, 3.\3\ The Government had not alleged
that Applicant lacked authority in the OSC. See RFAAX 2. Nonetheless,
the Government is not required to issue an amended OSC to notice an
allegation of a registrant's lack of state (or in this case territory)
authority that arises during the pendency of a proceeding regarding a
DEA registration. Hatem M. Ataya, M.D., 81 FR 8221, 8244 (2016).
Previous Agency decisions have stated that because the possession of
state authority is a prerequisite for obtaining and maintaining a
registration, the issue of state authority can be raised at any stage
of a proceeding. See Ataya, 81 FR at 8244; Joe M. Morgan, D.O., 78 FR
61961, 61973-74 (2013).\4\
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\2\ Based on the Declaration of a DEA Special Agent, the Agency
finds that the Government's service of the OSC on Applicant was
adequate and that Applicant was served with the OSC on July 8, 2021.
RFAAX 4, at 1; see also RFAAX 4, Appendix A. According to Applicant,
he responded to the OSC by email on August 8, 2021, and communicated
several times thereafter with DEA regarding his desire to withdraw
his application prior to submitting the August 31, 2021 letter.
RFAAX 3.
\3\ In its RFAA, the Government appears to have dropped the
allegations regarding material falsification and public interest.
RFAA, at 2-3.
\4\ Even so, in such cases, a registrant must be provided with a
meaningful opportunity to contest the allegation. See, e.g.,
Lawrence E. Stewart, M.D., 86 FR 15257, 15257 (2021); Cypress Creek
Pharmacy LLC, 86 FR 71927, 71927 (2021); Lesly Pompy, M.D., 84 FR
57749, 57749-50 (2019); Ataya, 81 FR at 8245; Morgan, 78 FR at
61973-74. On July 27, 2023, the Government submitted a Notice of
Notification of RFAA in which the Government asserted that it had
notified Applicant of the lack of authority allegation and had
provided Applicant with a copy of the RFAA via email. Notice of
Notification of RFAA, at 1; see also Notice of Notification of RFAA,
Exhibit 1. The Government's evidence included an email to Applicant
with instructions for submitting a response, if desired, to the lack
of authority allegation. Id. Accordingly, the Agency finds that
Applicant was notified of the RFAA and was provided with a
meaningful opportunity to contest the lack of authority allegation.
Further, more than two months have passed since the Government
notified Applicant and Applicant has not availed himself of the
opportunity to respond.
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The Agency makes the following findings of fact based on the
uncontroverted evidence submitted by the Government in its RFAA.
Findings of Fact
On August 10, 2022, the Puerto Rico Department of Health suspended
Applicant's Puerto Rico controlled substance license. RFAAX 5, Appendix
A, at 1. As of August 15, 2022, Applicant's Puerto Rico controlled
substance license remained suspended. Id.\5\ Accordingly, the Agency
finds that Applicant is not licensed to handle controlled substances in
Puerto Rico, the territory in which he seeks registration with DEA.
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\5\ The Agency has no indication that the status of Applicant's
controlled substance license (which is not publicly available
information) has changed. Following the submission of the
Government's RFAA and its notification to Applicant that it had
submitted the RFAA, the Agency to date has not received any
correspondence from Applicant regarding any changes to the status of
his controlled substance license. Accordingly, the Agency finds that
Applicant's Puerto Rico controlled substance license remains
suspended as of the date of signature of this Order. See Heather M.
Entrekin, DVM, 88 FR 17266, 17266 (2023). Applicant may dispute the
Agency's finding by filing a motion for reconsideration of findings
of fact within fifteen calendar days of the date of this Order with
supporting documentation (showing that Applicant was able to
dispense controlled substances on or before the date of this Order).
Any such motion and response shall be filed and served by email to
the other party and to the DEA Office of the Administrator, Drug
Enforcement Administration, at <a href="/cdn-cgi/l/email-protection#385c5d5916595c5c5716594c4c574a565d414b785c5d59165f574e"><span class="__cf_email__" data-cfemail="503435317e3134343f7e3124243f223e352923103435317e373f26">[email protected]</span></a>.
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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 CSA
``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 71,371 (2011), pet. for rev.
denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh Blanton,
M.D., 43 FR 27616, 27617 (1978).\6\
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\6\ This rule derives from the text of two provisions of the
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, Public Law
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 at 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 at 27,617.
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According to the Puerto Rico Controlled Substances Act, ``[a]ny
person who manufactures, distributes and dispenses controlled
substances in the Commonwealth of Puerto Rico . . . shall obtain a
registration certification annually, issued by the Secretary of Health,
pursuant to the rules and regulations approved and promulgated by said
government official.'' P.R. Laws Ann. tit. 24, section 2302(a) (West,
current through all acts translated by the Translation Office of the
Puerto Rico Government through the 2011 Legislative Session and various
acts from 2012 to the present). Further, ``dispense'' means ``the
prescribing, administering or delivering of a controlled substance to
an ultimate user, by prescription or order for administering it. It
includes the process of the compounding, labeling and packaging of a
controlled substance for such delivery. The term `dispenser' means the
practitioner who so delivers a controlled substance.'' Id. at section
2102(11).
Here, the undisputed evidence in the record is that Applicant lacks
authority to dispense controlled substances in Puerto Rico. As
discussed above, a physician must hold a controlled substances license
to dispense a controlled substance in Puerto Rico. Thus, because
Applicant lacks authority to handle controlled substances in Puerto
Rico, Applicant is not eligible to receive a DEA registration.
Accordingly,
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the Agency 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(g)(1), I hereby deny the pending application for a
Certificate of Registration, Control Number W19137777C, submitted by
Fares F. Yasin, M.D., as well as any other pending application of Fares
F. Yasin, M.D., for additional registration in Puerto Rico. This Order
is effective November 30, 2023.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 20, 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. 2023-23957 Filed 10-30-23; 8:45 am]
BILLING CODE 4410-09-P
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