[Federal Register Volume 88, Number 209 (Tuesday, October 31, 2023)]
[Notices]
[Pages 74523-74525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 74524]]

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,

[[Page 74525]]

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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