[Federal Register Volume 89, Number 197 (Thursday, October 10, 2024)]
[Notices]
[Pages 82259-82260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23504]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Salman Akbar, M.D.; Decision and Order

    On January 27, 2023, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause (OSC) to Salman Akbar, M.D., 
of Richmond, Virginia (Applicant). Request for Final Agency Action 
(RFAA), Exhibit (RFAAX) 1, Attachment E, at 1, 4. The OSC proposed the 
denial of Applicant's application for a DEA Certificate of Registration 
(registration), Control No. W22109452C, alleging that Applicant has 
committed acts that would render his registration inconsistent with the 
public interest. Id. at 1, 2 (citing 21 U.S.C. 823(g)(1),\1\ 824(a)(4) 
\2\).
---------------------------------------------------------------------------

    \1\ Effective December 2, 2022, the Medical Marijuana and 
Cannabidiol Research Expansion Act, Pub. L. 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). Accordingly, this Decision cites to the current 
designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA 
throughout.
    \2\ Prior Agency decisions have addressed whether it is 
appropriate to consider a provision of 21 U.S.C. 824(a) when 
determining whether to grant a practitioner registration 
application. For over forty-five years, Agency decisions have 
concluded that it is. Robert Wayne Locklear, M.D., 86 FR 33738, 
33744-45 (2021) (collecting cases); see also Dinorah Drug Store, 
Inc., 61 FR 15972, 15973-74 (1996).
---------------------------------------------------------------------------

    The OSC notified Applicant of his right to file with DEA a written 
request for hearing, and that if he failed to file such a request, he 
would be deemed to have waived his right to a hearing and be in 
default. Id. at 2 (citing 21 CFR 1301.43). Here, Applicant filed a 
timely answer and request for hearing on February 28, 2023,\3\ but 
ultimately withdrew his request for hearing on March 27, 2023. See 
RFAAX 1, Attachment F.\4\ On March 27, 2023, Chief Administrative Law 
Judge John J. Mulrooney, II, (the Chief ALJ) issued a Termination Order 
that terminated the proceedings. 21 CFR 1301.43(c) provides that, 
``[i]n the event . . . a person who has requested a hearing fails to 
plead . . . or otherwise defend, said party shall be deemed to be in 
default . . . .'' By voluntarily withdrawing his hearing request, 
Respondent ``fail[ed] to . . . otherwise defend.'' 21 CFR 1301.43(c). 
Accordingly, Respondent is ``deemed to be in default.'' Id.; Default 
Provisions for Hearing Proceedings Relating to the Revocation, 
Suspension, or Denial of a Registration, 87 FR 68036 (Nov. 14, 
2022).\5\ See RFAAX 1, Attachment G. ``A default, unless excused, shall 
be deemed to constitute a waiver of the registrant's/applicant's right 
to a hearing and an admission of the factual allegations of the 
[OSC].'' 21 CFR 1301.43(e).
---------------------------------------------------------------------------

    \3\ Based on the Government's submissions in its RFAA dated July 
3, 2023, the Agency finds that service of the OSC on Applicant was 
adequate. Specifically, the included Declaration of a DEA Diversion 
Investigator indicates that on January 30, 2023, Applicant was 
personally served with the OSC. RFAAX 1, at 2.
    \4\ Within the document where Applicant withdrew his request for 
hearing, Applicant's counsel indicated that Applicant would 
``continue with the Corrective Action Plan route that was parallel 
to the litigation path, but unrelated to the hearing.'' Id. at 1.
    \5\ See also 21 CFR 1301.43(f)(3) (``A party held to be in 
default may move to set aside a default final order issued by the 
Administrator by filing a motion no later than 30 days from the day 
of issuance by the Administrator of a default final order. Any such 
motion shall be granted only upon a showing of good cause to excuse 
the default.'') Any motion to set aside a default and any 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#f3979692dd9297979cdd9287879c819d968a80b3979692dd949c85"><span class="__cf_email__" data-cfemail="395d5c5817585d5d5617584d4d564b575c404a795d5c58175e564f">[email protected]</span></a>.
---------------------------------------------------------------------------

    Further, ``[i]n the event that a [registrant/applicant] . . . is 
deemed to be in default . . . DEA may then file a request for final 
agency action with the Administrator, along with a record to support 
its request. In such circumstances, the Administrator may enter a 
default final order pursuant to [21 CFR] Sec.  1316.67.'' Id. Sec.  
1301.43(f)(1). Here, the Government has requested final agency action 
based on Applicant's default pursuant to 21 CFR 1301.43(c), (d), 
1301.46. RFAA, at 1; see also 21 CFR 1316.67.

I. Findings of Fact

    The Agency finds that, in light of Applicant's default, the factual 
allegations in the OSC are admitted. Applicant is deemed to have 
admitted that on March 2, 2020, DEA issued Applicant an Immediate 
Suspension Order and Order to Show Cause that suspended Applicant's 
previous DEA registration, Control No. BA5092856, and immediately 
rendered Applicant without authority to issue prescriptions for 
controlled substances. RFAAX 1, Attachment E, at 1-2; see also RFAAX 1, 
Attachment B. Further, on October 20, 2021, by Order of the then-Acting 
Administrator, Applicant's DEA registration, Control No. BA5092856, was 
revoked. RFAAX 1, Attachment E, at 2; see also RFAAX 1, Attachment C.
    Nonetheless, Applicant is deemed to have admitted, and the Agency 
finds, that between on or about January 15, 2021, and on or about 
January 6, 2022, Applicant issued at least 17 prescriptions for 
controlled substances, including four prescriptions for oxycodone (a 
Schedule II controlled substance), two prescriptions for hydrocodone (a 
Schedule II controlled substance), five prescriptions for lorazepam (a 
Schedule IV controlled substance), two prescriptions for zolpidem (a 
Schedule IV controlled substance), one prescription for clonazepam (a 
Schedule IV controlled substance), two prescriptions for pregabalin (a 
Schedule V controlled substance), and one prescription for diazepam (a 
Schedule IV controlled substance). RFAAX 1, Attachment E, at 2; see 
also RFAAX 1, Attachment D. Applicant is deemed to have admitted, and 
the Agency finds, that each of these 17 prescriptions was issued 
without a DEA registration and outside the usual course of professional 
practice. Id.

II. Discussion

A. The Five Public Interest Factors

    Pursuant to section 303(g)(1) of the CSA, ``[t]he Attorney General 
shall register practitioners . . . to dispense . . . controlled 
substances . . . 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). Section 303(g)(1) further provides 
that an application for a practitioner's registration may be denied 
upon a determination that ``the issuance of such registration . . . 
would be inconsistent with the public interest.'' Id. In making the 
public interest determination, the CSA requires consideration of the 
following factors:

    (A) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (B) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (C) The applicant's conviction record under Federal or State 
laws relating to the

[[Page 82260]]

manufacture, distribution, or dispensing of controlled substances.
    (D) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (E) Such other conduct which may threaten the public health and 
safety.

21 U.S.C. 823(g)(1).

    The Agency considers these public interest factors in the 
disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each 
factor is weighed on a case-by-case basis. Morall v. Drug Enf't Admin., 
412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination 
of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508 
(1993).
    While the Agency has considered all of the public interest factors 
in 21 U.S.C. 823(g)(1),\6\ the Government's evidence in support of its 
prima facie case for denial of Applicant's application for registration 
is confined to Factors B and D. See RFAAX 1, Attachment E, at 1. 
Moreover, the Government has the burden of proof in this proceeding. 21 
CFR 1301.44. Here, the Agency finds that the Government's evidence 
satisfies its prima facie burden of showing that Applicant's 
registration would be ``inconsistent with the public interest.'' 21 
U.S.C. 824(a)(4).
---------------------------------------------------------------------------

    \6\ As to Factor A, the record contains no evidence of a 
recommendation from any State licensing board or professional 
disciplinary authority. 21 U.S.C. 823(g)(1)(A). Nonetheless, an 
absence of such evidence ``does not weigh for or against a 
determination as to whether continuation of [or granting of a] DEA 
certification is consistent with the public interest.'' Roni 
Dreszer, M.D., 76 FR 19434, 19444 (2011). As to Factor C, there is 
no evidence in the record that Applicant has been convicted of an 
offense under either Federal or State law ``relating to the 
manufacture, distribution, or dispensing of controlled substances.'' 
21 U.S.C. 823(g)(1)(C). However, as Agency cases have noted, there 
are a number of reasons why a person who has engaged in criminal 
misconduct may never have been convicted of an offense under this 
factor. Dewey C. MacKay, M.D., 75 FR 49956, 49973 (2010). Agency 
cases have therefore found that ``the absence of such a conviction 
is of considerably less consequence in the public interest inquiry'' 
and is therefore not dispositive. Id. Finally, as to Factor E, the 
Government's evidence fits squarely within the parameters of Factors 
B and D and does not raise ``other conduct which may threaten the 
public health and safety.'' 21 U.S.C. 823(g)(1)(E). Accordingly, 
Factor E does not weigh for or against Applicant.
---------------------------------------------------------------------------

B. Factors B and D

    Evidence is considered under Public Interest Factors B and D when 
it reflects compliance (or non-compliance) with laws related to 
controlled substances and experience dispensing controlled substances. 
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D., 
87 FR 21156, 21162 (2022). In the current matter, the Government has 
alleged that Applicant violated both Federal and State law regulating 
controlled substances. RFAAX 1, Attachment E, at 2.\7\ Specifically, 
Federal law states that ``[a] prescription for a controlled substance 
may be issued only by an individual practitioner who is: (1) 
[a]uthorized to prescribe controlled substances by the jurisdiction in 
which he is licensed to practice his profession and (2) [e]ither 
registered or exempted from registration pursuant to Sec. Sec.  
1301.22(c) and 1301.23 . . . .'' 21 CFR 1306.03(a)(1-2). As for State 
law, Virginia statute requires that ``[e]very person who manufactures, 
distributes or dispenses any substance that is controlled in 
[s]chedules I through V . . . except . . . those persons who are 
licensed practitioners of medicine . . . shall obtain annually a 
controlled substances registration certificate issued by the [Board of 
Pharmacy]. This registration shall be in addition to other licensing or 
permitting requirements enumerated in [Virginia's Drug Control Act] or 
otherwise required by law.'' Va. Code. Ann. section 54.1-3422(A).
---------------------------------------------------------------------------

    \7\ The Agency need not adjudicate the criminal violations 
alleged in the instant OSC. Ruan v. United States, 142 S. Ct. 2370 
(2022) (decided in the context of criminal proceedings).
---------------------------------------------------------------------------

    Here, Applicant has admitted that he repeatedly issued 
prescriptions for controlled substances while his DEA registration was 
suspended as well as after his DEA registration was revoked. As such, 
the Agency finds that Applicant violated 21 CFR 1306.03(a)(1-2) and 
Virginia Code section 54.1-3422(A).
    Accordingly, the Agency finds that Factors B and D weigh in favor 
of denial of Applicant's application and thus finds Applicant's 
continued registration to be inconsistent with the public interest in 
balancing the factors of 21 U.S.C. 823(g)(1). The Agency further finds 
that Applicant failed to provide any evidence to rebut the Government's 
prima facie case.

III. Sanction

    Where, as here, the Government has established grounds to deny 
Applicant's application, the burden shifts to the registrant to show 
why he can be entrusted with the responsibility carried by a 
registration. Garret Howard Smith, M.D., 83 FR 18882, 18910 (2018). To 
establish that he can be entrusted with registration, a registrant must 
both accept responsibility and demonstrate that he has undertaken 
corrective measures. Holiday CVS, L.L.C., dba CVS Pharmacy Nos 219 and 
5195, 77 FR 62316, 62339 (2012) (internal quotations omitted); see also 
Michele L. Martinho, M.D., 86 FR 24012, 24019 (2021); George D. Gowder, 
III, M.D., 89 FR 76152, 76154 (2024). Trust is necessarily a fact-
dependent determination based on individual circumstances; therefore, 
the Agency looks at factors such as the acceptance of responsibility, 
the credibility of that acceptance as it relates to the probability of 
repeat violations or behavior, the nature of the misconduct that forms 
the basis for sanction, and the Agency's interest in deterring similar 
acts. See, e.g., Robert Wayne Locklear, M.D., 86 FR at 33746.
    Here, although Applicant initially requested a hearing, he 
ultimately withdrew his hearing request and did not otherwise avail 
himself of the opportunity to refute the Government's case. As such, 
Applicant has made no representations as to his future compliance with 
the CSA nor demonstrated that he can be entrusted with registration. 
Moreover, the evidence presented by the Government shows that Applicant 
violated the CSA, further indicating that Applicant cannot be 
entrusted. Accordingly, the Agency will order the denial of Applicant's 
application.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 823(g)(1) and 21 U.S.C. 824(a), I hereby deny the pending 
application for a Certificate of Registration, Control No. W22109452C, 
submitted by Salman Akbar, M.D., as well as any other pending 
application of Salman Akbar, M.D., for additional registration in 
Virginia. This Order is effective November 12, 2024.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
October 4, 2024, 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. 2024-23504 Filed 10-9-24; 8:45 am]
BILLING CODE 4410-09-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>