[Federal Register Volume 88, Number 159 (Friday, August 18, 2023)]
[Notices]
[Pages 56662-56664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17794]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Ndubuisi J. Okafor, M.D.; Decision and Order

    On April, 10, 2023, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause and Immediate Suspension of 
Registration (OSC/ISO) to Ndubuisi J. Okafor, M.D. (Registrant) of 
Washington, DC. Request for Final Agency Action (RFAA), Exhibit (RFAAX) 
1, at 1.\1\ The OSC/ISO informed Registrant of the immediate suspension 
of his DEA Certificate of Registration No. FO4353188 (registration) 
pursuant to 21 U.S.C. 824(d), alleging that Registrant's continued 
registration constitutes `` `an imminent danger to the public health or 
safety.' '' Id. at 1. The OSC/ISO also proposed the revocation of 
Registrant's registration, alleging that Registrant's continued 
registration is inconsistent with the public interest. Id. (citing 21 
U.S.C. 824(a)(4), 823(g)(1)).
---------------------------------------------------------------------------

    \1\ Registrant's registered address is 7603 Georgia Avenue NW, 
Suite 100, Washington, DC 20012. Id. 2.
---------------------------------------------------------------------------

    The OSC/ISO notified Registrant of his right to file a written 
request for a hearing, and that if he failed to file such a request he 
would be deemed to be in default. Id. at 4 (citing 21 CFR 1301.43). 
Here, Registrant did not request a hearing. RFAA, at 1.\2\ ``A default, 
unless excused, shall be deemed to constitute a waiver of the 
[registrant's] right to a hearing and an admission of the factual 
allegations of the [OSC/ISO].'' 21 CFR 1301.43(e); see also RFAAX 1, at 
4.
---------------------------------------------------------------------------

    \2\ Based on the Government's submissions in its RFAA dated May 
30, 2023, the Agency finds that service of the OSC/ISO on Registrant 
was adequate. The April 11, 2023 Receipt for Cash or Other Items 
appears to be signed by Registrant and asserts that a DEA Special 
Agent personally served Registrant with the OSC/ISO. RFAAX 2.
---------------------------------------------------------------------------

    Further, ``[i]n the event that a registrant . . . 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.'' 21 CFR 1301.43(f)(1). Here, the 
Government has requested final agency action based on Registrant's 
default pursuant to 21 CFR 1301.43(c), (f) because Registrant has not 
timely requested a hearing nor filed an Answer to the April 10, 2023, 
OSC/ISO. See also id. Sec.  1316.67.

I. Findings of Fact

    The Agency finds that, in light of Registrant's default, the 
factual allegations in the OSC/ISO are admitted. Accordingly, between 
November 15, 2022, and February 1, 2023, Registrant unlawfully issued 
at least eleven prescriptions for promethazine with codeine 6.25-10mg/
5ml (a schedule V opioid) to eleven fictitious individuals. RFAAX 1, at 
3.\3\ Registrant sent all eleven prescriptions to be filled by out-of-
state pharmacies. Id. Pursuant to Registrant's default, Registrant 
admits that this conduct reflects negative experience in prescribing 
controlled substances and was in violation of federal and state laws. 
RFAAX 1, at 2-3. Registrant further admits that his

[[Page 56663]]

conduct was outside the usual course of professional practice. RFAAX 1, 
at 3.
---------------------------------------------------------------------------

    \3\ The eleven individuals had no associated public records, 
indicating that they were fictitious. Id.
---------------------------------------------------------------------------

II. Discussion

A. 21 U.S.C. 823(g)(1): The Five Public Interest Factors

    Under the Controlled Substances Act (CSA), ``[a] registration . . . 
to . . . dispense a controlled substance . . . may be suspended or 
revoked by the Attorney General upon a finding that the registrant . . 
. has committed such acts as would render his registration under 
section 823 of this title inconsistent with the public interest as 
determined under such section.'' 21 U.S.C. 824(a). 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 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).
    When making this determination, DEA considers the 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 
of 21 U.S.C. 823(g)(1),\4\ the Government's evidence in support of its 
prima facie case for revocation of Registrant's registration is 
confined to Factors B and D. See RFAA, at 2. Moreover, the Government 
has the burden of proof in this proceeding. 21 CFR 1301.44.
---------------------------------------------------------------------------

    \4\ As to Factor A, there is no record evidence of disciplinary 
action against Registrant's state medical license. 21 U.S.C. 
823(g)(1)(A). State authority to practice medicine is ``a necessary, 
but not a sufficient condition for registration . . . .'' Robert A. 
Leslie, M.D., 68 FR at 15230. Therefore, ``[t]he fact that the 
record contains no evidence of a recommendation by a state licensing 
board does not weigh for or against a determination as to whether 
continuation of the [Registrant's] 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 
Registrant has been convicted of any federal or state law offense 
``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. 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 
Registrant.
---------------------------------------------------------------------------

    Here, the Agency finds that the Government satisfies its prima 
facie burden showing that Registrant's continued registration would be 
``inconsistent with the public interest.'' 21 U.S.C. 824(a).
1. 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 Kareem Hubbard, M.D., 87 FR 21156, 21162 (2022). In the current 
matter, the Government has alleged that Registrant has violated both 
federal and D.C. law regulating controlled substances. RFAAX 1, at 2-3. 
According to the CSA's implementing regulations, a lawful controlled 
substance order or prescription is one that is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). A 
``practitioner must establish and maintain a bona fide doctor-patient 
relationship in order to act `in the usual course of . . . professional 
practice' and to issue a prescription for a `legitimate medical 
purpose.' '' \5\X Dewey C. Mackaw, 75 FR 49956, 49973 (2010).
---------------------------------------------------------------------------

    \5\ D.C. Mun. Regs. tit. 22-B, section 1399.1 provides that 
establishing a patient-practitioner relationship requires ``that at 
a minimum the practitioner has met face to face with the patient, 
has obtained a patient history, and conducted a physical examination 
or evaluation adequate to establish a diagnosis, identify underlying 
conditions and contraindications to the treatment recommended.''
---------------------------------------------------------------------------

    D.C.'s regulations require that ``a prescription for a controlled 
substance shall be issued or dispensed only for a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
or her professional practice.'' \6\ D.C. Mun. Regs. tit. 22-B, section 
1305.2 (2023); see also D.C. Code section 48-903.08(d) (2023) (``A 
controlled substance included in Schedule V shall not be distributed or 
dispensed other than for a medical purpose.'').
---------------------------------------------------------------------------

    \6\ The OSC/ISO quotes the language contained in D.C. Mun. Regs. 
tit. 22-B, section 1305.2, but incorrectly attributes that language 
to section 1305.1.
---------------------------------------------------------------------------

    Registrant admits that his prescribing was outside the usual course 
of professional practice and that his conduct reflects negative 
experience in prescribing controlled substances and was in violation of 
federal and state laws. Indeed, the record demonstrates that Registrant 
issued at least eleven controlled substance prescriptions to eleven 
fictitious individuals. Based on registrant's admissions, the Agency 
finds that Registrant's prescribing was outside the usual course of 
professional practice, and sustains the Government's uncontroverted 
allegations that Registrant violated 21 CFR 1306.04(a); D.C. Mun. Regs. 
tit. 22-B, section 1305.2; and D.C. Code section 48-903.08(d).
    In sum, the Agency finds that Factors B and D weigh in favor of 
revocation of Registrant's registration and thus finds Registrant'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 Registrant failed to provide sufficient evidence to rebut the 
Government's prima facie case.

III. Sanction

    Where, as here, the Government has established sufficient grounds 
to revoke Registrant's registration, 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). When a registrant has committed acts inconsistent with 
the public interest, he 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). 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 33738, 33746 
(2021).
    Here, Registrant did not request a hearing, submit a corrective 
action plan, respond to the OSC/ISO, or otherwise avail himself of the 
opportunity to refute the Government's case. As such, Registrant has 
made no representations as to his future compliance with the CSA nor 
demonstrated that he can be entrusted with registration.

[[Page 56664]]

Accordingly, the Agency will order the revocation of Registrant's 
registration.

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. 
FO4353188 issued to Ndubuisi J. Okafor, M.D. 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 Ndubuisi J. Okafor, M.D., to 
renew or modify this registration, as well as any other pending 
application of Ndubuisi J. Okafor, M.D., for additional registration in 
Washington, DC. This Order is effective September 18, 2023.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
August 14, 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. 2023-17794 Filed 8-17-23; 8:45 am]
BILLING CODE 4410-09-P