88 FR 159 pgs. 56662-56664 - Ndubuisi J. Okafor, M.D.; Decision and Order
Type: NOTICEVolume: 88Number: 159Pages: 56662 - 56664
Pages: 56662, 56663, 56664FR document: [FR Doc. 2023-17794 Filed 8-17-23; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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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)).
Footnotes:
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.
Footnotes:
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] §?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. §?1316.67.
I. Findings of Fact
[top] 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
Footnotes:
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.
Footnotes:
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).
Footnotes:
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.").
Footnotes:
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).
[top] 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.
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]
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