[Federal Register Volume 90, Number 72 (Wednesday, April 16, 2025)]
[Notices]
[Pages 15996-15999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06452]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Ajumobi Agu, M.D.; Decision and Order
I. Introduction
On November 14, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Ajumobi Agu, M.D., of Las Vegas, Nevada
(Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX)
1, at 1. The OSC/ISO informed Registrant of the immediate suspension of
his DEA Certification of Registration, Control No. FA4195459, 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. (quoting 21 U.S.C. 824(d)). The OSC/ISO also proposed the
revocation of Registrant's registration, alleging that Registrant's
registration should be revoked because Registrant lacks state authority
to handle controlled substances and Registrant's continued registration
is inconsistent with the public interest. Id. (citing 21 U.S.C.
823(g)(1), 824(a)(3), 824(a)(4)).
Specifically, the OSC/ISO alleged that Registrant continued to
dispense controlled substances after his state medical and controlled
substances licenses were suspended. Id. at 3. The OSC/ISO alleged that
Registrant's misconduct violated both the implementing regulations of
the Controlled Substances Act (CSA) and Nevada state law. Id. at 2.
The OSC/ISO notified Registrant of his right to file a written
request for hearing and an answer, 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 4-5 (citing 21 CFR 1301.43). Here, Registrant did
not request a hearing. RFAA, at 2.\1\ ``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/ISO].'' 21 CFR 1301.43(e); see also RFAAX 1, at 4-5 (providing
notice to Registrant).
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\1\ Based on the Government's submissions in its RFAA dated
August 22, 2024, the Agency finds that service of the OSC/ISO on
Registrant was adequate. Specifically, the included Declaration from
a DEA Diversion Investigator indicates that Registrant was
personally served with a copy of the OSC/ISO at his residential
address on November 17, 2023. RFAAX 2, at 1-2, see also RFAAX 3.
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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.'' Id. Sec. 1301.43(f)(1). Here,
the Government has requested final agency action based on Registrant's
default pursuant to 21 CFR 1301.43(a), (c), (f), 1301.46. RFAA, at 1;
see also 21 CFR 1316.67.
II. Lack of State Authority
A. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC/ISO are admitted. Accordingly,
Registrant admits that on July 14, 2023, the Nevada State Board of
Pharmacy suspended Registrant's Nevada controlled substance license.
RFAAX 1, at 3. Further, on September 19, 2023, the Nevada Board of
Medical Examiners suspended Registrant's Nevada medical license. Id. at
2-3.
According to Nevada's online records, of which the Agency takes
official notice, Registrant's Nevada controlled substance license is
now revoked.\2\ Nevada State Board of Pharmacy License Verification,
https://online.nvbop.org/#/verifylicense (last visited date of
signature of this Order). Further, Registrant's Nevada medical license
remains suspended. Nevada State Board of Medical Examiners Licensee
Search, https://nsbme.us.thentiacloud.net/webs/nsbme/register/# (last
visited date of signature of this Order).
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\2\ Under the Administrative Procedure Act, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979).
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Accordingly, the Agency finds that Registrant is not licensed to
practice medicine nor to handle controlled substances in Nevada, the
state in which he is registered with DEA.\3\
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\3\ Pursuant to 5 U.S.C. 556(e), ``[w]hen an agency decision
rests on official notice of a material fact not appearing in the
evidence in the record, a party is entitled, on timely request, to
an opportunity to show the contrary.'' The material fact here is
that Registrant, as of the date of this decision, is not licensed to
practice medicine and/or handle controlled substances in Nevada.
Registrant may dispute these facts by filing a properly supported
motion for reconsideration of findings of fact within fifteen
calendar days of the date of this Order. Any such motion and
response shall be filed and served by email to the other party and
to Office of the Administrator, Drug Enforcement Administration, at
[email protected].
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B. Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under 21 U.S.C. 823 ``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.
Gonzales v. Oregon, 546 U.S. 243, 270 (2006) (``The Attorney General
can register a physician to dispense controlled
[[Page 15997]]
substances `if the applicant is authorized to dispense . . . controlled
substances under the laws of the State in which he practices.' . . .
The very definition of a `practitioner' eligible to prescribe includes
physicians `licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices' to dispense
controlled substances. Sec. 802(21).''). The Agency has applied these
principles consistently. See, e.g., James L. Hooper, M.D., 76 FR 71371,
71372 (2011), pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012);
Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (1978).\4\
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\4\ 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). 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, M.D., 76 FR at 71371-72;
Sheran Arden Yeats, 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, M.D., 43 FR at 27617.
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According to Nevada statute, ``[e]very practitioner or other person
who dispenses any controlled substance within th[e] State or who
proposes to engage in the dispensing of any controlled substance within
th[e] State shall obtain biennially a registration issued by the
[Nevada State Board of Pharmacy] in accordance with its regulations.''
Nev. Rev. Stat. Sec. 453.226(1) (2024). Further, according to Nevada
statute, ``dispense'' means ``to deliver a controlled substance to an
ultimate user, patient or research subject by or pursuant to the lawful
order of a practitioner, including the prescribing, administering,
packaging, labeling or compounding necessary to prepare the substance
for that delivery.'' Id. Sec. 453.056(1).
Here, the undisputed evidence in the record is that Registrant
lacks authority to dispense controlled substances in Nevada because his
Nevada controlled substance license is now revoked. As discussed above,
an individual must hold a Nevada controlled substance license to
dispense a controlled substance in Nevada. Thus, because Registrant
lacks authority to handle controlled substances in Nevada, the state in
which he is registered with the DEA, Registrant is not eligible to
maintain a DEA registration. Accordingly, the Agency will order that
Registrant's DEA registration be revoked.
III. Public Interest
A. Applicable Law
As discussed above, the OSC/ISO alleges that Registrant violated
provisions of the CSA and its implementing regulations. As the Supreme
Court stated in Gonzales v. Raich, ``the main objectives of the CSA
were to conquer drug abuse and to control the legitimate and
illegitimate traffic in controlled substances. . . . To effectuate
these goals, Congress devised a closed regulatory system making it
unlawful to . . . dispense[ ] or possess any controlled substance
except in a manner authorized by the CSA.'' 545 U.S. 1, at 12-13
(2005). In maintaining this closed regulatory system, ``[t]he CSA and
its implementing regulations set forth strict requirements regarding
registration, . . . drug security, and recordkeeping.'' Id. at 14.
Here, the OSC/ISO's allegations concern the CSA's ``strict requirements
regarding registration . . . '' and, therefore, go to the heart of the
CSA's ``closed regulatory system'' specifically designed ``to conquer
drug abuse and to control the legitimate and illegitimate traffic in
controlled substances.'' Id.
Dispensing After State Authority Suspended (21 CFR 1306.04(a); Nev.
Rev. Stat. Sec. Sec. 453.226(1), 630.160(1), 630.020)
The OSC/ISO alleges that Registrant continued to dispense
controlled substances after his state medical and controlled substances
licenses were suspended. RFAAX 1, at 3. Under the CSA, a prescription
for a controlled substance is valid only if ``issued for a legitimate
medical purpose by an individual practitioner acting in the usual
course of his professional practice.'' 21 CFR 1306.04(a). Similarly,
Nevada regulations prohibit the dispensing of controlled substances
without a Nevada controlled substance license and prohibit the practice
of medicine, which includes prescribing, without a Nevada medical
license. Nev. Rev. Stat. Sec. Sec. 453.226(1), 630.160(1), 630.020
(2024).
B. Findings of Fact
Registrant is deemed to have admitted that following the initial
suspension of Registrant's Nevada medical license on June 30, 2023,
Registrant went on to issue approximately 22 prescriptions for
controlled substances, including oxycodone (a Schedule II opioid),
alprazolam (a Schedule IV benzodiazepine), and carisoprodol (a Schedule
IV muscle relaxant). RFAAX 1, at 3. Registrant prescribed these
medications to 14 patients from June 30, 2023, through at least
September 11, 2023.\5\ Id. As noted in supra II.A., Registrant's Nevada
controlled substance license was also suspended beginning on July 14,
2023. Id.
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\5\ Registrant's Nevada medical license was briefly reinstated
on August 10, 2023, but then suspended again on September 19, 2023,
based on findings that Registrant engaged in the practice of
medicine after the initial June 30, 2023 suspension of his Nevada
medical license. RFAAX 1, at 3. There is no evidence that
Registrant's controlled substance license was reinstated after it
was suspended on July 14, 2023.
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Accordingly, the Agency finds substantial record evidence that
Registrant issued at least 22 controlled substance prescriptions while
his Nevada medical and/or controlled substance license(s) were
suspended. Id.
C. Discussion
The Controlled Substances Act's Public Interest Factors
When the CSA's strict requirements are not met, the Attorney
General ``may deny, suspend, or revoke [a] registration if . . . the
[registrant's] registration would be `inconsistent with the public
interest.' '' Gonzales v. Oregon, 546 U.S. 243, 251 (2006) (quoting 21
U.S.C. 824(a)(4)). In the case of a ``practitioner,'' Congress directed
the Attorney General to consider five factors in making the public
interest determination. Id.; 21 U.S.C. 823(g)(1)(A-E).\6\
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\6\ The five factors are:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant'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)(A-E).
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The five factors are considered in the disjunctive. Gonzales v.
Oregon, 546 U.S. at 292-93 (Scalia, J., dissenting) (``It is well
established that these factors are to be considered in the
disjunctive,'' quoting In re Arora, 60 FR 4447, 4448 (1995)); Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a
case-by-case basis. David H. Gillis, M.D., 58 FR 37507, 37508 (1993);
see Morall v. Drug Enf't Admin.,
[[Page 15998]]
412 F.3d 165, 181 (D.C. Cir. 2005) (describing the Agency's
adjudicative process as ``applying a multi-factor test through case-by-
case adjudication,'' quoting LeMoyne-Owen Coll. v. N.L.R.B., 357 F.3d
55, 61 (D.C. Cir. 2004)). Any one factor, or combination of factors,
may be decisive, David H. Gillis, M.D., 58 FR at 37508, and the Agency
``may give each factor the weight . . . deem[ed] appropriate in
determining whether a registration should be revoked or an application
for registration denied.'' Morall, 412 F.3d. at 185 n.2 (Henderson, J.,
concurring) (quoting Robert A. Smith, M.D., 70 FR 33207, 33208 (2007));
see also Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C.
Cir. 2007).
Moreover, while the Agency is required to consider each of the
factors, it ``need not make explicit findings as to each one.'' MacKay
v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011) (quoting
Volkman v. U. S. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009));
Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d
823, 830 (11th Cir. 2018); Hoxie v. Drug Enf't Admin., 419 F.3d 477,
482 (6th Cir. 2005). ``In short, . . . the Agency is not required to
mechanically count up the factors and determine how many favor the
Government and how many favor the registrant. Rather, it is an inquiry
which focuses on protecting the public interest; what matters is the
seriousness of the registrant's misconduct.'' Jayam Krishna-Iyer, M.D.,
74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has
recognized, Agency decisions have explained that findings under a
single factor can support the revocation of a registration. MacKay, 664
F.3d at 821.
In this matter, while all of the 21 U.S.C. 823(g)(1) factors have
been considered,\7\ the Agency finds that the Government's evidence in
support of its prima facie public interest revocation case regarding
Registrant's violations of the CSA's implementing regulations is
confined to Factors B and D. See RFAAX 1, at 2-3. Moreover, the
Government has the burden of proof in this proceeding. 5 U.S.C.A. Sec.
556(d); 21 CFR 1301.44.
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\7\ As to Factor A, there is evidence in the record that
Registrant's state medical license was suspended on September 19,
2023, after Registrant engaged in the practice of medicine between
June 30, 2023 and August 9, 2023 while his state license was
suspended. RFAAX 1, at 3. Here, the Government has established that
Registrant prescribed controlled substances after his Nevada medical
license was suspended on June 30, 2023. See supra I. Prescribing is
part of the practice of medicine, but does not make up the entire
practice of medicine. See Nev. Rev. Stat. Sec. 630.020.
Accordingly, the Agency finds that Factor A does not weigh for or
against Registrant's continued registration.
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Here, the Agency finds that the Government's evidence satisfies its
prima facie burden of showing that Registrant's continued registration
would be ``inconsistent with the public interest.'' 21 U.S.C.
823(g)(1).
Factors B and/or D--Registrant Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
Evidence is considered under Public Interest Factors B and D when
it reflects compliance or non-compliance with federal and local laws
related to controlled substances and experience dispensing controlled
substances. 21 U.S.C. 823(g)(1)(B) and (D); see also Kareem Hubbard,
M.D., 87 FR 21156, 21162 (2022).
Here, the Registrant's conduct reflects negative experience in
prescribing with respect to controlled substances. See supra III.B.
Moreover, the Agency found substantial record evidence that Registrant
issued at least 22 controlled substance prescriptions while his Nevada
medical and/or controlled substance license(s) were suspended. Id.
Accordingly, there is substantial record evidence that Registrant
violated 21 CFR 1306.04(a) and Nev. Rev. Stat. Sec. Sec. 453.226(1),
630.160(1).
The Agency further finds that after balancing the factors of 21
U.S.C. 823(g)(1), Respondent's continued registration would be
``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).
Accordingly, the Government satisfied its prima facie burden of showing
that Respondent's continued registration would be ``inconsistent with
the public interest.'' 21 U.S.C. 824(a)(4). The Agency also finds that
there is insufficient mitigating evidence to rebut the Government's
prima facie case. Thus, the only remaining issue is whether, in spite
of the public interest determination, Respondent can be trusted with a
registration.
D. Sanction
Here, the Government has met its prima facie burden of showing that
Registrant's continued registration is inconsistent with the public
interest due to his violations pertaining to controlled substance
prescribing. Accordingly, the burden shifts to Registrant to show why
he can be entrusted with a registration. Morall, 412 F.3d. at 174;
Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d
823, 830 (11th Cir. 2018); Garrett Howard Smith, M.D., 83 FR 18882,
18904 (2018).
The issue of trust is necessarily a fact-dependent determination
based on the circumstances presented by the individual registrant.
Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total
Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is
the best predictor of future performance, DEA Administrators have
required that a registrant who has committed acts inconsistent with the
public interest must accept responsibility for those acts and
demonstrate that it will not engage in future misconduct. Jones Total
Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't
Admin., 54 F.3d 450, 452 (7th Cir. 1995). A registrant's acceptance of
responsibility must be unequivocal. Jones Total Health Care Pharmacy,
881 F.3d at 830-31. In addition, a registrant's candor during the
investigation and hearing has been an important factor in determining
acceptance of responsibility and the appropriate sanction. Id. Further,
the Agency has found that the egregiousness and extent of the
misconduct are significant factors in determining the appropriate
sanction. Id. at 834 & n.4. The Agency has also considered the need to
deter similar acts by the registrant and by the community of
registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
Here, Registrant failed to answer the allegations contained in the
OSC/ISO and did not otherwise avail himself of the opportunity to
refute the Government's case. As such, there is no record evidence that
Registrant takes responsibility, let alone unequivocal responsibility,
for the founded violations, meaning, among other things, that it is not
reasonable to believe that Registrant's future controlled substance-
related actions will comply with legal requirements. Accordingly,
Registrant did not convince the Agency that he can be entrusted with
registration.
Further, the interests of specific and general deterrence weigh in
favor of revocation. Given the foundational nature of Registrant's
violations, a sanction less than revocation would send a message to the
existing and prospective registrant community that compliance with the
law is not a condition precedent to maintaining a registration.
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) and 21 U.S.C. 823(g)(1), I hereby
[[Page 15999]]
revoke DEA Certificate of Registration No. FA4195459 issued to Ajumobi
Agu, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested
in me by 21 U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby deny any
pending applications of Ajumobi Agu, M.D., to renew or modify this
registration, as well as any other pending application of Ajumobi Agu,
M.D., for additional registration in Nevada. This Order is effective
May 16, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
April 10, 2025, by Acting Administrator Derek Maltz. 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. 2025-06452 Filed 4-15-25; 8:45 am]
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