[Federal Register Volume 86, Number 85 (Wednesday, May 5, 2021)]
[Notices]
[Pages 24020-24022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09461]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-21]


Emmanuel A. Ayodele, M.D.; Decision and Order

    On April 29, 2020, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause (hereinafter, OSC) to 
Emmanuel Ayodele, M.D. (hereinafter, Applicant) of Compton, California. 
OSC, at 1. The OSC proposed the denial of Applicant's application for a 
DEA Certificate of Registration. Id. It alleged that Applicant is 
without ``authority to handle controlled substances in California, the 
state in which [Applicant] seek[s] registration with DEA.'' Id. (citing 
21 U.S.C. 824(a)(3)).
    Specifically, the OSC alleged that the Medical Board of California 
(hereinafter, MBC) issued an order on February 3, 2020, revoking 
Applicant's California Physician's and Surgeon's Certificate. Id. at 2. 
The OSC further alleged that, because the Board revoked Applicant's 
medical license, Applicant lacks the authority to handle controlled 
substances in the State of California. Id.
    The OSC notified Applicant of the right to request a hearing on the 
allegations or to submit a written statement, while waiving the right 
to a hearing, the procedures for electing each option, and the 
consequences for failing to elect either option. Id. at 2-3 (citing 21 
CFR 1301.43). The OSC also notified Applicant of the opportunity to 
submit a corrective action plan. Id. at 3 (citing 21 U.S.C. 
824(c)(2)(C)).
    On June 24, 2020, Applicant, through counsel, requested a hearing, 
stating that Applicant ``has filed a writ of administrative mandate in 
the Superior Court of California, San Francisco Division . . . for 
judicial review of the decision of the Medical Board of California'' 
and that ``DEA should await the final judgment.'' Request for a 
Hearing, at 1.
    The Office of Administrative Law Judges put the matter on the 
docket and assigned it to Chief Administrative Law Judge John J. 
Mulrooney II (hereinafter, Chief ALJ), who issued an Order Directing 
the Filing of Government Evidence Regarding its Lack of State Authority 
Allegation and Briefing Schedule on June 25, 2020, with which the 
Government complied by filing a Motion for Summary Disposition 
(hereinafter, Govt Motion) on July 7, 2020.
    In its Motion, the Government submitted evidence that the MBC 
``found [Applicant] non-compliant with the probationary terms of its 
June 2017 order, ultimately resulting in the revocation of his 
California Physician's and Surgeon's Certificate.'' Govt Motion, at 3-
4. Further, the Government noted that the MBC had denied Applicant's 
Petition for Review of his revocation on April 14, 2020. Id. In light 
of these facts, the Government argued that DEA must deny Applicant's 
application. Id. at 5.
    On July 15, 2020, Applicant filed ``Applicant's Reply'' 
(hereinafter, App

[[Page 24021]]

Reply), in which he argued that there are no proceedings to stay, 
because Applicant is not requesting an action on his application at 
this time; therefore, he argued that the ``sole issue presented is 
whether the DEA should withhold action on [Applicant's] application--
which was submitted before his [California] medical license was 
revoked--until a final judgment is entered on his state petition for 
judicial review of the MBC's decision.'' App Reply, at 1.
    On July 21, 2020, the Chief ALJ issued an Order Granting the 
Government's Motion for Summary Disposition, and Recommended Rulings, 
Findings of Fact, Conclusions of Law, and Recommended Decision of the 
Administrative Law Judge (hereinafter, Summary Disposition or SD). The 
Chief ALJ noted that, ``[c]ontrary to the [Applicant's] assertions . . 
. the instant proceedings are, in fact, proceedings.'' SD, at 4 
(citations omitted). Further, the ALJ noted that it appeared that 
Applicant was not contesting the underlying facts surrounding the 
grounds for the proceedings. Id. at 5. Therefore, the Chief ALJ 
determined that ``in view of the Applicant's current lack of state 
authority, denial of the Applicant's application stands as the only 
legally available resolution.'' Id. The Chief ALJ further concluded 
that ``[s]ummary disposition is proper in an administrative enforcement 
proceeding where no genuine factual dispute exists.'' Id. at 6 (citing 
Veg-Mix, Inc. v. U.S. Dept. of Agriculture, 832 F.3d 601, 607 (D.C. 
Cir. 1987) (comparing the standard for summary disposition in an 
administrative proceeding to summary judgment in a civil proceeding); 
Citizens for Allegan County, Inc. v. Federal Power Commission, 414 F.2d 
1125, 1128 (D.C. Cir. 1969) (affirming that ``the right of opportunity 
for hearing does not require a procedure that will be empty sound and 
show, signifying nothing'')).
    By letter dated August 18, 2020, the ALJ certified and transmitted 
the record to me for final Agency action. In that letter, the ALJ 
advised that neither party filed exceptions. I find that the time 
period to file exceptions has expired. See 21 CFR 1316.66.
    I issue this Decision and Order based on the entire record before 
me. 21 CFR 1301.43(e). I make the following findings of fact.

Findings of Fact

Applicant's DEA Registration

    On or about June 6, 2018, Applicant filed an application 
(Application Control No. H18074119C) for a DEA Certificate of 
Registration as a practitioner in schedules II-V, with the proposed 
registered location of 1406 W 134th Street, Compton, California 90222. 
Govt Motion Exhibit (hereinafter, GX) 2 (Certification of Registration 
History), at 1.

The Status of Applicant's California License

    On February 3, 2020, the MBC revoked Applicant's medical license. 
GX 3 (MBC Order), at 19. According to the Order, Applicant was 
suspended by the MBC following Applicant's October 10, 2013 felony 
conviction for health care fraud. Id. On June 16, 2017, the MBC adopted 
a Stipulated Settlement and Disciplinary Order, which imposed a period 
of probation, during which Applicant would be required to complete 
continuing medical education coursework, perform community service, 
obtain a psychological evaluation at his own expense, pay all probation 
costs, and complete a clinical competence assessment program. Id. at 3. 
Applicant failed to meet the terms of his probation and therefore, the 
MBC revoked Applicant's medical license. GX 3, at 19. The Applicant 
petitioned the MBC for reconsideration and his petition was denied on 
April 14, 2020. GX 4 (MBC Order Denying Petition for Reconsideration).
    According to the online records of the California Department of 
Consumer Affairs, of which I take official notice, Applicant's license 
remains revoked.\1\ https://search.dca.ca.gov/results (last visited 
date of signature of this Order). California's online records show that 
Applicant's medical license remains revoked and that Applicant is not 
authorized in California to practice medicine. Id.
---------------------------------------------------------------------------

    \1\ 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). 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.'' Accordingly, Applicant may dispute my finding by filing 
a properly supported motion for reconsideration within fifteen 
calendar days of the date of this Order. Any such motion shall be 
filed with the Office of the Administrator and a copy shall be 
served on the Government. In the event Applicant files a motion, the 
Government shall have fifteen calendar days to file a response. Any 
such motion and response may be filed and served by email 
([email protected]).
---------------------------------------------------------------------------

    As the Chief ALJ noted, Applicant does not appear to contest the 
status of his medical license or his state authorization to handle 
controlled substances. See SD, at 5 (citing App Reply, at 2). Based on 
the entire record before me, I find that Applicant currently is not 
licensed to engage in the practice of medicine in California.

Discussion

    Applicant's application requests registration as a ``practitioner'' 
in California. GX 1 (Applicant's Application). With respect to a 
practitioner, the 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 71371 (2011), 
pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh 
Blanton, M.D., 43 FR 27616, 27617 (1978).
    This rule derives from the text of two provisions of the Controlled 
Substances Act (hereinafter, CSA). Controlled Substances Act 
(hereinafter, CSA). Pursuant to section 303(f) of the CSA, a 
prerequisite to registration as a practitioner is authorization to 
dispense controlled substances under the laws of the state in which the 
Applicant seeks to be registered.\2\ 21 U.S.C. 823(f) (``The 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.''). Further, the CSA defines ``practitioner'' as ``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).
---------------------------------------------------------------------------

    \2\ ``[D]ispense[ ] means to deliver a controlled substance to 
an ultimate user . . . by, or pursuant to the lawful order of, a 
practitioner, including the prescribing and administering of a 
controlled substance. . . .'' 21 CFR 802(10).
---------------------------------------------------------------------------

    The Agency has long interpreted these statutory requirements 
strictly. The ``controlling question'' is ``whether the Applicant is 
currently authorized to handle controlled substances in the state.'' 
Anne Lazar Thorn, M.D., 62 FR 12847, 12848 (1997); see also Frederick 
Marsh Blanton, M.D., 43 FR 27616 (1978). Accordingly, the Agency has 
rejected arguments that it should relax these statutory requirements. 
For example, the Agency rejected as ``of no consequence'' the fact that 
the MBC summarily suspended a doctor's California medical license. 
Robert T. Perez, M.D., 84 FR 3247, 3248 (2019). ``What is 
consequential,'' the Agency

[[Page 24022]]

determined, ``is my finding that Registrant is no longer currently 
authorized to dispense controlled substances in California, the State 
in which he is registered.'' Id. Similarly, the Agency rejected as ``of 
no consequence'' the argument that the MBC had not yet afforded the 
doctor a hearing to challenge the suspension of his California medical 
license. Frank D. Li, M.D., 82 FR 11238, 11240 (2017). See also Miles 
J. Nelson, M.D., 84 FR 3248, 3250 (2019) (summary suspension of state 
authority or state authority pending a final decision on the merits are 
of no consequence); Bourne Pharmacy, Inc., 72 FR 18273, 18274 (2007) 
(``Under the . . . [CSA], it is irrelevant that Applicant's state 
registration is being held in escrow pending state proceedings. Under 
the . . . [CSA], a practitioner must be currently authorized to handle 
controlled substances in `the jurisdiction in which [it] practices' in 
order to maintain its DEA registration.'').
    According to California statute, ``[n]o person other than a 
physician . . . shall write or issue a prescription.'' Cal. Health & 
Safety Code Sec.  11150 (West 2021). Further, ``physician,'' as defined 
by California statute, is a person who is ``licensed to practice'' in 
California. Id. at Sec.  11024.
    Here, the undisputed evidence in the record is that Applicant 
currently lacks authority to practice medicine in California. As 
already discussed, a physician must be a licensed practitioner to 
dispense a controlled substance in California. Thus, because Applicant 
lacks authority to practice medicine in California and, therefore, is 
not authorized to handle controlled substances in California, Applicant 
is not eligible to be granted a DEA registration. Accordingly, I 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(f), I hereby deny the application submitted by Emmanuel 
Ayodele, M.D for a Certificate of Registration, Control Number 
H18074119C, as well as any other pending application of Emmanuel 
Ayodele, M.D. for additional registration in California. This Order is 
effective June 4, 2021.

D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-09461 Filed 5-4-21; 8:45 am]
BILLING CODE 4410-09-P