[Federal Register Volume 87, Number 148 (Wednesday, August 3, 2022)]
[Notices]
[Pages 47465-47466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16631]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 22-25]


Michael Simental, M.D.; Decision and Order

    On January 24, 2022, the Drug Enforcement Administration 
(hereinafter, DEA or Government) issued an Order to Show Cause 
(hereinafter, OSC) to Michael Simental, M.D. (hereinafter, Applicant). 
OSC, at 1, 3. The OSC proposed the denial of Applicant's application 
for a Certificate of Registration No. W20129943C at the proposed 
registered address of 4201 Torrance Boulevard, Suite 590, Torrance, 
California 90503. Id. at 1. The OSC alleged that Applicant's 
application should be denied because Applicant is ``without authority 
to handle controlled substances in California, the state in which [he 
has] applied to be registered with DEA.'' Id. at 2 (citing 21 U.S.C. 
824(a)(3)).
    By letter dated May 11, 2022,\1\ Applicant requested a hearing. On 
May 12, 2022, Administrative Law Judge Teresa A. Wallbaum (hereinafter, 
the ALJ) issued an Order Directing Government to File Evidence of 
Service of the Order to Show Cause and Evidence of Lack of State 
Authority. On May 26, 2022, the Government filed its Notice of Filing 
of Evidence and Motion for Summary Disposition (hereinafter, Motion for 
Summary Disposition). On June 6, 2022, Applicant filed his Response to 
Government's Notice of Filing of Evidence and Motion for

[[Page 47466]]

Summary Disposition (hereinafter, Response).\2\
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    \1\ The record demonstrates that service was not accomplished 
until April 10, 2022 and the Government does not contest the 
timeliness of the request for a hearing. Motion for Summary 
Disposition, at n.2.
    \2\ In his Response, Applicant did not dispute that he lacks 
state authority nor did he otherwise oppose the denial of his 
application, but rather, Applicant indicated that he had 
``misguidedly applied for a DEA COR during the pendency of 
disciplinary proceedings before the Medical Board of California'' 
and had ``requested a hearing in the instant matter to see if the 
withdrawal of his application for a COR could be accomplished.'' 
Response, at 1.
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    On June 7, 2022, the ALJ granted the Government's Motion for 
Summary Disposition and recommended the denial of Applicant's 
application, finding that because Applicant lacks state authority to 
handle controlled substances, there is no genuine issue of material 
fact. Order Granting the Government's Motion for Summary Disposition, 
and Recommended Rulings, Findings of Fact, Conclusions of Law, and 
Decision of the Administrative Law Judge (hereinafter, Recommended 
Decision or RD), at 6.\3\
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    \3\ By letter dated July 5, 2022, the ALJ certified and 
transmitted the record to the Agency for final agency action and 
advised that neither party filed exceptions.
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    The Agency issues this Decision and Order based on the entire 
record before it, 21 CFR 1301.43(e), and makes the following findings 
of fact.

Findings of Fact

    On May 20, 2021, the Medical Board of California entered a Cease 
Practice Order against Applicant that prohibited him from engaging in 
the practice of medicine until ``a final Decision [had] been issued on 
an Accusation and/or a Petition to Revoke Probation filed pursuant to 
[the] [underlying] matter.'' Government Attachment 1, Exhibit A. 
According to California's online records, of which the Agency takes 
official notice, Applicant's state medical license was surrendered.\4\ 
Medical Board of California License Verification, https://www.mbc.ca.gov/License-Verification (last visited date of signature of 
this Order). Accordingly, the Agency finds that Applicant is not 
licensed to engage in the practice of medicine in California, the state 
in which he is registered with the DEA.
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    \4\ 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 the Agency's finding 
by filing a properly supported motion for reconsideration of finding 
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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Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823 of the 
Controlled Substances Act (hereinafter, CSA) ``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, 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 71,371 (2011), pet. for rev. denied, 481 F. App'x 826 (4th 
Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 
(1978).\5\
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    \5\ 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(f). Because 
Congress has clearly mandated that a practitioner possess state 
authority in order to be deemed a practitioner under the CSA, the 
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, 76 FR at 
71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 (2006); 
Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby Watts, 
M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh Blanton, 43 FR at 
27,617.
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    According to California statute, ``dispense'' means ``to deliver a 
controlled substance to an ultimate user or research subject by or 
pursuant to the lawful order of a practitioner, including the 
prescribing, furnishing, packaging, labeling, or compounding necessary 
to prepare the substance for that delivery.'' Cal. Health & Safety Code 
Sec.  11010 (West 2022). Further, a ``practitioner'' means a person 
``licensed, registered, or otherwise permitted, to distribute, 
dispense, conduct research with respect to, or administer, a controlled 
substance in the course of professional practice or research in this 
state.'' Id. at Sec.  11026(c).
    Here, the undisputed evidence in the record is that Applicant lacks 
authority to practice medicine in California. As discussed above, 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 receive a DEA registration. Accordingly, the Agency 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 pending application for a Certificate 
of Registration, Control Number W20129943C, submitted by Michael 
Simental, M.D., as well as any other pending application of Michael 
Simental, M.D., for additional registration in California. This Order 
is effective [insert Date Thirty Days From the Date of Publication in 
the Federal Register].

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
July 26, 2022, 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. 2022-16631 Filed 8-2-22; 8:45 am]
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