[Federal Register Volume 87, Number 215 (Tuesday, November 8, 2022)]
[Notices]
[Pages 67496-67497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24299]



[[Page 67496]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 22-37]


Nicky Shah, M.D.; Decision and Order

    On June 29, 2022, the Drug Enforcement Administration (hereinafter, 
DEA or Government) filed an Order to Show Cause (hereinafter, OSC) 
issued to Nicky Shah, M.D. (hereinafter, Respondent). OSC, at 1. The 
OSC proposed the revocation of Respondent's Certificate of Registration 
No. BS6061345 at the registered address of 293 Corbett Ave., San 
Francisco, CA 94114. Id. The OSC alleged that Respondent's registration 
should be revoked because Respondent is ``without authority to handle 
controlled substances in the State of California, the state in which 
[he is] registered with DEA.'' Id. at 1-2 (citing 21 U.S.C. 
824(a)(3)).\1\
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    \1\ According to Agency records, Respondent's Certificate of 
Registration No. BS6061345 expired on February 28, 2022, and 
Respondent's request for renewal of his registration was received on 
April 1, 2022.
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    By email dated August 3, 2022, Respondent requested a hearing.\2\ 
On August 23, 2022, the Government filed a Motion for Summary 
Disposition, which Respondent opposed. On September 13, 2022, the ALJ 
granted the Government's Motion for Summary Disposition and recommended 
the revocation of Respondent's registration and the denial of 
Respondent's request to renew his registration, finding that because 
Respondent lacks state authority to handle controlled substances in 
California, the state in which he is registered with DEA, 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 5-6.
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    \2\ On August 8, 2022, Respondent filed an additional hearing 
request document that included a more detailed response to the OSC.
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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 April 2, 2020, an Administrative Law Judge from the State of 
California, Office of Administrative Hearings, issued a Proposed 
Decision revoking Respondent's California medical license. Government 
Exhibit (hereinafter, GX) B, at 2, 12. On May 13, 2020, the Medical 
Board of California issued a Decision adopting the Administrative Law 
Judge's Proposed Decision, effective June 12, 2020. Id. at 1.
    According to California's online records, of which the Agency takes 
official notice, Respondent's state medical license is revoked.\3\ 
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 Respondent 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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    \3\ 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, Respondent 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 71371 (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(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 
71371-72; Sheran Arden Yeates, 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, 43 FR at 
27617.
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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 
section 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 section 11026(c).
    Here, the undisputed evidence in the record is that Respondent 
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 Respondent lacks authority to 
practice medicine in California and, therefore, is not authorized to 
handle controlled substances in California, Respondent is not eligible 
to maintain a DEA registration based in California. Accordingly, the 
Agency will order that Respondent's DEA registration be revoked and 
that Respondent's request for renewal of his registration be denied.\5\
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    \5\ Respondent argued that his registration should be renewed 
because prior to the issuance of the OSC, he had requested to renew 
his registration with a change of registered address to Iowa, where 
he maintains an unrestricted, active medical license and an Iowa 
controlled substance registration. Resp Opposition, at 4-6; see also 
RX B-D. As the ALJ stated ``[a]n attempt to modify the registered 
location of a [registration] is deemed an application for a new 
[registration].'' RD, at 5 (citing 21 CFR 1301.51(c); Gazelle A. 
Craig, D.O., 83 FR 27628, 27631 (2018)). Here, the subject of the 
current proceeding is Respondent's Certificate of Registration No. 
BS6061345, not Respondent's eligibility for a new registration based 
in Iowa. As such, it is only of consequence whether Respondent has 
state authority to handle controlled substances in California, the 
state in which Certificate of Registration No. BS6061345 is based.
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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

[[Page 67497]]

of Registration No. BS6061345 issued to Nicky Shah, M.D. Further, 
pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 
823(f), I hereby deny any pending applications of Nicky Shah, M.D., to 
renew or modify this registration, as well as any other pending 
application of Nicky Shah, M.D., for additional registration in 
California. This Order is effective December 8, 2022.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
November 1, 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. 2022-24299 Filed 11-7-22; 8:45 am]
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