[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21717-21719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07514]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Richard Washinsky, M.D.; Decision and Order

    On August 11, 2022, the Drug Enforcement Administration 
(hereinafter, DEA or Government) issued an Order to Show Cause and 
Immediate Suspension of Registration (hereinafter, OSC/ISO) to Richard 
Washinsky, M.D., (hereinafter, Registrant) of Las Vegas, Nevada. 
Request for Final Agency Action (hereinafter, RFAA), Exhibit 
(hereinafter, RFAAX) 2, at 1. The OSC/ISO informed Registrant of the 
immediate suspension of his DEA Certificate of Registration, Control 
No. BW3227318, 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. The OSC/ISO also proposed the revocation of 
Registrant's registration, alleging that Registrant has ``committed 
such acts as would render [his] registration inconsistent with the 
public interest'' and that Registrant is ``without authority to handle 
controlled substances in the State of Nevada, the state in which [he 
is] registered with DEA.'' \1\ Id. at 1, 3 (citing 21 U.S.C. 824(a)(4), 
823(g)(1),\2\ 824(a)(3)).
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    \1\ The registered address of Registrant's DEA Certificate of 
Registration, Control No. BW3227318, is 9010 West Cheyenne Avenue, 
Las Vegas, Nevada 89129. Id. at 2.
    \2\ Effective December 2, 2022, the Medical Marijuana and 
Cannabidiol Research Expansion Act, Public Law 117-215, 136 Stat. 
2257 (2022) (Marijuana Research Amendments or MRA), amended the 
Controlled Substances Act (CSA) and other statutes. Relevant to this 
matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC, as 
21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the current 
designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA 
throughout.
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    The Agency makes the following findings of fact based on the 
uncontroverted evidence submitted by the Government in its RFAA dated 
February 6, 2023.\3\
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    \3\ Based on the Declarations from two DEA Group Supervisors, 
the Agency finds that the Government's service of the OSC/ISO on 
Registrant was adequate. RFAAX 3, at 2-3; RFAAX 4, at 1-2. Further, 
based on the Government's assertions in its RFAA, the Agency finds 
that more than thirty days have passed since Registrant was served 
with the OSC/ISO and Registrant has neither requested a hearing nor 
submitted a corrective action plan and therefore has waived any such 
rights. RFAA, at 3; see also 21 CFR 1301.43 and 21 U.S.C. 824(c)(2).
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I. Findings of Fact

    On March 2, 2022, the Nevada State Board of Pharmacy issued an 
Order on Show Cause Hearing that immediately suspended Registrant's 
Nevada controlled substance license. RFAAX 3, Attachment C, at 1-2. On 
September 7, 2022, the Nevada State Board of Pharmacy issued a 
Stipulation and Order on Second Order to Show Cause that revoked 
Registrant's Nevada controlled substance license.\4\ RFAAX 3, 
Attachment F, at 1-2. According to Nevada's online records, of which 
the Agency takes official notice, Registrant's Nevada controlled 
substance license is still revoked.\5\ Nevada State Board of Pharmacy 
License Verification, https://bop.nv.gov/resources/ALL/License_Verification (last visited date of signature of this Order). 
Accordingly, the Agency finds that Registrant is not licensed to handle 
controlled substances in Nevada, the state in which he is registered 
with the DEA.
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    \4\ The September 7, 2022 Stipulation Order further states 
``[Registrant] may not possess (except pursuant to the lawful order 
of a practitioner), administer, prescribe or dispense a controlled 
substance until . . . the Board reinstates his certificate of 
registration.'' Id., at 2-3.
    \5\ 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, Registrant may dispute the Agency's finding 
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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    The Agency further finds that the Government's evidence shows that 
Registrant continued to prescribe controlled substances after his 
Nevada controlled substance license was suspended, with Registrant 
issuing at least three prescriptions for controlled substances from at 
least March 4, 2022, through at least July 15, 2022. RFAAX 5, at 3-6, 
9-12.

II. Discussion

A. 21 U.S.C. 824(a)(3): Loss of State Authority

    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 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).\6\
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    \6\ 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, 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 Nevada statute, ``[e]very practitioner or other person 
who dispenses any controlled substance within this State or who 
proposes to engage in the dispensing of any controlled substance within 
this State shall obtain biennially a registration issued by the [State 
Board of Pharmacy] in accordance with its regulations.'' Nev. Rev. 
Stat. Sec.  453.226(1) (2022). Further, Nevada statute defines a 
``practitioner'' as a ``physician . . . who holds a license to practice 
his or her profession in this State and is registered pursuant to [the 
Uniform Controlled Substances Act].'' Id. at Sec.  453.123(1). Finally, 
under 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. at Sec.  
453.056(1).
    Here, the undisputed evidence in the record is that Registrant's 
Nevada

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controlled substance license is revoked. As discussed above, a 
physician must hold a controlled substance registration to dispense a 
controlled substance in Nevada. Accordingly, the Agency finds that 
Registrant is unauthorized to handle controlled substances in Nevada, 
the state in which he is registered with the DEA, and is therefore not 
eligible to maintain a DEA registration. Accordingly, the Agency will 
order that Registrant's registration be revoked.

B. 21 U.S.C. 823(g)(1): The Five Public Interest Factors

    Section 304(a) of the CSA provides that ``[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).

    The DEA considers these public interest factors in the disjunctive. 
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (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 37,507, 37,508 
(1993).
    While the Agency has considered all of the public interest factors 
in 21 U.S.C. 823(g)(1),\7\ the Government's evidence in support of its 
prima facie case for revocation of Registrant's registration is 
confined to Factors A, B, and D. See RFAA, at 9-11. Moreover, the 
Government has the burden of proof in this proceeding. 21 CFR 1301.44.
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    \7\ As to Factor C, there is no evidence in the record that 
Registrant has been convicted of an offense under either federal or 
state law ``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, let alone prosecuted for one. Dewey 
C. MacKay, M.D., 75 FR 49,956, 49,973 (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 A, 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.
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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. 824(a). 
The Agency further finds that Registrant failed to provide sufficient 
evidence to rebut the Government's prima facie case.
1. Factor A
    In determining the public interest under Factor A, the Agency 
considers the recommendation of the appropriate state licensing board. 
Here, the state licensing board has taken disciplinary actions 
resulting in a loss of state authority, and one of those actions 
involved a matter that is a bases for the DEA OSC. See Kenneth Harold 
Bull, M.D., 78 FR 62,666, 62,672 (2013); see also George M. Douglass, 
M.D., 87 FR 67,497, 67,498 (2022); John O. Dimowo, 85 FR 15,800, 15,809 
(2020). Specifically, the record shows that the Nevada State Board of 
Pharmacy revoked Registrant's state controlled substance license 
following a June 14, 2022 Second Order to Show Cause, which alleged 
that on March 4, 2022, Registrant prescribed a controlled substance 
even though his controlled substance license had been immediately 
suspended two days prior. RFAAX 3, Attachment F, at 2, 21.
    In this matter, the Government has presented evidence establishing 
that Registrant issued three controlled substances prescriptions after 
his state controlled substance license was suspended: the March 4, 
2022, prescription that resulted in the revocation of Registrant's 
state controlled substance license, and two others issued after the 
date of the Second Order to Show Cause. RFAAX 5, at 3-6, 9-12. The 
Nevada State Board of Pharmacy revoked Registrant's Nevada controlled 
substance license with less record evidence than is available here, and 
Registrant's Nevada controlled substance license has not since been 
restored. As such, the Agency finds that Factor A weighs against 
Registrant's continued registration.
2. 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 21,156, 21,162 (2022). In the current 
matter, the Government has alleged that Registrant has violated both 
federal and Nevada state law regulating controlled substances. RFAAX 2 
(OSC/ISO), at 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). Further, Nevada law prohibits the dispensing of controlled 
substances without a Nevada controlled substance license. Nev. Rev. 
Stat. Sec.  453.226(1) (2022).
    Here, the record demonstrates that Registrant issued at least three 
controlled substance prescriptions after his Nevada controlled 
substance license was suspended, conduct in clear violation of Nevada 
law, which renders Registrant's prescribing outside the usual course of 
professional practice. As such, the Agency sustains the Government's 
allegations that Registrant violated 21 CFR 1306.04(a) and Nev. Rev. 
Stat. Sec.  453.226(1).
    In sum, the Agency finds that Factors A, 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).

III. Sanction

    Where, as here, the Government has established 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 18,882, 18,910 (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 62,316, 62,339 (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

[[Page 21719]]

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 
33,738, 33,746 (2021).
    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. Moreover, the 
evidence presented by the Government clearly shows that Registrant 
violated the CSA and the Agency has found that Registrant is ineligible 
to maintain a DEA registration. See supra at II.A. 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), I hereby revoke DEA Certificate of Registration No. 
BW3227318 issued to Richard Washinsky, 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 Richard Washinsky, M.D., to 
renew or modify this registration, as well as any other pending 
application of Richard Washinsky, M.D., for additional registration in 
Nevada. This Order is effective May 11, 2023.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
April 4, 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. 2023-07514 Filed 4-10-23; 8:45 am]
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