Notice2024-16212
Donna Winingham, MD; Decision and Order
Primary source
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Published
July 24, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 89 Issue 142 (Wednesday, July 24, 2024)</title>
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[Federal Register Volume 89, Number 142 (Wednesday, July 24, 2024)]
[Notices]
[Pages 59932-59933]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16212]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Donna Winingham, MD; Decision and Order
On July 19, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Donna Winingham,
M.D. (Registrant). Request for Final Agency Action (RFAA), Exhibit
(RFAAX) 2, at 1, 3. The OSC proposed the revocation of Registrant's
Certificate of Registration No. AW1730729 in Templeton, CA 93465. Id.
at 1. The OSC alleged that Registrant's registration should be revoked
because Registrant is ``currently without authority to prescribe,
administer, dispense, or otherwise handle controlled substances in the
State of California, the state in which [she is] registered with DEA.''
Id. at 2 (citing 21 U.S.C. 824(a)(3)).
The OSC notified Registrant of her right to file with DEA a written
request for hearing, and that if she failed to file such a request, she
would be deemed to have waived her right to a hearing and be in
default. Id. (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] right to a hearing and an
admission of the factual allegations of the [OSC].'' 21 CFR 1301.43(e).
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\1\ Based on the Government's submissions in its RFAA dated
September 26, 2023, the Agency finds that service of the OSC on
Registrant was adequate. Specifically, the Government's included
Notice of Service of Order to Show Cause indicates that Registrant
was served with the OSC by certified mail on August 9, 2023. RFAAX
1, at 1; see also id. at 6.
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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(c), (f), 1301.46. RFAA, at 1; see
also 21 CFR 1316.67.
Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are admitted. According to the OSC,
effective July 30, 2021, the Medical Board of California revoked
Registrant's California medical license. RFAAX 2, at 2. According to
California's online records, of which the Agency takes official notice,
Registrant's California medical license remains revoked.\2\ California
DCA License Search, <a href="https://search.dca.ca.gov/">https://search.dca.ca.gov/</a> (last visited date of
signature of this Order). Accordingly, the Agency finds that Registrant
is not licensed to practice medicine in California, the state in which
she is registered with DEA.
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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). 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 the DEA Office of the Administrator,
Drug Enforcement Administration at <a href="/cdn-cgi/l/email-protection#d8bcbdb9f6b9bcbcb7f6b9acacb7aab6bda1ab98bcbdb9f6bfb7ae"><span class="__cf_email__" data-cfemail="f4909195da9590909bda9580809b869a918d87b4909195da939b82">[email protected]</span></a>.
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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 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.
See, e.g., James L. Hooper, D.O., 76 FR 71371, 71372 (2011), pet. for
rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh Blanton,
D.O., 43 FR 27616, 27617 (1978).\3\
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\3\ This rule derives from the text of two provisions of the
Controlled Substances Act (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, 76 FR 71371-72; Sheran Arden Yeates, D.O., 71
FR 39130, 39131 (2006); Dominick A. Ricci, D.O., 58 FR 51104, 51105
(1993); Bobby Watts, D.O., 53 FR 11919, 11920 (1988); Frederick
Marsh Blanton, 43 FR 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 2024). 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 [the]
state.'' Id. section 11026(c).
Here, the undisputed evidence in the record is that Registrant
currently 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 Registrant
currently lacks authority to practice medicine in California and,
therefore, is not currently authorized to handle controlled substances
in California, Registrant is not eligible to maintain a DEA
registration. Accordingly, the Agency will order that Registrant's DEA
registration be revoked.
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.
AW1730729 issued to Donna Winingham, 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 Donna Winingham, M.D., to renew
or modify this registration, as well as any other pending application
of Donna Winingham, M.D., for additional registration in California.
This Order is effective August 23, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
July 15, 2024, by Administrator Anne
[[Page 59933]]
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. 2024-16212 Filed 7-23-24; 8:45 am]
BILLING CODE 4410-09-P
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