Notice2024-18100
Irene Kimura, M.D.; Decision and Order
Primary source
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Published
August 14, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 89 Issue 157 (Wednesday, August 14, 2024)</title>
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[Federal Register Volume 89, Number 157 (Wednesday, August 14, 2024)]
[Notices]
[Pages 66140-66141]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-18100]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Irene Kimura, M.D.; Decision and Order
On July 12, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Irene Kimura, M.D.
(Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX)
3, at 1, 3. The OSC proposed the revocation of Registrant's Certificate
of Registration No. BK4376112 at the registered address of 1017 W
Broadway Ave., Moses Lake, WA 98837. 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 Washington, 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 3.\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
October 6, 2023, the Agency finds that service of the OSC on
Registrant was adequate. Specifically, the included email chain from
a DEA Diversion Investigator to Registrant indicates that Registrant
was successfully served with the OSC by email on July 17, 2023.
RFAAX 2, at 1-2.
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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, on
or about November 9, 2021, the State of Washington Department of Health
Washington Medical Commission issued an ``Ex Parte Order of Summary
Action--Restriction'' that restricted Registrant from prescribing
controlled substances. RFAAX 3, at 2. According to Washington's online
records, of which the Agency takes official notice, Registrant's
Washington medical license is revoked.\2\ Washington State Department
of Health Provider Credential Search, <a href="https://fortress.wa.gov/doh/providercredentialsearch/">https://fortress.wa.gov/doh/providercredentialsearch/</a> (last visited date of signature of this
Order). Accordingly, the Agency finds that Registrant is not licensed
to practice medicine in Washington, 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#9ffbfafeb1fefbfbf0b1feebebf0edf1fae6ecdffbfafeb1f8f0e9"><span class="__cf_email__" data-cfemail="d7b3b2b6f9b6b3b3b8f9b6a3a3b8a5b9b2aea497b3b2b6f9b0b8a1">[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 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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[[Page 66141]]
According to Washington statute, ``[a] practitioner may dispense or
deliver a controlled substance to or for an individual or animal only
for medical treatment or authorized research in the ordinary course of
that practitioner's profession.'' Wash. Rev. Code section 69.50.308(j)
(2024). Further, a ``prescription'' means ``an order for controlled
substances issued by a practitioner duly authorized by law or rule in
the state of Washington to prescribe controlled substances within the
scope of his or her professional practice for a legitimate medical
purpose.'' Id. section 69.50.101(oo). Finally, a ``practitioner'' as
defined by Washington statute includes ``[a] physician under chapter
18.71 RCW.'' Id. section 69.50.101(nn)(1).\4\
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\4\ Chapter 18.71 regulates physicians.
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Here, the undisputed evidence in the record is that Registrant
currently lacks authority to practice medicine in Washington. As
discussed above, a physician must be a licensed practitioner to
dispense or prescribe a controlled substance in Washington. Thus,
because Registrant currently lacks authority to practice medicine in
Washington and, therefore, is not currently authorized to handle
controlled substances in Washington, 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.
BK4376112 issued to Irene Kimura, 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 Irene Kimura, M.D., to renew or
modify this registration, as well as any other pending application of
Irene Kimura, M.D., for additional registration in Washington. This
Order is effective September 13, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
August 8, 2024, 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. 2024-18100 Filed 8-13-24; 8:45 am]
BILLING CODE 4410-09-P
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