[Federal Register Volume 89, Number 157 (Wednesday, August 14, 2024)]
[Notices]
[Pages 66140-66141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, https://fortress.wa.gov/doh/providercredentialsearch/ (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 [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 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]
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