Importer of Controlled Substances Application: Curia New York, Inc., 106589-106590 [2024-31292]
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Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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 (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, 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. Gonzales v.
Oregon, 546 U.S. 243, 270 (2006) (‘‘The
Attorney General can register a
physician to dispense controlled
substances ‘if the applicant is
authorized to dispense . . . controlled
substances under the laws of the State
in which he practices.’ . . . The very
definition of a ‘practitioner’ eligible to
prescribe includes physicians ‘licensed,
registered, or otherwise permitted, by
the United States or the jurisdiction in
which he practices’ to dispense
controlled substances. § 802(21).’’). The
Agency has applied these principles
consistently. See, e.g., James L. Hooper,
M.D., 76 FR 71371, 71372 (2011), pet.
for rev. denied, 481 F. App’x 826 (4th
Cir. 2012); Frederick Marsh Blanton,
M.D., 43 FR 27616, 27617 (1978).4
Under Louisiana statute, ‘‘dispense’’
means ‘‘to deliver a controlled
dangerous substance to the ultimate
user or human research subject by or
pursuant to the lawful order of a
practitioner, including the packaging,
labeling, or compounding necessary to
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(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, M.D., 76 FR 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, M.D., 43 FR
27617.
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prepare the substance for such
delivery.’’ La. Stat. Ann. section
40:961(14) (2024). A ‘‘practitioner’’
means ‘‘a physician . . . or other person
licensed, registered, or otherwise
permitted to distribute, dispense,
conduct research with respect to, or
administer a controlled dangerous
substance in the course of professional
practice or research in th[e] state.’’ Id.
section 40:961(35).
Further, Louisiana statute states that
‘‘[e]very person who . . . distributes,
procures, possesses, prescribes, or
dispenses any controlled dangerous
substance within th[e] state . . . shall
obtain a controlled dangerous substance
license issued by the Louisiana Board of
Pharmacy in accordance with the rules
and regulations promulgated by the
board prior to engaging in such
activity.’’ Id. section 40:973(A)(1).
Here, the undisputed evidence in the
record is that Respondent currently
lacks authority to handle controlled
substances in Louisiana because
Respondent’s Louisiana medical license
is suspended, and Respondent’s
Louisiana controlled substance license
is lapsed. As discussed above, an
individual must be a licensed
practitioner and must hold a Louisiana
controlled substance license to dispense
controlled substances in Louisiana.
Thus, because Respondent lacks
authority to practice medicine in
Louisiana, as well as lacks authority to
handle controlled substances in
Louisiana, Respondent is not eligible to
maintain a DEA registration. RD, at 5–
6. Accordingly, the Agency will order
that Respondent’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. BA7786013 issued to
Shiva Akula, 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 Shiva Akula, M.D., to renew or
modify this registration, as well as any
other pending application of Shiva
Akula, M.D., for additional registration
in Louisiana. This Order is effective
January 29, 2025.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on December 20, 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
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106589
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. 2024–31320 Filed 12–27–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1463]
Importer of Controlled Substances
Application: Curia New York, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Curia New York, Inc. has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to Supplementary
Information listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before January 29, 2025. Such
persons may also file a written request
for a hearing on the application on or
before January 29, 2025.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement
SUMMARY:
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106590
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
In
accordance with 21 CFR 1301.34(a), this
is notice that on November 13, 2024,
SUPPLEMENTARY INFORMATION:
Curia New York, Inc., 33 Riverside
Avenue, Rensselaer, New York 12144,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ...................................................................................................................................
The company plans to import the
listed controlled substances for bulk
manufacturing into other controlled
substances to be distributed to their
customers. No other activity for this
drug code is authorized for this
registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration approved or nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–31292 Filed 12–27–24; 8:45 am]
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
September 1, 2023, the Dental Board of
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ddrumheller on DSK120RN23PROD with NOTICES1
Samreen Riaz, D.D.S.; Decision and
Order
On February 27, 2024, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause (OSC) to Samreen Riaz, D.D.S., of
Hawthorne, California (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. FR4257792, alleging 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 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
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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).
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] § 1316.67.’’ Id. § 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.
1 Based on the Government’s submissions in its
RFAA dated May 23, 2024, the Agency finds that
service of the OSC on Registrant was adequate. The
included declaration from a DEA Diversion
Investigator (DI) indicates that on March 12, 2024,
the DI attempted to serve Registrant with the OSC
at Registrant’s registered address, a clinic. RFAAX
1, at 1. However, the clinic manager who was at the
registered location claimed to not know Registrant,
despite working at the location for nearly five years.
Id. The DI then left several voicemails with the
clinic’s Human Resources department, which went
unanswered. Id. at 2. On March 19, 2024, the DI
mailed a copy of the OSC to a different address
Registrant had on file with DEA; however, as of
April 5, 2024, the mailing was never claimed by
Registrant and was scheduled to be returned to
DEA. Id. Finally, on April 5, 2024, the DI emailed
a copy of the OSC to Registrant’s registered email
address. Id.; see also id., Attachment A. The DI did
not receive any error message in response to the
email. Id. at 2. Accordingly, the Agency finds that
Registrant was successfully served the OSC by
email. Mohammed S. Aljanaby, M.D., 82 FR 34552,
34552 (2017) (finding that service by email satisfies
due process where the email is not returned as
undeliverable and other methods have been
unsuccessful). Further, the Agency finds that the
DI’s efforts to serve Registrant by other means were
‘‘‘reasonably calculated, under all the
circumstances, to apprise [Registrant] of the
pendency of the action.’’’ Jones v. Flowers, 547 U.S.
220, 226 (2006) (quoting Mullane v. Central
Hanover Bank & Trust Co., 339 U.S. 306, 314
(1950)). Therefore, due process notice requirements
have been satisfied.
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2010
Schedule
I
California revoked Registrant’s
California dental license. RFAAX 2, at 2.
According to California online records,
of which the Agency takes official
notice, Registrant’s California dental
license remains revoked.2 California
DCA License Search, https://
search.dca.ca.gov (last visited date of
signature of this Order). Accordingly,
the Agency finds that Registrant is not
licensed to practice as a dentist in
California, the state in which she is
registered with DEA.
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. Gonzales v.
Oregon, 546 U.S. 243, 270 (2006) (‘‘The
Attorney General can register a
physician to dispense controlled
substances ‘if the applicant is
authorized to dispense . . . controlled
substances under the laws of the State
in which he practices.’ . . . The very
definition of a ‘practitioner’ eligible to
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 Office of the
Administrator, Drug Enforcement Administration at
dea.addo.attorneys@dea.gov.
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Agencies
[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106589-106590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31292]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1463]
Importer of Controlled Substances Application: Curia New York,
Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Curia New York, Inc. has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
Supplementary Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants, therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
January 29, 2025. Such persons may also file a written request for a
hearing on the application on or before January 29, 2025.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment. All
requests for a hearing must be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement
[[Page 106590]]
Administration, Attn: DEA Federal Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing should also be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on November 13, 2024, Curia New York, Inc., 33 Riverside
Avenue, Rensselaer, New York 12144, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............... 2010 I
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
bulk manufacturing into other controlled substances to be distributed
to their customers. No other activity for this drug code is authorized
for this registration.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import
of Food and Drug Administration approved or non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-31292 Filed 12-27-24; 8:45 am]
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