Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Ohana Bio Pharma, LLC, 13886 [2025-05277]
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Federal Register / Vol. 90, No. 58 / Thursday, March 27, 2025 / Notices
necessary to prepare the substance for
that delivery.’’ Ga. Code Ann.
section 16–13–21(9) (2024). Further, a
‘‘practitioner’’ means a ‘‘physician . . .
or other person licensed, registered, or
otherwise authorized under the laws of
[Georgia] to distribute, dispense,
conduct research with respect to, or
administer a controlled substance in the
course of professional practice or
research in [Georgia].’’ Id. at section 16–
13–21(23)(A).
Here, the undisputed evidence in the
record is that Registrant lacks authority
to practice medicine in Georgia. As
discussed above, a physician must be a
licensed practitioner to dispense a
controlled substance in Georgia. Thus,
because Registrant lacks authority to
practice medicine in Georgia and,
therefore, is not authorized to handle
controlled substances in Georgia,
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. FL2241305, issued to
Harvey Leslie, 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 Harvey Leslie, M.D., to renew or
modify this registration, as well as any
other pending application of Harvey
Leslie, M.D., for additional registration
in Georgia. This Order is effective April
28, 2025.
lotter on DSK11XQN23PROD with NOTICES1
Signing Authority
This document of the Drug
Enforcement Administration was signed
on March 20, 2025, by Acting
Administrator Derek Maltz. 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. 2025–05165 Filed 3–26–25; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1523]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Ohana Bio
Pharma, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
The Drug Enforcement
Administration (DEA) is providing
notice of an application it has received
from an entity applying to be registered
to manufacture in bulk basic class(es) of
controlled substances listed in schedule
I. DEA intends to evaluate this and other
pending applications according to its
regulations governing the program of
growing marihuana for scientific and
medical research under DEA
registration.
SUMMARY:
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 May 27, 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.’’
SUPPLEMENTARY INFORMATION: The
Controlled Substances Act (CSA)
prohibits the cultivation and
distribution of marihuana except by
persons who are registered under the
CSA to do so for lawful purposes. In
accordance with the purposes specified
in 21 CFR 1301.33(a), DEA is providing
notice that the entity identified below
has applied for registration as a bulk
manufacturer of schedule I controlled
substances. In response, registered bulk
manufacturers of the affected basic
class(es), and applicants therefor, may
submit electronic comments on or
objections of the requested registration,
DATES:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
as provided in this notice. This notice
does not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for product development and
distribution to DEA registered
researchers. If the application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
specifically authorized by DEA
regulations. DEA will evaluate the
application for registration as a bulk
manufacturer for compliance with all
applicable laws, treaties, and
regulations and to ensure adequate
safeguards against diversion are in
place.
As this applicant has applied to
become registered as a bulk
manufacturer of marihuana, the
application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA will
conduct this evaluation in the manner
described in the rule published at 85 FR
82333 on December 18, 2020, and
reflected in DEA regulations at 21 CFR
part 1318.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on December 6, 2024, Ohana Bio
Pharma, LLC, 22 Frontage Road,
Westerly, Rhode Island 02891 applied to
be registered as a bulk manufacturer of
the following basic class(es) of
controlled substances:
Controlled substance
Drug
code
Schedule
Marihuana Extract .............
Marihuana .........................
Tetrahydrocannabinol .......
7350
7360
7370
I
I
I
I
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–05277 Filed 3–26–25; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1524]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Royal
Beverages, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
The Drug Enforcement
Administration (DEA) is providing
SUMMARY:
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 90, Number 58 (Thursday, March 27, 2025)]
[Notices]
[Page 13886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-05277]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1523]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Ohana Bio Pharma, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is providing notice
of an application it has received from an entity applying to be
registered to manufacture in bulk basic class(es) of controlled
substances listed in schedule I. DEA intends to evaluate this and other
pending applications according to its regulations governing the program
of growing marihuana for scientific and medical research under DEA
registration.
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
May 27, 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.''
SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA)
prohibits the cultivation and distribution of marihuana except by
persons who are registered under the CSA to do so for lawful purposes.
In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is
providing notice that the entity identified below has applied for
registration as a bulk manufacturer of schedule I controlled
substances. In response, registered bulk manufacturers of the affected
basic class(es), and applicants therefor, may submit electronic
comments on or objections of the requested registration, as provided in
this notice. This notice does not constitute any evaluation or
determination of the merits of the application submitted.
The applicant plans to manufacture bulk active pharmaceutical
ingredients (APIs) for product development and distribution to DEA
registered researchers. If the application for registration is granted,
the registrant would not be authorized to conduct other activity under
this registration aside from those coincident activities specifically
authorized by DEA regulations. DEA will evaluate the application for
registration as a bulk manufacturer for compliance with all applicable
laws, treaties, and regulations and to ensure adequate safeguards
against diversion are in place.
As this applicant has applied to become registered as a bulk
manufacturer of marihuana, the application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the
manner described in the rule published at 85 FR 82333 on December 18,
2020, and reflected in DEA regulations at 21 CFR part 1318.
In accordance with 21 CFR 1301.33(a), DEA is providing notice that
on December 6, 2024, Ohana Bio Pharma, LLC, 22 Frontage Road, Westerly,
Rhode Island 02891 applied to be registered as a bulk manufacturer of
the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
Tetrahydrocannabinol.................... 7370 I
------------------------------------------------------------------------
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-05277 Filed 3-26-25; 8:45 am]
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