Bulk Manufacturer of Controlled Substances Application: Maridose LLC, 9555-9556 [2025-02596]
Download as PDF
<![CDATA[
9555
Federal Register / Vol. 90, No. 29 / Thursday, February 13, 2025 / Notices
Controlled substance
Marihuana Extract ...........
Marihuana ........................
Tetrahydrocannabinols ....
Nabilone ..........................
Phenylacetone .................
Ecgonine ..........................
Levorphanol .....................
Methadone ......................
Thebaine ..........................
Opium, raw ......................
Opium, powdered ............
Opium, granulated ...........
Noroxymorphone .............
Poppy Straw Concentrate
Tapentadol ......................
Drug
code
Schedule
7350
7360
7370
7379
8501
9180
9220
9250
9333
9600
9639
9640
9668
9670
9780
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–02600 Filed 2–12–25; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
ddrumheller on DSK120RN23PROD with NOTICES1
Drug Enforcement Administration
[Docket No. 1447]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: University
of Kentucky Cannabis Center
Drug Enforcement
Administration, Justice.
AGENCY:
16:39 Feb 12, 2025
Notice of application.
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 April 14, 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), the Drug
Enforcement Administration (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
SUMMARY:
The company plans to import Opium,
Raw (9600), Opium, Powdered (9639)
and Opium, Granulated (9640) to
manufacture an Active Pharmaceutical
Ingredient (API) only for distribution to
its customers. The company plans to
import Phenylacetone (8501) and Poppy
Straw Concentrate (9670), to bulk
manufacture other controlled substances
for distribution to its customers. The
company plans to import impurities of
buprenorphine that have been
determined by DEA to be captured
under Thebaine (9333). In reference to
Marihuana Extract (7350), Marihuana
(7360), and Tetrahydrocannabinols
(7370), the company plans to import as
synthetic. The company plans to import
an isomer of methadone (9250) not
currently available domestically to
manufacture a non-controlled
substance. No other activities for these
drug codes are 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.
VerDate Sep<11>2014
ACTION:
Jkt 265001
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
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 July 1, 2024, University of Kentucky
Cannabis Center, 845 Angliana Avenue,
Lexington, Kentucky 40508, applied to
be registered as a bulk manufacturer of
the following basic class(es) of
controlled substances:
Controlled substance
Marihuana ........................
Drug
code
Schedule
I 7360 II
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–02595 Filed 2–12–25; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1487]
Bulk Manufacturer of Controlled
Substances Application: Maridose LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Maridose LLC has applied to
be registered as a bulk manufacturer 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 April 14, 2025. Such
persons may also file a written request
for a hearing on the application on or
before April 14, 2025.
SUMMARY:
E:\FR\FM\13FEN1.SGM
13FEN1
9556
Federal Register / Vol. 90, No. 29 / Thursday, February 13, 2025 / Notices
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: In
accordance with 21 CFR 1301.33(a), this
is notice that on December 30, 2024,
Maridose LLC, 74 Orion Street, Unit 7,
Brunswick, Maine 04011, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
ADDRESSES:
Controlled substance
Marihuana Extract ...........
Marihuana ........................
Tetrahydrocannabinols ....
I
Drug
code
Schedule
7350
7360
7370
I
I
I
I
The company plans to bulk
manufacture the listed controlled
substances to supply the Drug
Enforcement Administration-registered
researchers for their approval studies.
No other activities for these drug codes
are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–02596 Filed 2–12–25; 8:45 am]
BILLING CODE P
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before March 17, 2025. Such
persons may also file a written request
for a hearing on the application on or
before March 17, 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
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 December 10, 2024,
Mylan Inc., 3711 Collins Ferry Road,
Morgantown, West Virginia 26505–
2362, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–1486]
Amphetamine ..................
Methylphenidate ..............
Oxycodone ......................
Hydromorphone ...............
Methadone ......................
Morphine ..........................
Fentanyl ...........................
Importer of Controlled Substances
Application: Mylan Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
ddrumheller on DSK120RN23PROD with NOTICES1
AGENCY:
Mylan 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
SUMMARY:
VerDate Sep<11>2014
16:39 Feb 12, 2025
Jkt 265001
Drug
code
Schedule
1100
1724
9143
9150
9250
9300
9801
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances as bulk
active pharmaceutical ingredients for
internal testing purposes only and
finished dosage forms for analytical
testing and distribution for clinical trials
to support foreign market participation.
No other activities for these drug codes
are authorized for this registration.
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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. 2025–02594 Filed 2–12–25; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1490]
Importer of Controlled Substances
Application: Janssen Pharmaceuticals
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Janssen Pharmaceuticals 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 March 17, 2025. Such
persons may also file a written request
for a hearing on the application on or
before March 17, 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:
E:\FR\FM\13FEN1.SGM
13FEN1
]]>Agencies
[Federal Register Volume 90, Number 29 (Thursday, February 13, 2025)]
[Notices]
[Pages 9555-9556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02596]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1487]
Bulk Manufacturer of Controlled Substances Application: Maridose
LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Maridose LLC has applied to be registered as a bulk
manufacturer 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
April 14, 2025. Such persons may also file a written request for a
hearing on the application on or before April 14, 2025.
[[Page 9556]]
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: In accordance with 21 CFR 1301.33(a), this
is notice that on December 30, 2024, Maridose LLC, 74 Orion Street,
Unit 7, Brunswick, Maine 04011, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
Tetrahydrocannabinols................... 7370 I
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances to supply the Drug Enforcement Administration-registered
researchers for their approval studies. No other activities for these
drug codes are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-02596 Filed 2-12-25; 8:45 am]
BILLING CODE P
