Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Entheogen Pharmaceuticals Inc, 37246-37247 [2024-09789]
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37246
Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices
By order of the Commission.
Pisgah Laboratories Inc., 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 July 5, 2024. Such persons
may also file a written request for a
hearing on the application on or before
July 5, 2024.
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
SUMMARY:
Issued: April 30, 2024.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2024–09746 Filed 5–3–24; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1360]
Bulk Manufacturer of Controlled
Substances Application: Pisgah
Laboratories Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
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 March 15, 2024, Pisgah
Laboratories Inc., 3222 Old
Hendersonville Highway, Pisgah Forest,
North Carolina 28768, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Drug code
4-Bromo-2,5-dimethoxyphenethylamine ..............................................................................................................................
Methylone (3,4-Methylenedioxy-N-methylcathinone) ..........................................................................................................
Amphetamine .......................................................................................................................................................................
Lisdexamfetamine ................................................................................................................................................................
Methylphenidate ..................................................................................................................................................................
Diphenoxylate ......................................................................................................................................................................
Meperidine ...........................................................................................................................................................................
Methadone ...........................................................................................................................................................................
Tapentadol ...........................................................................................................................................................................
The company plans to bulk
manufacture the above-listed controlled
substances in bulk for internal research
purposes and distribution to its
customers. No other activities for these
drug codes are authorized for this
registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–09810 Filed 5–3–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1354]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Entheogen
Pharmaceuticals Inc
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
ddrumheller on DSK120RN23PROD with NOTICES1
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
SUMMARY:
VerDate Sep<11>2014
18:02 May 03, 2024
Jkt 262001
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.
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 July 5, 2024.
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.’’
DATES:
PO 00000
Frm 00087
Fmt 4703
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9780
Schedule
I
I
II
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II
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06MYN1.SGM
06MYN1
37247
Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices
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 11, 2023, Entheogen
Pharmaceuticals Inc, 17349 Muskrat
Avenue, Adelanto, California, 92301
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Drug
code
Controlled substance
Ibogaine ...........................................................................................................................................................................
Lysergic Acid Diethylamide .............................................................................................................................................
Marihuana Extract ...........................................................................................................................................................
Marihuana ........................................................................................................................................................................
Mescaline .........................................................................................................................................................................
Dimethyltryptamine ..........................................................................................................................................................
Psilocybin .........................................................................................................................................................................
Psilocyn ...........................................................................................................................................................................
In reference to drug codes 7260
(Ibogaine), 7315 (Lysergic Acid
Diethylamide), 7381 (Mescaline), 7435
(Dimethyltryptamine), 7437
(Psilocybin), and 7438 (Psilocyn), the
company plans to bulk manufacture the
listed controlled substances for internal
research and analytical development
purposes. No other activities for these
drug codes are authorized for this
registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–09789 Filed 5–3–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1358]
Importer of Controlled Substances
Application: Lipomed
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Lipomed 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.
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 June 5, 2024. Such persons
may also file a written request for a
hearing on the application on or before
June 5, 2024.
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
DATES:
ddrumheller on DSK120RN23PROD with NOTICES1
Jkt 262001
PO 00000
Frm 00088
Fmt 4703
In
accordance with 21 CFR 1301.34(a), this
is notice that on February 7, 2024,
Lipomed, 150 Cambridgepark Drive,
Suite 705, Cambridge, Massachusetts
02140–2300, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
Drug code
Sfmt 4703
I
I
I
I
I
I
I
I
SUPPLEMENTARY INFORMATION:
3-Fluoro-N-methylcathinone (3–FMC) .................................................................................................................................
Cathinone ............................................................................................................................................................................
Methcathinone .....................................................................................................................................................................
4-Fluoro-N-methylcathinone (4–FMC) .................................................................................................................................
Pentedrone (a-methylaminovalerophenone) .......................................................................................................................
Mephedrone (4-Methyl-N-methylcathinone) ........................................................................................................................
4-Methyl-N-ethylcathinone (4–MEC) ...................................................................................................................................
Naphyrone ...........................................................................................................................................................................
N-Ethylamphetamine ...........................................................................................................................................................
N,N-Dimethylamphetamine ..................................................................................................................................................
Fenethylline .........................................................................................................................................................................
Aminorex ..............................................................................................................................................................................
4-Methylaminorex (cis isomer) ............................................................................................................................................
Gamma Hydroxybutyric Acid ...............................................................................................................................................
Methaqualone ......................................................................................................................................................................
Mecloqualone ......................................................................................................................................................................
Etizolam (4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine ....................................
18:02 May 03, 2024
7260
7315
7350
7360
7381
7435
7437
7438
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.
Controlled substance
VerDate Sep<11>2014
Schedule
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2010
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2780
Schedule
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]]>Agencies
[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Pages 37246-37247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09789]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1354]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Entheogen Pharmaceuticals Inc
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
July 5, 2024.
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
[[Page 37247]]
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 11, 2023, Entheogen Pharmaceuticals Inc, 17349 Muskrat
Avenue, Adelanto, California, 92301 applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Ibogaine........................... 7260 I
Lysergic Acid Diethylamide......... 7315 I
Marihuana Extract.................. 7350 I
Marihuana.......................... 7360 I
Mescaline.......................... 7381 I
Dimethyltryptamine................. 7435 I
Psilocybin......................... 7437 I
Psilocyn........................... 7438 I
------------------------------------------------------------------------
In reference to drug codes 7260 (Ibogaine), 7315 (Lysergic Acid
Diethylamide), 7381 (Mescaline), 7435 (Dimethyltryptamine), 7437
(Psilocybin), and 7438 (Psilocyn), the company plans to bulk
manufacture the listed controlled substances for internal research and
analytical development purposes. No other activities for these drug
codes are authorized for this registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-09789 Filed 5-3-24; 8:45 am]
BILLING CODE P
