Bulk Manufacturer of Controlled Substances Application: Organix Chemistry Solutions, LLC, 82398-82399 [2023-25946]
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82398
Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1296]
Bulk Manufacturer of Controlled
Substances Application: Navinta LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Navinta 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 January 23, 2024. Such
persons may also file a written request
for a hearing on the application on or
before January 23, 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
SUMMARY:
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 September 27, 2023,
Navinta LLC, 1499 Lower Ferry Road,
Ewing, New Jersey 08618–1414, applied
to be registered as a bulk manufacturer
of the following basic class(es) of
controlled substance(s):
Controlled substance
Pentobarbital .................
Levomethorphan ............
Levorphanol ...................
Remifentanil ...................
Drug
code
2270
9210
9220
9739
Schedule
II
II
II
II
The company plans to bulk
manufacture the listed controlled
substances for validation purposes as
part of the Food Administration
approval process before distributing to
their customers. No other activities for
these drug codes are authorized for this
registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–25991 Filed 11–22–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1288]
Bulk Manufacturer of Controlled
Substances Application: Organix
Chemistry Solutions, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Organix Chemistry Solutions,
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 January 23, 2024. Such
persons may also file a written request
for a hearing on the application on or
before January 23, 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: In
accordance with 21 CFR 1301.33(a), this
is notice that on September 29, 2023,
Organix Chemistry Solutions LLC, 240
Salem Street, Woburn, Massachusetts
01801–2029, applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
SUMMARY:
Drug
code
ddrumheller on DSK120RN23PROD with NOTICES1
Controlled substance
Gamma Hydroxybutyric Acid ........................................................................................................................................................
Lysergic acid diethylamide ...........................................................................................................................................................
Marihuana .....................................................................................................................................................................................
Tetrahydrocannabinols .................................................................................................................................................................
Mescaline .....................................................................................................................................................................................
3,4,5-Trimethoxyamphetamine .....................................................................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine .......................................................................................................................................
3,4-Methylenedioxyamphetamine .................................................................................................................................................
3,4-Methylenedioxymethamphetamine .........................................................................................................................................
5-Methoxy-N-N-dimethyltryptamine ..............................................................................................................................................
Alpha-Methyltryptamine ................................................................................................................................................................
Bufotenine ....................................................................................................................................................................................
Diethyltryptamine ..........................................................................................................................................................................
Dimethyltryptamine .......................................................................................................................................................................
Psilocybin .....................................................................................................................................................................................
Psilocyn ........................................................................................................................................................................................
2-(2,5-Dimethoxy-4-methylphenyl) ethanamine (2C–D) ...............................................................................................................
2-(2,5-Dimethoxyphenyl) ethanamine (2C–H) ..............................................................................................................................
2-(4-Iodo-2,5-dimethoxyphenyl) ethanamine (2C–I) ....................................................................................................................
Heroin ...........................................................................................................................................................................................
Morphine .......................................................................................................................................................................................
VerDate Sep<11>2014
21:46 Nov 22, 2023
Jkt 262001
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
E:\FR\FM\24NON1.SGM
24NON1
2010
7315
7360
7370
7381
7390
7392
7400
7405
7431
7432
7433
7434
7435
7437
7438
7508
7517
7518
9200
9300
Schedule
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
II
82399
Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices
The company plans to synthesize the
listed controlled substances for
distribution to its customers. In
reference to drug codes 7360
(Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Claude Redd,
Acting Deputy Assistant Administrator.
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Bulk Manufacturer of Controlled
Substances Application: Groff NA
Hemplex LLC
I
7350
7360
7370
I
I
I
I
[FR Doc. 2023–25990 Filed 11–22–23; 8:45 am]
BILLING CODE P
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Groff NA Hemplex 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 January 23, 2024. Such
persons may also file a written request
for a hearing on the application on or
before January 23, 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: In
accordance with 21 CFR 1301.33(a), this
is notice that on September 19, 2023,
Groff NA Hemplex LLC., 2218 South
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
Marihuana Extract .........
Marihuana ......................
Tetrahydrocannabinols ..
Schedule
Claude Redd,
Acting Deputy Assistant Administrator.
[Docket No. DEA–1295]
21:46 Nov 22, 2023
Drug
code
Controlled substance
The company is federally authorized
to conduct cultivation activities in order
to bulk manufacture the listed
controlled substances for internal use
and for sale to federally registered
research investigators. No other
activities for these drug codes are
authorized for this registration.
[FR Doc. 2023–25946 Filed 11–22–23; 8:45 am]
VerDate Sep<11>2014
Queen Street, York, Pennsylvania
17402, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Jkt 262001
[Docket No. DEA–1293]
Importer of Controlled Substances
Application: Organic Standards
Solutions International, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Organic Standards Solutions
International, LLC 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 December 26, 2023. Such
persons may also file a written request
for a hearing on the application on or
before December 26, 2023.
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
SUMMARY:
PO 00000
Frm 00087
Fmt 4703
Sfmt 9990
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on November 6, 2023,
Organic Standards Solutions
International, LLC, 7290 Investment
Drive, Unit B, North Charleston, South
Carolina 29418–8305, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Marihuana Extract .........
Marihuana ......................
Tetrahydrocannabinols ..
Psilocybin ......................
Psilocyn .........................
Drug
code
7350
7360
7370
7437
7438
Schedule
I
I
I
I
I
The company plans to import the
listed controlled substances to produce
analytical reference standards for sale
and distribution to its customers. Drug
codes 7350 (Marihuana Extract) and
7360 (Marihuana) will be used for the
manufacture of cannabidiol only. In
reference to drug codes 7370
(Tetrahydrocannabinols) the company
plans to import a synthetic version of
this 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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–25948 Filed 11–22–23; 8:45 am]
BILLING CODE P
E:\FR\FM\24NON1.SGM
24NON1
]]>Agencies
[Federal Register Volume 88, Number 225 (Friday, November 24, 2023)]
[Notices]
[Pages 82398-82399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25946]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1288]
Bulk Manufacturer of Controlled Substances Application: Organix
Chemistry Solutions, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Organix Chemistry Solutions, 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
January 23, 2024. Such persons may also file a written request for a
hearing on the application on or before January 23, 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: In accordance with 21 CFR 1301.33(a), this
is notice that on September 29, 2023, Organix Chemistry Solutions LLC,
240 Salem Street, Woburn, Massachusetts 01801-2029, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............. 2010 I
Lysergic acid diethylamide............. 7315 I
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
Mescaline.............................. 7381 I
3,4,5-Trimethoxyamphetamine............ 7390 I
4-Bromo-2,5-dimethoxyphenethylamine.... 7392 I
3,4-Methylenedioxyamphetamine.......... 7400 I
3,4-Methylenedioxymethamphetamine...... 7405 I
5-Methoxy-N-N-dimethyltryptamine....... 7431 I
Alpha-Methyltryptamine................. 7432 I
Bufotenine............................. 7433 I
Diethyltryptamine...................... 7434 I
Dimethyltryptamine..................... 7435 I
Psilocybin............................. 7437 I
Psilocyn............................... 7438 I
2-(2,5-Dimethoxy-4-methylphenyl) 7508 I
ethanamine (2C-D).
2-(2,5-Dimethoxyphenyl) ethanamine (2C- 7517 I
H).
2-(4-Iodo-2,5-dimethoxyphenyl) 7518 I
ethanamine (2C-I).
Heroin................................. 9200 I
Morphine............................... 9300 II
------------------------------------------------------------------------
[[Page 82399]]
The company plans to synthesize the listed controlled substances
for distribution to its customers. In reference to drug codes 7360
(Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to
bulk manufacture these drugs as synthetic. No other activities for
these drug codes are authorized for this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-25946 Filed 11-22-23; 8:45 am]
BILLING CODE P
