Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 82398 [2023-25991]
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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 .......................................................................................................................................................................................
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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
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]]>Agencies
[Federal Register Volume 88, Number 225 (Friday, November 24, 2023)]
[Notices]
[Page 82398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25991]
[[Page 82398]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1296]
Bulk Manufacturer of Controlled Substances Application: Navinta
LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: 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 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):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Pentobarbital.......................... 2270 II
Levomethorphan......................... 9210 II
Levorphanol............................ 9220 II
Remifentanil........................... 9739 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
