Bulk Manufacturer of Controlled Substances Application: Restek Corporation, 20699-20700 [2024-06193]
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Federal Register / Vol. 89, No. 58 / Monday, March 25, 2024 / Notices
The company plans to import the
listed controlled substance to bulk
manufacture other controlled substances
for distribution to its customers. No
other activity for this drug code is
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.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–06177 Filed 3–22–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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 January 24, 2024,
SpecGx LLC, 3600 North 2nd Street,
Saint Louis, Missouri 63147–3457,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
[Docket No. DEA–1343]
Controlled substance
Importer of Controlled Substances
Application: SpecGx LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
SpecGx 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.
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 April 24, 2024. Such
persons may also file a written request
for a hearing on the application on or
before April 24, 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
khammond on DSKJM1Z7X2PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:08 Mar 22, 2024
Jkt 262001
Phenylacetone .................
Coca Leaves ...................
Thebaine ..........................
Opium, raw ......................
Poppy Straw Concentrate
Tapentadol ......................
Drug
code
Schedule
8501
9040
9333
9600
9670
9780
II
II
II
II
II
II
The company plans to import the
listed controlled substances for bulk
manufacture into Active Pharmaceutical
Ingredients (API) for distribution to its
customers. In reference to Tapentadol
(9780) and Thebaine (9333), the
company plans to import intermediate
forms of these controlled substances for
further manufacturing prior to
distribution to its customers. No other
activity for these drugs is authorized for
this registration. Placement of these
codes onto the company’s registration
does not translate into automatic
approval of subsequent permit
applications to import controlled
substances.
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.
Marsha Ikner,
Acting Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1346]
Bulk Manufacturer of Controlled
Substances Application: Restek
Corporation
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Restek Corporation 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.
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 24, 2024. Such persons
may also file a written request for a
hearing on the application on or before
May 24, 2024.
DATES:
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.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on January 31, 2024,
Restek Corporation, 110 Benner Circle,
Bellefonte, Pennsylvania 16823–8433
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
[FR Doc. 2024–06181 Filed 3–22–24; 8:45 am]
BILLING CODE P
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
20699
E:\FR\FM\25MRN1.SGM
25MRN1
20700
Federal Register / Vol. 89, No. 58 / Monday, March 25, 2024 / Notices
Controlled substance
Drug code
Gamma Hydroxybutyric Acid .................................................................................................................................................
Methaqualone ........................................................................................................................................................................
JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) ....................................................................................
JWH–200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ................................................................................................
CP–47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) ......................................................................
CP–47,497 C8 Homologue (5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-phenol) ................................................
Lysergic acid diethylamide ....................................................................................................................................................
Marihuana ..............................................................................................................................................................................
Tetrahydrocannabinols ..........................................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine ...................................................................................................................................
3,4-Methylenedioxyamphetamine ..........................................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine .............................................................................................................................
3,4-Methylenedioxymethamphetamine ..................................................................................................................................
Bufotenine ..............................................................................................................................................................................
Psilocybin ...............................................................................................................................................................................
Psilocyn .................................................................................................................................................................................
Cyprenorphine .......................................................................................................................................................................
Dihydromorphine ...................................................................................................................................................................
Heroin ....................................................................................................................................................................................
Normorphine ..........................................................................................................................................................................
Beta-hydroxyfentanyl .............................................................................................................................................................
Beta-hydroxy-3-methylfentanyl ..............................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for the Drug Enforcement
Administration-exempted certified
reference materials. In-house synthesis
gives access to compounds that are
difficult to source. 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.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–06193 Filed 3–22–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1345]
Importer of Controlled Substances
Application: Halo Pharmaceutical Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Halo Pharmaceutical 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 April 24, 2024. Such
persons may also file a written request
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:08 Mar 22, 2024
Jkt 262001
for a hearing on the application on or
before April 24, 2024.
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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on February 21, 2024, Halo
Pharmaceuticals Inc., 30 North Jefferson
Road, Whippany, New Jersey 07981–
1030, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
PO 00000
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Fmt 4703
Sfmt 4703
Controlled substance
Psilocybin .......................
Schedule
2010
2565
7118
7200
7297
7298
7315
7360
7370
7395
7400
7404
7405
7433
7437
7438
9054
9145
9200
9313
9830
9831
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
Drug
code
Schedule
7437
I
The company plans to import the
listed controlled substance to support
formulation development and use in
clinical trials. 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.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–06190 Filed 3–22–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1344]
Bulk Manufacturer of Controlled
Substances Application: Promega
Corporation
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Promega Corporation has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUMMARY:
E:\FR\FM\25MRN1.SGM
25MRN1
]]>Agencies
[Federal Register Volume 89, Number 58 (Monday, March 25, 2024)]
[Notices]
[Pages 20699-20700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06193]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1346]
Bulk Manufacturer of Controlled Substances Application: Restek
Corporation
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Restek Corporation 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
May 24, 2024. Such persons may also file a written request for a
hearing on the application on or before May 24, 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 January 31, 2024, Restek Corporation, 110 Benner
Circle, Bellefonte, Pennsylvania 16823-8433 applied to be registered as
a bulk manufacturer of the following basic class(es) of controlled
substance(s):
[[Page 20700]]
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.................. 2010 I
Methaqualone............................... 2565 I
JWH-018 (also known as AM678) (1-Pentyl-3- 7118 I
(1-naphthoyl)indole).
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1- 7200 I
naphthoyl)indole).
CP-47,497 (5-(1,1-Dimethylheptyl)-2- 7297 I
[(1R,3S)-3-hydroxycyclohexyl-phenol).
CP-47,497 C8 Homologue (5-(1,1- 7298 I
Dimethyloctyl)-2-[(1R,3S)3-
hydroxycyclohexyl-phenol).
Lysergic acid diethylamide................. 7315 I
Marihuana.................................. 7360 I
Tetrahydrocannabinols...................... 7370 I
4-Methyl-2,5-dimethoxyamphetamine.......... 7395 I
3,4-Methylenedioxyamphetamine.............. 7400 I
3,4-Methylenedioxy-N-ethylamphetamine...... 7404 I
3,4-Methylenedioxymethamphetamine.......... 7405 I
Bufotenine................................. 7433 I
Psilocybin................................. 7437 I
Psilocyn................................... 7438 I
Cyprenorphine.............................. 9054 I
Dihydromorphine............................ 9145 I
Heroin..................................... 9200 I
Normorphine................................ 9313 I
Beta-hydroxyfentanyl....................... 9830 I
Beta-hydroxy-3-methylfentanyl.............. 9831 I
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for the Drug Enforcement Administration-exempted certified
reference materials. In-house synthesis gives access to compounds that
are difficult to source. 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.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-06193 Filed 3-22-24; 8:45 am]
BILLING CODE P
