Importer of Controlled Substances Application: Unither Manufacturing LLC, 33914-33915 [2023-11167]
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33914
Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices
(Cannabis) as botanical raw material
and/or active pharmaceutical
ingredients (API) to DEA research
registrants and manufacturers. No other
activities for these drug codes are
authorized for this registration.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1202]
Bulk Manufacturer of Controlled
Substances Application: Royal
Emerald Pharmaceuticals
Matthew Strait,
Deputy Assistant Administrator.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
[FR Doc. 2023–11177 Filed 5–24–23; 8:45 am]
Royal Emerald
Pharmaceuticals 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 24, 2023. Such persons
may also file a written request for a
hearing on the application on or before
July 24, 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
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 27, 2023, Royal
Emerald Pharmaceuticals, 14011 Palm
Drive, Building B, Desert Hot Springs,
California 92240–6845, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
DEPARTMENT OF JUSTICE
AGENCY:
BILLING CODE P
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Controlled substance
Marihuana Extract ...........
Marihuana ........................
Tetrahydrocannabinols ....
Drug
code
Schedule
7350
7360
7370
I
I
I
The company plans to bulk
manufacture the listed controlled
substances to provide Marihuana
VerDate Sep<11>2014
18:04 May 24, 2023
Jkt 259001
Drug Enforcement Administration
Controlled substance
Psilocybin ........................
Psilocyn ...........................
Drug
code
Schedule
7437
7438
I
I
The company plans to bulk
manufacture the listed controlled
substances as Active Pharmaceutical
Ingredients (API) for sale to its
customers. No other activities for these
drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–11175 Filed 5–24–23; 8:45 am]
[Docket No. DEA–1200]
BILLING CODE P
Bulk Manufacturer of Controlled
Substances Application: Promega
Corporation
Drug Enforcement Administration
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
[Docket No. DEA–1192]
Promega 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 July 24, 2023. Such persons
may also file a written request for a
hearing on the application on or before
July 24, 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
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 April 5, 2023, Promega
Corporation, 3075 Sub Zero Parkway,
Fitchburg, Wisconsin 53719, applied to
be registered as a bulk manufacturer of
the following basic class(es) of
controlled substance(s):
SUMMARY:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
DEPARTMENT OF JUSTICE
Importer of Controlled Substances
Application: Unither Manufacturing
LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Unither Manufacturing 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 June 26, 2023. Such
persons may also file a written request
for a hearing on the application on or
before June 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
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:
SUMMARY:
E:\FR\FM\25MYN1.SGM
25MYN1
33915
Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices
(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 April 7, 2023, Unither
Manufacturing LLC, 331 Clay Road,
Rochester, New York 14623–3226,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Controlled substance
Methylphenidate ..............
Drug
code
Schedule
1724
II
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. 2023–11167 Filed 5–24–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1190]
Importer of Controlled Substances
Application: United States
Pharmacopeial Convention
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
United States Pharmacopeial
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 June 26, 2023. Such
persons may also file a written request
for a hearing on the application on or
before June 26, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
SUMMARY:
The company plans to import the
listed controlled substance solely for
updated analytical testing purposes to
meet European Union requirements for
their finished dosage form product. This
analysis is required to allow the
company to export domesticallymanufactured finished dosage forms to
foreign markets. No other activities 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).
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on March 23, 2023, United
States Pharmacopeial Convention, 7135
English Muffin Way, Frederick,
Maryland 21704, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
Controlled substance
Drug code
Cathinone .......................................................................................................................................................................
Methcathinone ...............................................................................................................................................................
Methaqualone ................................................................................................................................................................
Lysergic acid diethylamide ............................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine ............................................................................................................................
3,4-Methylenedioxyamphetamine ..................................................................................................................................
4-Methoxyamphetamine ................................................................................................................................................
Codeine-N-oxide ............................................................................................................................................................
Difenoxin ........................................................................................................................................................................
Heroin ............................................................................................................................................................................
Morphine-N-oxide ..........................................................................................................................................................
Norlevorphanol ...............................................................................................................................................................
Methamphetamine .........................................................................................................................................................
Lisdexamfetamine ..........................................................................................................................................................
Phenmetrazine ...............................................................................................................................................................
Methylphenidate .............................................................................................................................................................
Amobarbital ....................................................................................................................................................................
Pentobarbital ..................................................................................................................................................................
Secobarbital ...................................................................................................................................................................
Glutethimide ...................................................................................................................................................................
Phencyclidine .................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) ...................................................................................................................
Phenylacetone ...............................................................................................................................................................
Alphaprodine ..................................................................................................................................................................
Anileridine ......................................................................................................................................................................
Cocaine ..........................................................................................................................................................................
Dihydrocodeine ..............................................................................................................................................................
VerDate Sep<11>2014
18:04 May 24, 2023
Jkt 259001
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
E:\FR\FM\25MYN1.SGM
25MYN1
1235
1237
2565
7315
7395
7400
7411
9053
9168
9200
9307
9634
1105
1205
1631
1724
2125
2270
2315
2550
7471
8333
8501
9010
9020
9041
9120
Schedule
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]]>Agencies
[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33914-33915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11167]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1192]
Importer of Controlled Substances Application: Unither
Manufacturing LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Unither Manufacturing 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
June 26, 2023. Such persons may also file a written request for a
hearing on the application on or before June 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 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:
[[Page 33915]]
(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 April 7, 2023, Unither Manufacturing LLC, 331 Clay
Road, Rochester, New York 14623-3226, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methylphenidate......................... 1724 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance solely
for updated analytical testing purposes to meet European Union
requirements for their finished dosage form product. This analysis is
required to allow the company to export domestically-manufactured
finished dosage forms to foreign markets. No other activities 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 non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-11167 Filed 5-24-23; 8:45 am]
BILLING CODE P
