Importer of Controlled Substances Application: United States Pharmacopeial Convention, 33915-33916 [2023-11166]
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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
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Sfmt 4703
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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
I
I
I
I
I
I
I
I
I
I
I
I
II
II
II
II
II
II
II
II
II
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II
33916
Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices
Controlled substance
Drug code
Diphenoxylate ................................................................................................................................................................
Levomethorphan ............................................................................................................................................................
Levorphanol ...................................................................................................................................................................
Meperidine .....................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ............................................................................................................
Thebaine ........................................................................................................................................................................
Oxymorphone ................................................................................................................................................................
Noroxymorphone ...........................................................................................................................................................
Alfentanil ........................................................................................................................................................................
Sufentanil .......................................................................................................................................................................
The company plans to import the bulk
control substances for distribution as
analytical reference standards to its
customers for analytical testing of raw
materials. 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–11166 Filed 5–24–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1198]
Importer of Controlled Substances
Application: Almac Clinical Services
Incorp. (ACSI)
In
accordance with 21 CFR 1301.34(a), this
is notice that on May 1, 2023, Almac
Clinical Services Incorp (ACSI), 25 Fretz
Road, Souderton, Pennsylvania 18964,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Almac Clinical Services
Incorp (ACSI) 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:
lotter on DSK11XQN23PROD with NOTICES1
Controlled substance
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
DATES:
VerDate Sep<11>2014
18:04 May 24, 2023
Jkt 259001
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.
Psilocybin ........................
Oxycodone ......................
Hydromorphone ...............
Morphine ..........................
Tapentadol ......................
Fentanyl ...........................
Drug
code
Schedule
7437
9143
9150
9300
9780
9801
I
II
II
II
II
II
The company plans to import the
listed controlled substances as finished
dosage form units for clinical trials
purposes only. No other activities for
these drug codes are authorized for this
registration.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
9170
9210
9220
9230
9273
9333
9652
9668
9737
9740
Schedule
II
II
II
II
II
II
II
II
II
II
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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–11173 Filed 5–24–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22–11]
Gary Gray d/b/a Complex; Decision
and Order
On November 22, 2021, the Drug
Enforcement Administration (DEA or
the Agency) issued an Order to Show
Cause (OSC) to Gary Gray d/b/a
Complex (hereinafter, the Respondent)
seeking to deny Respondent’s
application for a DEA Certificate of
Registration to manufacture marihuana,
Control No. W14063382E. OSC, at 1.
After a hearing, the Chief
Administrative Law Judge (Chief ALJ)
issued his Recommended Rulings,
Findings of Law, and Decision of the
Administrative Law Judge
(Recommended Decision or RD), which
recommended Respondent’s application
for a manufacturing registration be
denied because ‘‘the plain language of
the controlling regulations compels the
denial of the present application as a
matter of law.’’ RD, at 2, 11. The Agency
agrees with the Chief ALJ’s
recommendation, and, for the reasons
explained below, denies Respondent’s
application as inconsistent with the
public interest under 21 U.S.C. 823(a).1
1 Effective December 2, 2022, the Medical
Marijuana and Cannabidiol Research Expansion
Act, Public Law 117–215, 136 Stat. 2257 (2022)
(Marijuana Research Amendments or MRA),
amended the Controlled Substances Act (CSA) and
E:\FR\FM\25MYN1.SGM
25MYN1
Agencies
[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33915-33916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11166]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1190]
Importer of Controlled Substances Application: United States
Pharmacopeial Convention
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: 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
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.
SUPPLEMENTARY INFORMATION: 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):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Cathinone........................... 1235 I
Methcathinone....................... 1237 I
Methaqualone........................ 2565 I
Lysergic acid diethylamide.......... 7315 I
4-Methyl-2,5-dimethoxyamphetamine... 7395 I
3,4-Methylenedioxyamphetamine....... 7400 I
4-Methoxyamphetamine................ 7411 I
Codeine-N-oxide..................... 9053 I
Difenoxin........................... 9168 I
Heroin.............................. 9200 I
Morphine-N-oxide.................... 9307 I
Norlevorphanol...................... 9634 I
Methamphetamine..................... 1105 II
Lisdexamfetamine.................... 1205 II
Phenmetrazine....................... 1631 II
Methylphenidate..................... 1724 II
Amobarbital......................... 2125 II
Pentobarbital....................... 2270 II
Secobarbital........................ 2315 II
Glutethimide........................ 2550 II
Phencyclidine....................... 7471 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Phenylacetone....................... 8501 II
Alphaprodine........................ 9010 II
Anileridine......................... 9020 II
Cocaine............................. 9041 II
Dihydrocodeine...................... 9120 II
[[Page 33916]]
Diphenoxylate....................... 9170 II
Levomethorphan...................... 9210 II
Levorphanol......................... 9220 II
Meperidine.......................... 9230 II
Dextropropoxyphene, bulk (non-dosage 9273 II
forms).
Thebaine............................ 9333 II
Oxymorphone......................... 9652 II
Noroxymorphone...................... 9668 II
Alfentanil.......................... 9737 II
Sufentanil.......................... 9740 II
------------------------------------------------------------------------
The company plans to import the bulk control substances for
distribution as analytical reference standards to its customers for
analytical testing of raw materials. 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 non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-11166 Filed 5-24-23; 8:45 am]
BILLING CODE P