Importer of Controlled Substances Application: United States Pharmacopeial Convention, 33915-33916 [2023-11166]

Download as PDF 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 I I I I I I I I I I I I II II II II II II II II II II II II II II 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]


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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
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