Importer of Controlled Substances Application: United States Pharmacopeial Convention

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Published

May 31, 2024

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

United States Pharmacopeial Convention 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.

Full Text

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<title>Federal Register, Volume 89 Issue 106 (Friday, May 31, 2024)</title>
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[Federal Register Volume 89, Number 106 (Friday, May 31, 2024)]
[Notices]
[Pages 47177-47178]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11890]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1379]


Importer of Controlled Substances Application: United States 
Pharmacopeial Convention

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: United States Pharmacopeial Convention 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 
July 1, 2024. Such persons may also file a written request for a 
hearing on the application on or before July 1, 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 April 5, 2024, 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):

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           Controlled substance               Drug code       Schedule
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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 (ANPP)            8333  II
Phenylacetone............................            8501  II
Alphaprodine.............................            9010  II
Anileridine..............................            9020  II
Cocaine..................................            9041  II
Dihydrocodeine...........................            9120  II
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
------------------------------------------------------------------------


[[Page 47178]]

    The company plans to import the above listed 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 J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-11890 Filed 5-30-24; 8:45 am]
BILLING CODE P


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