[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.

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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]
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