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Code · REGISTER · 2025-05-01 · Drug Enforcement Administration, Justice · Notices

Notices. Notice of application

542 words·~2 min read·/register/2025/05/01/2025-07576

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BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-1538] Importer of Controlled Substances Application: United States Pharmacopeial Convention AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of application. 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 June 2, 2025. Such persons may also file a written request for a hearing on the application on or before June 2, 2025. 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 February 24, 2025, 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 Butyryl Fentanyl 9822 I Fentanyl-Related Substance 9850 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 forms) 9273 II Thebaine 9333 II Oxymorphone 9652 II Noroxymorphone 9668 II Alfentanil 9737 II Sufentanil 9740 II Tapentadol 9780 II The company plans to import the listed controlled 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. 2025-07576 Filed 4-30-25; 8:45 am]
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