Notice2025-07576
Importer of Controlled Substances Application: United States Pharmacopeial Convention
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 1, 2025
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 90 Issue 83 (Thursday, May 1, 2025)</title>
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[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18707-18708]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07576]
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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.
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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
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 <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
[[Page 18708]]
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 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):
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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
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 9273 II
forms).
Thebaine................................. 9333 II
Oxymorphone.............................. 9652 II
Noroxymorphone........................... 9668 II
Alfentanil............................... 9737 II
Sufentanil............................... 9740 II
Tapentadol............................... 9780 II
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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]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on May 1, 2025.
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