DEA Notice: United States Pharmacopeial Convention Application to Import Controlled Substances

FR: Drug Enforcement Administration

Published March 19th, 2026

Detected March 19th, 2026

Summary

The Drug Enforcement Administration (DEA) has published a notice regarding an application from the United States Pharmacopeial Convention to be registered as an importer of various controlled substances, including Schedule I and II drugs. The public has until April 20, 2026, to submit comments or request a hearing.

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What changed

The Drug Enforcement Administration (DEA) has issued a notice concerning an application submitted by the United States Pharmacopeial Convention (USP) to be registered as an importer of a broad range of controlled substances. These substances fall under Schedule I and Schedule II classifications, as detailed in the supplementary information, and include compounds such as Cathinone, Methaqualone, Heroin, Fentanyl-Related Substances, Methamphetamine, and Methylphenidate. This notice serves as an opportunity for registered bulk manufacturers and other interested parties to voice objections or request a hearing regarding USP's application.

Regulated entities, particularly registered bulk manufacturers of the affected controlled substances, should review the application details and the list of substances. Any objections or requests for a hearing must be submitted electronically through the Federal eRulemaking Portal or in writing to the DEA by the deadline of April 20, 2026. Failure to submit timely comments or requests may result in the DEA proceeding with the registration without further input, potentially impacting the supply chain and availability of these controlled substances for legitimate research and manufacturing purposes.

What to do next

Review the application details for the United States Pharmacopeial Convention's controlled substance importer registration.
Submit electronic comments or written requests for a hearing to the DEA by April 20, 2026, if objections exist.
Ensure compliance with DEA regulations regarding the importation of controlled substances.

Source document (simplified)

Notice

Importer of Controlled Substances Application: United States Pharmacopeial Convention

A Notice by the Drug Enforcement Administration on 03/19/2026

This document has a comment period that ends in 32 days.
(04/20/2026) View Comment Instructions
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Public Inspection Published Document: 2026-05359 (91 FR 13338) Document Headings ###### Department of Justice

Drug Enforcement Administration

Docket No. DEA-1684 # 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 April 20, 2026. Such persons may also file a written request for a hearing on the application on or before April 20, 2026.

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 11, 2026, 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.

Thomas Prevoznik,

Deputy Assistant Administrator.

[FR Doc. 2026-05359 Filed 3-18-26; 8:45 am]

BILLING CODE 4410-09-P

Published Document: 2026-05359 (91 FR 13338)