DEA Notice: US Pharmacopeial Convention Seeks Importer Registration

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. These substances are intended for use as analytical reference standards.

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What changed

The Drug Enforcement Administration (DEA) has issued a notice of application for registration. The United States Pharmacopeial Convention has applied to be registered as an importer of specific basic classes of controlled substances, including Cathinone, Methamphetamine, Fentanyl-Related Substance, and others listed in Schedules I and II. These substances are intended solely for distribution as analytical reference standards for testing purposes.

Registered bulk manufacturers and other applicants have until April 20, 2026, to submit electronic comments or objections to the proposed registration, or to request a hearing. The DEA emphasizes that all comments must be submitted electronically via the Federal eRulemaking Portal. The notice specifies the controlled substances by drug code and schedule, and clarifies that no other activities beyond importing for reference standards are authorized under this potential registration.

What to do next

Submit electronic comments or objections by April 20, 2026.
File a written request for a hearing by April 20, 2026.

Source document (simplified)

Content

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