DEA Notice: Patheon API Services Importer Registration Application

Regs.gov: Drug Enforcement Administration

Published March 18th, 2026

Detected March 19th, 2026

Summary

The DEA has published a notice regarding an application from Patheon API Services, Inc. for registration as an importer of specific controlled substances, including Dimethyltryptamine, Psilocybin, Psilocyn, Amphetamine, and Methadone. Interested parties can submit comments or hearing requests by April 20, 2026.

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What changed

The Drug Enforcement Administration (DEA) has issued a notice regarding an application submitted by Patheon API Services, Inc. to be registered as an importer of specific controlled substances, including Dimethyltryptamine (Schedule I), Psilocybin (Schedule I), Psilocyn (Schedule I), Amphetamine (Schedule II), and Methadone (Schedule II). These substances are intended for use as reference standards for research and development in API manufacturing. The application was filed on February 19, 2026.

Registered bulk manufacturers and other applicants have until April 20, 2026, to submit electronic comments or objections to the proposed registration, or to file a written request for a hearing. Comments must be submitted through the Federal eRulemaking Portal. This notice is informational and does not impose new obligations beyond the standard application and comment process for controlled substance registrations.

What to do next

Review application details for Patheon API Services, Inc.
Submit comments or objections electronically by April 20, 2026, if applicable.
File a written request for a hearing by April 20, 2026, if applicable.

Source document (simplified)

Content

ACTION:

Notice of application.

SUMMARY:

Patheon API Services, Inc. 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 19, 2026, Patheon API Services, Inc., 101 Technology
Place, Florence, South Carolina 29501, applied to be registered as an importer of the following basic class(es) of controlled
substance(s):

| Controlled substance | Drug code | Schedule |
| --- | --- | --- |
| Dimethyltryptamine | 7435 | I |
| Psilocybin | 7437 | I |
| Psilocyn | 7438 | I |
| Amphetamine | 1100 | II |
| Methadone | 9250 | II |
The company plans to import the listed controlled substances as reference standards for research and development as part of
API Manufacturing. 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. 2026-05355 Filed 3-18-26; 8:45 am] BILLING P