DEA Notice: Patheon API Services Controlled Substance Application

Regs.gov: Drug Enforcement Administration

Detected March 15th, 2026

Summary

The DEA has published a notice regarding an application from Patheon API Services Inc. to be registered as a bulk manufacturer of controlled substances, including Dimethyltryptamine, Psilocybin, Psilocyn, Amphetamine, and Methadone. Interested parties can submit comments or requests for a hearing by May 12, 2026.

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What changed

The Drug Enforcement Administration (DEA) has issued a notice concerning an application from Patheon API Services Inc. for registration as a bulk manufacturer of Schedule I and II controlled substances, specifically Dimethyltryptamine, Psilocybin, Psilocyn, Amphetamine, and Methadone. This notice is in accordance with 21 CFR 1301.33(a) and allows for public input on the proposed registration.

Registered bulk manufacturers and other interested parties have until May 12, 2026, to submit electronic comments or written requests for a hearing regarding this application. Comments must be submitted through the Federal eRulemaking Portal at regulations.gov. Failure to submit comments or requests by the deadline may result in the application proceeding without further objection.

What to do next

Review the DEA notice regarding Patheon API Services Inc.'s application for controlled substance manufacturing registration.
Submit electronic comments or written requests for a hearing by May 12, 2026, if applicable.

Source document (simplified)

Content

ACTION:

Notice of application.

SUMMARY:

Patheon API Services Inc. has applied to be registered as a bulk manufacturer 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 May 12, 2026. Such persons may also file a written
request for a hearing on the application on or before May 12, 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.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.33(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 a bulk manufacturer 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 bulk manufacture the listed controlled substances for distribution to its customers. No other activities
for these drug codes are authorized for this registration.

Thomas Prevoznik, Deputy Assistant Administrator. [FR Doc. 2026-04973 Filed 3-12-26; 8:45 am] BILLING CODE 4410-09-P