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Notice

Bulk Manufacturer of Controlled Substances Application: Patheon API Services Inc

A Notice by the Drug Enforcement Administration on 03/13/2026

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3. Document Details Published Content - Document Details Agencies Department of Justice Drug Enforcement Administration Agency/Docket Number Docket No. DEA-1681 Document Citation 91 FR 12448 Document Number 2026-04973 Document Type Notice Page 12448 (1 page) Publication Date 03/13/2026 Published Content - Document Details

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• Document Dates Published Content - Document Dates Comments Close 05/12/2026 Dates Text 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. Published Content - Document Dates

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Patheon API Services Inc (DEA 1681)

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Department of Justice

Drug Enforcement Administration

1. [Docket No. DEA-1681]

AGENCY:

Drug Enforcement Administration, Justice.

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

Published Document: 2026-04973 (91 FR 12448)