90 FR 74 pgs. 16554-16555 - Bulk Manufacturer of Controlled Substances Application: Patheon API Services Inc.

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Type: NOTICEVolume: 90Number: 74Pages: 16554 - 16555

Docket number: [Docket No. DEA-1529]

FR document: [FR Doc. 2025-06707 Filed 4-17-25; 8:45 am]

Agency: Justice Department

Sub Agency: Drug Enforcement Administration

Official PDF Version: PDF Version

Pages: 16554, 16555

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1529]

Bulk Manufacturer of Controlled Substances Application: Patheon API Services Inc.

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 June 17, 2025. Such persons may also file a written request for a hearing on the application on or before June 17, 2025.

ADDRESSES:

[top] 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 5, 2025, 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 to support the clinical trials of their customers. No other activities for these drug codes are authorized for this registration.

Matthew Strait,

Deputy Assistant Administrator.

[FR Doc. 2025-06707 Filed 4-17-25; 8:45 am]

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