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Notice

Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.

Notice of application.

📖 Research Context From Federal Register API

Summary:

Janssen Pharmaceuticals, 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.

Key Dates
Citation: 90 FR 59583
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 February 17, 2026. Such persons may also file a written request for a hearing on the application on or before February 17, 2026.
Comments close: February 17, 2026
Public Participation

In Plain English

What is this Federal Register notice?

This is a notice published in the Federal Register by Justice Department, Drug Enforcement Administration. Notices communicate information, guidance, or policy interpretations but may not create new binding obligations.

Is this rule final?

This document is classified as a notice. It may or may not create enforceable regulatory obligations depending on its specific content.

Who does this apply to?

Notice of application.

When does it take effect?

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 February 17, 2026. Such persons may also file a written request for a hearing on the application on or before February 17, 2026.

Open for public comment until February 17, 2026.

Document Details

Document Number2025-23467
FR Citation90 FR 59583
TypeNotice
PublishedDec 19, 2025
Effective Date-
RIN-
Docket IDDocket No. DEA-1635
Pages59583–59583 (1 pages)
Text FetchedNo

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