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List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act" that appeared in the Federal Register of May 1, 2026. In the Federal Register notice, FDA requested comments on FDA's proposal not to include semaglutide, tirzepatide, or liraglutide on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
- Document type
- Notice
- Federal Register document number
- 2026-12937
- Published
- Jun 26, 2026
- Action
- Notice; extension of comment period.
- Docket
- FDA-2018-N-3240 · FDA_FRDOC_0001
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- FDA is extending the comment period on the notice published in the Federal Register of May 1, 2026 (91 FR 23431). Either electronic or written comments must be submitted by July 30, 2026.
- Topics (auto-tagged)
- GMP / manufacturing
Source: Federal Register API, document 2026-12937. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.