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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
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion 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). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.
- Document type
- Notice
- Federal Register document number
- 2026-08552
- Published
- May 1, 2026
- Action
- Notice.
- Docket
- FDA-2018-N-3240
- Comments posted on Regulations.gov (at last check)
- 4,279
- DATES section (from the document)
- Either electronic or written comments on the notice must be submitted by June 30, 2026.
- Topics (auto-tagged)
- GMP / manufacturing
Source: Federal Register API, document 2026-08552. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.