The notice names three bulk drug substances the agency has considered and proposes to leave off the list that outsourcing facilities draw on when compounding.
Washington, 1 May 2026 — The Food and Drug Administration published a notice stating that it is evaluating substances nominated for inclusion on the list of bulk drug substances for which there is a clinical need for outsourcing facilities to use in compounding, which the notice calls the 503B Bulks List.
The notice identifies three substances the agency has considered and proposes not to include: semaglutide, tirzepatide and liraglutide. It records that further nominated substances remain under consideration and may be the subject of future notices.
The document is a notice issued by the Food and Drug Administration, not a rule, and carries Federal Register document number 2026-08552. A second notice issued on 26 June 2026 extended the period for comment on it.
Source documents
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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
- Identifier
- Federal Register document 2026-08552
- As the record states
- 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 number
- 2026-08552
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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
- Identifier
- Federal Register document 2026-12937
- As the record states
- 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 number
- 2026-12937