Comment period extended on the 503B bulks list notice

The agency gave interested persons longer to respond to its 1 May proposal, acting on a request for an extension.

Washington, 26 June 2026 — The Food and Drug Administration extended the comment period for the notice titled "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act", which appeared in the Federal Register of 1 May 2026.

The earlier notice asked for comment on the agency’s proposal not to include semaglutide, tirzepatide or liraglutide on the 503B Bulks List. The extension notice records that the agency is taking the action in response to a request for an extension to allow interested persons more time to respond.

Source documents

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 Notice · Food and Drug Administration · 26 June 2026
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
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice · Food and Drug Administration · 1 May 2026
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