Federal Register #FDA2018N3240

FDA Extends Comment Period for 503B Bulks List Proposal (Semaglutide, Tirzepatide, Liraglutide)

This opportunity concerns the FDA's extension of the comment period for its proposal regarding the 503B Bulks List for outsourcing facilities: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs/Manufacturers Mentioned: - Manufacturers of semaglutide, tirzepatide, and liraglutide (e.g., Novo Nordisk, Eli Lilly) - Products/Services Requested: - No procurement of products or services is being requested - The notice addresses bulk drug substances: semaglutide, tirzepatide, liraglutide - Notable Requirements: - The FDA is seeking public comment on the clinical need for these substances to determine their inclusion on the 503B Bulks List - No purchase, contract, or solicitation for goods or services is involved - This is an informational notice, not a procurement action

Description

The Food and Drug Administration (FDA) is extending the comment period for its notice regarding the list of bulk drug substances for which there is a clinical need under Section 503B of the Federal Food, Drug, and Cosmetic Act. The notice specifically addresses FDA's proposal not to include semaglutide, tirzepatide, or liraglutide on the 503B Bulks List, which is a list of active pharmaceutical ingredients for outsourcing facilities to use in compounding. The extension allows interested persons additional time to submit comments, with the new deadline being July 30, 2026. The FDA encourages comments to address the clinical need standard and the rationale provided in the original May 1, 2026 notice.

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