Federal Register #2026-08552

FDA Seeks Input on Clinical Need for Compounded Semaglutide, Tirzepatide, and Liraglutide

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is seeking public input on the clinical need for three bulk drug substances nominated for the 503B Bulks List, which supports compounding by outsourcing facilities. - Government Buyer: - Food and Drug Administration (FDA), Center for Drug Evaluation and Research, under the Department of Health and Human Services - OEMs and Vendors: - No specific OEMs or vendors are named, but the notice references FDA-approved products and their manufacturers - Products/Services Requested: - Evaluation and public comment on the clinical need for the following bulk drug substances: - Semaglutide (FDA-approved as Ozempic, Wegovy, Rybelsus; part numbers: NDA 209637, NDA 215256, NDA 218316, NDA 213051) - Tirzepatide (FDA-approved as Mounjaro, Zepbound; part numbers: NDA 215866, NDA 217806) - Liraglutide (FDA-approved as Saxenda, Victoza; part numbers: NDA 206321, NDA 022341, ANDA 215503) - No purchase quantities or direct procurement of products/services; this is a regulatory evaluation - Unique or Notable Requirements: - FDA is specifically requesting comments and supporting information from stakeholders regarding the clinical need for these substances in compounded form - The agency has determined that there is no clinical need for compounding these substances due to the availability and medical suitability of existing FDA-approved products - The outcome will inform the final determination of whether these substances are included on the 503B Bulks List - Referenced FDA-Approved Products: - Ozempic, Wegovy, Rybelsus (semaglutide) - Mounjaro, Zepbound (tirzepatide) - Saxenda, Victoza (liraglutide) - No direct procurement, quantities, or part numbers for purchase are specified

Description

The Food and Drug Administration (FDA) is evaluating substances nominated for inclusion on a list of bulk drug substances 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—semaglutide, tirzepatide, and liraglutide—that FDA has considered and proposes not to include on the 503B Bulks List. Additional bulk drug substances nominated for inclusion are under consideration and may be the subject of future notices. Comments on this proposal must be submitted by June 30, 2026.

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