Federal Register #FDA2025N6895

FDA Advisory Committee Meeting on Bulk Drug Substances for Section 503A List

This notice announces a public advisory committee meeting hosted by the Food and Drug Administration (FDA) to review bulk drug substances for potential inclusion on the Section 503A Bulk Drug Substances List. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - OEMs and Vendors: - No OEMs or vendors are specified, as this is not a procurement or acquisition notice - Products/Services Requested: - No products or services are being procured - The meeting will discuss the following bulk drug substances (in both free base and acetate forms): - BPC157 - KPV - TB500 - MOTs-C - Emideltide - Semax - Epitalon - Evaluated uses include ulcerative colitis, wound healing, obesity, osteoporosis, opioid withdrawal, insomnia, cerebral ischemia, migraine, and neuralgia - Unique or Notable Requirements: - The FDA is soliciting public comments and presentations from nominators of these substances - The meeting is open to the public and will be accessible both in-person and online - No procurement, purchase, or contract is involved - Location: - FDA White Oak Campus, Silver Spring, MD (with online access available)

Description

The Food and Drug Administration (FDA) announces a public advisory committee meeting of the Pharmacy Compounding Advisory Committee to discuss bulk drug substances nominated for inclusion on the Section 503A Bulk Drug Substances List. The meeting will be held on July 23-24, 2026, at the FDA White Oak Campus and via online teleconferencing. The FDA is establishing a public docket for comments on these substances, with a deadline of July 22, 2026. The meeting is open to the public and will include presentations from nominators and opportunities for public comment.

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