PCAC peptide hearing July 23–24: key deadlines arrive this month
Several procedural deadlines for the FDA’s July 23–24, 2026 Pharmacy Compounding Advisory Committee (PCAC) meeting on peptides fall within the next few weeks.
The committee is scheduled to consider whether seven peptides — BPC-157, KPV, TB-500, MOTS-c, emideltide (DSIP), Semax, and Epitalon, in their free-base and acetate forms — should be eligible for compounding under section 503A of the Federal Food, Drug, and Cosmetic Act. The meeting follows the FDA’s earlier removal of a group of peptides from the restrictive “Category 2” designation on the 503A interim list.
According to the FDA’s notices, requests to give a formal oral presentation are due June 30, 2026; written comments intended to reach the committee before the meeting are due July 9, 2026; and the public docket (FDA-2025-N-6895) closes July 22, 2026. The agency says it intends to post background material and the webcast link no later than two business days before the meeting. PCAC recommendations are advisory and non-binding, and adding a substance to the 503A list would still require separate notice-and-comment rulemaking.
Primary sources: FDA Advisory Committee Calendar — PCAC, July 23–24, 2026; Federal Register notice (docket FDA-2025-N-6895)
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