FDA Vote Docket FDA-2025-N-6895

PCAC Advisory Committee Vote — July 24, 2026

All scheduled peptides subject to review. Vote outcome determines 503A bulk drug listing eligibility. Public comments open through July 9, 2026.

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Regulatory Context

In April 2026, the FDA removed all peptides above from the Category 2 Bulk Drug Substances list, creating a regulatory gray zone for compounding pharmacies. The Pharmacy Compounding Advisory Committee (PCAC) is scheduled to vote on July 24, 2026 on whether each peptide should be added to the 503A Bulk Drug Substances list — the list that governs legal compounding eligibility.

A favorable vote allows licensed 503A compounding pharmacies to continue preparing these peptides for patient-specific prescriptions. An unfavorable vote effectively ends legal compounding access.

Docket: FDA-2025-N-6895 · Public comment deadline: July 9, 2026 · Submit comment at regulations.gov ↗