PCAC Peptide Vote Enters Month Five With No FDA Proposed Rule, Notice, or Interim Policy
The Pharmacy Compounding Advisory Committee (PCAC) recommended on July 23-24, 2026 that six peptides (BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon) be added to the Section 503A Bulk Drug Substances List, with only Emideltide (DSIP) falling short. As of Wednesday August 26, 2026 the FDA has issued no proposed rule, no Federal Register notice, no interim enforcement policy, and no draft guidance following the recommendation. The agency stated it will 'review the record.' Removal from Category 2 in April did not automatically place these substances on the 503A bulks list; they exist in a regulatory gray zone until the PCAC recommendation is formally acted upon, a process that typically runs a year or longer. Warning-letter activity from CDER to compounding pharmacies is up roughly 50% year-over-year in FY 2025. The next PCAC meeting is scheduled for February 2027 to review cathelicidin (LL-37), GHK-Cu, dihexa acetate, melanotan II, and PEG-MGF.