FDA Advisory Committee Votes to Recommend Six Peptides for Compounding Pharmacy Use

Published Jul 27, 08:45 PM UTC

The FDA's Pharmacy Compounding Advisory Committee (PCAC) voted to recommend adding six peptides—BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax—to the 503A bulks list for specific uses, potentially allowing compounding pharmacies to produce customized medications. The committee voted against recommending emideltide for opioid withdrawal and sleep disorders. The vote comes amid a growing gray market for peptides, with imports from China doubling to $328 million in the first three quarters of 2025. HHS Secretary Robert F. Kennedy Jr., a self-described 'big fan of peptides,' had previously removed 12 peptides from a banned Category 2 list for re-evaluation. FDA scientists opposed the recommendation, citing insufficient safety and efficacy evidence. At least seven PCAC members had financial ties to the peptide industry. The FDA is not bound by the vote but typically follows committee recommendations; final regulations could take months or years.