The Partnership for Safe Medicines (PSM) has formally submitted comments to the U.S. Food and Drug Administration (FDA) Pharmacy Compounding Advisory Committee (PCAC), strongly opposing the addition of seven bulk peptide drug substances to the Section 503A Bulk Drug Substances List. The substances under consideration—BPC-157, KPV, TB-500, MOTS-C, Emideltide (DSIP), Semax, and Epitalon—are being evaluated for custom compounding despite a disqualifying absence of adequate human clinical trials to establish their safety or efficacy.

PSM underscores that allowing these unapproved peptides to enter the compounding market would effectively transform the American public into involuntary clinical trial participants while severely undermining the economic and safety integrity of the established FDA drug approval system. Read our comments here.