Overview
- A narrow majority of the FDA’s Pharmacy Compounding Advisory Committee voted Thursday, July 23, to recommend adding BPC-157, KPV, TB-500 and MOTS-c to the 503A bulks list so state-licensed compounding pharmacies could make them with a prescription.
- Those votes are advisory only and the FDA must now weigh the panel’s recommendations, public comments and agency analyses before deciding through notice-and-comment rulemaking whether to restore compounding access.
- Career FDA scientists told the panel they oppose listing any of the seven peptides under review because human safety and efficacy data are scant and the substances are not well characterized.
- Critics warned that many panel members have financial or clinical ties to the peptide industry, a factor that shaped the debate over whether regulated compounding would be safer than the existing online gray market.
- If the FDA follows the panel, the change could create a large telehealth and compounding market worth billions while raising concerns that listing might be mistaken for formal FDA approval and could reduce incentives for clinical trials.