HHS allows temporary compounding of six unapproved peptides

HHS on Oct. 28, 2026 said it will not take enforcement action against 503A pharmacies, federal facilities and licensed physicians that compound six unapproved peptides—BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500—if they meet conditions on ingredient quality, manufacturing, patient-specific prescriptions, labeling and adverse-event reporting. The policy is not FDA approval and does not cover 503B facilities. In July 2026, FDA's Pharmacy Compounding Advisory Committee voted to add the six to the 503A bulk list. FDA staff recommended against it over insufficient safety and effectiveness evidence. CONTESTED: Scott Brunner of the Alliance for Pharmacy Compounding said patients already use these peptides and regulated compounding is preferable to illicit suppliers, bringing pharmacy standards and adverse-event reporting. Robert Steinbrook of Public Citizen said Kennedy undermined the FDA and threatened public health and that peptides should go through standard FDA approval. Shabbir Safdar of Partnership for Safe Medicines said the decision leaves a grey area on safety and that newly appointed PCAC members appear to have peptide-related conflicts of interest. That group filed a citizen petition urging FDA to reject the PCAC recommendation. Joshua Fritzler said 503A pharmacies will not meet demand. The notice is set for Federal Register publication Oct. 30, 2026, with comments open for two weeks after. HHS may revise or withdraw the policy if safety or quality issues arise.