HHS allows temporary compounding of six unapproved peptides

HHS is temporarily allowing licensed pharmacies, federal facilities and physicians to compound six unapproved peptides—BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500—without immediate federal enforcement action while the FDA considers whether to change its compounding rules. The policy is conditional on requirements for ingredient identity and quality, compliant manufacturing, patient-specific prescriptions, labeling and reporting adverse events; it is not FDA approval of the peptides or products made with them. Supporters say regulated compounding could offer a safer alternative to products sold through an unregulated market, while FDA scientists and medical researchers warn that evidence for the compounds’ safety and effectiveness remains insufficient.