HHS Grants Compounding Pharmacies Enforcement Discretion for Six Peptides
The federal government now allows state‑licensed pharmacies and clinicians to compound specific peptide drugs without fear of enforcement while the FDA finishes rulemaking.
HHS’ interim enforcement discretion policy lifts the possibility of enforcement action against state‑licensed pharmacies, federal facilities, and licensed physicians that compound drug products containing six designated peptide bulk substances—BPC‑157, Epitalon, KPV, MOTS‑c, Semax and TB‑500—while the FDA completes rulemaking on the 503A list. The policy establishes strict compounding requirements: the peptide must be a listed bulk substance manufactured by an FDA‑registered, CGMP‑compliant facility with a valid certificate of analysis; the product must be compounded under a patient‑specific prescription, contain a single active ingredient, be labeled “This is a compounded drug product. Not for resale,” and, for oral formulations, be supported by adequate bioavailability documentation. All compounding must satisfy 503A sanitary conditions, involve FDA‑cleared syringes for delivery devices, and include serious adverse event and quality issue reporting to MedWatch and relevant state authorities. The policy is interim and may be revised or withdrawn if safety signals surface, prompting firms to closely monitor the formal Federal Register publication and adjust compounding protocols to remain compliant.