Health and Human Services drafts compounding policy for BPC-157, five other peptides
The Department of Health and Human Services (HHS) announced a draft interim policy on Oct. 30 outlining conditional enforcement discretion for specified pharmacies, facilities and physicians compounding six peptides while rulemaking proceeds. The draft did not approve the drugs; HHS said compounded drugs are not FDA-approved and remain subject to safeguards.
The Department of Health and Human Services (HHS) announced on Oct. 30 that it had made available a draft interim policy describing when it did not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding certain peptides under section 503A. The draft was intended to apply while the agency developed, through rulemaking, the list of bulk substances eligible for section 503A compounding.1,2
Appendix A named BPC-157, epitalon, KPV, MOTS-c, semax and TB-500, with identity and administration-route limits specified for each. The proposed discretion was conditional: requirements included valid patient-specific prescriptions, registered manufacturers and certificates of analysis, single-active-ingredient products, adverse-event and quality reporting, and other applicable compounding safeguards.2
HHS said compounded drugs are not FDA-approved and are not reviewed by FDA for safety, effectiveness or quality before marketing; it also said the interim policy was nonbinding and could be revisited if safety or quality concerns arose. The distinction was relevant to trainers because it separated a limited compounding-enforcement policy from regulatory approval or a safety determination, amid HHS’s stated interest in peptide use.1,2
