The federal government has issued a new policy allowing state-licensed pharmacies, federal facilities, and licensed physicians to compound drug products using specific peptide bulk substances, marking a notable shift in regulatory enforcement. The directive follows a July meeting of an advisory committee that reviewed evidence regarding peptides and recommended permitting specialty pharmacies to dispense them without standard scientific review.
The committee, composed of newly appointed members who consulted with or were employed by companies interested in promoting or dispensing peptides, advanced its recommendations despite warnings from Food and Drug Administration staff who advised against the move. The FDA had previously moved to effectively ban peptides in 2023 due to underlying safety concerns.
According to the policy document signed by Kennedy, the Department of Health and Human Services concluded following the July sessions that public interest in obtaining these substances from compounding pharmacies was significant. The notice stated that to expand and improve patient access, the agency does not intend to take enforcement action against entities compounding drugs using a peptide bulk substance included in the policy’s Appendix A.
The list of approved substances in Appendix A encompasses six specific compounds: BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. These are the identical peptides recommended by the advisory committee during its summer deliberations. The policy notice was scheduled for formal publication in the Federal Register on Oct. 30.
