HHS adopts enforcement discretion allowing compounding pharmacies to produce six unapproved peptides

HHS announced an "enforcement discretion" policy that permits compounding pharmacies to make six peptide products that have not received FDA approval.

The list includes BPC-157 and TB-500, which are marketed online as a "Wolverine stack" for muscle growth and tissue repair, despite the FDA's 2023 warning about potential immunogenicity.

The policy follows a July vote by the FDA's Pharmacy Compounding Advisory Committee, which approved compounding of the six peptides but rejected a seventh, emideltide (also called DSIP), that is promoted for sleep benefits.

HHS says the move is intended to steer patients away from unregulated foreign-sourced research-use-only peptides and to provide a more controlled option under appropriate safeguards.