HHS Lets Compounders Make Six Unapproved Peptides, Including BPC-157, Under Interim Policy
- HHS issued an interim enforcement-discretion policy under which it will not act against compounding of six unapproved peptides, among them BPC-157 and TB-500, the pair sold online as the 'Wolverine stack'.
- Only state-licensed pharmacies, federal facilities and licensed physicians may compound them, with 'appropriate safeguards'. HHS frames it as steering people away from research-use-only imports.
- The peptides are still off the FDA bulk-substances list, so this is temporary. Compounder groups welcomed it; PhRMA and the Partnership for Safe Medicines criticized it.
💡 Points Based on public reports
Enforcement discretion is a faster route than formal rulemaking, but it leaves a legal grey zone and no efficacy bar. Compounders gain a new product line; branded peptide makers face a lightly regulated competitor, hence PhRMA's objection. The durability question is whether FDA completes the bulks-list process or the policy is reversed.
HHS clears compounding pharmacies to manufacture 6 unapproved peptides ↗