Overview
- HHS published an interim enforcement-discretion policy on Wednesday that says it will not seek legal action against state-licensed pharmacies or licensed physicians that compound six unapproved peptides.
- The six peptides named are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500, none of which are approved by the FDA and which lack robust human safety and effectiveness data.
- To qualify for the policy’s protection, compounders must use ingredients from FDA-registered manufacturers with certificates of analysis, provide patient-specific prescriptions, report serious adverse events to MedWatch and meet other quality and labeling requirements.
- Most FDA scientific staff opposed the move and had limited input in drafting the notice, while an HHS-selected advisory panel had earlier recommended allowing these peptides for compounding, raising questions about conflicts and process.
- Supporters say the change will curb a risky gray market for research-use-only peptides from overseas, but public-health groups warn wider legal access could increase harms, obscure safety signals and reduce incentives for proper clinical trials.