HHS moves to permit compounding of six unapproved peptides despite FDA staff objections

The Department of Health and Human Services has moved to allow licensed compounding pharmacies to prepare six unapproved peptides under an enforcement-discretion policy backed by Health Secretary Robert F. Kennedy Jr.

The policy covers BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. It does not grant Food and Drug Administration approval or establish that the substances are safe and effective. Instead, HHS says it will generally refrain from enforcement action against eligible pharmacies and physicians who compound them under specified conditions.

Those safeguards include patient-specific prescriptions, ingredients from FDA-registered manufacturers, laboratory certificates for raw materials, quality testing and reporting of serious adverse events, according to HHS. The department said the approach would give patients a more controlled alternative to peptides sold through unregulated channels.

Most FDA drug scientists opposed easing access, according to reporting by The Associated Press, which cited six people familiar with the policy’s development. Staff members said evidence was insufficient to establish the six peptides’ safety and effectiveness and raised concerns that the approach could weaken controls on unproven drugs. An advisory panel voted in July to recommend allowing the substances in compounding, contrary to FDA staff recommendations.

Kennedy has publicly described himself as a supporter and user of peptides. Some of the covered substances, including BPC-157 and TB-500, are promoted for injury recovery or muscle building, but have not completed the FDA review required for approved drugs.