HHS Announces Interim Enforcement Discretion Policy for Compounding Six Peptides

November 10, 2026Pharmaceuticals, Food and Drug Administration (FDA), Life Sciences, Enforcement, Health & Human Services (HHS), Drug Development

On October 30, 2026, the Department of Health & Human Services (HHS) published a notice in the Federal Register announcing an “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances.” The Food and Drug Administration (FDA) is still building the Section 503A bulks list through rulemaking. Until it finishes, HHS does not intend to take enforcement action against State-licensed pharmacies, Federal facilities or licensed physicians that compound with six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.

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