Federal Register #2026-22192

HHS draft enforcement discretion policy for compounding certain peptide bulk drug substances

HHS has issued a draft policy on enforcement discretion for compounding certain peptide bulk drug substances under section 503A. - Government office: U.S. Department of Health and Human Services (HHS), Office of the Secretary. - Policy scope: HHS describes its intended enforcement approach while the section 503A bulk drug substances list is developed through rulemaking. - Covered entities and substances: HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians compounding products with peptide bulk drug substances listed in Appendix A. - Important limitation: The policy is nonbinding and may be revisited if safety signals or product quality concerns arise. - Procurement details: No products, services, quantities, part numbers, OEMs, or vendors are identified; this is a policy announcement, not a procurement opportunity.

Description

HHS announces the availability of a draft enforcement discretion policy regarding the use of certain peptide bulk drug substances in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act. The policy describes HHS’s enforcement approach while the 503A bulks list is developed through rulemaking. HHS states that it does not intend to take enforcement action against a state-licensed pharmacy, federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance listed in Appendix A. The interim policy is not binding and may be revisited if safety signals or product quality issues arise.

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