Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances

The Secretary of HHS announced the availability of an enforcement discretion policy governing the use of certain peptide bulk drug substances in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The policy applies while the official list of bulk drug substances eligible for use in 503A compounding (the 503A bulks list) is being developed through notice-and-comment rulemaking. Section 503A of the FD&C Act (21 U.S.C. § 353a) provides conditions under which a licensed pharmacist or physician may compound drug products for identified individual patients without the compounded product being subject to certain FDA requirements, including new drug approval, adequate directions for use, and cGMP requirements. One condition is that any bulk drug substance used must appear on an FDA-established list developed through rulemaking, or meet other specified criteria. The enforcement discretion policy describes the circumstances under which HHS will refrain from taking enforcement action against 503A compounders using certain peptide bulk drug substances that are not yet on the finalized 503A bulks list. The policy is interim in nature, operative during the period that the rulemaking process for the 503A bulks list remains ongoing. The document was published in the Federal Register on October 30, 2026, under docket number 2026-22192.