HHS will not enforce against compounding of certain peptides

The Department of Health and Human Services says it will not take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding drugs from certain peptide bulk substances, under an interim policy published for the Federal Register on October 30.

Why it matters: The policy temporarily opens a legal route to compounded versions of popular but unapproved wellness peptides while the FDA decides, through rulemaking, which substances belong on the permanent 503A bulks list.

Data as of Federal Register public inspection document FR Doc. 2026-22192, filed October 28, 2026 at 11:15 am for publication October 30, 2026, read in full in this run; all policy terms are HHS's own. STAT's report of October 28, 2026, read in this run, is the source for the six peptides having been backed by an FDA advisory committee in July. The HHS appendix listing the peptide substances could not be opened in this run, so the individual substances are not named here. Developing item.

The Department of Health and Human Services has announced an interim enforcement discretion policy under which it does not intend to take action against a state-licensed pharmacy, a federal facility or a licensed physician compounding a drug product using a peptide bulk drug substance listed in the policy’s appendix, while the list of bulk substances permitted under section 503A of the Food, Drug, and Cosmetic Act is developed through rulemaking. The notice, signed by Secretary Robert F. Kennedy Jr. and filed on October 28 for publication in the Federal Register on October 30, says HHS acted because of significant interest in these peptides and the lack of approved products, and warns that it may revisit the policy if a safety signal or product quality issue arises. STAT reported that the policy covers six peptides that an FDA advisory committee voted in July to recommend for compounding, and comments on the draft policy can be filed on regulations.gov under docket HHS-OASH-2026-0496 until two weeks after publication.

HHS will not enforce against compounding of certain peptides

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