HHS Releases Enforcement Discretion Policy Covering Six Peptides for 503A Compounding

The U.S. Department of Health and Human Services has made public a draft policy titled Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. HHS filed the notice of availability for public inspection on October 28, 2026, and the notice was published in the Federal Register on October 30, 2026, as Document 2026-22192, under Docket HHS-OASH-2026-0496 and RIN 0910-ZD94. The notice is signed by HHS Secretary Robert F. Kennedy Jr. and lists the Office of the Secretary as the issuing office.

Under the policy, HHS states that it does not intend to take enforcement action against a state-licensed pharmacy, a federal facility, or a licensed physician that compounds one of the six peptides listed in Appendix A of the policy: BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500, when all of the policy conditions are met. Each peptide is limited to the specific forms described in the policy appendices. Enforcement discretion is a statement about enforcement intent. It is not an FDA approval, it does not add any substance to the 503A bulks list, and the FDA has not yet proposed adding these peptides to that list through rulemaking.

AJMC reported that the policy sets 10 conditions for the discretion to apply. The conditions address where bulk substances come from and how they are documented, limit each product to a single listed active ingredient, keep the patient-specific prescription requirement in place, require labeling that identifies the product as a compounded drug product that is not for resale, and require reporting of serious adverse events and product quality issues to the FDA MedWatch program and to the relevant states. HHS stated that the policy is intended in part to discourage continued widespread use of research-use-only peptides supplied by foreign manufacturers by offering a more controlled alternative.

The policy follows the July 23 and 24, 2026, meeting of the FDA Pharmacy Compounding Advisory Committee, which voted to recommend these six peptides for the 503A bulks list and voted against the seventh peptide reviewed, emideltide. AJMC reported that Appendix B of the policy acknowledges that the FDA Center for Drug Evaluation and Research had recommended against listing each of the six peptides, and that FDA briefing materials found the available studies small and short and insufficient to establish safety or effectiveness. The policy document was submitted to the White House for review on October 14, 2026, and that review concluded on October 27, 2026, with changes, one day before the text became public.

The notice states that the policy remains in place for each peptide until the FDA addresses it in a final rule, that HHS may revisit the policy if a safety signal or product quality issue arises, and that written comments are due two weeks after Federal Register publication under Docket HHS-OASH-2026-0496. None of the six peptides is FDA-approved for any use, and this policy does not change that status. It also does not change the status of research-use-only peptide products sold outside the 503A compounding framework described in the policy.