HHS Peptide Policy Is Out: 10 Conditions, One Long COA List
HHS published its draft 503A peptide policy on 30 October. The ten conditions, the COA tests it lists, and how the two-week comment window works.
Summary. The Department of Health and Human Services' notice announcing a draft "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" is published in the Federal Register on 30 October 2026 (FR Doc. 2026-22192, Docket HHS-OASH-2026-0496, RIN 0910-ZD94), after it was filed for public inspection on 28 October. The notice comes from the Office of the Secretary rather than FDA, and written comments can be submitted via regulations.gov for two weeks after publication. Under the draft, HHS says it does not intend to take enforcement action against a state-licensed pharmacy, federal facility or licensed physician compounding with one of the six peptide bulk drug substances in its Appendix A, but only when all of the policy's conditions are met. The policy is not binding, is not an FDA approval and does not add anything to the 503A bulks list; HHS says FDA's future rulemaking may propose adding some or all of the six. Our FDA Peptide Compounding Policy Tracker follows each step.
Research context (RUO). Much of the policy is about documentation. Its conditions include a bulk substance from an FDA-registered facility with a valid certificate of analysis, an original manufacturer that is registered and in compliance with current good manufacturing practice with its facility location printed on the COA, single-ingredient products, a patient-specific prescription, reporting of serious adverse events and quality issues to FDA's MedWatch program, and the label statement "This is a compounded drug product. Not for resale." HHS says the aim is to discourage the widespread use of research-use-only peptides supplied by foreign manufacturers. Appendix B sets out a testing standard for the COA: identity confirmed by at least two orthogonal methods (independent procedures based on different physicochemical principles), an HPLC assay against a reference standard, net peptide content, peptide-related impurities, nitrosamines, residual solvents by gas chromatography, elemental impurities by ICP-MS, residual TFA, counter-ion and water content, bioburden and bacterial endotoxins. Each COA should also name the manufacturer with its FDA establishment number and address, the batch number, synthesis and release dates, the expiry or retest date and each test method used, and be signed by the quality unit. For laboratories the list is a useful reference for what a full lot-level record contains; our Academy chapter HPLC and mass spectrometry explained covers how the two core methods work. The policy concerns compounding for patients, not research-grade material.
This summary is for research-community awareness only and is not legal advice. For research use only. Not for human or veterinary use.