The Department of Health and Human Services has announced a draft policy on enforcement discretion for compounding drugs with certain peptide ingredients. Its October 30 notice describes a temporary approach while the list of bulk substances allowed under section 503A of federal drug law is developed through rulemaking.
What the notice describes
HHS says 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 the policy's Appendix A.
The notice says future FDA rulemaking may propose adding some or all of those peptides to the section 503A list, based on available evidence. It also says HHS may revisit the interim policy, in whole or in part, if a safety signal or product-quality issue arises with a compounded product within its scope, among other circumstances.
The notice calls the document a draft and says it establishes no rights for any person and is not binding on HHS or the public.
Enforcement discretion is not approval
The notice explains that compounding generally involves combining, mixing or altering drug ingredients to create medication tailored to an individual patient.
It expressly says compounded drugs are not FDA-approved: FDA does not review their safety, effectiveness or quality before marketing. The notice says these drugs can serve an important medical need for some patients and can also pose risks.
Comments and the unread appendix
The notice invites written comments through Regulations.gov under HHS-OASH-2026-0496 until two weeks after Federal Register publication. That is the document's stated interval, not a printed calendar deadline.
The notice links to the policy on HHS's website, but that PDF returned an access refusal during this reading. The appendix's peptide list and any additional conditions in that separate document therefore remain unverified here. The short notice alone does not establish that a particular peptide or preparation qualifies.