# HHS Sets Peptide Compounding Policy

HHS issued an interim enforcement-discretion policy for Section 503A compounding using six specified peptide bulk drug substances while rulemaking on the 503A bulks list continues. The policy is scheduled for Federal Register publication on October 30, 2026, with comments due November 13, 2026. It does not cover Section 503B outsourcing facilities and may be revised or withdrawn if safety or quality concerns arise.

- Compounders and peptide manufacturers should assess the policy’s conditions for substance identity, route, sourcing, testing, prescriptions, reporting, and labeling when managing affected products and supply chains.
- The November 13 comment deadline gives affected industry participants two weeks from scheduled publication to submit feedback on the interim policy.
- This is a regulatory development, not a procurement solicitation or contract award; procurement teams supporting affected operations should account for the policy’s limited scope and potential revision.

**Jurisdictions:** federal
**Industries:** Healthcare
**Topics:** Regulatory Compliance
**Published:** October 29, 2026

### Government Entities
- U.S. Department of Health and Human Services (HHS)
- U.S. Food and Drug Administration (FDA)

### Sources
- [HHS Issues Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances | BakerHostetler - JDSupra](https://www.jdsupra.com/legalnews/hhs-issues-enforcement-discretion-3976108) - JD Supra