HHS Announces Limited Peptide Compounding Policy: Six Substances, Ten Conditions

Announcement and timing

HHS has released an enforcement-discretion policy for certain Section 503A peptide compounding. Its notice was filed for public inspection October 28 and is scheduled for Federal Register publication October 30, 2026. The notice describes the document as a draft, interim, nonbinding policy.^[1]

OIRA review of RIN 0910-ZD94 concluded October 27 with the action “Consistent with Change.” That review conclusion is not FDA product approval.^[3]

Enforcement discretion is not FDA approval. Retatrutide is not covered. This is not a final addition to the 503A bulks list, a 503B policy, or a blanket authorization to sell research peptides.

HHS states that it does not intend to take enforcement action in the specified circumstances against State-licensed pharmacies, Federal facilities or licensed physicians while rulemaking addresses these substances. HHS may revisit the policy if safety or quality issues arise.^[2]

The public-inspection notice invites comments through docket HHS-OASH-2026-0496 for two weeks after Federal Register publication. Publication is still scheduled as of this review; we do not treat the announcement as a permanent rule or infer a separate effective date.^[1]

Six covered substances: form and route matter

Appendix A supplies the names; Appendix B narrows the chemical identities and routes. Its descriptions support the forms below, not every salt, analogue or product sold under a similar name.^[2]

TB-500 here is the specific acetylated seven-amino-acid fragment identified in Appendix B. The name should not be generalized to all thymosin-beta-4 products. Oral BPC-157 or KPV coverage remains subject to the oral-bioavailability condition below.^[2]

All ten conditions matter

The following is a reading guide to the policy's ten numbered circumstances, not a substitute for its complete wording, testing tables or applicable law.^[2]

1. Listed substance. The substance must appear in Appendix A.
2. Exact identity and route. Meet Appendix B's chemical identity and route limitations.
3. Characterization. Use a registered source and a valid COA documenting the specified testing.
4. Original manufacturer. FDA registration, CGMP compliance and location on the COA; intermediary vendor and COA validation where applicable.
5. Reporting. Report products, serious adverse events and quality issues to FDA and relevant States; provide patient reporting instructions.
6. Label. Identify the product as compounded and not for resale.
7. Single active ingredient. Use a single Appendix A active ingredient; this is not a peptide-blend policy.
8. Oral formulations. Maintain formulation-specific documentation of adequate human oral bioavailability.
9. Delivery device. Only an FDA 510(k)-cleared syringe may be co-packaged with or contain the drug.
10. Other legal requirements. Meet the remaining FD&C Act requirements, including sanitary conditions and a valid patient-specific prescription.

A certificate of analysis alone does not demonstrate that a finished product meets every condition, or that it is clinically safe or effective.

What this does not establish

Compounded products are not FDA-approved. The policy does not permanently place these substances on the 503A bulks list, cover Section 503B outsourcing facilities, or replace applicable State law. Retatrutide, CJC-1295, ipamorelin and emideltide/DSIP are absent from Appendix A. Their omission supplies no permission under this policy.^[1][2]

HHS presents controlled compounding as an alternative to research-use-only supply. Appendix B describes CDER recommendations against listing and differing PCAC recommendations, then gives HHS's reasons for enforcement discretion. Those are the department's policy judgments; this article does not treat them as independent clinical validation or demonstrated improvements in patient outcomes.^[2]

Primary documents

1. Federal Register public-inspection notice, FR Doc. 2026-22192 (filed October 28; scheduled publication October 30, 2026)
2. HHS policy and Appendices A/B (16 pages): ten conditions on pp. 2–4; identities and route limits on pp. 5–10
3. OIRA completed-review record, RIN 0910-ZD94

This article reports the documents available October 29. The notice calls the policy a draft; later publication, revisions and final rulemaking require separate verification.