HHS’s Peptide Compounding Policy: The 6 Peptides Covered and the 10 Conditions

What is the HHS peptide compounding policy?

It is an enforcement discretion policy issued by the Secretary of Health and Human Services. HHS says it does not intend to take enforcement action against a state-licensed pharmacy, a federal facility or a licensed physician that compounds a drug from one of six peptide bulk drug substances (BPC-157, epitalon, KPV, MOTS-c, semax and TB-500) under section 503A of the FD&C Act, provided all ten conditions in the policy are met. It applies until each peptide is addressed in a final rule on the 503A bulks list (HHS policy; Federal Register notice).

The notice of availability was filed on 28 October 2026 and published on 30 October 2026 (FR Doc. 2026-22192, 91 FR 68526). It invites written comments for two weeks after publication on docket HHS-OASH-2026-0496. Two law firms, Foley & Lardner and McDermott Will & Schulte, put the deadline at 13 November 2026 (Foley; McDermott). The notice’s background calls the document a “draft”, and HHS says its website holds the most current version. The text could still change after comments.

How did it get here?

Which peptides are covered, and by which routes?

Appendix A names six substances. Appendix B fixes the identity (salt form, amino-acid sequence, molecular formula and weight) and the routes of administration for which HHS says enforcement discretion is appropriate. A compounded product outside these routes is outside the policy.

For each peptide, Appendix B notes that FDA’s drug center (CDER) recommended against listing and the advisory committee voted in favour. It then gives HHS’s reasons for going ahead: use is now documented, newer lot-specific certificates from FDA-registered facilities supply test results CDER had found missing, and the policy’s conditions are meant to manage the remaining risk. These are HHS’s stated reasons. They are not a finding that the products are safe or effective, and this article makes no such claim.

What are the 10 conditions?

HHS lists ten circumstances that must all be present (HHS policy, pp. 2–4):

1. Listed substance. The peptide appears in Appendix A.
2. Identity and route. It matches the identity and route limits in Appendix B.
3. Characterisation. The bulk substance comes from a facility registered under section 510 and has a valid certificate of analysis with results consistent with FDA criteria. HHS says this covers identity, purity, potency and the absence of contaminants such as endotoxins, heavy metals, microbes and impurities.
4. Original manufacturer. The original manufacturer is FDA-registered and CGMP-compliant, and its physical location is listed on the COA. If a repacker, relabeler or reseller is involved, that firm must have documented its own validation of the manufacturer and the COA.
5. Reporting. Products compounded, serious adverse events and product-quality issues are reported to FDA through MedWatch and to the states involved. Product reporting includes the active ingredient and strength, the original manufacturer and its facility identifier, and the dosage form and route.
6. Label statement. “This is a compounded drug product. Not for resale.”
7. Single API. The product contains only one active ingredient from Appendix A.
8. Oral bioavailability. For oral forms, the compounder keeps documentation that the specific formulation achieves adequate oral bioavailability in humans.
9. Device. The only delivery device co-packaged with or containing the drug is an FDA 510(k)-cleared syringe.
10. Everything else in the FD&C Act. No insanitary conditions, and a valid patient-specific prescription as section 503A requires.

McDermott’s analysis points out two practical effects. The single-API condition puts common multi-peptide blends outside the policy. The bioavailability requirement may be a substantial hurdle for oral products (McDermott). The testing standard behind condition 3 is explained in what the HHS peptide testing standard asks a COA to show.

Who does it apply to, and who is left out?

State pharmacy and medical boards keep their own authority. A federal enforcement policy does not override state rules on what a pharmacy may compound or how a physician must evaluate a patient (McDermott). The RUO side is covered in RUO vs compounded vs FDA-approved peptides.

What does the policy not change?

• Approval. HHS repeats that compounded drugs are not FDA-approved and that FDA does not review their safety, effectiveness or quality before marketing (notice).
• The 503A bulks list. It is unchanged. HHS says FDA’s future rulemaking “may propose adding some or all of these peptides”. FDA’s 503A page still lists only the 2019 final rule and 2019 proposed amendments (FDA).
• Permanence. HHS may revisit the policy “in whole or in part” if a safety signal or product-quality issue arises. The notice says the policy creates no rights and is not binding on HHS or the public.
• Other peptides. GHK-Cu, ipamorelin, CJC-1295, emideltide and the others listed as “nominated but withdrawn” are not covered. Holland & Knight reported in October that a second advisory committee meeting on five of them was expected before the end of February 2027, with no date set (Holland & Knight).
• Advertising rules. Ad platforms apply their own healthcare and unapproved-substance policies, and an enforcement policy is not product approval. See Google’s Unapproved Substances policy.

What should you watch next?

• Comments and revisions on docket HHS-OASH-2026-0496 after 13 November 2026, and any updated version on the HHS site.
• A proposed rule adding any of the six to the 503A bulks list. That would open its own comment period.
• A second advisory committee meeting on the remaining withdrawn peptides.
• FDA category pages and warning letters, including enforcement against sellers outside the compounding channel.

We recheck each item and log the date on the peptide regulatory tracker. For BPC-157 specifically, see BPC-157’s regulatory status.

Sources

• Federal Register, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, FR Doc. 2026-22192, 30 October 2026 (full text read via govinfo)
• HHS, policy text with Appendices A and B. hhs.gov refused automated access on 4 November 2026, so we read the identical-titled PDF as reposted by Reason
• Regulations.gov docket HHS-OASH-2026-0496
• OIRA, completed EO 12866 reviews (RIN 0910-ZD94) · OIRA meeting log
• FDA, 503A bulk drug substances page · FDA, category 2 safety-risk page
• McDermott Will & Schulte, 2 November 2026 · Foley & Lardner, 30 October 2026 · Holland & Knight, 16 October 2026

First published 28 October 2026, while the policy was under OIRA review. Rewritten 4 November 2026 from the published text. This article explains public records. It is not legal or medical advice.

Frequently asked