Policy
HHS's draft peptide compounding policy: what it covers and how to comment
Last checked: November 2, 2026. Educational only, not medical advice. PeptideX is not affiliated with any drug manufacturer.
On October 30, 2026, HHS published a notice in the Federal Register announcing a draft enforcement-discretion policy. It covers compounding with certain peptide bulk drug substances under section 503A while FDA develops the 503A bulks list through rulemaking. The draft says it isn't binding and creates no rights. Compounded drugs are not FDA approved.
Under the draft, "HHS 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 found in Appendix A" (91 FR 68526).
Which peptides are covered?
The Federal Register notice refers to the peptides only as "Appendix A" and doesn't list them in its text. Read the list in the policy document on the regulations.gov docket.
How to comment
Comments are due by 11:59 PM Eastern, Friday, November 13, 2026, on regulations.gov docket HHS-OASH-2026-0496.
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Comments close Nov 13, 2026. Final rules come after.
The HHS policy is a draft policy, not final. Comments close Nov 13, 2026. We'll email you when HHS updates, finalizes or withdraws it. Free, unsubscribe anytime.
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Questions
Is the HHS peptide policy final?
The October 30, 2026 notice describes it as a draft policy, and comments are open until November 13, 2026. It is not final.
Does this make these peptides FDA approved?
Compounded drugs are not FDA approved, and the notice says FDA may consider the peptides for the 503A bulks list in future rulemaking.
How do I comment?
Through regulations.gov, under docket HHS-OASH-2026-0496, by 11:59 PM Eastern on November 13, 2026.
What is BPC-157's FDA status?
BPC-157 is not FDA approved for any use in people. FDA listed it in 2023 among bulk substances that may pose significant safety risks in compounding ("Category 2"). On April 22, 2026, FDA removed it from that list because the nomination was withdrawn, not because FDA found it safe, and it was not added to the substances pharmacies may compound from. On October 30, 2026, HHS published a notice of a draft policy (draft, not final) about compounding with certain peptides; it is not binding and is not FDA approval. Comments are open until 11:59 PM Eastern on November 13, 2026, on regulations.gov docket HHS-OASH-2026-0496.
BPC-157 sources: FDA; 91 FR 68526; docket. Educational info, not medical advice. PeptideX doesn't give dosing advice. Talk to a licensed clinician.
Sources: 91 FR 68526, FR Doc. 2026-22192, Docket HHS-OASH-2026-0496 (govinfo.gov); comment deadline from the regulations.gov record. Checked November 2, 2026. PeptideX is an independent education site. It has no government connection and doesn't sell medicines. See also the earlier explainer.
Canonical: https://peptidex.ai/hhs-peptide-draft-policy