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Compounding • Peptides • 503A • FDA • Compliance

HHS Publishes Peptide Policy Notice; Comments Due November 13

HHS’s peptide policy notice was published October 30, making November 13 the end of its two-week comment period. The published notice still calls the underlying policy a draft and states that it is nonbinding. Publication does not establish FDA approval or add the six substances to the final 503A bulks list. This update confirms the public-comment timing while preserving the status qualifications, identity and route limits, and operating conditions described in the earlier analysis.

By Toby C. “Chad” Frost • Updated October 30, 2026
3 min read

Publication confirms the comment period

HHS published its notice of availability October 30, 2026, following the October 28 filing. The notice provides two weeks after publication for comments in docket HHS-OASH-2026-0496, which places the end of the period on November 13. It announces a peptide enforcement-discretion policy while FDA develops the 503A bulks list through rulemaking. The published notice still calls the document a draft and states that it is nonbinding.1

The separately posted policy uses present-tense language stating that HHS does not intend to take enforcement action when all listed circumstances are satisfied, until a final rule addresses whether the substance belongs on the 503A bulks list. That wording appears alongside the notice’s draft designation. A separate implementation date was not verified. Compounded drugs remain unapproved; HHS may revisit the policy if safety or quality concerns arise.12

Six substances, with specific identities and routes

Appendix A lists BPC-157, epitalon, KPV, MOTS-c, Semax, and TB-500. Appendix B further specifies the identities and routes addressed. BPC-157 acetate is described for subcutaneous, intramuscular, oral, and topical forms. TB-500 acetate and MOTS-c acetate are described for subcutaneous or intramuscular forms. Epitalon acetate is described for those injectable routes in intermittent courses. Semax free base is described for intranasal use. KPV acetate is described for topical and oral forms.3

A peptide name alone does not satisfy the policy’s identity condition. Appendix B includes amino acid sequences, chemical structures, molecular weights and formulas, route limits, and testing criteria. The text also calls for only a single listed active ingredient in the compounded product and documentation that any oral formulation achieves adequate bioavailability in humans.34

The operating conditions extend beyond an ingredient list

The circumstances described are cumulative. They include a valid patient-specific prescription and compliance with other applicable FD&C Act requirements, including the prohibition on insanitary conditions. The original ingredient manufacturer must be FDA-registered, comply with current good manufacturing practice and other applicable requirements, and have its physical location identified on the certificate of analysis. A repacker, relabeler, or reseller must document the specified manufacturer and certificate validation.4

The certificate must characterize the ingredient and include the described testing. The policy addresses reporting compounded products, serious adverse events regardless of suspected causation, and quality issues to FDA and the relevant states. It calls for patient labeling that explains reporting procedures and identifies the preparation as a compounded product that is not for resale. Any co-packaged or drug-containing delivery device is limited to an FDA-cleared syringe.4

The policy addresses state-licensed pharmacies, federal facilities, and licensed physicians operating under section 503A. It does not announce a 503B bulks-list change or FDA approval of the listed substances. The notice leaves final 503A list decisions to later rulemaking.12

Build a review file before changing practice

Chad’s analysis: Treat this as a document-control and evidence problem. Confirm the current policy’s status, match the exact ingredient identity and proposed route, verify the original manufacturer, and obtain the supporting tests. Evaluate prescription controls, reporting, labeling, and applicable state requirements together. A supplier’s statement that a peptide is available does not establish that the pharmacy has met the conditions described.

Chad’s analysis: The comment period is an opportunity to seek clarity on implementation timing, practical testing standards, oral bioavailability evidence, and the reporting process. Publication now anchors the two-week period to November 13. Confirm the docket’s filing instructions before submitting. The notice’s publication does not resolve the tension between its draft designation and the companion policy’s present-tense enforcement language.1

Source notes

  1. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, 91 Fed. Reg. 68,526–27 (Oct. 30, 2026) (notice of availability), Docket No. HHS-OASH-2026-0496.
  2. U.S. Dep’t of Health & Hum. Servs., HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances 1–2 (reviewed Oct. 30, 2026).
  3. Id. at 4–10, apps. A–B.
  4. Id. at 2–4, conditions 1–10, & 10–16, testing standards.