Enforcement discretion is not FDA approval. None of these peptides is FDA-approved. This page tracks regulatory status. It is not a recommendation to use any of them.
Where it stands
Last checked 5 November 2026 against the Federal Register notice, HHS’s policy text, and FDA’s pages.
- HHS draft policy. On 30 October 2026, HHS published a notice of availability of a draft “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances” (91 FR 68526, Docket HHS-OASH-2026-0496). HHS says it does not intend to take enforcement action against a State-licensed pharmacy, Federal facility or licensed physician compounding with an Appendix A peptide, under conditions, while the 503A bulks list is developed through rulemaking. The notice says it creates no rights and is not binding. Federal Register notice · policy text
- Comment period. Comments are due two weeks after publication: 13 November 2026, on Regulations.gov (Docket HHS-OASH-2026-0496).
- FDA advisory committee. FDA’s Pharmacy Compounding Advisory Committee met July 23–24, 2026 on seven peptides. HHS’s Appendix B says the committee voted in favor of each of the six below; emideltide, the seventh, is not in Appendix A, and press reports say it was the one not recommended. FDA’s own meeting page lists the agenda and materials but, as of its August 6, 2026 update, reports no outcome. A committee recommendation is advice to FDA, not a rule. FDA meeting page
- FDA bulk-substance categories. FDA’s page lists all six as nominations withdrawn by the nominators, previously in Category 2 (“significant safety risks”). FDA page
- Not yet happened. As of the check date I found no final HHS policy and no FDA proposed rule adding any of these peptides to the 503A bulks list. Adding one requires rulemaking.
The six peptides in Appendix A
| Peptide | Form and route covered (Appendix B) | FDA list status | Advisory committee (July 2026) |
|---|---|---|---|
| BPC-157 | BPC-157 acetate: subcutaneous, intramuscular, oral and topical dosage forms | Withdrawn from FDA Category 2 | Voted in favor Per HHS Appendix B |
| Epitalon | Epitalon acetate: subcutaneous or intramuscular injectable, dispensed in intermittent courses | Withdrawn from FDA Category 2 | Voted in favor Per HHS Appendix B |
| KPV | KPV acetate: topical and oral | Withdrawn from FDA Category 2 | Voted in favor Per HHS Appendix B |
| MOTS-c | MOTS-c acetate: subcutaneous or intramuscular injectable only | Withdrawn from FDA Category 2 | Voted in favor Per HHS Appendix B |
| Semax | Semax (free base): intranasal only | Withdrawn from FDA Category 2 | Voted in favor Per HHS Appendix B |
| TB-500 | TB-500 acetate: subcutaneous or intramuscular injectable only | Withdrawn from FDA Category 2 | Voted in favor Per HHS Appendix B |
Routes from HHS Appendix B. Other forms and routes are not covered.
What the draft policy requires of the compounder
A plain-language summary of the ten conditions. Read the policy for exact wording.
- The peptide is listed in Appendix A, in the Appendix B form and route.
- It comes from a facility registered with FDA, with a valid certificate of analysis, and from the original manufacturer (or a registered reseller that documented vendor validation).
- The compounder reports products compounded and serious adverse events and quality problems to FDA’s MedWatch and to the States.
- The label carries the required statement and tells the patient how to report problems.
- One Appendix A active ingredient per product. Oral products need documentation of adequate oral bioavailability. The only co-packaged device is an FDA 510(k)-cleared syringe.
- Everything else in the FD&C Act still applies, including the patient-specific prescription requirement.
Pharmacist-level detail: Peptide Compounding Law for Pharmacists. Patient-level background: BPC-157 benefits, risks and side effects. The hearing: BPC-157 and the FDA.
If you are considering a compounded product
Use the patient checklist and compare the two pathways in the 503A vs 503B chart.