Short answer. Appendix B describes enforcement discretion for semax free base, for intranasal use, compounded from an ingredient with a certificate of analysis that meets the policy [2]. It does not approve semax. As of Oct 29, 2026.

Free base, not "any semax"

The policy prints semax free base as molecular formula C37H51N9O10S, molecular weight 813.9 g/mol, sequence H-Met-Glu-His-Phe-Pro-Gly-Pro-OH [2]. No acetate is in that identity line. The discretion sentence says "semax free base" and "intranasal use" [2].

A vial that says semax acetate, or a shot, is not the product that sentence describes. Selank is a different peptide. It is not in Appendix A [2]. The comparison page Semax vs selank is the place for that split.

Category 2 status until April 22, 2026 did not change 503A status. CDER recommended against listing. The advisory committee voted in favor [2]. The notice says the 503A list is still in rulemaking, and that compounded drugs are not FDA-approved [1].

What HHS said about the human record

HHS says the intranasal human record CDER compiled covers several hundred subjects with no reported adverse outcome, and that bleeding and abuse-potential signals had no clinical counterpart in that record [2]. That is HHS's justification for discretion. It is not a safety label, and it is not a claim that semax treats a disease. The policy also says it may be revisited if a safety signal appears [2].

Sommar Club does not prescribe or sell semax. Evidence page: Semax.

FAQ

Does the policy cover semax injections? The sentence we read names intranasal free base [2].

Is semax FDA-approved? No [1].

Sources

1. HHS notice, FR Doc. 2026-22192, filed Oct 28, 2026. https://public-inspection.federalregister.gov/2026-22192.pdf

2. HHS policy, Appendix B, semax. https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf

Education only. Not medical or legal advice. As of Oct 29, 2026.