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Peptides
5 min read
Short answer. The policy's Appendix A names six peptides: BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500. Appendix B then limits each one to a named form and named routes [2]. As of Oct 29, 2026.
The notice says HHS does not intend to take enforcement action when a covered compounder uses a peptide bulk drug substance in Appendix A [1]. The policy says the substance also has to match the identity and the route limits in Appendix B [2]. Identity includes the amino acid sequence, chemical structure, molecular weight, and molecular formula [2].
The table in the policy
Peptide | Form the policy names | Routes the policy names |
|---|---|---|
BPC-157 | Acetate | Under the skin, into muscle, oral, topical |
TB-500 | Acetate | Under the skin or into muscle |
Epitalon | Acetate | Under the skin or into muscle, in intermittent courses |
Semax | Free base | Intranasal |
KPV | Acetate | Topical and oral |
MOTS-c | Acetate | Under the skin or into muscle |
Source: Appendix B of the policy [2]. "Intermittent courses" is the policy's phrase for epitalon. The policy does not publish a dose.
What a close name does not do
A free-base version is not the acetate the policy names, except for semax, where the policy names the free base [2]. A route that is not in the row is not a route this discretion describes. A blend of two names is outside the single-ingredient condition [2].
Category 2 placement until April 22, 2026 did not change the 503A status of these substances. The policy says that for each of them. It also says FDA's drug center recommended against listing them, and the Pharmacy Compounding Advisory Committee voted to include them [2]. A vote is not the bulks list. The notice says the list is still in rulemaking [1].
Each peptide has its own note in this batch. Start with the hub if you want the whole announcement in one place: HHS and 6 peptides: what changed.
FAQ
Are these six FDA-approved now? No. The notice says compounded drugs are not FDA-approved [1].
Does any similar peptide get the same treatment? Only if it is one of these six, in the form and route Appendix B names [2].
Sources
HHS notice, FR Doc. 2026-22192, filed Oct 28, 2026. https://public-inspection.federalregister.gov/2026-22192.pdf
HHS policy, Appendices A and B. https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf
Sommar Club does not prescribe or sell these six. Education only. Not medical or legal advice. As of Oct 29, 2026.
