The short answer. Selank is not FDA-approved and, as of September 26, 2026, has no lawful compounding pathway. It left Category 2 in September 2024 because the nominator said it meant to nominate a different substance. FDA has never reviewed it at an advisory committee, and it remains on FDA’s safety-risk page.
| FDA approved | No. |
|---|---|
| 503A pharmacy | No pathway. Not on 21 CFR 216.23 and in no category since Sep 27, 2024. |
| 503B outsourcing facility | No pathway. Never in a 503B category. |
| Latest FDA action | Listed on FDA’s safety-risk page with an immunogenicity concern. No advisory committee review. |
| Military | DoD prohibited dietary supplement ingredient (unapproved drug). |
| MDside position | Our providers do not prescribe it. |
| Last verified | 2026-09-26 |
Selank left Category 2 for a different reason
Selank acetate, also called TP-7, went into 503A Category 2 on September 29, 2023. By the September 27, 2024 update FDA had removed it, stating that the nominator had told FDA it intended to nominate a different substance. That makes selank different from BPC-157 and semax, which left in April 2026 after withdrawn nominations. The result is the same: selank sits in no category and gets no enforcement discretion.
It has never had a hearing
Selank was not on the October 2024, December 2024 or July 2026 advisory committee agendas, and no Federal Register document names it. With no pending nomination, nothing is moving it toward the 503A list. FDA’s safety-risk page still lists selank acetate, citing a possible immunogenicity risk and a lack of information on its safety in people.
The enforcement record
FDA named selank as ineligible for 503A in its 2020 warning letter to Tailor Made Compounding and its 2021 letter to the Guyer Institute. The Department of Defense lists it as a prohibited dietary supplement ingredient because it is an unapproved drug.
What this means for you
Keep selank off your menu, including nasal sprays sold for anxiety or focus. It is further from a pathway than the peptides FDA reviewed in July 2026, because no nomination is pending at all. The semax page covers its closest relative.
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Frequently asked questions
Is selank legal to compound?
No. As of September 26, 2026 selank is not FDA-approved, is not on the 503A bulks list and sits in no FDA category. It left Category 2 in September 2024 because the nominator meant a different substance, and no nomination for it is pending, so nothing is moving it toward a pathway.
Why did FDA remove selank from Category 2?
FDA’s September 2024 update says the nominator told FDA it had intended to nominate a different bulk drug substance. The removal was administrative and says nothing about safety. FDA still lists selank acetate on its page of substances that may present significant safety risks, citing immunogenicity.
Has FDA reviewed selank at an advisory committee?
No. Selank was not on the October 2024, December 2024 or July 2026 Pharmacy Compounding Advisory Committee agendas, and no Federal Register document names it. Without a pending nomination, there is no review underway that could lead to a listing.
Primary sources. Last verified September 26, 2026. Corrections are welcome: contact us.
- FDA, 503A bulk drug substance categories (updated May 14, 2026)
- FDA, Certain bulk drug substances that may present significant safety risks (updated Apr 22, 2026)
- FDA, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (Jan 2025)
- 21 CFR 216.23, the 503A bulks list
- FDA warning letter, Tailor Made Compounding (Apr 1, 2020)
- FDA warning letter, Advanced Nutriceuticals dba Guyer Institute of Molecular Medicine (Nov 10, 2021)
- DoD Operation Supplement Safety, prohibited ingredient: selank
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.