The short answer. Semax is not FDA-approved and, as of September 26, 2026, has no lawful compounding pathway in the United States. Its Russian registration does not change that. It left Category 2 in April 2026 after its nominators withdrew, and FDA’s briefing for the July 24, 2026 advisory committee recommended against listing it.
| FDA approved | No. FDA’s briefing notes it is a registered drug in Russia, as nasal drops. |
|---|---|
| 503A pharmacy | No pathway. Not on 21 CFR 216.23 and in no category since Apr 22, 2026. |
| 503B outsourcing facility | No pathway. Never in a 503B category. |
| Latest FDA action | Advisory committee, Jul 24, 2026 (cerebral ischemia, migraine, trigeminal neuralgia). FDA’s briefing recommended against listing both forms. |
| Military | DoD prohibited dietary supplement ingredient. |
| MDside position | Our providers do not prescribe it. |
| Last verified | 2026-09-26 |
A foreign registration does not make a US pathway
FDA’s briefing states that semax is registered in Russia as 0.1% and 1% nasal drops. That registration has no effect in the United States. A 503A pharmacy needs a USP monograph, an FDA-approved drug containing the substance, or a listing at 21 CFR 216.23. Semax has none of the three.
What happened, in order
| Date | What happened |
|---|---|
| Sep 29, 2023 | FDA placed semax in 503A Category 2. |
| Apr 14, 2026 | Withdrawal letters from both nominators posted to the docket. |
| Apr 22, 2026 | Removed from Category 2. It now sits in no category. |
| Jul 24, 2026 | The advisory committee reviewed the free base and the acetate. FDA proposed that neither be listed. |
FDA singled out the nasal spray
The nominations proposed a nasal spray and an injection. FDA’s briefing raised strong concerns about the nasal spray because the nomination gave no information on the container or the pump that delivers it. FDA’s safety-risk page adds a possible immunogenicity risk and says FDA has little or no safety information for the proposed routes. FDA also reports that no outsourcing facility has reported compounding semax since 2019.
Market reports say the committee voted in favor. FDA had not posted minutes as of September 26, 2026, so we cannot confirm the tally from an FDA source. Each compound also had two separate votes, one for the free base and one for the acetate. A committee vote is advice to FDA. Only notice-and-comment rulemaking adds a substance to 21 CFR 216.23, and none has started.
What this means for you
Take semax off your menu, in every form, including nasal sprays marketed for focus or cognition. Claims of that kind also make it a drug claim, whatever the label says. FDA named semax as ineligible for 503A in warning letters to Tailor Made Compounding in 2020 and the Guyer Institute in 2021. See why a research label is no shield.
Read next
Frequently asked questions
Is semax legal in the US?
Not as a compounded or prescribed drug. As of September 26, 2026 semax is not FDA-approved, is not on the 503A bulks list and sits in no FDA category. It left Category 2 in April 2026 because its nominators withdrew, which opened no compounding pathway.
Semax is approved in Russia. Does that matter?
Not for US compounding. FDA’s briefing notes semax is a registered drug in Russia as nasal drops, but a foreign registration creates no US pathway. A 503A pharmacy needs a USP monograph, an FDA-approved drug containing the substance, or a listing on the 503A bulks list, and semax has none.
Can a pharmacy make semax nasal spray?
No. Semax has no 503A or 503B pathway in any form. FDA’s July 2026 briefing also raised strong concerns about the proposed nasal spray because no information was provided about the container or pump. A research-use label does not change the position for a clinic that dispenses it.
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, Pharmacy Compounding Advisory Committee, July 23-24, 2026
- 91 FR 20465 (Apr 16, 2026), Pharmacy Compounding Advisory Committee meeting notice, Docket FDA-2025-N-6895
- FDA briefing document, semax (July 2026 PCAC)
- FDA, voting questions, July 2026 PCAC
- Regulations.gov, withdrawal of nominations by Wells Pharmacy Network, FDA-2015-N-3534-0484 (posted Apr 14, 2026)
- Regulations.gov, withdrawal of nominations by LDT Health Solutions, FDA-2015-N-3534-0485 (posted Apr 14, 2026)
- 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: semax
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.