U.S. regulatory status

Semax

Also known as Semax acetate

In limboPCAC recommended listing (8-5, Jul 24, 2026) - advisory only; still not on the 503A list

Is Semax legal right now?

Semax is a synthetic heptapeptide with no FDA-approved drug product and no USP monograph in the United States, so a positive listing on the 503A (or 503B) bulk drug substances list is the only route to legal compounding - and Semax is on neither.

On July 24, 2026 the FDA’s Pharmacy Compounding Advisory Committee voted 8-5, with 1 abstention, to recommend adding it to the 503A list, against the recommendation of the FDA’s own review staff. The vote is advisory and does not bind the FDA.

Nothing about Semax’s legal status changed on the day of the vote. Before it could be compounded lawfully the FDA would have to accept the recommendation and complete notice-and-comment rulemaking - a process the agency has not begun and that is generally estimated at 12 to 24 months.

Separately, nominations to add Semax to the 503B bulks list - the list for outsourcing facilities, not the 503A list the committee reviewed - were posted to the FDA’s docket on August 25, 2026; a nomination starts a review and changes nothing on its own.

In limbo: Moved on paper - nominated, removed from a restricted list, or recommended by an FDA committee - but not added to the 503A list. The headline implies a change; the legal status has not moved.

Verified Sep 22, 2026 (ET) · status held since Jul 24, 2026

Primary source: Federal Register All 12 sources

The committee vote

July 24, 2026

The question put to the FDA Pharmacy Compounding Advisory Committee (PCAC) “Should Semax (free base) be placed on the list? - and, as a separate vote, Semax acetate?”

Recommended by the committee

8 in favour
5 against
1 abstained

14 votes recorded. Tally reported by Healio and the FDA Law Blog (Hyman, Phelps & McNamara). The panel was not the same size for every substance - the meeting roster seats temporary voting members for single topics - so the totals legitimately differ between votes. The FDA has not yet published the minutes, so treat the counts as reported, not official.

What this does not do: an advisory committee recommendation is not an FDA decision and does not bind the agency. Semax is not on the 503A Bulk Drug Substances List, and a pharmacy compounding it today has no more federal authorisation than it did the day before the vote. Only a completed FDA rulemaking can change that.

Where it sits in the process

Nominated (completed)
Under review (advisory committee recommended it - not yet legal)
Rulemaking (upcoming)
Compounding-legal (upcoming)

Recommended by the committee - not yet legal. Next step: FDA rulemaking.

What changed last

Aug 25, 2026
BPI Labs’ nominations to add Semax (free base and acetate) to the 503B bulks list - the list for outsourcing facilities, not the 503A list the July panel reviewed - were posted to the FDA docket. A nomination starts a review and changes nothing on its own.
Review scheduledView on regulations.gov
Jul 24, 2026
FDA advisory committee (PCAC) voted 8-5, with 1 abstention, to recommend adding Semax to the 503A list. Advisory only - Semax is still not on the list and still not legal to compound until the FDA accepts the recommendation and completes rulemaking.
Not legalizedView on healio.com
Apr 16, 2026
Placed on the July 24, 2026 FDA advisory committee agenda for possible inclusion on the 503A list.
Review scheduledView on federalregister.gov

Status elsewhere

Semax: regulatory status by jurisdiction
Jurisdiction	Status	Note
United States (FDA)	In limbo	Not on the 503A Bulks List. PCAC recommended adding it on Jul 24, 2026 (8-5, 1 abstention); the recommendation is advisory and the FDA has not acted.
Australia (TGA)	Unscheduled	Not individually named in the Poisons Standard; sits in a grey area.
United Kingdom (MHRA)	Restricted	No UK marketing authorisation; supply for human use treated as an unlicensed medicine.
European Union (EMA)	Restricted	No EU marketing authorisation; sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level.
Canada (Health Canada)	Restricted	No Health Canada authorization; named in an August 2025 Health Canada seizure advisory on unauthorized injectable peptides, which cannot legally be sold in Canada.
Sport / anti-doping (WADA)	Restricted	Not individually named, but prohibited at all times under the S0 catch-all for non-approved substances.

The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it

Sources & transparency

Sources for this entry

Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895) Federal Register · primarySemax (free base and acetate) on the July 24, 2026 agenda.
FDA - PCAC meeting page, July 23-24, 2026 FDA · primaryOfficial meeting record. FDA has not yet published the minutes or vote tallies.
FDA - PCAC July 23-24, 2026: questions put to the committee FDA · primaryFDA’s own vote questions. Confirms each substance was voted on twice - free base and acetate separately - and gives the session order.
FDA - PCAC July 23-24, 2026: meeting roster FDA · primaryVoting members plus temporary voting members seated for single topics, which is why the vote totals differ between substances.
Regulations.gov - 503B bulks nomination, Semax (free base), BPI Labs (posted Aug 25, 2026) Regulations.gov · primaryA nomination to the 503B bulks list; it does not change any status.
Regulations.gov - 503B bulks nomination, Semax (acetate), BPI Labs (posted Aug 25, 2026) Regulations.gov · primaryA nomination to the 503B bulks list; it does not change any status.
Health Canada advisory: Unauthorized injectable peptide drugs seized and sold by Canada Peptide (Aug 1, 2025) Health Canada · primaryBasis for the Canada (Health Canada) status row.
Union Register of medicinal products (European Commission) EU · primaryBasis for the European Union (EMA) status row.
FDA Law Blog - FDA’s Pep(tide) Rally (Hyman, Phelps & McNamara) AnalysisSemax moved to Category 2 in 2023; under PCAC review; recommendation non-binding.
Healio - FDA committee recommends looser restrictions for several peptides AnalysisReported per-substance vote tallies; also records that FDA review staff recommended against all seven.
Mintz - FDA’s Advisory Committee Votes on Peptides: What It Does and Doesn’t Do AnalysisLegal analysis: the vote is not an agency action and nothing has legally changed.
MHRA guidance: Supply unlicensed medicinal products (specials) AnalysisBasis for the United Kingdom (MHRA) status row.

Last verified by a human: Sep 22, 2026 (ET) · how we verify
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