Understand the name
What does the US record say?
FDA approval, a pharmacy licence and a name in a government drug record mean different things. A name in that record does not mean FDA approved the medicine.
No approved US product
The US record dated September 30, 2026 contains no FDA approval for Semax and no official US drug label.
The same dated review records Russian registration for nasal drops, based on FDA's account.
Registration in another country does not supply US approval.
Requests and the advisory panel
A withdrawn request did not give permission
Compounding is making a medicine to order.
The FDA page marked current to April 22, 2026 places Semax among ingredients whose compounding requests were withdrawn.
FDA has a special ingredient list for medicines made to order for one patient. Semax was not on that list when checked on September 30, 2026.
Withdrawing an ingredient request does not grant permission to compound it.
What the panel discussion means
For the July 2026 advisory meeting, FDA staff wrote a report recommending that Semax stay off the ingredient list.
The panel discussed Semax on July 24, 2026; by September 30, 2026, FDA had posted no official record of its votes.
An advisory panel gives advice. Changing the list requires a formal government process, so a panel vote alone does not change the rules.
Ask anyone offering Semax: “What rule lets you legally provide this product?” Ask for the answer in writing. A prescription or pharmacy licence does not by itself permit an ingredient.