Semax Without Prescription: 10 mg at $3.00/mg, No Pharmacy

Four statements, in order, because the sequence is what competing pages lose.

So the sentence to carry is: nominated, placed in category 2 under the interim policies, then withdrawn, and today on no category list at all. Anyone telling you Semax is currently FDA category 2 is repeating something that used to be true. Anyone telling you it was never in category 2 is also wrong. FDA's own document describes the safety-risks page as covering substances in category 2 as well as other bulk drug substances that were previously in category 2 but were withdrawn, which is precisely the box Semax sits in.

What none of that amounts to is a ban. Being on no list is not the same as being prohibited, and it is not the same as being cleared either. It means the evaluation was abandoned before it reached a conclusion, and the compound is left exactly where it was: unapproved, unevaluated to a finish, and sold in the United States as research material.

For the record on identity, since regulatory pages are also where compounds get confused with each other: Semax is a synthetic heptapeptide, Met-Glu-His-Phe-Pro-Gly-Pro, the ACTH(4-7) fragment with a Pro-Gly-Pro tail. PubChem registers it as CID 9811102 with the formula C37H51N9O10S and a molecular weight of 813.9, and FDA's own compounding page names it Semax (heptapeptide), which independently confirms the seven residue count. It is not the same molecule as Selank, the other Russian heptapeptide, and the two are constantly swapped for one another.

The 503A bulks list exists to name the substances a compounding pharmacy may use when there is no approved drug to start from. A substance that is not on it, and not otherwise eligible, is not material a 503A pharmacy can lawfully compound with. Semax is not on it, because the nomination that would have put it there was withdrawn.

That closes the channel in a way worth being precise about. It is not that compounding is expensive for this compound, or that pharmacies choose not to stock it, or that you need to find the right clinic. There is no lawful supply route through a US compounding pharmacy at all, which means a prescription would have nowhere to go even if a physician wrote one.

The Russian registration does not change this. Semax has been registered in Russia for decades, including for cognitive and cerebrovascular indications, and that is a fact about Russian regulation rather than evidence accepted by FDA. Registration in one jurisdiction is not approval in another, and it is not proof of efficacy by Western evidentiary standards. This site reports the registration and does not adopt the claim, and neither should any page you read on the subject.

Selank sits in exactly the same position, listed on the same withdrawn page with near-identical language, which is covered on our Selank legal position page. NAD+ is a genuinely different case worth contrasting, because there a clinic infusion channel does exist and the question becomes one of price rather than availability, worked through on the NAD+ page.

FDA's recorded reasoning is short enough to quote in full, and it is worth quoting because it tells you what to look for rather than merely that something is wrong.

Compounded drugs containing semax (heptapeptide) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has no, or limited, safety-related information for proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans.

Read that closely and it is two separate statements. The first names a mechanism, aggregation and peptide-related impurities, both of which are measurable in a laboratory. The second names an absence, which is that FDA has no adequate human data for the routes people propose. A certificate can speak to the first and can say nothing at all about the second.

Batch 30-05260628 speaks to the first about as fully as a research peptide certificate does. Purity 99.886% against a specification of greater than 98%. Identity confirmed by LC-MS. Net content weighed at 11.23 mg. A bacterial endotoxin test by kinetic chromogenic LAL to USP Chapter 85, reporting under 0.20 EU/mL against a 0.5 EU/mL acceptance limit, run against an E. coli O111:B4 standard. A rapid sterility screen returning no bacterial growth and no fungi or yeast. Arsenic, cadmium, lead and mercury all under their ICP-MS limits, with spike recoveries between 91 and 102 percent confirming the method worked on this matrix.

Three honest limits on that. The sterility result is a rapid screen and the report says so, noting that full USP Chapter 71 sterility testing may be required for regulatory compliance. Every figure belongs to one batch. And the strongest certificate in the world does not answer the second half of FDA's sentence, because that half is about human data that does not exist. A well documented unapproved compound is still an unapproved compound.

A prescription arrives divided. Someone else has decided the concentration, filled the syringe or the pen, printed the strength on the label and taken responsibility for the arithmetic. This does not.

The arithmetic that gets handed to you is small and unforgiving. A 10 mg vial made up to 2 mL is 5 mg/mL, so one unit on a U-100 barrel is 0.01 mL and carries 50 mcg, ten units draws 500 mcg, and the whole vial is 200 units of volume. Cost follows the mass and not the volume: 500 mcg is $1.50 with the code whether the vial went into 1 mL or 5 mL, while the cost per unit falls from 30 cents to 6 cents across that same range and means nothing on its own. Our reconstitution guide and syringe measurement guide cover the handling side, and these are laboratory figures for research material rather than instructions for administering anything.

One correction nobody makes for you. The certificate weighed this batch at 11.23 mg, not 10 mg, an overfill of 12.3 percent. Two millilitres into that vial is 5.615 mg/mL, and a unit carries 56.15 mcg rather than 50. If a net content is published for your batch, divide that number by your volume. If it is not, the label figure is all you have, and knowing which situation you are in is the kind of thing a dispensing label would have told you.

Five figures, in the order they become relevant, with what each one would have to say before the price means anything.

• The batch number on the vial. It should match the certificate exactly. A certificate for a different batch is a document about material you do not have, and this is the single most common failure across research peptide storefronts.
• Purity against a stated specification. A percentage with no specification beside it cannot be assessed. Here it is 99.886% against a greater-than-98% specification, so the result clears its own bar with room.
• Identity, not just purity. Purity tells you how much of the vial is one substance. Identity by mass spectrometry tells you which substance. A certificate with the first and not the second has confirmed that the powder is 99 percent something.
• Endotoxin, with the volume it was measured across. Endotoxin is reported per millilitre, so the figure is meaningless without a volume. Here it is under 0.20 EU/mL measured across 2.0 mL, which is under 0.40 endotoxin units in the whole vial, and it stays inside the 0.5 EU/mL limit at any reconstitution volume of 1 mL or more.
• Net content, if it is published. It changes your concentration and your true cost per milligram, from $3.00 to $2.67 on this batch. Both figures are correct and only the first one is a promise.

Two of these are arithmetic rather than chemistry, and they are the two most often skipped. The endotoxin figure moves with your volume choice; the concentration moves with the net content. Neither is difficult, and neither will be done for you.

What none of it establishes is that any of this is safe to use, which is the honest end of the page. FDA's position is that it lacks the information to know, the material is sold for laboratory research only, and a complete certificate is evidence about what is in the vial rather than about what the contents do.