Salt forms and "research use only": two labels that change what you are buying

Two phrases on a product page tell you more about what you would be buying than any amount of testimonial. One is the chemical form of the active ingredient. The other is a disclaimer.

Salt forms

Ozempic, Wegovy, Mounjaro and Zepbound contain the base form of their peptide. Some sellers of "semaglutide" have used semaglutide sodium or semaglutide acetate, salt forms that are easier to source as bulk chemicals. FDA's position, stated on its GLP-1 concerns page, has three parts:

1. The salt forms are different active ingredients from the one in the approved drugs.
2. FDA does not have information on whether the salts have the same chemical and pharmacologic properties as the base.
3. FDA is not aware of a basis for compounding semaglutide sodium or semaglutide acetate under section 503A, because neither meets the bulk-substance conditions: no USP monograph, not a component of an approved drug, not on the 503A bulks list.

The first public warning letter to spell this out was dated October 2, 2023, to www.semaspace.com, which was selling 2 mg and 5 mg "generic semaglutide" vials. The letter cited sections 301(a), 301(d), 301(k), 503(b) and 505(a) of the FD&C Act: introducing an unapproved new drug, a misbranded drug, and a prescription drug without a prescription.

How to find out which form you are being offered: ask, in writing, and ask to see the identity line on the finished-product certificate of analysis. A COA that says "semaglutide acetate" is answering the question. One that says "semaglutide" may be using the word loosely; ask the pharmacy to confirm base.

"Research use only"

A vial or a website marked "for research use only," "not for human consumption," "RUO" or "laboratory reagent" is telling you it is not a drug product. That sentence has legal consequences the seller is relying on and that you should understand:

• No pharmacy compounded it under section 503A and no outsourcing facility under 503B. The exemptions do not apply because nobody is claiming the product is a compounded drug.
• No prescriber prescribed it. There is no patient-specific determination, no medical history, no follow-up.
• No state board licensed the seller. There is nobody to look up and nobody to complain to at state level.
• The product was not made to USP 797 or CGMP. Sterility and endotoxin status are whatever the seller says they are.
• If the seller also markets the product for weight loss, healing or any other effect in people, FDA treats it as an unapproved and misbranded new drug regardless of the disclaimer. The warning letters on the enforcement timeline include several of this kind.

There is one honest use of the phrase: a laboratory supplier selling reagents to laboratories. The tell is whether the site talks about doses, cycles, injection sites, results or "clients." Laboratories do not have cycles.

Where FormBlends sits on this

FormBlends dispenses compounded medication through licensed 503A pharmacies on a prescription, and its regulatory status page describes the form of the active ingredient it dispenses and the basis it relies on. Read it with the two questions on this page in hand, the same way you would read anyone else's. The vetting checklist asks both.