FDA warns that compounded semaglutide may contain salt forms, not the approved ingredient

The U.S. Food and Drug Administration warned on May 31, 2023 that some compounded products sold as semaglutide contain salt forms of the drug — specifically semaglutide sodium and semaglutide acetate — which the agency says are different active ingredients from the semaglutide used in the approved medicines Ozempic, Wegovy and Rybelsus ^[1][3].

In its alert, FDA said it "does not have information on whether these salts have the same chemical and pharmacologic properties as the active ingredient in the approved drug," and added that it is "not aware of any lawful basis for their use in compounding" ^[1]. As CNN reported at the time, the agency also said that "products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective" ^[2].

What compounding has to do with it

Compounding is the process of combining, mixing or altering ingredients to make a medication tailored to an individual patient ^[2]. Under federal law, when a drug is on FDA's shortage list, compounders may be able to prepare a version of it if they meet certain requirements of the Federal Food, Drug, and Cosmetic Act ^[2]. Ozempic and Wegovy had been on the shortage list since 2022 ^[2].

But compounded drugs are not FDA approved, which means the agency does not review them for safety, effectiveness or quality before they are marketed ^[1][2]. FDA's position in the May 2023 warning was that the salt forms fall outside what the law allows compounders to use, even during a shortage ^[2].

Semaglutide itself is approved as Ozempic and Rybelsus for type 2 diabetes and as Wegovy for overweight and obesity ^[2]. The agency said it had received reports of adverse events in people who used compounded semaglutide, and that patients "should not use a compounded drug if an approved drug is available" ^[2].

FDA's standing guidance in the same alert says compounded drugs should only be used when a patient's medical needs cannot be met by an FDA-approved drug, that patients should get a prescription from their doctor and fill it at a state-licensed pharmacy, and that its BeSafeRx campaign has resources for buying prescription medicines online ^[1]. FDA has continued to update that alert page over time with additional concerns, including dosing errors tied to compounded injectable semaglutide that led to reports of adverse events, some requiring hospitalization ^[1].

Why it matters for patients

The practical issue is that a vial or syringe labeled "semaglutide" from a compounder may not contain the same molecule that was tested in the trials behind Ozempic, Wegovy and Rybelsus. FDA's point is not that the salt forms are proven dangerous — it is that the data to say how they behave in the body simply does not exist, and the agency says it does not know whether their chemical and pharmacologic properties match the approved ingredient ^[1].

Labels do not always make this obvious. FDA has separately flagged fraudulent compounded semaglutide and tirzepatide with false label information, including products listing compounding pharmacies that do not exist or that did not make the product ^[1]. The agency also lists telehealth red flags, such as a company claiming its compounded drug is the same as an FDA-approved drug, prices that seem too good to be true, or no licensed doctor available to answer questions after the medicine arrives ^[1].

How many people received salt-form products, and whether any harm was traced specifically to them, is not stated in these sources.

What happened next

On June 20, 2023, Novo Nordisk said it had begun legal proceedings against certain U.S. med spas, weight loss and wellness clinics and compounding pharmacies over "false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide" ^[2]. Those first suits targeted five health spas, clinics and pharmacies in Florida, New York, Tennessee and Texas ^[3].

On July 6, 2023, the company filed a second wave in federal courts in Florida and Tennessee against four more companies — DCA Pharmacy in Nashville, Brooksville Rx in Tampa, and TruLife Pharmacy and WellHealth Rx in Jacksonville — alleging they used an unauthorized version of the active ingredient ^[3]. None of the companies immediately responded to a request for comment ^[3].