Health care professionals who are considering working with compounders of semaglutide should be aware that compounders may be using salt forms of semaglutide.
Drug compounding is a process where ingredients are mixed, combined, or altered to create medications customized for individual patients. Sometimes, compounders combine two or more drugs to make a specific medication. However, the Food and Drug Administration (FDA) has issued a warning against using compounded medicines as substitutes for popular weight loss and diabetes drugs like Ozempic, Rybelsus, and Wegovy. This warning was as a result of the reports of people experiencing "adverse events" from using compounded versions of these drugs. The FDA is concerned that the compounded versions may have ingredients which are similar to the active ingredients of semaglutide, but are actually different because they are in salt form. Hence the officials say that patients should be aware that some products sold as 'semaglutide' may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. Patients and health care providers should be aware that compounded drugs are not FDA-approved, and the safety and efficacy of compounded drugs are not verified.
The FDA encourages patients to only obtain drugs containing semaglutide with a prescription from a licensed healthcare provider and should only get medicines from state-licensed pharmacies or outsourcing facilities registered with the FDA. Purchasing medication online from unregulated and unlicensed sources can expose patients to potentially unsafe products that have not undergone proper evaluation, approval, or quality standards. If patients with diabetes choose to use an online pharmacy, the FDA recommends referring to the BeSafeRx campaign resources and tools to make safer and more informed decisions.