The rapidly growing popularity of glucagon-like peptide 1 (GLP-1) receptor agonists for use in weight loss has led to widespread shortages of these medications. Given the shortages and often limited insurance coverage, online and brick-and-mortar pharmacies are offering compounded versions of the drugs. Unfortunately, this increase in demand and opportunity has resulted in instances of illegitimate compounding practices.
Based on the Federal Food, Drug, and Cosmetic (FD&C) Act, compounding of most GLP-1 drugs is considered legal for as long as the shortages persist. However, the FDA does not regulate the efficacy or safety of compounded drug products. Therefore, those involved in the prescribing, reimbursement, and administration of a compounded GLP-1 drug should verify the legitimacy of a compounding pharmacy.
The FDA’s Drug Establishments Current Registration Site, can be used to ensure the manufacturer of an active pharmaceutical ingredient is registered with the FDA. Stakeholders can interview a compounding pharmacy to identify where the bulk ingredients are sourced from, and then look up the manufacturer using the FDA tool. Only semaglutide base products should be utilized in compounding, not salts.
