Compounded GLP-1 Receptor Agonists in the Post-Shortage Era: Costs, Safety and Regulatory Challenges

We explore the costs and safety of compounded Glucagon-Like Peptide-1 receptor agonist (GLP-1 RA) and dual Glucagon-Like Peptide-1/Glucose-dependent insulinotropic polypeptide receptor agonist (GLP-1/GIP RA) therapy. Compounded products were widely utilized during a period of shortage after the approval for weight loss, but their safety and role today has changed.

Since the FDA removed permissions for pharmacies and outsourcing facilities to compound GLP-1 RA and dual GLP-1/GIP RA products, many are still operating inappropriately, and their advertisements can be misleading to consumers. Patients may inadvertently purchase products that are not FDA-approved or regulated. Additionally, several case reports and safety analyses of compounded GLP-1 RA and dual GLP-1/GIP RA products highlight dosing and administration errors as well as sterility concerns.

With widespread availability of manufactured GLP-1 RA and dual GLP-1/GIP RA products, compounded products should be reserved for patients who otherwise would not tolerate the commercially available product. Patients and prescribers should verify if pharmacies have accreditation for compounding by the National Association of Boards of Pharmacy or the Pharmacy Compounding Accreditation Board and utilize the FDA’s BeSafeRx to evaluate the safety and legitimacy of pharmacies.