Today marks the last deadline imposed by the FDA for the use of compounded versions of GLP-1 receptor agonists—specifically semaglutide and tirzepatide. While compounded products in this class of drugs were previously allowed, due to a drug shortage, that is no longer the case.
Given the enormous popularity of these drugs and the fact that many patients have sought out compounded formulations, it is important that physicians are aware of these regulations to ensure compliance with federal regulations and avoid potential legal repercussions.
Patient Safety Concerns
Compounded GLP-1 medications have been associated with safety risks, including dosing inconsistencies and contamination. As of April 20, 2025, the FDA has received over 520 adverse event reports related to compounded semaglutide and more than 480 for compounded tirzepatide, some requiring hospitalization. These issues underscore the importance of using FDA-approved medications that have undergone rigorous safety and efficacy evaluations.
Transitioning Patients to Approved Therapies
Healthcare practitioners should proactively transition patients from compounded GLP-1 therapies to FDA-approved alternatives. If there are insurance coverage and cost considerations, practitioners can explore options like patient assistance programs or alternative therapies to ensure continuity of care.
Patient Education and Communication
It’s crucial to inform patients about the discontinuation of compounded GLP-1 medications and the reasons behind this change. Educating patients on the benefits of FDA-approved treatments and the potential risks associated with compounded versions can facilitate informed decision-making and adherence to new treatment plans. For more information, please see the May 16, 2025 FDA memo, “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss.”