Compounding Wars: The FDA's Flip-Flip on Lilly's Mounjaro and Wegovy

Semiglucagon-like peptide (GLP-1) injections for diabetes and weight loss surged in popularity over the last three years, and patient demand has continually outpaced supply by manufacturers like Eli Lilly and Novo Nordisk. As a result, the US Food and Drug Administration’s (FDA) Drug Shortage List has included GLP-1 since December 2022. To mitigate the impact of this supply shortage on patients, the FDA has allowed pharmacies to offer compounded versions to patients. The FDA tentatively determined the shortage of tirzepatide injections has been “resolved” as of October 2, 2024, which means that pharmacies must stop compounding tirzepatide-containing products or face potential FDA enforcement action. However, FDA has since announced that it is reviewing this decision in light of legal action taken filed on behalf of aggrieved compounding pharmacies.

Should the initial FDA determination stand, it will impact the pharmacy landscape at large. When a drug is considered “available,” by law, compounding pharmacies may not make “copies,” or replications, of the original, approved drug. Alternatively, when a drug is considered “in shortage,” the FDA allows compounding pharmacies to prepare copies of the drug. For the past two years, compounding pharmacies could manufacture and sell tirzepatide. With the removal of tirzepatide from the shortage, only the manufacturer, Lilly, will be able to manufacture it, and the drug will be distributed through traditional pharmacies.