In a much-anticipated update, the U.S. Food and Drug Administration (FDA) on 12/19/24 clarified its stance on compounded GLP-1 medications. This announcement comes amidst steep demand for GLP-1 receptor agonists, widely prescribed for managing Type 2 diabetes and increasingly used for weight management.

Why the Clarification?

The announcement comes as the supply of commercially manufactured GLP-1 medications have begun to stabilize. These drugs have faced shortages over the past two years, prompting significant reliance on compounding pharmacies to meet patient needs.

Key Takeaways from the FDA's Update

• The FDA regulates compounding practices under federal laws. Traditionally, compounding pharmacies are allowed to produce medications that are not commercially available, including medicines that are under an FDA-declared drug shortage. As of this announcement, on December 19, the FDA has determined that the shortage of Mounjaro (trizepatide) injections has been resolved.

• Consequently, compounded versions of tirzepatide must phase out within specific timelines with a final end date of March 19, 2025. The FDA intends this phase out will assist in a smooth transition for patients while manufacturers ramp up production to meet national demand.

• While tirzepatide’s shortage has been resolved, other GLP-1 medications, such as semaglutide (Ozempic and Wegovy) and liraglutide (Victoza and Saxenda), remain in limited supply. Manufacturers have reported improvements in availability, but certain presentations are still constrained. The FDA emphasized that compounded medications for these drugs are permissible only during an active shortage and under strict compliance with 503A and 503B regulations.

Looking Ahead

For patients using GLP-1 therapies, this policy shift signals improving availability of FDA-approved medications. However, it removes cheaper, compounded products from the market and will again make GLP-1 therapies out of reach for many Americans. Patients are encouraged to communicate with their providers and pharmacists to understand their options and ensure uninterrupted treatment.