The FDA has recently clarified its policies regarding compounded GLP-1 medications, such as semaglutide (Wegovy®) and tirzepatide (Zepbound®), following the resolution of their national shortages. Previously, compounded versions of these drugs were permitted due to reported shortages. However, with the FDA’s determination that these shortages have ended, the agency has set firm deadlines for compounding pharmacies to cease production of these unapproved medications. For instance, state-licensed pharmacies were required to stop compounding semaglutide by April 22, 2025, and tirzepatide by March 19, 2025. Outsourcing facilities had slightly longer deadlines of May 22, 2025, for semaglutide and March 19, 2025, for tirzepatide. Patients who have been using these compounded versions may face higher costs and limited access as they transition to FDA-approved alternatives.

In the April 2025 Poll, PHSL asked respondents how Wegovy® and Zepbound® will be impacted by these changes.  80% of respondents believe the change will have mixed results due to multiple factors, while 20% expect a moderate impact, mainly as patients try to navigate lack of insurance coverage.

Full results:

With compounded GLP-1 drugs going away, how will Wegovy® and Zepbound® be impacted?

Limited impact due to the cost – 0%

Limited impact due to direct manufacturer options – 0%

Moderate impact to overcome lack of insurance coverage – 20%

Mixed results due to multiple factors – 80%

Enhanced impact due to employer support – 0%