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GLP-1s: Compounders Get Temporary Reprieve But US FDA May Be Building Stronger Case

 
• By Sarah Karlin-Smith

FDA law experts do not buy the outsourcers’ argument that the agency must go through notice-and-comment rulemaking to remove a drug from the shortage list.

The FDA agreed to reconsider its decision to remove Lilly's GLP-1 drug from the shortage list following a compounder lawsuit. (Shutterstock)

Compounding of Eli Lilly and Company’s diabetes and obesity drugs, Mounjaro and Zepbound, may resume temporarily as the US Food and Drug Administration reconsiders its decision to remove the active ingredient tirzepatide from the drug shortage list, but experts believe the reprieve will be short-lived.

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