FDA’s Weight Loss Drug ‘No Man’s Land’ Adds Risk for Compounders

Pharmacies currently making copycat versions of Eli Lilly’s tirzepatide face heightened exposure to state enforcement actions and legal challenges while the FDA reconsiders whether or not there is a shortage of the weight loss drug.

The Food and Drug Administration’s decision to reassess Eli Lilly & Co.'s capacity to produce tirzpeatide—a diabetes and obesity treatment branded as Mounjaro and Zepbound—is pressuring compounding pharmacies to weigh the risks of producing versions of the drug while the agency deliberates.

The FDA’s reassessment comes after the agency was hit with a lawsuit this month from the Outsourcing Facilities Association and compounding pharmacy FarmaKeio ...