The Food and Drug Administration has declared the shortage of tirzepatide, the active ingredient in Eli Lilly’s diabetes and weight loss drugs Mounjaro and Zepbound, to be over. This decision means that most compounding pharmacies will no longer be able to make compounded versions of the drug within 90 days. Compounded medications are copies made by licensed pharmacists and are typically prescribed by doctors. Despite the FDA’s initial declaration of the shortage being over in October, a trade group for compounding pharmacists sued, leading the agency to reevaluate the situation. During this reevaluation, the FDA stated that pharmacists can continue making compounded versions of tirzepatide. Pharmacists have until February 18 to distribute their remaining supply of the compounded drugs, while bulk producers have until March 19. The FDA warns that it may still take action against violations of other regulations. Novo Nordisk’s semaglutide, the active ingredient in Ozempic and Wegovy, is still in shortage.
This decision is a victory for Lilly, who has maintained that the shortage of tirzepatide was resolved. They have also criticized compounded versions of the drug as untested and unapproved knockoffs. Lilly had initially announced in August that the shortage would be resolved soon.
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