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VisitFDA enforcement against 503(b) compounders for tirzepatide by March 31, 2024?
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Official FDA announcements or press releases
FDA Resolves Shortage of Eli Lilly's Tirzepatide and Zepbound Drugs as of December 19, 2024
Dec 19, 2024, 02:43 PM
The U.S. Food and Drug Administration (FDA) has officially declared the shortage of Eli Lilly's obesity drug tirzepatide resolved. This announcement, made on December 19, 2024, follows a re-evaluation of the drug's supply status. The FDA's determination means that compounding pharmacies will be required to cease operations related to the drug within 60 to 90 days. The resolution of the tirzepatide shortage also extends to Eli Lilly's other weight-loss drug, Zepbound, which is no longer in short supply. The FDA plans to enforce regulations against compounding pharmacies starting in mid-February for 503(a) compounders and mid-March for 503(b) compounders. Meanwhile, the supply status of semaglutide remains unchanged, with the FDA listing it as still in shortage, although Novo Nordisk has reported that all doses are available.
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