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Draft guidance on semaglutide this draft guidance, when finalized, will represent the current thinking of the food and drug administration (fda, or the agency) on this topic. Read important safety information, including boxed warning. The fda has officially determined that the shortage of both semaglutide and tirzepatide injection products is now resolved
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The fda determined on february 21, 2025, that the shortage of semaglutide injection products (ozempic and wegovy) is resolved. The fda declared that shortages of tirzepatide and semaglutide had ended when the drug manufacturers’ “stated product availability and manufacturing capacity can meet the present and projected. On march 10 th, the fda issued guidance clarifying that 503a and 503b drug compounders must soon cease compounding semaglutide injection products [i] or risk enforcement action.
This draft guidance, when finalized, will represent the current thinking of the food and drug administration (fda, or the agency) on this topic
It does not establish any rights for any. Our fda/food, drug & device and health care groups have developed an initial checklist for providers to consider during the fda’s enforcement discretion period In february 2025, the food and drug administration (fda) announced the shortage resolution for semaglutide injection products.
