FDA Ends Tirzepatide Shortage Exception, Allowing Compounding Pharmacies 60-90 Day Transition

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FDA Ends Tirzepatide Shortage Exception, Allowing Compounding Pharmacies 60-90 Day Transition
FDATirzepatideShortage
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The Food and Drug Administration (FDA) has declared that the active ingredient in Eli Lilly's weight loss drug Zepbound is no longer in shortage, effectively preventing compounding pharmacies from producing unbranded versions. However, the FDA will grant a 60 to 90-day transition period during which it will not penalize pharmacies for making compounded tirzepatide, giving patients time to switch to the branded drug. This decision marks the end of a period during which certain pharmacies could compound, distribute, or dispense tirzepatide without facing violations related to the treatment's shortage status.

The Food and Drug Administration said the active ingredient in Eli Lilly's weight loss drug Zepbound is no longer in shortage, a decision that will eventually bar compounding pharmacies from making unbranded versions of the injection.

The FDA said it will provide a 60- to 90-day transition period where it will not take action against pharmacies for making compounded tirzepatide, which will give patients time to switch to the branded version. The U.S. Food and Drug Administration does not review the safety and efficacy of compounded products, and the agency hasFeeling out of the loop? We'll catch you up on the Chicago news you need to know. Sign up for the weekly

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