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FDA reconsiders shortage allowing compounding pharmacies to resume production of tirzepatide


The Food and Drug Administration (FDA) has decided to allow pharmacists to continue making compounded versions of tirzepatide, the active ingredient in Eli Lilly’s diabetes and weight loss drugs, Mounjaro and Zepbound, while it reconsiders its decision to remove the drug from its nationwide shortage list. The FDA’s original announcement that the shortage was resolved had caused outrage among compounding pharmacists and patients, leading to a lawsuit by a compounding trade group. The FDA’s recent decision in response to the lawsuit allows for continued production of the drug by compounding pharmacies as it reviews its previous decision.

Patients, such as Simone Williams and Elizabeth Kenly, who rely on compounded tirzepatide for weight loss due to its cheaper cost compared to brand-name drugs, were relieved by the FDA’s reversal. The availability of tirzepatide through compounding pharmacies helps these patients continue their successful therapy. While the FDA maintains that tirzepatide is not in shortage according to Eli Lilly, organizations like the Outsourcing Facilities Association and the Alliance for Pharmacy Compounding are pleased with the FDA’s decision to continue allowing compounding of the drug.

The ongoing debate surrounding the availability of tirzepatide highlights the challenges faced by patients in accessing affordable medications while dealing with drug shortages. The FDA’s decision to allow compounding of tirzepatide provides relief to patients and pharmacists alike, ensuring continued access to necessary medications during this time of uncertainty.

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www.nbcnews.com

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