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On October 22, 2024, Novo Nordisk submitted a nomination to the FDA, arguing that semaglutide products belong on the Demonstrable Difficulties for Compounding (DDC) list due to “the complexities associated with their formulations, delivery mechanisms, dosage forms, achievement of bioavailability, compounding processes, and physicochemical and analytical testing.” The FDA has yet to make a final decision on whether to ban compounded versions of semaglutide
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[DOI] [PubMed] [Google Scholar] 100.Loomba R, Abdelmalek MF, Armstrong MJ, et al
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