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Regulatory Flexibility: While 503B facilities must adhere to strict quality standards, they have some flexibility in how they operate compared to traditional drug manufacturers

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But Novo argued that semaglutide, marketed as Ozempic for diabetes and Wegovy for obesity, should be on the FDAs Demonstrable Difficulties for Compounding Lists, which are lists of complex medications that compounders are not allowed to make regardless of shortages, according to documents the agency posted this week