Incorrect storage may reduce semaglutide potency, potentially leading to inadequate blood glucose control and hyperglycaemia
In a statement, Scott Brunner, CEO of the Alliance for Pharmacy Compounding, questioned whether the FDA's resolution of the shortage had taken into account demand for the compounded drug and "the number of patients wholl need to be transitioned from a compounded version to a FDA-approved version. "Thats likely hundreds of thousands of patients," Brunner said
On February 22nd, the US Food and Drug Administration (FDA) announced the resulution of a years-long shortage of semaglutide, the key ingredient in popular GLP-1 weight loss and diabetes medications Ozempic amd Wegovy
Section 503B covers outsourcing facilities, a distinct category registered with the FDA and subject to different obligations
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