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It is not classified as a medicinal product, dietary supplement, food ingredient, cosmetic, or therapeutic substance, and must not be administered to or used on people or animals

The clinical benefit over compounded versions is negligible for most patients: the active ingredients and mechanisms are identical, and 503B facilities are subject to the same sterility and potency standards as pharmaceutical manufacturers for non-FDA-approved formulations

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Earlier initiation of SGLT2is or GLP-1RAs may provide cardiometabolic protection before the development of advanced disease, whereas longer-standing disease often necessitates combination therapy due to progressive -cell dysfunction and accumulated risk [8]