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Compounding pharmacies make customized medicines for individual patients, and under section 503A of the Food, Drug, and Cosmetic Act, a pharmacy can compound from a bulk substance only if that substance has an official quality monograph, is a component of an FDA-approved drug, or has been formally added to an approved “bulks list.” BPC-157 qualifies on none of those counts, which is why the FDA placed it in “Category 2” of its 503A bulk-substance review in September of 2023
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