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If collapse is present or the gap is too wide, the GPP is deferred

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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