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USA 108 , 2061520620 (2011)

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Under Section 503A of the Federal Food, Drug, and Cosmetic Act, compounding pharmacies can legally prepare individualized medications for patients with valid prescriptions provided the bulk drug substance they use meets one of three criteria: it appears on the FDA's Category 1 list of approved bulk substances, it has a USP/NF monograph, or it is a component of an FDA-approved drug

This autoimmune condition destroys gastric parietal cells, eliminating intrinsic factor production essential for B12 absorption