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It was previously available through compounding pharmacies as a bulk drug substance, but the FDA reclassified it as a Category 2 substance, which effectively restricts compounding pharmacies from producing it
Clinical Features and Outcomes of Complementary and Alternative Medicine Induced Acute Liver Failure and Injury
However, this patient had a pre-existing -thalassemia diagnosis, and it was determined that the incident was unlikely related to the dietary intervention
Compounding pharmacies create these formulations under Section 503A or 503B of the Federal Food, Drug, and Cosmetic Act
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