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Background on the Pharmacy Compounding Advisory Committee and the 503A Bulk Drug Substances List The Pharmacy Compounding Advisory Committee provides advice to the FDA on scientific, technical, and medical issues concerning drug compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

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[9] Therefore, the guideline from the British Society for Hematology suggested offering quantitative assays to female patients directly, since these patients may be heterozygous and misclassified by screening tests