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Under Section 503A, which governs traditional compounding by state-licensed pharmacies and physicians for individual patients pursuant to valid prescriptions, bulk drug substances that are not the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, and that are not components of FDA-approved drug products, may be used in compounding only if they appear on a list of bulk drug substances developed by the FDA through notice-and-comment rulemaking (the 503A Bulks List)
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