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A substance must meet one of the following criteria to be used as an active ingredient by a 503A pharmacy: Have an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph Are a component of an FDA-approved drug Are on the FDAs 503A Bulk Substances List (sometimes referred to as the positive list) According to the Drug Quality and Security Act, ingredients only need to comply with one of the criteria above, and those that do not meet any of them cannot be used as active ingredients for human compounding by 503A pharmacies

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