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Summary 503A pharmacies can use bulk drug substances as active ingredients for human compounding as long as those substances fulfill one of the following criteria: It has an applicable USP or NF monograph (excluding dietary supplement monographs, according to the FDA) It is a component of an FDA-approved drug It is included in Category 1 of the FDAs interim substance list It is on the FDAs positive list, which includes the six substances announced in the FDAs rule that is effective March 21, 2019 A.J

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Its properties and behavior are evaluated exclusively within controlled laboratory and analytical research environments