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503A compounding pharmacies may work with materials which, in addition to being accompanied by a valid certificate of analysis (CoA) and manufactured in an FDA registered facility, must meet one of the below three requirements: Complies with an applicable USP or NF monograph if one exists* Is a component of an FDA-approved drug product if an applicable USP or NF monograph does not exist

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The FDA has not concluded that the compound is safe for human compounding use, which is part of why it remains on Category 2 rather than Category 1