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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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To view a copy of this licence, visit About this article Cite this article Ye, X., Chen, W., Yan, F