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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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For example, billing a vaccine administration with a CPT code instead of G0010 for a Medicare patient will result in a denial

doi: 10.1016/j.talanta.2018.06.023 71 Theratechnologies Inc