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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 US Food and Drug Administration (FDA) classified these HCG injections under pregnancy category C, which means animal studies have shown adverse effects on the fetus, and there are no controlled studies in humans