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[PMC free article] [PubMed] [Google Scholar] 183.Ener R.A., Meglathery S.B., Van Decker W.A., Gallagher R.M

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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