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[DOI] [PMC free article] [PubMed] [Google Scholar] [84].Chow HM, Shi M, Cheng A, Gao Y, Chen G, Song X, et al

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The agency also proposed six criteria it would consider when evaluating drugs for inclusion on a DDC list: Complex formulation Complex drug delivery mechanism Complex dosage form Bioavailability achievement complexity Compounding process complexity Physicochemical or analytical testing complexity Regulatory Context and Industry Response While the FDA has not identified specific currently marketed products affected by the proposal, the rule reflects increased regulatory attention to compounded drug product complexity