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doi: 10.1016/j.ajpath.2019.10.008 89 ShaSLiuXZhaoRQingLHeQSunLet al

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or identical or nearly identical A drug, a component of which is a bulk drug substance (i.e., active pharmaceutical ingredient) that is a component of an approved drug, unless there is a change that produces for an individual patient a clinical difference , , between the compounded drug and the comparable approved drug. as determined by the prescribing practitioner See Section 503B(d)(2)(A)-(B) (codified at 21 U.S.C

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