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2008), which states that compounded drugs are in fact new drugs as defined by [21 U.S.C.] 321(p) but are exempt from the requirements of [21 U.S.C.] 351(a)(2)(B), 352(f)(1), and 355 if and only if they comply with the conditions set forth in [21 U.S.C.] 353a

[DOI] [PMC free article] [PubMed] [Google Scholar] Cahill LE, El-Sohemy A

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