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Compounding pharmacies that prepare AOD-9604 operate under Section 503A of the FD&C Act, which exempts them from standard new-drug-application requirements but does not exempt them from current Good Manufacturing Practice inspections [3]

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10.1002/0471142956.cy0124s51 2 BernardF.JalecoS.DardalhonV.SteinbergM.YsselH.NorazN.et al (2002)