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Under Section 503A, a compounded drug is not essentially a copy where a change from the commercially available drug, made for an individual identified patient, produces a significant difference for that patient, as determined by the prescribing practitioner

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Autoimmune modulation in statin-induced liver injury Seven patients experienced hepatocellular pattern liver injury after being started on atorvastatin, and three experienced it after starting rosuvastatin (Table 1)