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2 Specifically, the FDA has made clear in guidance that it does not intend to take action against state-licensed pharmacies or licensed physicians that compound from a Category 1 bulk, provided that: (i) the bulk is manufactured solely in FDA-registered establishments

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However, the therapeutic utility of doxorubicin is undermined by its dose-dependent cardiotoxicity, possibly arising as a result of futile redox cycling, with NADH dehydrogenase within the mitochondria proposed as the most likely site of anthracycline reduction 9,10