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10.4018/978-1-7998-2094-9.ch004 39 BhattacharjeeP.MajumderP

"When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need," FDA Commissioner Marty Makary stated in the agency's announcement

One proposed mechanism involves the regulation of chromatin-bound copper ions, leading to oxidative DNA damage and fragmentation that triggers apoptotic pathways (289, 290)

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