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[DOI] [Google Scholar] 25.Alagawany M., Elnesr S.S., Farag M.R

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Pending finalization of the 503A Bulks List through regulation, the FDA has operated under an interim policy that places nominated bulk drug substances into three categories: Category 1 (Permitted): Bulk substances that have been evaluated by the FDA or are currently permitted for use under interim compounding policies because they lack immediate safety red flags