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[DOI] [PMC free article] [PubMed] [Google Scholar] 191.Alsubaiei SRM, Alfawaz HA, Almubarak AY, Alabdali NA, Ben Bacha A, El-Ansary A

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Category 1 Bulk substance the FDA considers eligible for use in compounding pending final rulemaking Generally permitted Category 2 Bulk substance the FDA has significant safety, identity, or quality concerns about Not permitted during review Category 3 Substance requiring further evaluation Case-by-case Critically, Category 1 status is not FDA approval