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Vzquez-Oliva G, Zamora A, Ramos R, et al
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Calculate to view estimated mL, U-100 syringe units, concentration, total medication, doses per vial, and estimated weeks
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
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