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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

V water = 0.2 mL 80 mg3.2 mg = 5 mL BAC water The KLOW Calculator above solves the fixed-ratio math for other vial sizes and draw volumes

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Zecca, E., Zuppa, A

For a clean distribution, slowly trickle your sterile solvent (such as bacteriostatic water) down the inner glass wall of the vial

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