Test your knowledge of USP standards, 503A/503B compounders, sterile compounding requirements, and the Drug Quality and Security Act. Full explanations included.
10 questions · ~10 minutes · Covers high-yield MPJE compounding topics
503A = traditional pharmacy compounding (patient-specific Rx). 503B = outsourcing facilities (large-scale, FDA-registered, no Rx required per batch).
Governs nonsterile compounding. BUDs: aqueous oral = 14 days refrigerated; non-aqueous = 6 months; water-containing topical = 30 days.
Governs sterile compounding. Categories: Category 1 (≤12 hr BUD, no sterility testing) and Category 2 (longer BUDs, full environmental monitoring).
Hazardous drug handling. Applies to ANY entity that handles HDs — not just compounding pharmacies. Requires C-PEC, C-SEC, negative-pressure rooms for some HDs.