USP 797 Exam Questions (65 Qs) – Sterile Compounding, ISO Classes, BUD, Risk Levels | Pharmacy Course | University of Michigan, UNC, UF

This document includes 65 highly relevant and fully answered exam questions based on the 2023 guidelines of USP <797>, designed for pharmacy students and professionals preparing for the 2025/2026 academic year. It comprehensively reviews standards and procedures critical for sterile compounding, aseptic processing, and cleanroom compliance in healthcare settings. Key topics covered include: Risk level classification: low, medium, and high Beyond-Use Dating (BUD) under various storage conditions ISO classification standards (ISO 5, 7, 8) for cleanrooms and workbenches Required cleaning schedules for buffer rooms and anterooms Aseptic technique, hand hygiene, and proper garbing protocols Sterility testing procedures and environmental monitoring Facility design (anteroom, buffer area, cleanroom layout) Hazardous drug compounding requirements (BSCs, isolators) Media-fill testing, HEPA filtration, and 503B compliance This material is ideal for: PharmD (Doctor of Pharmacy) students BS in Pharmaceutical Sciences students Pharmacy Technician Certification (PTCB, NHA, ExCPT) candidates Hospital and outpatient pharmacy personnel involved in sterile compounding Residency applicants and professionals preparing for state board exams The content is particularly useful for students in accredited U.S. pharmacy schools such as the University of Michigan, University of Florida, University of North Carolina, and other institutions that follow FDA and USP standards for sterile product preparation. Keywords: USP 797, sterile compounding, aseptic technique, ISO cleanroom standards, pharmacy exam prep, beyond-use dating, CSP risk levels, pharmacy technician certification, HEPA filter, media fill test, buffer area, laminar flow hood, garbing procedures, hazardous drugs, BUD guidelines