USP 797 Study Guide (2025/2026) – Sterile Compounding, ACDs, BUD, Risk Levels, Patient Training | Pharmacy Course | University of Michigan, UNC, UF

This detailed study guide provides 60+ exam-based Q&As tailored to the 2025/2026 USP <797> standards, with a focus on sterile compounding procedures, aseptic techniques, quality assurance, and patient handling protocols. Designed to support students and professionals preparing for pharmacy certification, institutional assessments, or continuing education, this guide helps users understand both theoretical and procedural aspects of sterile compounding in compliance with U.S. regulations. Topics thoroughly covered include: Risk level classification (low, medium, high) and their corresponding Beyond-Use Dates (BUD) Laminar airflow workbench (LAFW) certification, HEPA filtration, and PEC cleaning procedures Compounding Aseptic Containment Isolators (CACI), glove boxes, and automated compounding devices (ACDs) Visual inspection protocols, sterility testing (media-fill and broth tests), and endotoxin awareness Patient and caregiver training for home-administered CSPs and labeling requirements Pharmacist responsibilities for documentation, shipping, transport, and quality assurance Adverse event monitoring and SOP requirements in clinical and home care settings Storage conditions, labeling policies, and transport control for compounded sterile preparations This guide is especially suitable for: PharmD students in clinical and compounding-focused courses Pharmacy technician trainees preparing for PTCB, ExCPT, or NHA exams Practicing pharmacists and technicians needing a refresher on USP <797> Students in U.S.-based programs at institutions such as the University of Michigan, University of Florida, University of North Carolina, and similar pharmacy schools that follow FDA and USP guidelines Whether preparing for exams, practical assessments, or regulatory compliance in pharmacy operations, this study guide ensures mastery of core sterile compounding concepts. Keywords: USP 797, sterile compounding, study guide pharmacy, aseptic technique, glove box, CSP risk levels, beyond-use dating, ACD calibration, media-fill test, PEC cleaning, LAFW certification, home care compounding, pharmacy technician exam, quality assurance SOPs, caregiver training