Beyond-Use Date Basics for Nonsterile Compounding

Course overview

Assigning appropriate beyond-use dates (BUDs) is a critical component of safe and compliant nonsterile compounding practice. Pharmacists and pharmacy technicians must understand the factors that influence the stability, quality, and microbial integrity of compounded nonsterile preparations (CNSPs) to ensure patient safety throughout storage and use. Recent revisions to USP General Chapter 795 introduced significant updates to beyond-use dating recommendations, including the incorporation of water activity concepts and revised guidance for aqueous and nonaqueous formulations. This educational activity will review the principles of beyond-use dating, factors that affect CNSP stability, and current USP 795 recommendations for assigning and extending BUDs. Practical considerations related to water activity, preservatives, storage conditions, documentation, and regulatory compliance will also be discussed.