Assigning Beyond-Use Dates for Compounded Sterile Preparations (USP 797)

Course overview

This course provides a detailed examination of the beyond-use date (BUD) requirements for compounded sterile preparations (CSPs) as established by USP 797, including the criteria and conditions that determine allowable BUD categories, the role of sterility testing and stability data in extending BUDs, and the documentation practices required to support BUD assignments. Learners will develop the knowledge needed to accurately determine and assign BUDs across a range of sterile compounding scenarios in compliance with current USP 797 standards.