Extended stability data and the ability to effectively interpret that data in harmony with USP standards determines BUDs. This session will provide SCC participants with a risk-based approach to determining appropriate beyond-use-dates for compounded sterile products frequently used in home infusion in accordance with USP standards and research data available. This session will also cover the use of sterility testing to determine BUDs.
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Learning Objectives:
Review basic principles in reviewing and interpreting extended stability data.
Understand the revised USP 797 BUD assignment process.
Learn the concepts of sterility testing and how this can be used to extend BUDs.
