What is the BUD for a CSP stored at room temperature?

The correct answer regarding the beyond-use date (BUD) for a Compounded Sterile Preparation (CSP) stored at room temperature is that it is 48 hours for Category 2 CSPs. This regulation is based on the requirements set forth by USP 797, which classifies sterile compounding into different categories determined by factors such as the complexity of the preparation process and the sterility assurance level.

Category 2 CSPs involve more complex preparation which may include multiple sterile ingredients, the use of a buffer area, and enhanced conditions to maintain sterility. The BUD of 48 hours at room temperature indicates that CSPs from this category can be kept at room temperature for this maximum duration before their sterility is at risk or compromised. This time frame allows for sufficient flexibility for institutions and practitioners while ensuring patient safety remains a priority.

Understanding the BUD effectively aids pharmacy personnel in ensuring medications are administered within safe timeframes and reduces the risks associated with using outdated or possibly contaminated preparations.