What is the beyond-use date (BUD) timeframe for a medium risk CSP stored in the refrigerator?

The beyond-use date (BUD) for a medium risk compounded sterile preparation (CSP) stored in the refrigerator is 9 days. This timeframe is based on the risk level of the CSP and the storage conditions. Medium risk CSPs typically include preparations that are compounded from multiple sterile products or involve complex manipulations.

According to guidelines set by the United States Pharmacopeia (USP), when such preparations are refrigerated, the recommended BUD is up to 9 days. This is because refrigeration can help to slow bacterial growth and prolong the stability of the compounded product compared to room temperature.

In contrast, lower-risk CSPs generally have shorter BUDs due to a higher potential for contamination, while higher-risk CSPs may have even stricter requirements depending on their formulation and handling. This regulation is designed to ensure patient safety by minimizing the risk of contamination and degradation of the product over time. Therefore, knowing the specific BUDs for different risk levels and storage conditions is crucial for pharmacists and pharmacy personnel in maintaining compliance with safety standards.