What is the BUD for Low Risk CSPs when kept in a refrigerator?

The beyond-use date (BUD) for low-risk compounded sterile preparations (CSPs) stored in a refrigerator is typically set at 14 days. This guideline ensures that the compounded product remains safe and effective for use within a specific timeframe. Low-risk CSPs are those prepared in a clean environment under controlled conditions, minimizing the risk of contamination.

When refrigerated, these preparations have a greater stability than those stored at room temperature, thus allowing for a longer BUD. The specific timeframe of 14 days is established based on stability studies that have demonstrated that the ingredients remain effective and safe for that duration when refrigerated.

Other timeframes mentioned in the options are not applicable for low-risk CSPs in a refrigerated setting. For instance, a BUD of 3 days would typically apply to low-risk CSPs stored at room temperature, while 45 days and 9 days do not align with established guidelines for low-risk preparations. Therefore, understanding these standards is essential for proper pharmaceutical practice and maintaining patient safety.