What is the maximum storage period for high risk CSPs at controlled room temperature in the absence of sterility tests?

The maximum storage period for high-risk compounded sterile preparations (CSPs) at controlled room temperature, in the absence of sterility tests, is 24 hours. This limit is established to ensure patient safety, as high-risk CSPs are more susceptible to contamination due to their preparation involving non-sterile ingredients or in un-sterile conditions.

After being compounded, high-risk CSPs must be used or administered within this 24-hour timeframe unless they undergo sterility testing to confirm their safety for longer storage. This is critical in preventing potential infections and maintaining the integrity of the compounded product. The shorter time frame emphasizes the need for strict adherence to aseptic techniques and proper handling practices to minimize the risk of microbial contamination in high-risk environments.