What is the longest allowed storage time for high risk CSPs when frozen?

The longest allowed storage time for high-risk compounding sterile preparations (CSPs) when frozen is 45 days. This guideline is established by the United States Pharmacopeia (USP) standards, specifically in USP <797>. High-risk CSPs are those that have a higher probability of contamination due to the complexity of their preparation or the environment in which they are prepared.

When frozen, these preparations can be maintained for 45 days to ensure both their stability and efficacy. Beyond this time frame, the risk of degradation or compromise in potency increases, which could lead to safety issues for patients.

Understanding these time constraints is crucial for pharmacy compounding professionals in order to comply with regulations and ensure the safety of compounded sterile products. The options for longer storage times are not applicable for high-risk CSPs, as they exceed the established safety limits for stability when frozen.