What is the maximum beyond-use date for frozen CSPs at all risk levels?

The maximum beyond-use date for frozen compounded sterile preparations (CSPs) at all risk levels is 45 days. This guideline is based on the stability of the compounded products when stored in a frozen state. The guidance provided by USP 797 ensures that the efficacy and safety of CSPs are maintained during their intended use period. Freezing can help extend the shelf life of certain medications by slowing down degradation processes, but it is important to adhere to the specified time limits to minimize risks associated with microbial contamination and chemical instability. Therefore, 45 days is an appropriate time frame that balances safety and practicality for frozen CSPs across different risk levels.