What is the maximum Beyond Use Dating for Low Risk preparations when frozen?

The maximum Beyond Use Date (BUD) for low-risk compounded sterile preparations that are stored in a frozen state is indeed 45 days. This guideline is based on industry standards which allow for low-risk preparations to have a specific BUD depending on the storage conditions. For compounds that are prepared in low-risk environments, the stability of the product is greater when frozen, thus allowing a longer BUD than when stored at room temperature.

In sterile compounding, the assessment of stability is critical, and the guidelines aim to ensure that the compounded product maintains its efficacy and safety for the duration of its intended use. The parameters for Beyond Use Dates are established by the United States Pharmacopeia (USP) and provide a systematic approach for pharmacy technicians in managing compounded sterile products. By adhering to these guidelines, technicians play a vital role in patient safety and the integrity of the compounded medications.