Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

According to USP 797, what is the BUD for high risk sterile compounds stored in the refrigerator?

1. 3 days

2. 9 days

3. 14 days

4. 30 days

The correct answer is: 3 days

The correct understanding regarding the beyond-use date (BUD) for high-risk sterile compounds stored in the refrigerator is that it is set at 3 days. High-risk compounding refers to preparations that involve non-sterile ingredients, lack adequate sterilization processes, or have been exposed to risks that can compromise their sterility. Due to the increased potential for contamination with high-risk compounds, the shorter BUD reflects the need for ensuring patient safety. Storing these high-risk sterile compounds in the refrigerator allows for some preservation of the compound, but it does not extend the BUD significantly compared to lower-risk categories. Since high-risk compounding has an inherent risk of microbial contamination, the stringent time limit helps mitigate potential risks associated with their use. In contrast, options such as 9 days, 14 days, and 30 days do not align with the guidelines outlined in USP 797 for high-risk formulations, which emphasize the need for rapid utilization or disposal to ensure quality and safety. Thus, 3 days is the appropriate BUD for high-risk sterile compounds stored in the refrigerator.