Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What is the BUD for high risk sterile compounds mixed in a clean room at room temperature under USP 797?

1. 24 hours

2. 12 hours

3. 30 hours

4. 48 hours

The correct answer is: 24 hours

The Beyond-Use Date (BUD) for high-risk sterile compounds mixed in a clean room at room temperature is indeed 24 hours according to the United States Pharmacopeia (USP) guidelines outlined in USP 797. High-risk sterile compounding refers to preparations that involve a higher potential for contamination or instability due to factors such as using non-sterile ingredients, handling sterile materials in non-sterile environments, or storing compounded products for extended periods before use. In these situations, the sterile compound is at significant risk for microbial growth if not used promptly. USP 797 categorizes high-risk products and sets stringent standards to minimize contamination risks and ensure patient safety. The 24-hour BUD helps ensure that these products are used while they are still deemed safe and effective. Beyond this time frame, the potential for contamination increases, and the risks associated with using such products become significantly greater. The other options reflect longer durations, which are inconsistent with the considerations around microbial growth and maintaining sterility in high-risk compounding scenarios. Therefore, given the strict guidelines established for high-risk compounds, a 24-hour BUD is appropriate and necessary to safeguard patient health.