Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

Under USP 797, what is the BUD for medium risk sterile compounds mixed within a clean room?

1. 30 hours at room temperature

2. 48 hours at room temperature

3. 12 hours at refrigerator temperature

4. 24 hours at room temperature

The correct answer is: 30 hours at room temperature

The beyond-use date (BUD) for medium risk sterile compounds mixed within a clean room is defined by the United States Pharmacopeia (USP) Chapter 797 guidelines. For medium-risk preparations, the BUD at room temperature is 30 hours. This classification applies to sterile compounding procedures where multiple products are combined, and where the process involves a higher degree of risk due to factors such as the complexity of preparation or longer times for manipulation. Identifying BUDs is crucial for ensuring the safety and effectiveness of sterile products, as they indicate how long the product can be properly stored before the potential for contamination increases, thereby posing a risk to patients. The specific time frame for medium risk compounds, being 30 hours at room temperature, reflects the considerations of sterility and stability associated with these types of preparations. Other options provided, such as 48 hours at room temperature, 12 hours at refrigerator temperature, and 24 hours at room temperature, do not align with the standards established under USP 797 for medium risk compounding and therefore are not applicable in this context.