Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What defines low risk compound sterile preparations (CSPs) according to USP 797?

1. Only one ingredient used

2. Compounded within ISO 5 hood and no more than 3 ingredients

3. Non-sterile ingredients are allowed

4. Using devices without sterilization

The correct answer is: Compounded within ISO 5 hood and no more than 3 ingredients

Low-risk compound sterile preparations (CSPs) are defined by specific criteria established in USP Chapter 797. The correct definition indicates that these preparations must be compounded in an ISO Class 5 environment, which provides a controlled atmosphere to minimize contamination, and typically involves no more than three ingredients. This standard ensures that the preparations maintain a level of sterility that is essential for patient safety and efficacy. Compounding within an ISO Class 5 hood is crucial, as it is certified to provide a clean air environment that reduces the risk of airborne contaminants. The restriction to no more than three ingredients helps simplify the compounding process and limits potential sources of contamination. These requirements are in place to uphold the quality and safety of CSPs, ensuring they are appropriate for patient use. In contrast, other choices describe conditions that do not meet the low-risk criteria. Using only one ingredient may simplify the compounding process but does not define the risk level. Allowing non-sterile ingredients contradicts the fundamental principles of sterility in CSPs. Similarly, using devices without sterilization would increase the risk of contamination, which is counter to the low-risk designation. Thus, the conditions described in the correct choice directly reflect the key criteria for establishing low-risk CSPs according