Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What is a common characteristic of high risk CSPs?

1. Use of very few ingredients

2. Use of sterile water

3. Using non-sterile ingredients

4. Storage in a freezer

The correct answer is: Using non-sterile ingredients

High risk compounded sterile preparations (CSPs) are categorized as such primarily due to the use of non-sterile ingredients during the compounding process. When non-sterile ingredients are included in a preparation, particularly when they are intended to be administered via injection or otherwise taken into the body, they pose a significant risk of contamination. This risk is amplified because non-sterile ingredients can introduce viable microorganisms or endotoxins into the preparation. For example, if a pharmacist uses a non-sterile powder to create a sterile injectable solution, the end product may not be safe for patient use without proper sterilization processes being applied afterward. Consequently, the handling, preparation, and storage practices for high risk CSPs must be meticulously controlled to mitigate these risks. The other characteristics mentioned do not classify a CSP as "high risk." While the use of sterile water and the number of ingredients included are important factors in the compounding process, they do not inherently indicate a high risk status. Similarly, storage conditions such as freezing do not determine the risk level of a CSP itself, although proper storage is critical to maintaining the integrity and sterility of the compounded product.