Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

Which of the following is NOT a criterion for low risk CSPs?

1. Compounded in an ISO 5 hood

2. In clean room with ISO Class 7 or better

3. Using up to 5 ingredients in one preparation

4. No more than 3 ingredients added to 1 package/container

The correct answer is: Using up to 5 ingredients in one preparation

Low risk Compounded Sterile Preparations (CSPs) are defined by specific criteria that ensure safety and quality in the compounding process. One of the key aspects of low risk CSPs is that they must be compounded using no more than three different sterile ingredients in a single preparation, which refers to the total ingredients used in the preparation—this includes any active pharmaceutical ingredients and excipients. In this context, the use of up to five ingredients in one preparation exceeds the established guidelines for low risk compounding. The limit on the total number of ingredients, specifically three, is designed to reduce the risk of contamination and maintain a controlled compounding environment. The other criteria mentioned, such as compounding in an ISO 5 hood and doing so within a clean room with at least ISO Class 7 or better, are essential to ensuring a sterile environment, which is crucial for low risk CSPs. These requirements focus on the physical conditions under which compounding takes place to prevent contamination. Thus, the number of ingredients allowed becomes the defining factor for what constitutes a low risk preparation.