Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What characterizes high risk CSPs according to USP 797?

1. Use of sterile ingredients only

2. Using non-sterile ingredients and lack of sterilization methods

3. Use of preservatives

4. Compounded in ISO Class 5 hoods

The correct answer is: Using non-sterile ingredients and lack of sterilization methods

High risk compounding sterile preparations (CSPs) are characterized by the use of non-sterile ingredients and the absence of effective sterilization methods prior to administration. This definition stems from the guidelines established by the United States Pharmacopeia (USP) in Chapter 797, which outlines conditions and practices necessary to minimize the risk of contamination. In high risk CSPs, the presence of non-sterile ingredients significantly increases the potential for microbial contamination since these preparations are intended for administration to patients who may be immunocompromised or otherwise vulnerable to infections. If these products are not subjected to thorough sterilization processes, they pose a serious health risk to patients receiving them, as they can introduce pathogens directly into sterile areas of the body. Contextually, the other answer choices do not accurately reflect high risk CSPs. The use of sterile ingredients alone does not classify a preparation as high risk; in fact, the use of sterile components characterizes lower risk preparations. The presence of preservatives is more relevant to certain formulations to enhance stability and prevent microbial growth, which would generally not apply to high risk scenarios. Furthermore, while compounding in ISO Class 5 hoods is necessary for the aseptic preparation of CSPs, this aspect alone does not