FPGEE for NABP 2025 – 400 Free Practice Questions to Pass the Exam

Low-risk level preparations, as defined by USP 797, must be compounded using sterile ingredients and require aseptic manipulations to ensure sterility throughout the process. The environment for these manipulations must be controlled, specifically within an ISO Class 5 area or better, to minimize contamination risks.

Using aseptic techniques in an ISO Class 5 environment ensures that the preparation process is performed under conditions that provide a high level of protection against microbial contamination. This is essential for maintaining the quality and safety of the compounded sterile preparations. Thus, focusing on aseptic manipulations in an appropriate environment is critical for defining low-risk compounding.

While other options might present relevant concepts around preparation, they do not meet the strict criteria laid out by USP 797 for low-risk level preparations. For example, nonsterile ingredients do not align with the requirements for sterile compounding, while multiple sterile product combinations or prolonged manipulations may indicate a higher level of risk. Hence, the emphasis on proper aseptic techniques within a controlled environment is the definitive criterion for low-risk level preparations.