What defines low-risk level compounding?

Low-risk level compounding is defined by aseptic manipulations involving a limited number of sterile ingredients. This designation indicates that the process is designed to minimize the potential for contamination. In low-risk compounding, the intention is to use sterile ingredients and to maintain a controlled environment that reduces the risk of microbial contamination.

Typically, low-risk compounding may involve the preparation of products with not more than three sterile ingredients and involves simple manipulations, such as transferring a sterile drug from one container to another using proper aseptic techniques. The focus is on maintaining sterility throughout the process, which is crucial in ensuring patient safety when administering compounded sterile preparations.

Options that refer to non-sterile ingredients, large batch sizes, or multiple active pharmaceutical ingredients do not align with the criteria for low-risk level compounding, as those factors introduce greater complexity and potential for contamination risks, thereby categorizing the compounding as higher risk.