In which condition would a compounded sterile preparation be classified as high risk?

A compounded sterile preparation is classified as high risk when it involves the use of non-sterile ingredients and equipment. This is significant because the introduction of non-sterile components poses a greater risk of microbial contamination. In sterile compounding, maintaining strict aseptic conditions is crucial to ensure the safety and efficacy of the preparation, especially for patients with compromised immune systems.

Using non-sterile ingredients can lead to growth of harmful microorganisms, which could potentially cause infections when administered to patients. This classification is essential in determining the appropriate sterilization and handling procedures necessary to mitigate risks associated with contamination.

Other scenarios, such as preparing a compounded preparation from sterile ingredients in controlled environments (like ISO Class 5) or involving more than three sterile products, may not necessarily constitute "high risk" as long as they are executed within a sterile environment and according to proper protocols. Similarly, using preservatives can actually reduce the risk of microbial growth by acting as a barrier against contamination. This highlights the unique dangers associated with high-risk situations, particularly the implications of using any non-sterile materials in sterile compounding.