Which of the following indicates a Low risk level in compounding?

A Low risk level in sterile compounding is characterized by procedures that involve using sterile ingredients and equipment, with minimal potential for contamination. The definition of "Low risk" under USP 797 includes specific parameters that ensure the safety and sterility of compounded preparations.

Compounding in an ISO Class 5 environment at all times is a key element of maintaining sterility throughout the compounding process. An ISO Class 5 environment ensures that the air quality is controlled to a level that minimizes the risk of airborne contaminants. This is critical in Low risk compounding, as it signifies that all compounded preparations are made in a setting designed to maintain their sterility, thereby reducing the chance of microbial contamination.

In contrast, while gowning procedures are vital for maintaining a sterile environment, they are only part of the overall protocol and do not alone define the risk level. Using sterile ingredients is also essential but does not necessarily relate to the overall compounding environment, which is integral for defining the risk level appropriately. Administering a mixture over several days typically signifies a higher risk of contamination, as longer exposure increases the potential for microbial growth. Therefore, consistent compounding in a controlled ISO Class 5 environment is the critical factor that indicates a Low risk level in compounding practices