What characterizes high risk compounding?

High-risk compounding is characterized by the mixing of non-sterile ingredients or conducting the compounding process in a non-sterile environment. This classification indicates that the compounded preparation may pose a higher risk of contamination due to the lack of sterility of the raw materials or the conditions under which they are compounded.

In this context, the use of non-sterile ingredients means that the potential for microbial contamination is significant, making it vital for pharmacies to adhere to strict guidelines and proper sterilization techniques following the compounding of such products. High-risk compounding requires comprehensive measures to ensure safety, including thorough testing for sterility before the product is dispensed.

Sterile ingredients, mixing in a sterile environment, and validated processes relate to lower-risk categories of compounding, where the aim is to maintain a higher level of safety and minimize the chances of introducing pathogens or contaminants into the final product.