What terminology is used in the USP/NF classification system for home-use sterile drug products?

The terminology "low risk vs. high risk" is used in the USP/NF classification system specifically in the context of home-use sterile drug products. This classification helps to categorize sterile compounding based on the likelihood of contamination and the complexity associated with the preparation process.

Low-risk sterile compounding involves procedures that are relatively straightforward, typically requiring minimal manipulations and employing aseptic techniques, making them less prone to contamination. In contrast, high-risk compounding involves more complex steps that might include contact with contaminated surfaces or use of non-sterile components, which increases the risk of introducing contaminants into the final product.

Understanding this classification is crucial for healthcare professionals as it informs them about the required practices for preparing sterile drug products, guiding them in implementing appropriate safety measures and ensuring patient safety.

The other terms mentioned, such as "sterile vs. non-sterile" and "compounded vs. manufactured," while relevant in broader contexts, do not specifically address the risk assessment associated with home-use sterile drug products within the USP/NF framework. Similarly, "approved vs. investigational" pertains more to the regulatory status of drugs rather than their preparation practices.