Which of the following is true for high-risk compounded sterile products?

High-risk compounded sterile products indeed involve non-sterile starting materials that must undergo terminal sterilization to achieve sterility. This characteristic is part of the definition of high-risk compounding as per the United States Pharmacopeia (USP) standards. These products are considered high risk because the initial non-sterile components have a greater potential for contamination, hence the necessity for a terminal sterilization process that reliably removes any microbial contaminants.

The other options do not accurately reflect the standards or practices associated with high-risk compounded sterile products. For example, ISO class 7 is the recommended environment for medium-risk compounding, not specifically for high-risk products. It is crucial for high-risk formulations to be prepared using strict aseptic technique to minimize the risk of contamination, which dismisses the idea that they can be prepared without aseptic precautions. The beyond-use dates (BUDs) assigned to high-risk products are generally shorter than those for lower-risk products, particularly at room temperature, rather than being labeled "low" as stated in the last option. Understanding these definitions and standards is essential for safe and compliant pharmacy practice.