What is required for high-risk compounded sterile products before they are administered?

The requirement for high-risk compounded sterile products before administration is that they must be terminally sterilized. This is essential because high-risk products are often made from non-sterile ingredients or involve processes that carry a higher risk of contamination. Terminal sterilization ensures that any potential microbial contamination is eliminated, thus ensuring the safety and efficacy of the product for patients.

Terminal sterilization can be achieved through various methods, including autoclaving, dry heat, or using ethylene oxide, depending on the product’s characteristics. This step is crucial in maintaining the sterile integrity of compounded products that are intended for parenteral use.

While a cleanroom environment is critical for the preparation of all compounded sterile products to reduce contamination, the mere act of being prepared in a cleanroom does not address the sterilization of high-risk products post-preparation. Refrigeration is typically relevant for certain pharmaceuticals to maintain stability, but it does not guarantee sterility. Safety seals are not a standard requirement for ensuring the sterility of compounded products. Thus, the focus on terminal sterilization underlines its vital role in patient safety and compliance with pharmacy regulations concerning high-risk compounds.