If one or more starting components are nonsterile at the start of compounding, what must be achieved?

When compounding with nonsterile starting components, achieving sterilization is critical to ensure patient safety and the efficacy of the compounded preparation. Sterility is paramount because nonsterile ingredients can introduce harmful microorganisms that could cause infections or adverse reactions when administered to patients.

To ensure that a compounded product is safe for human use, any nonsterile starting components must undergo appropriate sterilization processes. This may involve methods such as autoclaving, filtration, or ethylene oxide gas, depending on the nature of the substances and the desired end product. Failure to achieve sterility can compromise the entire compounding process and result in potentially dangerous outcomes.

While quality testing, efficiency, and integrity are important considerations in pharmacy practice, they do not specifically address the requirement for sterilization when starting components are nonsterile. Hence, focusing on achieving sterility is essential in this context.