What is the primary focus of USP 797 standards?

The primary focus of USP 797 standards is to ensure the sterility and quality of compounded sterile preparations. This set of guidelines was established to protect patients by minimizing the risks associated with compounded sterile medications, which may be necessary for patient treatment but can also pose significant safety hazards if not prepared correctly.

USP 797 outlines specific practices and requirements for sterile compounding, such as proper facility design, environmental controls, personnel training, and quality assurance measures. These standards help uphold the integrity of the products being compounded, ensuring they are free from contaminants and are of the highest quality for patient administration. By adhering to these guidelines, healthcare professionals can effectively safeguard against the risks of infections and other complications that could arise from poorly compounded sterile preparations. Thus, the emphasis on quality and sterility in these standards is central to the safe practice of pharmacy compounding.