What is a key requirement for preparing sterile products in a pharmacy?

Preparing sterile products in a pharmacy is critical for ensuring patient safety and product efficacy, and compliance with USP General Chapter <797> is a key requirement in this process. This chapter establishes the standards for the compounding of sterile preparations, addressing the necessary conditions, practices, and training required to prevent contamination and ensure the sterility of the products being prepared.

USP <797> outlines specific guidelines related to the environment in which sterile compounding occurs, including the requirements for facilities, equipment, and the personal qualifications of pharmacists and technicians involved in the compounding process. These standards are designed to minimize contaminants that could lead to infections or other adverse effects for patients receiving these sterile products.

The focus on sterilization techniques, proper gowning and gloving procedures, as well as environmental controls, makes USP <797> a cornerstone of sterile compounding practice in any pharmacy engaged in preparing sterile medications. Adhering to these guidelines is crucial for patient safety and regulatory compliance.