Which organization sets the standards for sterile compounding practice?

The organization that sets the standards for sterile compounding practice is the United States Pharmacopeia (USP). USP is a scientific nonprofit organization that establishes quality standards for medicines, food ingredients, and dietary supplements. Specifically, USP Chapter 797 focuses on the sterile compounding of pharmaceutical products, outlining best practices and requirements to ensure the safety, quality, and efficacy of compounded sterile preparations.

The standards set forth by USP are critical for healthcare professionals involved in compounding to understand, as they provide guidance on facilities, personnel training, processes, and quality control measures necessary to minimize the risk of contamination and ensure the integrity of sterile products. By adhering to these standards, pharmacies and healthcare facilities can promote patient safety and enhance overall healthcare outcomes.

This emphasis on safety and quality is why USP holds a respected position within the healthcare system, making it the authoritative source for sterile compounding practices in the United States.