January 2004 USP Chapter <797> Pharmaceutical Compounding-Sterile Preparations became the first official, enforceable requirement for the compounding of sterile preparations. Quality standards and practices are provided to all who work within environments in which the CSP drugs and nutrients are prepared.
The goal is to protect patients from any harm, including death, which could be the result of Chemical and Physical Contaminants | Microbial Contamination | Medication Errors | Excessive Bacterial Endotoxins. It is designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals.
USP Chapter <797> has been revised and the new revision, which dictates compounding be performed under ISO 5 (Class 100) conditions, became official on 01 June 2008. Compliance with USP Chapter <797> is a challenging requirement that will be strictly enforced.
Visit www.usp797.org for more information.