USP Chapter <797>

 

Program Description

As health-system pharmacists, we understand the relationship between quality in sterile preparation compounding and patient safety. However, gaps between ideal and actual compounding practices persist. USP <797> will close the gap on significant variations in sterile compounding practices.

Pharmacists need guidance on important aspects of USP chapter <797> to ensure compliance in 2006. These aspects include the training of personnel, with didactic instruction, direct observation, and evaluation of aseptic manipulation skills through media fill testing. Environmental sanitation and monitoring are areas of chapter <797> of concern to many pharmacists, who need insight into requirements for cleaning and disinfecting the work environment and monitoring air quality for particulates and microorganisms. Requirements for documentation and corrective action also are important.

State board of pharmacy regulations, accreditation organization standards, and recommendations of other organizations for compounding sterile preparations are based on USP requirements and therefore, they are in a state of flux. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), in conjunction with ASHP, has developed a suggested timeline for the gradual phasing in of USP requirements. Although not required, these suggested timeframes can assist organizations in developing an individualized action plan. Pharmacists need to be aware of JCAHO's standards and timeline, recommendations of other organizations (e.g., the National Institute for Occupational Safety and Health), and state board of pharmacy regulations that impact compounding practices.