Baxa Corporation is Dedicated to Helping
You Achieve and Maintain USP <797> Compliance…


The US Pharmacopoeia's (USP) General Chapter <797> Pharmaceutical Compounding – Sterile Preparations1, which sets forth practice standards to help ensure that compounded sterile preparations (CSPs) are of high quality, initially became official on June 1, 2004 as the first enforceable standards for sterile compounding. The main focus of USP <797> is to set forth both procedural and practical standards for the safe compounding of sterile products to prevent patient harm and death from contaminated CSPs. The Chapter was written to improve the compunding of sterile products, thereby improving patient safety and saving lives.

USP <797> emphasizes the need to maintain high standards for the quality and control of processes, components and environments and for the skill and knowledge of personnel who prepare CSPs. The Chapter is built on two foundations: aseptic technique and environmental controls. Its overall goal is to prevent patient harm from microbial contamination (non-sterility), excessive bacterial endotoxins and large-content errors in the strength of ingredients in CSPs. As the importance of this chapter moves to the forefront in US health-system pharmacies, Baxa is dedicated to developing products and services to help you achieve and maintain <797> compliance.


THREE INDUSTRY LEADERS. ONE COMPLETE SOLUTION

Finally. A single gateway that leads you to the pharmacy consulting, training and documentation requirements you need to USP <797> compliant. Your complete compliance solution for USP <797> combines the expertise of three industry-leading companies:









For additional information please DOWNLOAD THE USP <797> FLYER.


COMPLIANCE TRAINING

Whatever your USP <797> training needs, Baxa can help. We offer a wide range of courses at our Skills Training, Academics and Resources (STAR) Center. This state-of-the-art cleanroom training facility provides unique experiences for health-system and industry participants to learn the key guidelines and practice compliance with working equipment in a facility purpose-built for regulatory compliance training. If you’re looking for training you can access from your desktop, CriticalPoint offers you the convenience of training on your time schedule and wherever you can access the Internet. Both training programs provide your staff with the understanding required to implement regulatory standards and industry best practices at your facility.


USP <797> REVISION

The first major revision to USP <797> released on December 3, 2007, after years of soliciting feedback and thousands of responses. The USP Revised General Chapter <797> Parmaceutical Compounding - Sterile Preparations1 became effective June 1, 2008. The main focus of Chapter <797> is to set forth both procedural and practical requirements for the safe compounding of sterile preparations in an effort to prevent patient harm and death from contaminated compounded sterile preparations (CSPs). This revision features an increased focus on procedural issues that contribute to contaminated CSPs. Baxa training programs, products and technical papers provide guidance on these updates to the procedural and practical requirements.

  1. USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations.
    United States Pharmacoepia. 2008.
    www.usp.org/USPNF/pf/generalChapter797.html