Those involved in healthcare place a high priority on patient safety, including pharmacists involved in compounded sterile preparations (CSPs). In 2004, the first official version of USP Chapter <797>, Pharmaceutical Compounding: Sterile Preparations, was published to address sterile compounding safety. Because it is a chapter numbered between <1> and <999>, the FDA has the authority to inspect pharmacies and enforce USP 797 in the interest of serving public health. Many state boards of pharmacy and national accrediting organizations, require compliance with USP 797.1
The overall intent of USP 797 is to provide comprehensive guidelines, procedures, and compliance requirements for any entity involved in CSPs. It applies to any setting where CSPs are prepared, such as hospital and satellite pharmacies; hospital care units; physician offices; and other healthcare institutions.
The key principle underlying USP 797 is to prevent harm from:
- microbial contamination
- excessive bacterial endotoxins
- variability in intended strength
- unintended physical and/or chemical contaminants
- using inappropriate quality ingredients
Key sections in USP 797
USP 797 is based upon the latest scientific information and best practices pertaining to sterile compounding preparations. It is divided into several sections, including the following:2
- Compounding personnel: This section details the responsibilities for personnel involved in CSPs. It requires, among other things, that both staff and management personnel are adequately trained, skilled, and regularly tested and monitored. Compounding personnel must ensure that CSPs are properly identified and prepared; also, that proper sterilization, packaging, and logistics procedures are followed.
- Microbial contamination risk levels: The three contamination risk levels are defined so each facility can determine their compounding risk. These risk levels are defined as low, medium and high.
- Environmental quality and control: Great detail regarding the physical facility and environmental requirements for each of the defined risk levels is provided in this section of USP 797.
- Training: USP 797 emphasizes the importance of training and details an appropriate training program. For example, ensuring that personnel are skilled in proper aseptic media fill procedures is one key to ensuring USP 797 compliance, as is a formal written exam to evaluate compounder competence.
What is USP 797: How software aids compliance
One of the best ways to ensure USP 797 control and compliance is to utilize a web-based USP 797 quality-management system that offers staff self-paced online learning, including interactive courses, video scenarios, and testing. Such software systems are involved in sterile compounding to achieve and maintain a state of control and compliance. Popular software include features that enable facilities to:
- customize the system for the specific needs of each compounding site
- research, revise, train, and evaluate
- evaluate trends, outcomes and exceptions
- easily manage tasks and schedules in a user-friendly interface
- stay current with updated standards
A thorough understanding and integration of USP 797 is central to ensuring the safety of compounded medications and will lead to better patient outcomes; a top-rate software system can help you achieve those goals.
What is USP 797? Can your staff answer that question?
1. Lee, Linda D. Compliant Compounding Meeting USP 797 Pharmacy Regulations, Health Facilities Management, Feb. 20, 2010.
2. Kastango, Eric S. The ASHP Discussion Guide on USP Chapter <797> Compounding Sterile Preparations.