Posted on November 20, 2014
The overall intent of USP Chapter 797 is to improve safety outcomes by reducing patient harm caused by improperly compounded sterile preparations (CSPs). Since the chapter was first published in 2004, progress has been made in improving pharmacy compliance with USP Chapter 797 guidelines, which spells out the minimum practices and quality standards expected of any entity involved in CSP storage, handling, preparation and transportation.
However, a number of compounding pharmacies have resisted full implementation of USP 797, believing that their existing compounding practices were good enough. As a result of poor compounding practices and facilities, 64 people died from fungal meningitis stemming from tainted steroid injections compounded by the New England Compounding Center (NECC). Because of this terrible tragedy, oversight was enacted from the FDA and state boards of pharmacy. Further inspections found other compounding pharmacies engaging in unsafe sterile compounding practices. Many pharmacies are now being held to USP 797 standards. To do so, consider these tips.
There are three initial steps required to attain USP 797 compliance. The first step is to determine your CSP compounding risk level. The second step necessitates conducting a gap analysis. This very important process should be regularly revisited to make sure your pharmacy doesn’t revert back to bad habits. A good gap analysis identifies where your operations are insufficient and serves as a guide for correcting problems.
Good gap analysis tools exist to determine how your operations compare with the standards of USP 797. For example, a web-based interactive tool provides the pharmacy with a summary compliance score based on questions developed from the text of USP 797. Once responses are scored, the third step requires the pharmacy to develop a specific action plan to address deficiencies.
A detailed compliance action plan defines where your facility has fallen short and what changes need to be made to become and stay compliant with USP 797. It puts management and pharmacy staff on the same page and can help prove to the FDA and other oversight bodies that the pharmacy is actively addressing areas of non-compliance. A good plan helps you develop and monitor key operational areas, including documentation, staff training, process control, environmental monitoring, and aseptic process and technique.
A growing number of hospitals are bringing production of CSPs in house, eschewing outside compounding facilities. Such institutions have concluded that insourcing IV preparations is a better strategy to “ensure reliable and safe sources for crucial IV drug admixtures.”1 If your pharmacy is interested in this approach, full support from hospital administration is essential, according to Erasmo Mitrano, RPh, Associate Chief of Pharmacy at Massachusetts General Hospital. This hospital decided to begin insourcing after the FDA shut down one of their primary CSP suppliers due to multiple manufacturing violations.
Achieving a state of compliance is not an end-point itself, but rather an ongoing process. Compliance can easily falter if the pharmacy doesn’t have sufficient tools for ongoing USP 797 compliance assessment. One of the most well-regarded tools is Simplifi 797®, a web-based compliance management program that provides standardized training, on-demand staff access, continually-updated standards and best practices, and a complete set of expert-based policies and procedures.
What USP 797 compliance challenges do you need help addressing?
1. Frandzel, Steve. Insourcing IV Sterile Compounding. Pharmacy Practice News. June 2014, Volume 41.