Late in 2022, the United States Pharmacopeia (USP) released its final revisions to General Chapter <797> Pharmaceutical Compounding - Sterile Preparations.
The revision, which becomes official November 1, 2023, represents a significant change from the 2008 standards currently in use.
Compounding pharmacies must respond to the new standards and requirements by:
Understanding the new compounded sterile preparation (CSP) category definitions and updating beyond-use dates (BUDs) for each
- Conducting role-based personnel training and evaluations
- Updating microbiological air and surface monitoring practices
- Effectively communicating new standards for cleaning tasks, frequencies, and agents
- Redefining the designated person(s) role and quality program
- Complying with new documentation requirements
A recent Wolters Kluwer webinar comprehensively walked through the most important of these changes and offered implementation suggestions for each. This article will give you a sense of just how demanding this will be by diving into one of the most critical new requirements – personnel training and competency. Read more >
Simplifi 797 is a customizable, expert-developed automated solution that takes the effort out of USP <795>, <797>, and <800> compliance. Optimize your operations and pass inspections with the only closed-loop compliance support on the market. More than 2,000 pharmacies trust Simplifi 797 for compounding compliance confidence. Wolters Kluwer provides trusted clinical technology and evidence-based solutions that drive effective outcomes across healthcare. Specialized in clinical effectiveness, learning, research, and safety.
This post is related to:
USP <795> Non-Sterile Resources, Compliance, Technology IV/Infusion Resources/USP <797> Resources
