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How to respond to the USP Chapter 797 revisions

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 >

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