Updated Changes to USP 797 and USP 800 Pharmaceutical Compounding Guidelines and Overview
The newest <797> comment period which concluded November 30, 2018 includes a 9-point summary (below) for the pharmaceutical compounding sector.
Improvements to clarity and readability of documentation are significant for all facilities, but specifically for those compounding both hazardous (800) and non-hazardous (797) drugs, or those administering CSPs.
Production Automation often fields inquiries from small-medium sized 797 facilities who find updates required by USP 800 documentation unclear. New revisions simplify formatting and limit redundancy. General chapter (825) is also proposed for public comment.
Final revisions become official on December 19, 2019, although this date has previously been subject to change. Some sections may have longer adoption dates to allow amicable time for facility changes.