USP Seeks Comment on Proposal Changes to Pharmaceutical Compounding Guidelines
The newest <797> comment period (July 27 – November 30, 2018) includes a 9-point summary (below) for the pharmaceutical compounding sector. Submissions must be made before November 30, 2018 through the online form.
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 fielded a number of inquiries from small-medium sized 797 facilities who found 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. Submit comments using the form available here or view proposed chapter online (USP 797 Revisions Updated PDF Download)