Attention CompoundersPost date: Aug 14, 2018
USP <797> & <825> Are Open for Public Comment
The new revised USP <797> chapter on sterile preparations & the USP <825> chapter on radiopharmaceuticals are now open for public comment. USP General Chapter <797> provides standards for compounding quality sterile preparations. You can access the new version of <797> here.
This is the second round of public comments for USP <797>. It was opened for public comment July 27, 2018. The public comment period will run through November 30, 2019.
You can also register for the open microphone session scheduled for September 5, 2018, through the link above. During the Open Microphone session, USP will highlight proposed revised standards and answer questions about the approach of the revisions.
These new revisions eliminate the section Radiopharmaceuticals as Compounded Sterile Preparations (CSPs) and replace it with a reference to General Chapter 825 Radiopharmaceuticals ‒ Preparation, Compounding, Dispensing, and Repackaging. USP <825> is available here and is also open for comment through November 30, 2018.