The proposed revision to USP General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparations is now available for public comment.

USP General Chapter <795> provides standards for compounding quality nonsterile preparations. The chapter describes requirements for the compounding process, facilities, equipment, components, documentation, quality controls, and training.

The proposed revision to USP <795> is available for download.

Please submit your comments no later than July 31, 2018 using the electronic form.

To learn more, register for the Open Microphone session scheduled for April 20, 2018. During the Open Microphone session, USP will highlight changes in the proposed revised standard and answer stakeholder questions about the approach and methodology of the revision.