USP Virtual Open Forum Series: Proposed Revisions to Compounding General Chapters

Proposed Updates to USP General Chapters <795> and <797>

Agenda Speaker biographies 

Event Recordings

On January 12, 2022, and January 19, 2022, USP hosted Several Seminars on the published proposed revisions to USP General Chapter <795> Pharmaceutical Compounding — Nonsterile Preparations and General Chapter <797> Pharmaceutical Compounding—Sterile Preparations for public comment. Stakeholders are encouraged to submit comments on or before March 17, 2022.

Discussions at each session were based on questions from attendees, so participants are encouraged to attend both sessions.

Open Forums

During each session, members of the CMP EC highlighted the proposed revisions to USP General Chapters <795> and <797> and briefly provided the rationale for the requirements and recommendations in the proposed revisions. Participants had the opportunity to pose questions on the proposed revisions from the members of the CMP EC. Sessions were recorded and listed below for on-demand viewing. To facilitate robust and productive dialogue, the CMP EC offered a number of pre-read materials for attendees. Participants were strongly encouraged to download and review these documents before each session.

Pre-read materials - Click here

  • Stability studies for compounded preparations: a resource document for compounders
  • Briefing materials for proposed revisions to USP General Chapter <795>
  • Briefing materials for proposed revisions to USP General Chapter <797>

Event Presentations

Virtual Meeting