USP Publishes Notice of Intent to Revise Chapter on Sterile Compounding Preparations

October 7, 2015

Topics: Compounding

The Compounding Expert Committee of the United States Pharmacopeial Convention (USP) intends to propose revisions to General Chapter <797> Pharmaceutical Compounding—Sterile Preparationsto improve clarity and reflect stakeholder input. The revisions made to the General Chapter include reorganized sections, merging of microbial risk categories into two categories, removal of information on handling hazardous drugs and adding of cross-references to General Chapter <800>Hazardous Drugs—Handling in Healthcare Settings, and introduction of new terminology, “in-use time.”

On November 2, 2015, the proposed revisions to General Chapter <797> will be published for public comment in Pharmacopeial Forum (PF) 41(6) [Nov.–Dec. 2015]. Before the proposed revisions are published in PF 41(6), USP has made the chapter available in the online notice. The notice provides instructions for submitting comments, which will be accepted until January 31, 2016.