CHA News Article

USP to Revise Sterile Compounding Facility Standards Again
Plans another round of public comments

The United States Pharmacopeial Convention (USP) is revising its 797 standard, which governs sterile preparation spaces for pharmaceutical compounding. USP received more than 8,000 comments on the rule from more than 2,500 stakeholders from Sept. 25, 2015, to Jan. 31, 2016.

Based on the number of comments, USP will publish the revised chapter for a second round of public comments before issuing the final standard. At this time, USP does not have an anticipated date for the chapter’s republication.