General Chapter <797> Pharmaceutical Compounding—Sterile Preparations will be Posted for Second Round of Public Comments
General Chapter <797> is currently undergoing revision. Initially, the proposed chapter revision was published for public comment from September 25, 2015 to January 31, 2016. During the public comment period, USP received more than 8,000 comments from more than 2,500 stakeholders. The Compounding Expert Committee is currently evaluating all of the information received in the public comments and using these data to inform the chapter revision as appropriate. Based on ongoing dialog and the nature and significance of the public comments received, the proposed revised chapter will be republished in the Pharmacopeial Forum for another round of public comments. Although General Chapter <797> is undergoing revision, the published version of the chapter which became official on June 1, 2008 is currently the official standard.
At this time, USP does not have an anticipated date for the chapter’s republication. USP encourages stakeholders to follow the status of the chapter and sign up for the USP Healthcare Quality Standards Update at http://www.usp.org/HQS-Signup-Form. For additional information, you can also visit USP’s FAQ page on this chapter.
Should you have any questions, please contact the USP Healthcare Quality and Safety team at CompoundingSL@usp.org.