USP to Seek Second Round of Public Comments for General Chapter 797 Pharmaceutical Compounding—Sterile Preparations
USP is currently revising General Chapter <797>. The initial proposed chapter revision was published for public comment from September 25, 2015 to January 31, 2016. During that public comment period, USP received more than 8,000 comments from more than 2,500 stakeholders. Based on 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. StayAlert! is monitoring this topic and will publish additional information as it becomes available.Follow the link below for additional information.
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