February 16, 2017
The U.S. Pharmacopeial Convention (USP) recently announced that it will seek a second round of public comments for general chapter <797>, which is undergoing revision. Initially, the proposed chapter revision was published for public comment from September 25, 2015, to January 31, 2016. However, 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 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. For additional information, you can also visit USP’s FAQ page on this chapter.
SNMMI recently participated in a roundtable meeting on compounding. The session was productive, and SNMMI appreciates the USP’s efforts on the revision of <797>. The society looks forward to working with USP in the future.