USP Compounding General Chapters Now Available for Public Comment

 

USP Compounding General Chapters are now available for public comment. The USP team has scheduled an Open Microphone session for September 5, 2018. During the Open Microphone session, USP will highlight changes in the proposed revised standard and answer stakeholder questions about the approach and methodology of the revision.

 

To register please follow this link HERE

The proposed revisions to USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations are now available for a second round of public comment. USP General Chapter <797> provides standards for compounding quality sterile preparations.

Since the first public comment period, which began in September 2015, there has been significant input from stakeholders including roundtable meetings, discussion forums, and review of more than 8,000 written public comments. The Expert Committee has reviewed all of the public comments from the September 2015 proposal along with additional guidance from many stakeholders to propose a new revision for a second round of public comment. To supplement the review, expert consultants have been engaged to assist the Expert Committee during this revision process.

The proposed chapter is available for download. Please provide your comments no later than November 30, 2018 using the electronic form.

To learn more, register for the Open Microphone session scheduled for September 5, 2018. During the Open Microphone session, USP will highlight changes in the proposed revised standard and answer stakeholder questions about the approach and methodology of the revision. The registration link will be made available on August 5, 2018.

The anticipated revisions to <797> will eliminate the section Radiopharmaceuticals as Compounded Sterile Preparations (CSPs) and replace it with a reference to General Chapter <825> Radiopharmaceuticals ‒ Preparation, Compounding, Dispensing, and Repackaging. 

General Chapter <825> is also available for public comment between July 27 and November 30, 2018. To learn more visit the GC <825> web pageand register for the Open Microphone session scheduled for October 5, 2018 (link will be made available September 5, 2018). Please note that this chapter is specifically tailored for radiopharmaceuticals.

 

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