Friday, October 28, 2016

USP 797 - Update on Current Status of Revisions

As is well known, USP is in the process of updating USP 797.

A brief history and update on the current revisions to USP 797 is listed below. This update is current as of the date of this article, October 2016.

Initially, the revision to USP 797 General Chapter was proposed in September 2015 for public comment. The public comment period for the proposed ended on January 31, 2016 and the Compounding Expert Committee is currently reviewing all of the public comments received.

The chapter is currently being revised based on the input USP received. USP does not yet have an anticipated date for the publication of the chapter due to the volume of comments during the public comment period. Based on the nature and significance of the public comments received, the Committee in charge of the revisions will determine whether the chapter will be republished in the Pharmacopeial Forum for another round of public comments.

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