USP Compounding Standards Update

The United States Pharmacopeia (USP) Appeals Panel has issued final decisions regarding General Chapters <795> Pharmaceutical Compounding – Nonsterile Preparation, <797> Pharmaceutical Compounding – Sterile Preparations, and new chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging.

In summary, the current official version of <795> 2014 and <797> 2008 will remain official as the appeals were granted for these chapters. The appeal for <825> was denied, therefore they may reinstate the official date of this new chapter. the Expert committee must provide at least a six-month implementation period, and the chapter will be information unless required by a regulatory body.

https://www.usp.org/sites/default/files/usp/document/our-work/compounding/decisions-appeals-fs.pdf