USP Publishes Notice of Intent to Revise Compounding Standards

Rockville, Md., September 23, 2019 — USP published a Notice of Intent To Revise (NITR) for the new and revised compounding standards released on June 1, 2019—<795> Pharmaceutical Compounding – Nonsterile Preparations, <797> Pharmaceutical Compounding – Sterile Preparations and new chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. In the interim, the currently official chapters of <795> (last revised in 2014) and <797> (last revised in 2008) including the section Radiopharmaceuticals as CSPs will remain official. Relevant chapter <800> Hazardous Drugs – Handling in Healthcare Settings will become official on December 1, 2019. USP remains committed to advancing public health and to promoting the quality of compounded medicines and the safe handling of hazardous drugs. USP is committed to transparency and will continue to communicate updates on the compounding chapters.


About USP

USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and food for billions of people worldwide. For more information about USP, visit www.usp.org.