New & Important: USP Releases Final Versions of Compounding Chapters
On June 1, 2019, USP released the newly revised compounding standards to help ensure the quality of compounded medicines; https://www.usp.org/compounding
USP <795> Pharmaceutical Compounding—Nonsterile Preparations
USP <797> Pharmaceutical Compounding— Sterile Preparations
USP <800> Hazardous Drug Handling in Healthcare Settings
USP <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging
Complimentary access to the digital versions of the final chapters is available through the USP website following registration from June 1, 2019 – January 1, 2020.
Through much work from the USP expert committees and thousands of comments from the public, all newly released chapters are synchronized and easy to navigate. Collectively, these USP General Chapters provide a set of standards to assist healthcare providers with consistently producing quality compounded preparations to help ensure patients receive medicines that are not adulterated.
FDA has taken notice of the revised chapters and Janet Woodcock, Director of the Center for Drug Evaluation and Research at the U.S. FDA, stated: “The revised USP standards recognize risks associated with nonsterile and sterile compounding and tighten controls in areas that directly affect the quality and safety of compounded medicines, The changes to these USP chapters should improve the quality of compounded products and help protect public health.”[i]
The USP has revised its website for each chapter and provides an incredible amount of FREE resources to assist with compliance. One of the most useful features is the FAQ’s; https://www.usp.org/frequently-asked-questions. The FAQs provide guidance to some of the ‘gray’ standards/recommendations where sites will be required to make educated interpretations.
Without these standards, healthcare providers have no guidance or structure to compounding medications safely for patients. The importance of these chapters cannot be overemphasized as we continue to advance patient safety.
Cleanroom Technology: USP Publishes new and revised sterile compounding standards. June 5, 2019; https://www.cleanroomtechnology.com/news/article_page/USP_publishes_new_and_revised_sterile_compounding_standards/155186