USP<797> Sampling Instructions - Surface Testing Surfaces of each ISO classified cleanroom area must be tested "periodically" (General Chapter USP<797>, 2008). The frequency of surface testing may change to a monthly requirement soon. The purpose of the testing includes evaluation 1.2 When did <797> become official? <797> has been an official standard since 2004. It was revised in 2008. A proposed revision was published in 2019 but was appealed and returned to the USP Compounding Expert Committee to evaluate and/or revise. 6. 1.3 Why is there a need for a chapter on sterile compounding? USP 797 & 800 When it comes to selecting a fixture for a compounding pharmacy you should look for these features: Our recommended products: USP797 relates to sterile drugs. USP800 is about hazardous drugs. Both need to be handled within a properly designed compounding pharmacy. Much like traditional Clean Rooms, under USP797 and USP800 Search USP Careers Attend a USP Event USP General Chapter <797> Frequently Asked Questions Revised January 12, 2010 Responses have been provided for informational purposes only, and should not be construed as an official interpretation of USP text or relied on to demonstrate compliance with USP standards or requirements. General What is USP <797>? • USP-NF establishes standards for medicines, food ingredients and dietary supplements. • General Chapter USP <797> establishes best practices and regulations for the production of compounded sterile preparations. 5 Monographs General Chapters General Notices General Chapters establish procedures, methods and practices. USP General Chapter <797> Informational Documents. September 1, 2021: BUD Scientific Rationale for the 2021 Proposed Revisions to <797>. September 1, 2021: BUD Reference for the 2021 Proposed Revisions to <797>. September 1, 2021: Compounding Expert Committee Responses to Stakeholder Engagement Themes for the 2021 Proposed Revisions to <797>. 1. Identify key aspects of USP 797/800 updates 2. Describe initial lessons learned from USP 797/800 implementation at Wave Travis sites 3. State the challenges of implementing USP 797/800 at small, medium, and large MTFs 4. Discuss options for training and maintenance of compliance records 2004 - USP Chapter <797> published 2008 - MO Department of Health Sterile Compounding rules 2012 - New England Compounding Center (NECC) tragedy 2013 - Federal law creates 503B Registered Outsourcing Facilities 2015 - CMS added USP <797> to the State Operations Manual 2018 - The Joint Commission announces it is focusing on sterile USP <797> Sampling Air and Surface Sampling for USP <797> Objective • To perform environmental monitoring in the context of USP general chapter Pharmaceutical Compounding - Sterile Preparations. To detect and quantify viable particles (bacteria or fungi) in ISO-classified cleanrooms. On January 1, 2004, USP chapter 797, Pharmaceutical Compounding—Sterile Preparations,15 became official, re-placing USP chapter 1206, Sterile Drug Products for Home Use.20 The change from a chapter numbered above 1000 to a chapter below 1000 marked a change from an advisory stan-dard to an enforceable one. USP chapter 797 has since been USP <797> Pharmaceutical Compounding - Sterile Preparations Proposed Revision: Understanding the Impact to Home Infusion Connie Sullivan, BSPharm Vice President of Research and Innovation New Revision of USP<797>: Key Changes in Cleaning, Disinfecting, and Garbing-Related Activities HCA029 061719. ph: 1-84-03-8333 healthcarecontecinc