{"id":3189,"date":"2023-02-20T09:00:47","date_gmt":"2023-02-20T15:00:47","guid":{"rendered":"https:\/\/www.imegcorp.com\/?p=3189"},"modified":"2023-02-20T09:11:34","modified_gmt":"2023-02-20T15:11:34","slug":"complying-with-usp-800-ensures-safety-and-reduces-healthcare-facility-risk","status":"publish","type":"post","link":"https:\/\/imegcorp.com\/insights\/blog\/complying-with-usp-800-ensures-safety-and-reduces-healthcare-facility-risk\/","title":{"rendered":"Complying with USP <800> ensures safety and reduces healthcare facility risk"},"content":{"rendered":"
By Mike Zorich<\/span>\u00a0<\/span><\/p>\n O<\/span>ver the past couple of years<\/span>,<\/span>\u00a0<\/span>I\u2019ve been writing and presenting about the\u00a0<\/span>new United States\u00a0<\/span>Pharmacopeial<\/span>\u00a0General Chapter 800 \u201cHazardous Drugs \u2013 Handling in Healthcare Settings,\u201d generally known as\u00a0<\/span>USP<\/span> <800>.<\/span>\u00a0<\/span>The standard is i<\/span>ntended to protect healthcare workers and patients from harm associated with exposure to hazardous drugs<\/span>, and m<\/span>any healthcare facilities have taken steps to meet compliance<\/span>;\u00a0<\/span>IMEG<\/span>\u00a0has provided engineering consulting on\u00a0<\/span>more than\u00a0<\/span>200<\/span>\u00a0such projects.<\/span>\u00a0<\/span><\/p>\n The number of facilities yet to begin the compliance process is substantial, however. P<\/span>erhaps this is because,\u00a0<\/span>like<\/span>\u00a0<\/span>USP<\/span> <797>, <\/span>USP<\/span> <800> is a set of rules and standards written in a<\/span>\u00a0<\/span>context that could be enforced, but neither chapter has authority until it is adopted<\/span>\u00a0<\/span>by an authority having jurisdiction<\/span>,<\/span>\u00a0such as\u00a0<\/span>a<\/span>\u00a0state<\/span>\u2019s<\/span>\u00a0board of pharmacists.<\/span>\u00a0<\/span>\u00a0<\/span><\/p>\n Still<\/span>, both\u00a0<\/span>USP<\/span>\u00a0<797> and\u00a0<\/span>USP<\/span>\u00a0<800> are identified as the standard of care<\/span>\u00a0<\/span>for the industry, and many healthcare organizations voluntarily follow the chapters<\/span>\u00a0<\/span>to ensure patient and staff safety<\/span>.\u00a0<\/span>Overall, the new guideline is a significant step in the healthcare industry\u2019s growing regulatory focus on compounding practices, which, when subpar, can result in preventable patient and staff incidents, penalties, and other risks for an organization.\u00a0<\/span>\u00a0<\/span><\/p>\n The most recent USP <795> and <797> chapters were published on Nov. 1, 2022, and there is a one-year implementation period before it becomes official. Therefore, the industry is tracking Nov. 1, 2023, as the enforcement date, which also includes USP <800>.\u00a0 But regardless of the deadline, healthcare facilities now working toward compliance and those who will do so in the future need to have a comprehensive grasp of USP <800>. It\u2019s also important to understand a facility\u2019s sterile and nonsterile compounding processes, set a realistic construction budget, and achieve early engagement of a certifier. <\/span>\u00a0<\/span><\/p>\n Together, these steps will lay the foundation for success in completing a\u00a0<\/span>USP<\/span> <800> compliance project.\u00a0 <\/span>\u00a0<\/span><\/p>\n