{"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:\/\/www.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":"<p><span data-contrast=\"auto\">By Mike Zorich<\/span><span data-ccp-props=\"{&quot;201341983&quot;:2,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">O<\/span><span data-contrast=\"auto\">ver the past couple of years<\/span><span data-contrast=\"auto\">,<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">I\u2019ve been writing and presenting about the\u00a0<\/span><span data-contrast=\"auto\">new United States\u00a0<\/span><span data-contrast=\"auto\">Pharmacopeial<\/span><span data-contrast=\"auto\">\u00a0General Chapter 800 \u201cHazardous Drugs \u2013 Handling in Healthcare Settings,\u201d generally known as\u00a0<\/span><span data-contrast=\"auto\">USP<\/span><span data-contrast=\"auto\"> &lt;800&gt;.<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">The standard is i<\/span><span data-contrast=\"auto\">ntended to protect healthcare workers and patients from harm associated with exposure to hazardous drugs<\/span><span data-contrast=\"auto\">, and m<\/span><span data-contrast=\"auto\">any healthcare facilities have taken steps to meet compliance<\/span><span data-contrast=\"auto\">;\u00a0<\/span><span data-contrast=\"auto\">IMEG<\/span><span data-contrast=\"auto\">\u00a0has provided engineering consulting on\u00a0<\/span><span data-contrast=\"auto\">more than\u00a0<\/span><span data-contrast=\"auto\">200<\/span><span data-contrast=\"auto\">\u00a0such projects.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:2,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The number of facilities yet to begin the compliance process is substantial, however. P<\/span><span data-contrast=\"auto\">erhaps this is because,\u00a0<\/span><span data-contrast=\"auto\">like<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">USP<\/span><span data-contrast=\"auto\"> &lt;797&gt;, <\/span><span data-contrast=\"auto\">USP<\/span><span data-contrast=\"auto\"> &lt;800&gt; is a set of rules and standards written in a<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">context that could be enforced, but neither chapter has authority until it is adopted<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">by an authority having jurisdiction<\/span><span data-contrast=\"auto\">,<\/span><span data-contrast=\"auto\">\u00a0such as\u00a0<\/span><span data-contrast=\"auto\">a<\/span><span data-contrast=\"auto\">\u00a0state<\/span><span data-contrast=\"auto\">\u2019s<\/span><span data-contrast=\"auto\">\u00a0board of pharmacists.<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:2,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Still<\/span><span data-contrast=\"auto\">, both\u00a0<\/span><span data-contrast=\"auto\">USP<\/span><span data-contrast=\"auto\">\u00a0&lt;797&gt; and\u00a0<\/span><span data-contrast=\"auto\">USP<\/span><span data-contrast=\"auto\">\u00a0&lt;800&gt; are identified as the standard of care<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">for the industry, and many healthcare organizations voluntarily follow the chapters<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">to ensure patient and staff safety<\/span><span data-contrast=\"auto\">.\u00a0<\/span><span data-contrast=\"auto\">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><span data-ccp-props=\"{&quot;201341983&quot;:2,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The most recent USP &lt;795&gt; and &lt;797&gt; 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 &lt;800&gt;.\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 &lt;800&gt;. 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><span data-ccp-props=\"{&quot;201341983&quot;:2,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Together, these steps will lay the foundation for success in completing a\u00a0<\/span><span data-contrast=\"auto\">USP<\/span><span data-contrast=\"auto\"> &lt;800&gt; compliance project.\u00a0 <\/span><span data-ccp-props=\"{&quot;201341983&quot;:2,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><em><a href=\"https:\/\/vimeo.com\/363665582\">Watch a recording of Mike Zorich\u2019s webinar on USP &lt;800&gt; compliance.<\/a><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>By Mike Zorich\u00a0 Over the past couple of years,\u00a0I\u2019ve been writing and presenting about the\u00a0new United States\u00a0Pharmacopeial\u00a0General Chapter 800 \u201cHazardous Drugs \u2013 Handling in Healthcare Settings,\u201d generally known as\u00a0USP &lt;800&gt;.\u00a0The standard is intended to protect healthcare workers and patients from harm associated with exposure to hazardous drugs, and many healthcare facilities have taken steps to<\/p>\n","protected":false},"author":5,"featured_media":3190,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_links_to":"","_links_to_target":""},"categories":[147],"tags":[],"acf":[],"yoast_head":"\n<title>Complying with USP  ensures safety and reduces healthcare facility risk - 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