{"id":265,"date":"2024-08-07T20:18:18","date_gmt":"2024-08-07T20:18:18","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=265"},"modified":"2024-08-07T20:18:18","modified_gmt":"2024-08-07T20:18:18","slug":"hand-sanitizer-regulation","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2024\/08\/07\/hand-sanitizer-regulation\/","title":{"rendered":"HAND SANITIZER REGULATION"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">The FDA (Food and Drug Administration) regulates hand\nsanitizers to ensure they are safe and effective for consumer use even though\nit is considered as cosmetics in some foreign countries.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA recognizes ethanol or ethyl\nalcohol (60% to 95 %) and isopropyl alcohol (70% to 91.3 %) as safe and effective\nto be used as an active ingredient in hand sanitizers. Benzalkonium chloride is\nanother active ingredient considered safe and effective, though less effective\nthan alcohol-based sanitizers against certain germs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA consider\nhand sanitizers as <a href=\"https:\/\/www.fdahelp.us\/otc-drug-products.html\">OTC\ndrugs<\/a> and must comply with below requirements.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">Register the\nmanufacturing establishment<\/a> with FDA.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Submit <a href=\"https:\/\/www.fdahelp.us\/fda-labeler-code.html\">labeler code<\/a> request to\nFDA for the establishment.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Submit drug listing with unique 10-digit NDC\nnumber for each hand sanitizer after FDA assign labeler code to the company.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Label Compliance \u2013 Antiseptic hand sanitizer\nmust have &#8220;Drug Facts&#8221; labeling and all other required information\nlike usage, directions, and warnings.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Comply with GMP Requirements as per 21 CFR 211 &#8211;\n<a href=\"https:\/\/www.iso-certification.us\/hand-sanitizer-gmp.html\">Hand\nSanitizer GMP<\/a> which requires testing to ensure that the products are free\nfrom contamination and impurities.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers that continue to make\nhand sanitizer products as of December 31, 2024, will be identified as OTC\nmonograph drug facilities and be subject to an OMUFA facility fee for FY 2025\nwhereas if a company stopped the manufacturing process of hand sanitizers and\nderegister and de-lists their products before December 31<sup>st<\/sup> ,2024\nwill not be subject to FY 2025 OMUFA fee.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">Liberty Management Group<\/a> provides assistance with drug establishment registration, drug listing and label review and US agent service to foreign drug companies.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sudha S<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory Consultant<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email : office@libertymanagement.us<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">www.fdahelp.us<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA (Food and Drug Administration) regulates hand sanitizers to ensure they are safe and effective for consumer use even though it is considered as cosmetics in some foreign countries. The FDA recognizes ethanol or ethyl alcohol (60% to 95 %) and isopropyl alcohol (70% to 91.3 %) as safe and effective to be used &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-news\/2024\/08\/07\/hand-sanitizer-regulation\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;HAND SANITIZER REGULATION&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[42],"class_list":["post-265","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug","tag-fda-drug-registration"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/265","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=265"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/265\/revisions"}],"predecessor-version":[{"id":266,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/265\/revisions\/266"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=265"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=265"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=265"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}