{"id":287,"date":"2025-04-28T16:29:17","date_gmt":"2025-04-28T16:29:17","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=287"},"modified":"2025-04-28T16:29:17","modified_gmt":"2025-04-28T16:29:17","slug":"omufa-fy-2025","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2025\/04\/28\/omufa-fy-2025\/","title":{"rendered":"OMUFA FY 2025"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.fdahelp.us\/fda-otc-drug-fees-2025.html\">OMUFA<\/a>\nfor FY 2025 gives out fees for facilities and OTC Monograph Order Requests\n(OMORs), in effect from October 1, 2024, through September 30, 2025.\u200b <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">OTC Monograph Drug facilities registered with FDA from\nJanuary 1, 2024, through December 31, 2024, are liable for the FY 2025 FDA\nfees.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA Fees for OTC Monograph Drug\nFacility Registration for Fiscal Year 2025<\/strong><\/p>\n\n\n\n<table class=\"wp-block-table\"><tbody><tr><td>\n  <strong>Type of Registration \/\n  Application<\/strong>\n  <\/td><td>\n  <strong>MDF Facility<\/strong>\n  <\/td><td>\n  <strong>CMO Facility<\/strong>\n  <\/td><\/tr><tr><td>\n  OTC\n  Monograph Drug Facility Fee (OMUFA)\n  <\/td><td>\n  $37,556\n  <\/td><td>\n  $25,037\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p class=\"wp-block-paragraph\">The above fees are applicable to the establishment\nmanufacture or processing the finished dosage form of an OTC drug.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This fee must be paid by Monday June 2<sup>nd<\/sup>, 2025.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Payment is due within twenty calendar days of the original\ndue date, and it must be paid in US dollars either by electronic check or wire\ntransfer. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Applicable wire transfer fees must be included with payment\nto ensure fees are fully paid.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The consequences of arrear payments are as below.<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>The\n     facility will be placed on the arrears list. <\/li><li><a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">OTC drug<\/a>\n     manufactured in such facilities will be considered misbranded and the\n     company will be placed FDA\u2019s arrears list.<\/li><li>An OMOR\n     submitted by a person subject to fees shall be considered incomplete and\n     not be accepted for filing until all fees owed by such person have been\n     paid. <\/li><li>A\n     person subject to fees shall be considered ineligible for OTC monograph\n     drug meetings until they have paid the fees.<\/li><\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Liberty Management Group Ltd, a leading FDA consulting group provides assistance with <a href=\"https:\/\/www.fdahelp.us\/fda-otc-drug-fees-2025.html\">OMUFA<\/a> PIN creation, <a href=\"https:\/\/www.fdahelp.us\/api-listing.html\">API drug establishment registration<\/a>, <a href=\"https:\/\/www.fdahelp.us\/drug-establishment-registration-renewal.html\">Drug establishment registration and listing renewals<\/a> and <a href=\"https:\/\/www.fdahelp.us\/fda_registration\/us-fda-agents-requirements.html\">US agent service to foreign countries.<\/a><\/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@libertymanagment.us<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">www.fdahelp.us<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>OMUFA for FY 2025 gives out fees for facilities and OTC Monograph Order Requests (OMORs), in effect from October 1, 2024, through September 30, 2025.\u200b OTC Monograph Drug facilities registered with FDA from January 1, 2024, through December 31, 2024, are liable for the FY 2025 FDA fees. FDA Fees for OTC Monograph Drug Facility &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-news\/2025\/04\/28\/omufa-fy-2025\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;OMUFA FY 2025&#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":[42,47],"class_list":["post-287","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug","tag-fda-drug-registration","tag-fda-omufa-fees"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/287","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=287"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/287\/revisions"}],"predecessor-version":[{"id":288,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/287\/revisions\/288"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=287"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=287"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=287"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}