According to CARES Act, the Over-the-Counter Monograph Drug\nUser Fee Program (OMUFA) is a program implemented by the U.S. Food and Drug\nAdministration (FDA) to help fund the regulation of over the counter (OTC) drug\nproducts. The program aims to expedite the review and approval process for OTC\ndrugs and improve the safety and availability of OTC products.<\/p>\n\n\n\n
OMUFA’s goal is to provide the FDA with the necessary\nresources to evaluate, approve, and regulate new or modified OTC drug products\nmore efficiently. It helps cover the costs of the FDA’s review activities,\nwhich are critical to ensuring the safety and effectiveness of OTC medications.<\/p>\n\n\n\n
FDA has introduced two types of fees.<\/p>\n\n\n\n
Companies that wish to introduce a new OTC drug or update\nexisting OTC monographs must pay user fees to the FDA. <\/p>\n\n\n\n
OTC\ndrugs<\/a> are that products that fall under FDA\u2019s OTC monograph which does not\nrequire FDA approval and can be marketed without a prescription. OMUFA was\ncreated to support the process of revising the monographs and reviewing drug\nproducts.<\/p>\n\n\n\n Manufacturers can submit new OTC drug products or requests\nfor changes to the FDA\u2019s existing monographs. These submissions are subject to\nreview, and manufacturers must pay the applicable user fees.<\/p>\n\n\n\n OTC\nmonograph<\/a> drug facility (MDF) is a foreign or domestic establishment that\nis engaged in manufacturing or processing the finished dosage form of an OTC\nmonograph drug.<\/p>\n\n\n\n A contract manufacturing organization (CMO) facility is an\nOTC monograph drug facility where neither the owner nor any affiliated partner or\nthe establishment sells the OTC monograph drug produced at such facility\ndirectly to wholesalers, retailers, or consumers in the United States.<\/p>\n\n\n\n FDA Fees for OTC Monograph\nDrug Facility Registration for Fiscal Year 2025<\/strong><\/a>
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