As per CARES Act, over-the counter (OTC) drugs otherwise\nknown as OTC monograph drugs, can be marketed without an approved drug\napplication if they meet the other applicable requirements. Under this OTC\nmonograph reform legislation, FDA is entitled to assess and collect user fees\ndedicated to OTC monograph drug activities.<\/p>\n\n\n\n
FDA states that OMUFA fee will fund a portion of their regulatory\nactivities for OTC monograph drugs and its performance goals, which includes\nreviewing of new submissions within specific time frames and inspections.<\/p>\n\n\n\n
On March 16th<\/sup>, 2022, FDA announced the OMUFA for\nFY 2022.<\/p>\n\n\n\n As per FD&C Act, a facility fee for FY 2022 will be calculated\nbased on the facility that is identified as an OTC monograph drug facility\nduring the fee-liable period from January 1, 2021, through December 31, 2021.<\/p>\n\n\n\n FDA will calculate and collect facility fees with respect to\nthe two types of OTC monograph drug facilities\u2014MDF and CMO facilities. Facility\nfees will be calculated to each qualifying person that owns a facility\nidentified as an MDF and a reduced facility fee (two- thirds) will be assessed\nto each qualifying person that owns a facility identified as a CMO facility. FY\n2022 facility fees are due on June 1, 2022.<\/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 2022<\/strong><\/a>
\n
\n<\/p>\n\n\n\n