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After regrouping in January, the FDA has published their finalized FY2021 OTC Monograph User Fees in the Federal Register Vol 86, No. 57.

This is the official announcement industry has been expecting from the agency which gives the required amount and due date for OTC drug manufacturing facility user fees. The announcement also reiterates previously shared information for OTC Monograph Order Requests, although the FDA does not yet have a system in place to process such an order.

For OMUFA purposes:

  • An OTC monograph drug is a nonprescription drug without an approved new drug application which is governed by the provisions of section 505G of the FD&C Act
  • An OTC monograph drug facility (MDF) is a foreign or domestic business or other entity that, in addition to meeting other criteria, is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug
  • A contract manufacturing organization (CMO) facility is an OTC monograph drug facility where neither the owner nor any affiliate of the owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States, and
  • An OTC Monograph Order Request (OMOR) is a request for an administrative order, with respect to an OTC monograph drug, which is submitted under section 505G(b)(5) of the FD&C Act

Each registered facility that is identified as an OTC monograph drug facility during the period from January 2020-December 2020 will be responsible for these fees. MDF facility fees are $20,322 and CMO facility fees are $13,548. These fees are for the period from 1 October 2020 through 30 September 2021.

  • OTC monograph drug facilities are exempt from FY 2021 facility fees if they had ceased OTC monograph drug activities, and updated their registration with FDA to that effect, prior to December 31, 2019.
  • Entities that registered with FDA during the Coronavirus Disease 2019 (COVID-19) pandemic whose sole activity with respect to OTC monograph drugs during the pandemic consists (or had consisted) of manufacturing OTC hand sanitizer products are not identified as OTC monograph drug facilities subject to OMUFA facility fees.

OTC Monograph Order Request user fees remain the same as previously stated for FY2021, Tire 1 OMOR rate is $500,000 and Tire 2 OMOR rate is $100,000.

Do note, OMUFA fees are not applicable to API manufacturing facilities.

Payment of OMUFA fees are due 45 days after the date of the Federal Register notice publication (26 March 2021) which would be 10 May 2021, and will be processed through the FDA User Fee system.

See the Federal Register notice for further details.

As your FDA regulatory support, EAS is here If you have any questions on whether the user fee applies to your facility, or if you need assistance establishing an FDA user fee system account. Please contact Victoria Pankovich.

Posted in Client Update, Drugs.