The FDA has published the fees applicable to products considered over the counter or OTC drugs for fiscal year 2021 in the Federal Register Vol 86, No. 57. This is the official announcement that the industry has been waiting for from the FDA agency. The announcement also reiterates information previously shared for OTC drug monograph order requests.

Over the Counter

  • An OTC monotherapy drug is a nonprescription drug that does not have an approved new drug application and is governed by the provisions of section 505G of the FD&C Act.
  • A monograph OTC drug facility (MDF) is a foreign or domestic company or other entity that, in addition to meeting other criteria, is engaged in the manufacture or processing of the finished dosage form of a monograph OTC drug.
  • A contract manufacturing organization (CMO) facility is an OTC monotherapy drug facility in which neither the owner nor any affiliate of the owner or the facility sells the OTC monotherapy 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, that is filed under section 505G(b)(5) of the FD&C Act.

 

 

Each registered facility that identifies itself as an OTC monographic (OTC) drug facility during the period January 2020 through December 2020 will be responsible for payment of these fees. The fees for MDF facilities are $20,322 and the fees for CMO facilities are $13,548. These fees are for the period October 1, 2020, through September 30, 2021.

  • OTC monograph drug (OTC) facilities are exempt from paying facility or establishment registration fees for FY 2021 if they have ceased OTC monograph drug (OTC) manufacturing activities and have updated their registration with FDA to that effect, by December 31, 2019.
  • Entities that registered with FDA during the 2019 coronavirus disease pandemic (COVID-19) and whose only activity with respect to OTC monograph drugs during the pandemic consists of (or had consisted of) the manufacture of OTC hand sanitizer (anti-bacterial) products for human hands are not identified as OTC monograph drug facilities subject to OMUFA facility fees.

 

The OTC monograph OTC order solicitation user fees, remain the same as previously stated for FY 2021, the Category 1 OMOR fee is $500,000 and the Category 2 OMOR fee is $100,000.

It should be noted that the OMUFA rates are not applicable to API manufacturing facilities. (Active Ingredient of Pharmaceuticals)

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