On March 26, 2021, the U.S. Food and Drug Administration (FDA) published new Over-the-Counter (OTC) Monograph user fees for fiscal year (FY) 2021.  Beginning this year, FDA will require covered OTC drug facilities to pay an annual facility fee under the OTC Monograph User Fee Program (OMUFA), which was established by the passage of the March 2020 CARES Act.  FDA states that facility fees for FY 2021 are due 45 days after publication of the Federal Register Notice (May 10, 2021).

This replaces a former Notice published in December 2020 that was withdrawn by FDA.

Who Must Pay OMUFA Facility Fees?

FDA will now require facilities that manufacture or process a finished dosage form of an OTC monograph drug to pay an annual monograph drug facility (MDF) fee.  The MDF fee for FY 2021 is $20,322.  Contract manufacturing organizations (CMOs), which are MDFs where the owner or affiliates do not sell their finished drug directly to wholesalers, retailers, or consumers, are required to pay two-thirds of the regular MDF fee.  The CMO fee for FY 2021 is $13,548.

FDA expects to collect these fees from MDFs and CMOs that registered with FDA or renewed their FDA registrations between January 1 and December 31, 2020.  Establishments that have registered with FDA for the first time on or after January 1, 2021 do not need to pay the FY 2021 OMUFA fees, but will be subject to the FY 2022 fees once published.

The fees in this March 2021 Notice are higher than those published in the original December 2020 Notice, which stated $14,060 for MDFs and $9,373 for CMOs.  The fee amounts were determined based on the estimated fees necessary to support the cost of operating OTC monograph drug activities and the estimated number of establishments paying the fee.  Under the new March Notice, “FDA will not assess OMUFA facility fees upon firms that first registered with FDA on or after the January 27, 2020 declaration of the COVID-19 public health emergency (PHE) solely to manufacture OTC hand sanitizer products during the PHE”. In an email to industry, FDA stated that “because certain hand sanitizer product facilities will not be assessed fees, the facility fees for the remaining payors have increased for FY21, since the number of manufacturers subject to OMUFA facility fees has decreased.”

The OMUFA fees do not apply to facilities that only manufacture active pharmaceutical ingredients (APIs), produce clinical research supplies, conduct testing, or place outer packaging on already packaged products for use in a kit.  Likewise, facility fees do not apply if a drug establishment’s registration indicates it has ceased all activities related to OTC monograph drugs prior to December 31, 2019.

Assistance with New OTC Monograph Drug User Fees

Not sure which fees may apply to your drug establishment?  Registrar Corp can help determine your applicable fees and facilitate payment to FDA as part of our U.S. Agent and Registrant Contact services.  Contact Registrar Corp by email at info@registrarcorp.com or by phone at +1-757-224-0177.  Alternatively, you can chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat