US FDA OTC Monograph User Fee for FY 2021 Update

The US Food and Drug Administration (FDA) announced new Over-the-Counter (OTC) Monograph consumer fees for fiscal year (FY) 2021 on March 26, 2021. The OTC Monograph User Fee Program (OMUFA), which was created by the passage of the March 2020 CARES Act, would require covered OTC drug facilities to pay an annual facility fee starting this year. According to the FDA, facility fees for FY 2021 are due 45 days after the Federal Register Notice is released (May 10, 2021).





This replaces a previous FDA Notice from December 2020 that was removed.


Who is responsible for OMUFA Facility Fees?


An annual monograph drug facility (MDF) fee will be expected of facilities that produce or process a finished dosage type of an OTC monograph drug. For FY 2021, the MDF fee is $20,322. Contract manufacturing organizations (CMOs), which are MDFs whose owners or affiliates do not market their finished medication directly to wholesalers, manufacturers, or customers, must pay two-thirds of the total cost. CMOs, which are MDFs where the owner or affiliates do not market their finished medication directly to wholesalers, manufacturers, or customers, must pay two-thirds of the normal MDF rate. For fiscal year 2021, the CMO charge is $13,548.


MDFs and CMOs that registered with FDA or renewed their FDA registrations between January 1 and December 31, 2020 are required to pay these fees. Establishments that first register with FDA on or after January 1, 2021 are exempt from the FY 2021 OMUFA fees, but will be subject to the FY 2022 fees once they are released.


The fees in this March 2021 Notice are higher than those in the original December 2020 Notice, which reported that MDFs would cost $14,060 and CMOs would cost $9,373. The fee amounts were calculated based on the estimated fees needed to cover the costs of running OTC monograph drug operations and the estimated number of establishments that would be required to pay the fee. According to the latest 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 the corporate community, the FDA stated: “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.”


Facilities that either manufacture active pharmaceutical ingredients (APIs), clinical research materials, perform testing, or put outer packaging on already packaged goods for use in a kit are exempt from the OMUFA fees. Moreover, facility fees are also waived if a drug establishment’s registration shows that it has stopped all activities related to OTC monograph drugs by December 31, 2019.


Help with OMUFA & Other OTC Assessment Criteria


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