The Food and Drug Administration (FDA) announced last week the fee rates under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. The federal register notice was released December 29th, 2020 with the new rates listed.

Qualifying facilities

FDA will assess and collect facility fees with respect to the two types of OTC monograph drug facilities—MDF and CMO facilities. A full facility fee will be assessed to each qualifying person that owns a facility identified as an MDF, and a reduced facility fee of two-thirds will be assessed to each qualifying person that owns a facility identified as a CMO facility.

Below are definitions of each type of facility:

• Monograph Drug Facility (MDF) – 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.
• Contract Manufacturing Organization (CMO) – 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.

Exemptions

Those facilities that only manufacture the active pharmaceutical ingredient (or API) of an OTC monograph drug do not meet the definition of an OTC monograph drug facility. Likewise, a facility is not considered an OTC monograph drug facility if its only manufacturing or processing activities are one or more of the following: (a) Production of clinical research supplies; (b) testing; or (c) placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.

Fee Schedule for FY 2021

Facility Fee Rates 2021

MDF                           $14,060

CMO                            $9,373

Fees are due 45 days after publication – February 11, 2021

How to pay

The new fee rates are effective October 1, 2020, through September 30, 2021. To pay the MDF and CMO fees, complete an OTC Monograph User Fee Cover Sheet, available at: https://userfees.fda.gov/​OA_​HTML/​omufaCAcdLogin.jsp. A user fee identification (ID) number will be generated. Payment must be made in U.S. currency by electronic check or wire transfer, payable to the order of the Food and Drug Administration. The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card for payments under $25,000 (Discover, VISA, MasterCard, American Express).

UPDATE!

FDA has since removed these fees. Please disregard, but instead utilize to anticipate the possibility of these coming soon.

Please reach out if you have further questions. Bustos Law Group can assist with classifying your business to determine the fees that apply and assist with how to pay fees.