Author

Marco Theobold

Director of Medical Device and Drug Services

FDA Announces OTC Monograph Drug Facility User Fees for 2022

Mar 18, 2022

On March 14, 2022, the U.S. Food and Drug Administration (FDA) announced new fees for the Over-the-Counter (OTC) Monograph Drug User Fees (OMUFA) program for fiscal year (FY) 2022. Facility fees for FY 2022 are due June 1, 2022.

In 2021, FDA began collecting annual facility fees from covered OTC drug facilities under the OMUFA program, which was established by the passage of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act. FDA states that OMUFA facility fees are used to help fund regulatory activities that allow FDA to adhere to submission review timelines, with the goal of improving the public’s access to OTC drugs.

Not sure which fees may apply to your drug establishment? Registrar Corp can help.

Registrar Corp’s Regulatory Specialists can help determine applicable OMUFA fees for your OTC drug facility and facilitate payment to FDA as part of our U.S. Agent and Registrant Contact services.

For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.

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How have 2022 OMUFA fees changed from 2021? Keep reading for details about increased fees.

2022 OMUFA Facility Fees

FDA requires 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 2022 is $24,178.

Contract manufacturing organizations (CMOs) are OTC monograph drug facilities where neither the owner nor affiliates sells the drug produced at such facility directly to wholesalers, retailers, or consumers. CMOs are required to pay two-thirds of the regular MDF fee. The CMO fee for FY 2022 is $16,119.

Both the MDF and CMO fees for 2022 increased 19% from 2021. FDA largely attributes the increase in fees to a decreased number of fee-liable facilities, a decrease in the MDF to CMO ratio, and adjustments for inflation. FDA also increased fees to cover operating reserves needed to sustain the program through FY 2023.

FDA stated that hand sanitizer manufacturers that distributed hand sanitizer products under the COVID-19 public health emergency (PHE) will remain exempt from OMUFA facility fees: “FDA will not assess OMUFA facility fees upon those firms that first registered with FDA on or after the January 27, 2020 declaration of the COVID-19 public health emergency (PHE) solely for purposes of manufacturing OTC hand sanitizer products during the PHE.”

The OMUFA fees also 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. Additionally, as only human drugs are subject to OMUFA fees, facilities that only manufacture animal drugs are exempt.

Not sure which fees may apply to your drug establishment? Registrar Corp can help.

Registrar Corp’s Regulatory Specialists can help determine applicable OMUFA fees for your OTC drug facility and facilitate payment to FDA as part of our U.S. Agent and Registrant Contact services.

For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.

Get Assistance

Author


Marco Theobold

Director of Medical Device and Drug Services

A highly regarded expert in medical device and drug regulations by the U.S. Food & Drug Administration (FDA), Marco brings a unique perspective for medical device and drug companies seeking to distribute products in the United States. He proudly provides guidance on FDA regulations for pharmaceutical, medical device, and radiation emitting device (RED) companies.

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