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OTC
User Fee
Over-The-Counter (OTC) Monograph User Fee Program (OMUFA) Facility Fees

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) enacted on March 27, 2020, authorizes the FDA to assess and collect user fees dedicated to OTC monograph drug regulatory activities in a timely manner and ultimately help provide the public with access to innovative OTC monograph drugs.

OTC Monograph Reform is expected to accomplish the following:

  • Improve the process by replacing rulemaking with administrative orders
  • Improve efficiency, timeliness, and predictability
  • Facilitate innovation
  • Establish a process to rapidly address safety issues
  • Finalize pending monographs
  • Provide FDA with user fees to support OTC monograph drug activities

FDA collects two types of user fees under Over-The-Counter Monograph Drug User Fee Program (OMUFA):

■ Facility fees

■ OTC Monograph Order Request (OMOR) fees

Invoices were emailed on June 25, 2021, to facilities that have not satisfied their OMUFA user fees. The arrears list is available to the public.

If a facility does not pay the annual facility fee within 20 calendar days of the due date, the Agency will place the facility on a publicly available arrears list, and all OTC monograph drug products produced at that facility (or containing an ingredient manufactured at that facility) shall be deemed misbranded. Additionally, OMORs and meeting requests related to OMORs will not be accepted from persons, or their affiliate(s) in arrears.

LIMITED USER FEE EXEMPTION

Entities that registered with FDA during the Coronavirus Disease 2019 (COVID-19) pandemic, and whose sole activity consists (or had consisted) of manufacturing OTC hand sanitizer products, are not identified as OTC monograph drug facilities (MDF) subject to OMUFA facility fees.

Fiscal Year 2021 Facility User Fee Rates
Monograph Drug Facility (MDF) Facility Fee $20,322
Contract Manufacturing Organization (CMO) Facility Fee $13,548
Fiscal Year 2021 OMOR Fee Rates
Tier 1 $500,000
Tier 2 $100,000
OTC DRUG ESTABLISHMENT REGISTRATION

Domestic and foreign companies seeking our assistance in the FDA Registration of their establishments, also pay a much smaller annual service fee.

LIMITED OFFER
  • Company Registration
  • Product Listing
  • U.S. Agent Service
$350.00 ANNUAL SERVICE FEE
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