The U.S. Food and Drug Administration (FDA) has announced the release of "Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2025" which details the facility fee rates for the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) for Fiscal Year (FY) 2025. Effective from October 1, 2024, through September 30, 2025, these fees apply to facilities that manufacture or process OTC monograph drugs. The fees are designed to support the FDA’s regulatory oversight, including the review of OTC drug products, inspections, and compliance activities.
The OMUFA was established under the Coronavirus Aid, Relief, and Economic Security (CARES) Act to enhance the FDA’s ability to monitor and regulate the OTC drug market. It ensures that consumers can access safe, effective, and high-quality OTC products.
OTC Monograph Drug:
A non-prescription drug that conforms to established FDA standards (monographs) for safety, efficacy, and labeling. Monograph drugs do not require pre-market approval.
The FDA has established the following OMUFA fee rates for the fiscal year 2025:
OTC Monograph Drug Facility (MDF) Fee: $37,556
Contract Manufacturing Organization (CMO) Facility Fee: $25,037
The MDF fee applies to facilities producing OTC monograph drugs under their label, while the CMO fee applies to facilities engaged in contract manufacturing. Facilities are classified based on their primary operations.
The FDA determines OMUFA fees based on the target revenue specified under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Factors influencing the fee include:
Inflation adjustments
FDA resource needs
The number of registered facilities
Facilities must ensure the timely payment of their fees by June 1, 2025, to avoid penalties. Non-compliance can result in the facility being placed on the FDA’s arrears list and may prevent further regulatory interactions.
Who Must Pay the Fees?
OTC Monograph Drug Facilities: All facilities that manufacture or process OTC monograph drugs for commercial distribution in the U.S.
Contract Manufacturing Organizations (CMOs): Facilities that manufacture products under contract for other companies.
Certain facilities may qualify for fee exemptions or reductions under specific conditions, including:
Facilities that solely conduct research and development without manufacturing finished products.
Facilities manufacturing drugs under investigational new drug (IND) applications.
Companies qualifying as small businesses with limited revenue.
Failure to pay OMUFA fees can lead to serious consequences, including:
Placement on the FDA Arrears List: The facility may be publicly listed as non-compliant.
Prohibited Product Distribution: Products manufactured in non-compliant facilities may not be legally distributed in the U.S.
Regulatory Action: Facilities may face inspections, warning letters, and additional regulatory scrutiny.
The FDA offers support to OTC drug manufacturers through:
Guidance Documents: Providing detailed instructions on regulatory requirements.
Technical Assistance: To help companies navigate the OMUFA fee structure.
Workshops and Webinars: Covering topics related to OTC monograph drug compliance and fee obligations.
It is crucial for all applicable facilities to assess their fee obligations and meet the June 1, 2025 deadline.
🔗 For full details, visit: FDA Facility Fee Rates for FY 2025
Where did you find small business fee exemptions/reductions?