What manufacturers and importers of OTC products need to know now
The U.S. Food and Drug Administration (FDA) has published the Over-the-Counter (OTC) Monograph Drug Facility Fee Rates for Fiscal Year 2026, continuing its implementation of the OTC Monograph Drug User Fee Program (OMUFA).
These annual fees apply to facilities that manufacture or process OTC monograph drugs and are a key part of how the FDA funds regulatory oversight for non-prescription products in the U.S. market.
What are OTC monograph drug facility fees
Under OMUFA, the FDA collects two primary types of fees:
- Annual facility fees for OTC drug manufacturers
- Fees for OTC monograph order requests (OMORs)
Facility fees are assessed each fiscal year to qualifying manufacturers, including both domestic and foreign facilities producing OTC monograph drugs.
The program was established under the CARES Act to modernize OTC drug regulation and provide the FDA with resources to review, update, and monitor monograph products more efficiently.
Key FY 2026 considerations
While fee amounts are adjusted annually, they are based on several factors, including:
- The number of registered OTC monograph drug facilities
- The ratio of manufacturers to contract manufacturing organizations (CMOs)
- Inflation and total program funding targets
In prior years, facility fees have steadily increased, reflecting expanded regulatory activity and program funding needs.
All qualifying facilities must pay the applicable fee each year, regardless of company size or whether they participate in other FDA user fee programs.
Why this matters for importers
If you are importing OTC products into the United States, these fees have direct and indirect implications:
- Supply chain risk
Foreign manufacturers that fail to pay required OMUFA fees may be deemed non-compliant, which can impact product admissibility. - Cost pressure
Increased facility fees can drive up production costs, which may ultimately be reflected in product pricing. - Vendor due diligence
Importers should confirm that their suppliers are properly registered with the FDA and compliant with OMUFA fee requirements. - Regulatory visibility
The OMUFA program continues to expand FDA oversight of OTC products, increasing scrutiny across manufacturing and supply chains.
What importers should do now
- Verify that all OTC suppliers are registered and fee-compliant under OMUFA
- Monitor supplier communications for any cost adjustments tied to FY 2026 fees
- Evaluate sourcing strategies if relying on smaller or higher-risk manufacturers
- Stay informed on FDA updates impacting OTC monograph products
As FDA continues to modernize oversight of OTC drugs, compliance with OMUFA requirements is becoming a critical component of maintaining uninterrupted market access.
