The FDA has confirmed that FY 2025 OMUFA facility fees are due soon. If your business was registered as a manufacturer or contract manufacturer of over-the-counter (OTC) monograph drug products at any time in 2024, you’ll need to pay this annual fee.
The Over-the-Counter Monograph Drug User Fee Program (OMUFA) is modeled after the Prescription Drug User Fee Act (PDUFA). Under OMUFA, fees paid by industry help fund the FDA’s oversight of OTC monograph drugs. In return, the FDA commits to performance goals that include timelines for reviewing and updating OTC monograph activities.
OTC monograph drug facility fees for FY 2025 are due on Monday, June 2, 2025. If you miss the fee deadline, your facility could be placed on a public arrears list, and any OTC monograph drugs made there could be classified as misbranded.
Who this applies to and what’s required
The Over-the-Counter Monograph Drug User Fee Program (OMUFA) applies to manufacturers and contract manufacturers of OTC monograph drug products.
Under OMUFA, the FDA collects two types of user fees: facility fees and OTC Monograph Order Request (OMOR) fees. Facility fees are due annually, while OMOR fees are due at the time of submission. For FY 2025, the facility fee must be paid by Monday, June 2, 2025.
From fiscal years 2021 through 2025, facility fees are due on the later of either the first business day of June each year or the first business day after Congress passes an appropriations act allowing the FDA to collect OMUFA fees.
If your company qualifies, you have 20 calendar days from the official announcement (June 2, 2025) to pay. That puts your final deadline at June 22, 2025.
Missing this deadline means your company could appear on the FDA’s arrears list, your products could be labeled as misbranded, and your business may face regulatory or distribution delays.
How much is the FY 2025 FDA user fee?
The FDA has released the official FY 2025 OMUFA user fees:
- Monograph Drug Facility (MDF) Fee: $37,556 USD
- Contract Manufacturing Organization (CMO) Fee: $25,037 USD
You can review the complete list, including OMOR Tier 1 and Tier 2 fees, on the FDA’s OMUFA user fee page.
What to do before June 2
To avoid penalties and stay in good standing with the FDA, make sure to:
- Check your registration status: Was your facility registered with the FDA as an OTC drug manufacturer or contract manufacturer in 2024?
- Confirm your classification: Determine whether you’re subject to the MDF or CMO fee based on your facility’s role.
- Prepare and submit payment: Ensure the correct fee is paid before the June 22, 2025 deadline.
Taking action now helps prevent misbranding issues, delays in product distribution, and placement on the FDA’s arrears list.
Frequently asked questions
I received a fee notice, but I don’t think my facility should be charged an OMUFA facility fee for FY 2025. What should I do?
If you believe your facility is not an OTC monograph drug facility as described in this notice and should not be assessed an OMUFA FY 2025 facility fee, please contact CDERCollections@fda.hhs.gov.
Do large companies and small companies pay different fees?
No. All companies pay the same applicable fee (i.e., facility and/or OMOR), regardless of size.
Will the FDA remind me to pay?
No. It’s your responsibility to track your registration status and meet the payment deadline.
What if I miss the deadline?
Your facility may be listed publicly in arrears, and your OTC products could be misbranded. This can delay sales and trigger compliance actions.
How do I know if OMUFA applies to me?
We can help you assess your situation. Reach out and we’ll review your registration and business model to confirm.
Don’t risk being out of compliance
The OMUFA FY 2025 fee deadline is right around the corner. If you’re registered as a facility that makes or supports OTC monograph drugs, make sure to submit your payment by June 2, 2025.
Need support? Connect with our regulatory experts today and let us help you stay compliant.
