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 deadline is June 22, 2025. If you miss it, 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 any manufacturer or contract manufacturer of OTC monograph drug products, as well as facilities that were registered with the FDA between January 1 and December 31, 2024.
If your business fits this description, you’re required to pay the FY 2025 user fee within 20 calendar days of the official announcement made on June 2, 2025. This means your payment is due no later than June 22, 2025.
Failing to meet this deadline can have serious consequences. Your company may appear on the FDA’s arrears list, and any OTC drugs manufactured at your site could be considered misbranded. This can result in regulatory action, product delays, and broader business disruptions.
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
These fees apply to facilities that were registered and active at any point in 2024, depending on their manufacturing role.
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 22
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 didn’t manufacture any OTC drugs in 2024. Do I still owe the fee?
Yes. If your facility was registered at any point in 2024, the fee still applies, even if no production occurred.
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 22, 2025.
Need support? Connect with our regulatory experts today and let us help you stay compliant.
