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OTC Drug Establishment Renewal: Time to Renew with Provision
FDA requires every registered drug establishment to renew every year between October 1 and December 31. That window is open now.
FDA fees for FY2027
Registration renewal and listing certification: FDA does not charge for the renewal itself.
OMUFA facility fee (OTC monograph drug facilities only):
Monograph Drug Facility (MDF): $47,891
Contract Manufacturing Organization (CMO): $31,927
This is about a 149% increase from FY2026 ($19,188 and $12,792).
It is paid in two installments: 50% on October 1, 2026 and 50% on February 1, 2027.
Who needs to renew?
Any establishment that manufactures, packages, or labels OTC drugs for the U.S. market, including foreign facilities and contract manufacturers.
What needs to be done?
Renew your establishment registration.
Certify your drug listings.
What happens if you miss the deadline?
Your registration expires.
Your product listings may be treated as expired and removed from FDA’s database.
Unpaid OMUFA fees can put your facility on FDA’s arrears list, and its products can be considered misbranded.
Products can be held at import, and you may have to re-register.
Renew with Provision.
Whether you are an existing client or new to us, Provision can renew your OTC drug establishment registration and certify your listings. We work with domestic and foreign facilities, including contract manufacturers, and we’ll make sure your products stay active in FDA’s system.
Contact Us to get your renewal started.
For inquiries or expert assistance, please contact us today.
CONTACT US
Office: 1-909-493-3276
Email: ask@provisionfda.com