What Is OMUFA? FY2027 Fees for Foreign OTC Manufacturers

OMUFA is FDA's user fee programme for OTC monograph drugs and qualifying OTC monograph order requests. The 2020 CARES Act modernized the monograph process, and OMUFA II covers fiscal years 2026–2030. A product's OTC label or a drug establishment registration alone does not determine every facility fee. First identify the marketed product route, the work done at each facility and the applicable fee-liable period. https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa

Which facility owes an OMUFA fee?

For FY2027, FDA assesses a facility fee to a qualifying person that owns an OTC monograph drug facility identified during January 1–September 30, 2026. This generally concerns manufacturing or processing the finished dosage form of a human OTC monograph drug, including qualifying contract manufacturing, repackaging or relabeling. FDA registration data helps identify facilities, but an absent invoice is not an exemption and an invoice can be questioned if the classification is wrong. The owner, not automatically its US Agent, is the fee-liable person. OTC drugs marketed under an approved drug application are a different route and do not by themselves create an OMUFA monograph facility fee. An API-only site, a site doing only testing or the specified narrow overpackaging activity, and a site that ceased monograph activity and updated its registration before January 1, 2026 may be outside this FY2027 facility-fee scope. Apply the precise statutory conditions to the site. https://www.federalregister.gov/documents/2026/07/30/2026-15344/over-the-counter-monograph-drug-user-fee-rates-for-fiscal-year-2027

FY2027 FDA facility rates and payment schedule

FDA's FY2027 government facility fee is $47,891 for a qualifying monograph drug facility (MDF) or $31,927 for a qualifying contract manufacturing organization (CMO) facility. These are per-facility government fees, separate from FDABridge's professional quote and from any other programme. FDA scheduled two 50% installments for October 1, 2026 and February 1, 2027, subject to the statutory appropriations timing; verify the current FDA invoice and status rather than treating this guide as a payment demand. FDA says FY2027 facility invoices are issued in August and December 2026 and its older OTC monograph user fee cover sheet is unavailable for FY2027 payments. Fee questions and a disputed assessment can be directed to FDAUserFees@fda.hhs.gov. https://www.federalregister.gov/documents/2026/07/30/2026-15344/over-the-counter-monograph-drug-user-fee-rates-for-fiscal-year-2027

OMOR and GDUFA are separate questions

An OTC monograph order request (OMOR) is a separate administrative-order submission with its own fee when applicable; it is not a per-product listing charge or a routine step for every monograph product. FDA identifies limited safety-related OMOR fee exceptions. GDUFA, PDUFA and other FDA fee programmes have different triggers. Paying one programme does not cancel another, and a facility should not be assigned GDUFA merely because it makes an OTC monograph product. Review each actual product and application path before quoting a government fee. https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa

Registration, listing and product status

Drug establishment registration, product listing and an NDC code identify submitted information; none is FDA approval of the facility or product. A nonprescription drug marketed under an approved NDA or ANDA follows its approved-application conditions, while a monograph product must meet the applicable final order and general OTC requirements. Facility roles, labels and annual registration/listing maintenance should be scoped separately from OMUFA fee liability. https://www.fda.gov/drugs/development-approval-process-drugs/national-drug-code-database-background-information

Scope FDABridge support before filing

FDABridge can discuss its existing drug establishment registration, NDC labeler code, drug listing services and any agent coordination included in the agreed scope for the actual product and facility. We can identify what evidence a fee discussion needs, but the liable owner resolves its FDA assessment and pays any government fee separately. Ask for the professional scope and quote: https://fdabridge.com/drug and https://fdabridge.com/contact . No registration, NDC or fee payment guarantees product approval or US entry.