FDA Announces FY 2027 OMUFA Fees for OTC Monograph Drugs
- Daniel Jiménez
- 1 day ago
- 3 min read
The U.S. Food and Drug Administration has announced the fees applicable under the Over-the-Counter Monograph Drug User Fee Amendments, known as OMUFA, for fiscal year 2027.
These fees apply both to facilities that manufacture over-the-counter drugs regulated under an OTC monograph and to companies submitting OTC Monograph Order Requests, or OMORs.
Fiscal year 2027 will run from October 1, 2026, to September 30, 2027.
A Single Notice for All OMUFA Fees
Beginning in fiscal year 2027, the FDA will publish facility fees and OMOR fees in one consolidated Federal Register notice.
For fiscal years 2024 through 2026, these fees were announced in separate notices. Combining both categories into a single publication is intended to simplify the annual fee announcement process and support the transition to the new facility fee payment schedule.
The notice includes information on:
Fees applicable to OTC monograph drug facilities.
Fees for OMOR submissions.
The methodology used to calculate the fees.
Payment deadlines.
FDA payment procedures.
FY 2027 OMUFA Facility Fees
The facility fees established for fiscal year 2027 are as follows:
Facility type | FY 2027 fee |
Monograph Drug Facility — MDF | USD 47,891 |
Contract Manufacturing Organization — CMO | USD 31,927 |
The Monograph Drug Facility fee generally applies to establishments that manufacture or process OTC monograph drugs.
The reduced fee for Contract Manufacturing Organizations applies to certain facilities that manufacture OTC drugs on behalf of other companies.
New Two-Installment Payment Schedule
One of the main changes for fiscal year 2027 concerns the facility fee payment schedule.
Both MDF and CMO fees must be paid in two equal installments:
50% by October 1, 2026.
The remaining 50% by February 1, 2027.
Companies subject to these fees should take these deadlines into account when planning their regulatory and financial activities, as the first installment is due at the beginning of the U.S. fiscal year.
FY 2027 OMOR Fees
The FDA has also announced the fees applicable to OTC Monograph Order Requests:
Request type | FY 2027 fee |
OMOR Tier 1 | USD 614,608 |
OMOR Tier 2 | USD 122,921 |
Tier 1 OMORs generally involve broader or more complex regulatory changes, while Tier 2 OMORs apply to certain requests considered more limited in scope.
The correct classification of an OMOR should be carefully assessed before submission, as it determines both the applicable regulatory pathway and the corresponding fee.
Which Companies May Be Affected?
The announcement is particularly relevant to:
U.S. manufacturers of OTC monograph drugs.
Foreign manufacturers producing OTC drugs for the U.S. market.
Contract manufacturing organizations.
Companies responsible for OTC monograph drug products.
Businesses considering the submission of an OMOR.
Cosmetic and personal care brands whose products may be classified as OTC drugs in the United States.
Products such as sunscreens, antiperspirants, acne treatments, anti-dandruff shampoos and products promoted with certain therapeutic claims may fall within the U.S. OTC drug regulatory framework.
For this reason, companies should confirm the regulatory classification of their products before placing them on the market and determine whether the manufacturing facility is subject to FDA registration and OMUFA fees.
At Belab Services, we support international manufacturers and brands with OTC product classification, FDA establishment registration, drug listing and regulatory compliance in the United States.
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