Today, the U.S. Food and Drug Administration announced the Over-the-Counter (OTC) Monograph Drug User Fee Amendments (OMUFA) facility fee rates and OTC monograph order request (OMOR) fee rates for fiscal year (FY) 2027 in a Federal Register notice (FRN) titled “Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027.”
Beginning with FY 2027, FDA is consolidating the separate facility fee notices and OMOR fee notices (as used for FYs 2024 through 2026) into a single, unified FRN, for publication before the start of the fiscal year. This change:
- Resumes the use of a single FRN for announcing OMUFA fees
- Helps accommodate the FY 2027 transition to an October 1 facility fee due date
- Streamlines the annual fee announcement process
Accordingly, this FRN publishes annual OMUFA fees for both OTC monograph drug facilities and OMORs for FY 2027 (October 1, 2026 – September 30, 2027) and includes information about fee calculations, fee due dates, and fee payment procedures. The FY 2027 user fee rates are shown below. Regarding facility fees, note that the FY 2027 Monograph Drug Facility (MDF) and Contract Manufacturing Organization (CMO) facility fees are due in two equal installments: 50% by October 1, 2026 and the remaining 50% by February 1, 2027.
| FY 2027 OMUFA User Fee Rates |
|
Facility Fee Rates
Monograph Drug Facility (MDF) Fee
Contract Manufacturing Organization (CMO) Facility Fee
|
$47,891
$31,927
|
|
OTC Monograph Order Request (OMOR) Fee Rates:
Tier 1
Tier 2
|
$614,608
$122,921
|
The fee calculations for both facility fees and OMOR fees are described in detail in the FRN.
Please note that as a result of this consolidated FRN, there will not be a separate OMOR fee notice for FY 2027. For more information on the FY 2027 user fee rates, please refer to the FRN or FDA's Over-the-Counter Monograph Drug User Fee Program (OMUFA) webpage.
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