FDA Announces FY 2027 OMUFA User Fee Rates and Streamlines Fee process

The USFDA has announced the FY 2027 user fee rates under the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA) with significant increases in facility fees compared with FY 2026.

Fee	FY 2026	FY 2027
Monograph Drug Facility (MDF)	$19,188	$47,891
Contract Manufacturing Organization (CMO) Fee	$12,792	$31,927
OMOR – Tier 1	$587,529	$614,608
OMOR – Tier 2	$117,505	$122,921

The FY 2027 MDF and CMO facility fees represent an increase of approximately 149% from FY 2026. FDA attributes the increase largely to a one-time downward operating reserve adjustment that reduced FY 2026 facility fees.

A key change under OMUFA II is the consolidation of the previously separate facility and OMOR fee announcements into a single annual Federal Register notice beginning with FY 2027. This is intended to provide a more predictable and streamlined fee-setting process for FDA and industry.

The FY 2027 facility fee will be paid in two equal installments: 50% on October 1, 2026 and the remaining 50% on February 1, 2027, subject to the statutory appropriations conditions. From FY 2028 onward, the full facility fee will generally be due October 1. OMOR fees remain payable upon submission of the OMOR.

Companies that own qualifying OTC monograph drug facilities, including eligible CMOs, should assess their FY 2027 fee obligations and budget for the substantially higher facility fees. Companies planning to submit OMORs should also account for the increased OMOR fees. FDA’s OMUFA requirements apply independently of other FDA user fee programs such as PDUFA, GDUFA or MDUFA.

For more such updates, contact us.