Are You Aloof About OMUFA? What OTC Drug Companies Need to Know for FY 2027

Part 1 of the “Are You Aloof About OMUFA, MDUFA, and GDUFA?” series.

This is the first installment in a three-part series examining FDA user fee programs affecting OTC drugs, medical devices, and generic drugs. Part 1 covers OMUFA. Part 2 will address MDUFA, and Part 3 will cover GDUFA.

OTC Drugs Are Not Exempt from FDA Fees

Over-the-counter status does not mean free from FDA user fees.

The Over-the-Counter Monograph Drug User Fee Program (OMUFA) allows FDA to collect fees from qualifying OTC monograph drug facilities and from companies submitting certain OTC Monograph Order Requests (OMORs). These fees fund FDA regulatory activities and performance goals.

OMUFA was created under the CARES Act and reauthorized under OMUFA II for fiscal years 2026–2030.

Key questions for industry include:

• Is our facility an OTC monograph drug facility?
• Do we qualify as a Monograph Drug Facility (MDF) or Contract Manufacturing Organization (CMO)?
• Will we submit an OMOR?
• What fees apply in FY 2027?
• Have we budgeted correctly?

OMUFA Fee Types

OMUFA includes two main fees:

1. Annual facility fees
2. OMOR submission fees

Facility fees apply per qualifying facility, including certain CMOs.

An OMOR requests FDA to add, remove, or modify monograph conditions. Fees apply upon submission unless a statutory safety exemption applies, such as strengthening warnings or contraindications.

Who Owes the Facility Fee?

An OTC monograph drug facility is generally any domestic or foreign site that manufactures or processes finished OTC monograph drug dosage forms.

Importantly, the fee is assessed per facility, not per product or NDC.

This is critical for companies with large OTC portfolios: one facility may support many products but still incur only one annual fee.

Common Exclusions

• API-only facilities
• Certain testing, clinical supply, or packaging-only operations
• Facilities that ceased OTC monograph activity before Jan. 1, 2026, and updated FDA registration
• Facilities producing drugs under approved applications rather than monographs

Facility classification must be based on actual operations and FDA registration—not internal labels or contracts.

MDF vs. CMO Classification

OMUFA distinguishes between:

• Monograph Drug Facility (MDF) – standard rate
• Contract Manufacturing Organization (CMO) – reduced rate (two-thirds of MDF)

A CMO qualifies only if neither the owner nor affiliates sell the OTC monograph drugs directly in the U.S. market.

Ownership structure, affiliate relationships, and distribution channels all affect classification—not just contract terms.

FY 2027 OMUFA Fees

The FY 2027 facility fee increase is significant, at about 149%. FDA attributes this largely to a one-time reserve adjustment in FY 2026 tied to changes in payment timing under OMUFA II.

This means the spike is not necessarily a long-term trend, but it does materially affect FY 2027 budgeting.

New Payment Timing for FY 2027

OMUFA II changes facility fee timing:

• 50% due Oct. 1, 2026 (or first business day after appropriations)
• 50% due Feb. 1, 2027 (or next available business day if delayed)

Starting FY 2028, the full fee is generally due at the start of the fiscal year.

OMOR fees remain due at submission.

Companies should complete planning well before Oct. 1, 2026.

No Small-Business Discount

OMUFA does not provide general small-business reductions.

All companies pay the same facility and OMOR fees. Only CMO classification affects the rate—not company size.

This differs from programs like MDUFA, which include small-business fee reductions.

Other FDA Fees Still Apply

Paying under PDUFA, MDUFA, or GDUFA does not eliminate OMUFA obligations.

Companies operating across multiple FDA programs must map each facility and product line separately to the correct fee system.

Key Steps for FY 2027 Readiness

1. Confirm facility activities – verify OTC monograph manufacturing or processing
2. Validate MDF vs. CMO status – review ownership and sales structure
3. Reconcile FDA registration data – ensure accuracy of FEI, address, and operations
4. Budget for two payments – account for split FY 2027 installments
5. Assess planned OMORs – determine fee tier and possible exemptions

FDA Tells You the Fee. We Help You Manage the Process.

Knowing what OMUFA requires is only the starting point. The real challenge is coordinating the operational workflow behind every facility payment: validating fee liability, facility classification, and FEI data; generating the FDA cover sheet and PIN; coordinating and tracking payments; resolving discrepancies; and archiving receipts and supporting records.

Turn OMUFA payment management into a controlled, repeatable process—not a last-minute chain of emails and spreadsheets.

LexisNexis Life Sciences Solutions can support the approach that works best for your organization. Get in touch today.

Learn more about our pharmaceutical regulatory compliance and submission solutions and regulatory submission services .

Next in the series: Part 2 will cover MDUFA and FY 2027 medical device user fee planning.

Editorial note: Fee information is current as of August 13, 2026. Companies should confirm current FDA guidance before making decisions.