OMUFA FY 2026: FDA OTC Drug User Fees, Rates & Key Deadlines

The FDA has published the fiscal year 2026 fee rates under the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA II). The headline changes: facility fees for OTC monograph drug manufacturers have dropped approximately 50% compared to FY 2025, while OTC Monograph Order Request (OMOR) fees have increased roughly 5% due to inflation. FY 2026 facility fees are due by June 1, 2026. Here’s what OTC drug manufacturers need to know.

What Is OMUFA?

The Over-the-Counter Monograph Drug User Fee Program (OMUFA) is the FDA’s fee-based funding mechanism for OTC monograph drug regulatory activities. Established under the CARES Act of 2020, OMUFA authorizes the FDA to collect annual fees from manufacturers of OTC monograph drugs to support the agency’s review, oversight, and modernization of the OTC monograph system.

OMUFA II — the program’s reauthorization for fiscal years 2026 through 2030 — was signed into law on November 12, 2025, as part of the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026. This reauthorization ensures continued stable funding for FDA’s OTC monograph activities through FY 2030.

FY 2026 Facility Fee Rates — A Significant Drop

The FDA published FY 2026 facility fee rates on March 18, 2026, in a Federal Register notice. The rates represent a significant decrease from FY 2025:

Fee Type	FY 2025 Rate	FY 2026 Rate	Change
Monograph Drug Facility (MDF)	$37,556	$19,188	↓ ~49%
Contract Manufacturing Organization (CMO)	$25,037	$12,792	↓ ~49%

The drop is driven by a structural change under OMUFA II: starting in FY 2027, facility fees will shift from being due in June (third quarter) to October (first quarter). This transition reduces the FDA’s need to retain large operating reserves of carryover fees, which previously inflated the fee calculation. For FY 2026, the total target facility fee revenue is $16,885,000, down significantly from the FY 2025 target of $36,467,000.

Who Pays OMUFA Facility Fees?

Facility fees are assessed on any person who owns an OTC monograph drug facility, including contract manufacturing organizations that produce OTC drugs for other companies. Specifically, the fee applies to facilities identified as OTC monograph drug facilities in FDA’s Electronic Drug Registration and Listing System (eDRLS) during the applicable period — the 12-month period ending December 31, 2025.

There is no OMUFA facility fee for OTC drug products marketed under an approved New Drug Application (NDA). The fee applies only to monograph-pathway products.

FY 2026 Facility Fee Deadline

FY 2026 OMUFA facility fees are due on Monday, June 1, 2026. Beginning in FY 2027, the due date will shift to the first business day in October, with the FY 2027 fees payable in two equal installments — one in October and one in February.

Important: As of October 1, 2025, the FDA no longer accepts paper-based payments per Executive Order 14247. All payments must be made electronically — by ACH (eCheck), credit card, or wire transfer.

FY 2026 OMOR Fee Rates — Up ~5%

The FDA published FY 2026 OMOR fee rates on December 29, 2025. These fees apply when a company submits an OTC Monograph Order Request to modify an existing monograph — for example, to add a new active ingredient, change an indication, or update labeling.

OMOR Type	FY 2025 Rate	FY 2026 Rate	Change
Tier 1 OMOR (major changes — new ingredients, indications, therapeutic categories)	$559,608	$587,529	↑ ~5%
Tier 2 OMOR (minor changes)	$111,921	$117,505	↑ ~5%

The increase reflects a 4.9576% inflation adjustment calculated from FDA personnel compensation and Consumer Price Index data.

OMOR fees are due at the time of submission. They are not included in the OMUFA target revenue calculation, which is based entirely on facility fees.

Exemption: No OMOR fee is assessed if the request seeks to add or strengthen a contraindication, warning, precaution, abuse/misuse risk statement, or dosage instruction intended to improve safe use.

OMUFA II — What’s New in the Reauthorization

The OMUFA II reauthorization for FY 2026–2030 introduces several key changes beyond the fee adjustments:

The facility fee due date transitions from June to October starting in FY 2027, improving cash flow predictability for both the FDA and industry.

The program includes $2.373 million in additional annual revenue authorized by statute for FY 2026, reflecting expanded FDA OTC monograph activities.

OMUFA II maintains performance goals requiring the FDA to review OMORs within specific timeframes, including safety-related changes.

The reauthorization also requires the FDA to develop a stakeholder engagement plan on Rx-to-OTC drug switch and mandates a GAO supply chain assessment for OTC monograph drugs by September 2027.

The law additionally requires FDA to issue guidance on integrating real-world evidence for topically administered OTC active ingredients and to consider alternatives to animal testing, with guidance due by November 2026.

What This Means for OTC Drug Manufacturers

If you manufacture or process OTC monograph drug products for the U.S. market — whether as a brand owner or a contract manufacturer — here are the key action items:

✅ Verify your facility’s registration status in eDRLS to confirm whether you are fee-liable for FY 2026.

✅ Budget for your facility fee payment by the June 1, 2026 deadline — $19,188 for MDF or $12,792 for CMO facilities.

✅ Prepare for the October payment shift starting in FY 2027. Plan accordingly for the transitional two-installment structure.

✅ Review any planned OMOR submissions and budget for Tier 1 ($587,529) or Tier 2 ($117,505) fees.

✅ Ensure electronic payment capability is in place, as paper payments are no longer accepted by the FDA.

How Cosmereg Can Help

Cosmereg supports OTC drug manufacturers with all aspects of FDA compliance, including:

✅ Drug establishment registration and annual renewal via eDRLS

✅ Product listing with NDC assignment and SPL formatting

✅ OMUFA fee planning and payment coordination

✅ GMP compliance consulting under 21 CFR 210/211

✅ Drug Facts labeling review

✅ U.S. Agent designation for foreign OTC drug facilities

If you need assistance understanding your OMUFA obligations or managing your OTC drug compliance, contact our regulatory team today.