Over-The-Counter Monograph Drug User Fee Program (OMUFA)

Latest News

On July 29, 2026, FDA announced the FY 2027 rates for OTC monograph drug facility fees and OMOR fees in an FRN titled Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027
On July 28, 2026, FDA published the updated over-the-counter (OTC) Monograph Drug User Fee Program (OMUFA) arrears and paid facilities lists on this website under the “OMUFA Arrears and Paid Facilities Lists” tab.
The FDA User Fee program has transitioned to a new centralized email inbox: FDAUserFees@fda.hhs.gov. Please update your records and use this email address for future user fee communications.
On March 18, 2026, FDA announced the rates for OTC monograph drug facility fees for FY 2026 in an FRN titled Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026. This notice publishes the OMUFA facility fee rates for FY 2026 and describes the fee calculations in detail.
On December 29, 2025, FDA published the rates for over-the-counter (OTC) monograph order request (OMOR) fees for fiscal year (FY) 2026 in a Federal Register notice (FRN) titled Over-the-Counter Monograph Drug User Fee Amendments – OTC Monograph Order Request Fee Rates for Fiscal Year 2026.
In accordance with the President’s Executive Order 14247- Modernizing Payments to and from America’s Bank Account, FDA will no longer be accepting paper-based payments beginning October 1, 2025. Payments made to FDA must be made in U.S. currency drawn on a U.S. bank by electronic check, credit card, or wire transfer. The preferred method of payment is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express).

FY 2026 and FY 2027 User Fee Rates

Facility User Fee Rates	FY 2026	FY 2027
Monograph Drug Facility (MDF) Fee	$19,188	$47,891
Contract Manufacturing Organization (CMO) Fee	$12,792	$31,927

OMOR Fee Rates	FY 2026	FY 2027
Tier 1	$587,529	$614,608
Tier 2	$117,505	$122,921

Background and Legislation

On March 27, 2020, “the Coronavirus Aid, Relief, and Economic Security Act” (or the “CARES Act”) (Public Law No. 116-136,) was signed into law. The CARES Act added to the FD&C Act section 505G, which reforms and modernizes the regulation of OTC monograph drugs. The CARES Act also added to the FD&C Act section 744M, authorizing FDA to assess and collect user fees dedicated to OTC monograph drug activities, and accompanying sections 744L and 744N.

The OTC Monograph drug user fee program, which we refer to as “OMUFA,” is modeled after the successful Prescription Drug User Fee Act (PDUFA). Under the OMUFA program, industry-paid fees help support FDA’s regulatory activities related to OTC monograph drugs and FDA agrees to adhere to performance goals negotiated by FDA and industry, including specific time frames for conducting certain OTC monograph activities.

OMUFA must be reauthorized every 5 years to continue. The initial authorization of OMUFA covered fiscal years 2021 through 2025. On November 12, 2025, the president signed into law the “Over-the-Counter Monograph Drug User Fee Amendments” under title V of the Division F of the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extension Act, 2026 (Public Law No. 119-37), which reauthorized OMUFA for fiscal years 2026 through 2030 (OMUFA II).

Sources for Additional Background and Legislation:

Federal Register Documents and Guidances

Federal Register Documents

Guidances

Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program

OMUFA Fees (General)

Why is FDA consolidating the two OMUFA fee notices into one?
Beginning in FY 2027, FDA is publishing a single, unified Federal Register notice (FRN) that announces both OTC monograph drug facility fee rates and OTC monograph order request (OMOR) fee rates.

For the previous three fiscal years (i.e., FYs 2024-2026), these fees were announced in two separate notices—one for OMOR fees and one for facility fees—published on different timelines. The OMOR FRN was published prior to the start of the FY, while the facility fee notices were published in March of the FY, ahead of the June payment due date.

OMUFA II transitions the FY 2027 facility fee payment deadline to October 1, 2026, with a 50% 1^st installment due on that date and a 50% 2^nd installment due on February 1, 2027. For FY 2028 and future years, full payment is due October 1. OMUFA II also directs FDA to issue the FRN for a FY before the FY begins.

Consolidating the notices in this way reduces administrative complexity for both FDA and the regulated industry and creates a more streamlined and predictable annual fee announcement process. This approach also aligns the OMUFA FRN with agency practice for FRN publication under other FDA user fee programs.

What are the types of user fees under OMUFA?
FDA will collect two types of user fees under OMUFA:

Facility fees
OTC Monograph Order Request (OMOR) fees

When will OMUFA fees be due each fiscal year?
For fiscal year 2026, OMUFA facility fees will be due on the later of (a) the first business day of June of such year or (b) the first business day after the enactment of an appropriations Act providing for the collection and obligation of OMUFA fees for such year.

For fiscal year 2027, the OMUFA facility fees will be due (I) in a first installment representing 50 percent of such fee, on the later of (a) October 1, 2026 or (b) the first business day after the enactment of an appropriations Act providing for the collection and obligation of OMUFA fees for such year; and (II) in a second installment representing the remaining 50 percent of such fee, on (a) February 1, 2027; or (b) if an appropriations Act providing for the collection and obligation of OMUFA fees for the fiscal year is not in effect on February 1, 2027, the first business day after enactment of such an appropriations Act.

For fiscal years 2028 to 2030, the OMUFA facility fees will be due on the later of (a) the first business day on or after October 1 of the fiscal year or (b) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees.

See section 744M(a)(1)(D) of the FD&C Act.

The facility fee amounts will be published in advance of the due date through a Federal Register notice.

Fees for OTC monograph order requests (OMORs) are due on the date of submission of the OTC monograph order request, as stated in section 744M(a)(2)(B) of the FD&C Act.

Do large companies and small companies pay different fees?
No, all companies pay the same applicable fee (i.e., facility and/or OMOR), regardless of size.

Does paying user fees for other user fee programs (like PDUFA, GDUFA, or MDUFA) negate the need to pay over-the-counter drug user fees?
No. Payment of user fees under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Medical Device User Fee Act (MDUFA), or other user fee programs does not negate the need to pay OMUFA fees. For example, if you already pay prescription drug user fees under PDUFA and are also a qualifying person who owns an over-the-counter (OTC) monograph drug facility, you would need to pay an OMUFA facility fee. Additionally, each person that submits a qualifying over-the-counter (OTC) monograph order request (OMOR) is required to pay the OMOR fee at the time of submission.

For more information on these fees, please see the “Facility Fees” and “OTC Monograph Order Request (OMOR) Fees” sections on this webpage.

How are fees paid?
Information about facility fee and OMOR fee payment procedures can be found in the Federal Register notice, “Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027” issued in July 2026.

OMUFA Facility Fees

Who pays the OMUFA facility fee?
The facility fee will be assessed on qualifying persons who own an OTC monograph drug facility, including contract manufacturing organization facilities.

There is no OMUFA facility fee for human nonprescription drug products marketed under an approved drug application. The Federal Register notice referenced above provides more information about FY 2027 facility fees.

When are OMUFA facility fees due for FY 2027?
OTC monograph drug facility fees for FY 2027 are due in two equal installments, in a first installment representing 50% of such fee due on October 1, 2026, and in a second installment representing the remaining 50% of such fee due on February 1, 2027.

How were OTC monograph drug facility fees for FY 2027 calculated?
The statute mandates that facility fee rates shall be established to generate a calculated total facility fee revenue amount, which for FY 2027 is equal to $36,972,000 (rounded to the nearest thousand dollars). FDA calculated the number of fee-liable OTC monograph drug facilities of each type (Monograph Drug Facilities (MDF) and Contract Manufacturing Organizations (CMO)) using registration information from the Electronic Drug Registration and Listing System (eDRLS) and considering the breakdown of such facilities that paid prior FY OMUFA facility fees, in addition to other information. FDA calculated the per-facility fee based on the number of each type of facility and other relevant factors.

More information about the calculation of FY 2027 facility fees can be found in the Federal Register notice issued on July 29, 2026, Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027.

What is an OTC monograph drug facility?
Under section 744L of the FD&C Act, an OTC monograph drug facility is generally defined as a foreign or domestic business or other entity that:

is under one management, either direct or indirect, and at one geographic location or address engaged in manufacturing or processing the finished dosage form of an OTC monograph drug;
includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; and
does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies; testing; or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.

What is an OTC monograph drug contract manufacturing organization (CMO) facility?
As defined in section 744L of the FD&C Act, a CMO facility is an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.

Are these CMO facilities required to pay a facility fee?
Yes, a qualifying CMO facility pays a fee equal to two-thirds of the amount of the fee for a qualifying OTC monograph drug facility that is not a CMO facility.

Why did facility fees increase for FY 2027?
In calculating the facility fee rates for each fiscal year, in accordance with our statutory authority, FDA bases its calculations on factors that include the 1) number of fee-liable facilities, 2) ratio of Monograph Drug Facilities (MDF) to Contract Manufacturing Organization (CMO) facilities, and 3) increases in the total target revenue due to inflation and other adjustments.

This year’s facility fee reflects an increase of 149% compared to the FY 2026 fee amount. This increase is largely attributable to a downward operating reserve adjustment that was applied in FY 2026. Historically, OMUFA facility fees were due late in the FY (e.g., June 1), requiring FDA to retain sufficient carryover to sustain its statutorily-required OTC monograph drug activities until receipt of annual facility fee funding in the 3rd fiscal quarter. With the transition to an October 1 due date planned for FY 2027, the additional 35-week continuity set-aside utilized under OMUFA I was no longer necessary in setting FY 2026 fees and was omitted from fee calculations for FY 2026, resulting in a significant, one-time downward adjustment that year.

For a detailed explanation of the methodology used to calculate OMUFA facility fee rates for FY 2027, please refer to the Federal Register notice titled "Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027."

Does the FY 2027 OMUFA facility fee apply to my facility?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines which facilities are subject to an OMUFA fee. The OMUFA FY 2027 facility fee applies to facilities meeting the FD&C Act definition of an OTC monograph drug facility, in addition to other criteria, as described in the Federal Register notice “Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027” issued on July 29, 2026. Further, FD&C Act section 744M(d) requires each person that owns an OTC monograph drug facility to submit information about the facility’s business operation in that respect as part of annual establishment registration under FD&C Act section 510.

The FY 2027 OMUFA facility fee does not apply to the facilities and entities detailed below:

Those facilities that only manufacture the active pharmaceutical ingredient (API) of an OTC monograph drug, which do not meet the definition of an OTC monograph drug facility under section 744L(10)(A)(i)(II) of the FD&C Act; or
OTC monograph drug facilities that had ceased all activities related to OTC monograph drugs prior to January 1, 2026, and had updated their registration with FDA to reflect that change (see section 744M(a)(1)(B)(i) of the FD&C Act).

Will the facility fee be assessed per product listing submitted (label), one fee per formula, or one per facility?
The annual facility fee is assessed “per facility,” in accordance with the definition of an OTC monograph drug facility, as set forth in section 744L(10) of the FD&C Act, and the authority for facility fees under section 744M of the FD&C Act. As defined in the statute, an OTC monograph drug facility means a foreign or domestic business or other entity that, in addition to meeting other criteria, is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug. OTC monograph drug facilities can include a contract manufacturing organization (CMO) facility (see section 744L(10) of the FD&C Act). A CMO facility is an OTC monograph drug facility where neither the owner nor any affiliate of the owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States (see section 744L(2) of the FD&C Act).

I received a fee notice, but I don’t think my facility should be charged an OMUFA facility fee for FY 2027. What should I do?
If you believe your facility is not an OTC monograph drug facility as described in this notice and should not be assessed an OMUFA FY 2027 facility fee, please contact FDAUserFees@fda.hhs.gov.

What is an FDA Establishment Identifier number?
An FDA Establishment Identifier (FEI) number is a unique identifier issued by FDA to track inspections of the regulated establishment or facility. FEI numbers are also used to track OTC facility fee payments. Please note that an FEI number is different from a Central File Number and Federal Tax Identification Number. As stated in section 744L(4) of the FD&C Act, FEIs are automatically generated by FDA’s Field Accomplishments and Compliance Tracking System (FACTS) (or any successor system).

OTC Monograph Order Request (OMOR) Fees

Who pays an OMOR fee?
As described in section 744M(a) of the FD&C Act, beginning with FY 2021, each person that submits an OMOR is subject to an OMOR fee upon submission of the OMOR. However, a person that submits an OMOR shall not be subject to an OMOR fee if FDA finds that the OMOR seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—

(i) a contraindication, warning, or precaution;
(ii) a statement about risk associated with misuse or abuse; or
(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.

When are OMOR fees due?
Each person that submits an OMOR is subject to an OMOR fee upon submission of the OMOR.

However, a person who submits certain safety-related OMORs will not be subject to an OMOR fee. Specifically, under the statute, no OMOR fee will be assessed if the FDA finds that the OMOR seeks to change the Drug Facts labeling of an OTC monograph drug in a way that would add to or strengthen—

(i) a contraindication, warning, or precaution;
(ii) a statement about risk associated with misuse or abuse; or
(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.

How were OMOR fees calculated?
Under the statute, OMOR fees are adjusted for inflation using the previous fiscal year’s OMOR fee rates.

OMUFA Arrears and Paid Facilities Lists

Reauthorization Activities

OMUFA Reauthorization for Fiscal Years 2026 - 2030
OMUFA I Negotiations
- Public Meeting: Over-the-Counter Monograph User Fees, June 10, 2016
- Frequently Asked Questions: June 10, 2016 Public Meeting on OTC Monograph User Fees
- Minutes of meetings between FDA and regulated industry, July 2016 – April 2017
- Over the Counter Monograph User Fees Program Performance Goals and Procedures
  Dates of commitments will be updated to reflect the date of passage of the legislation
  - Updated Over-the-Counter Monograph User Fee Program Performance Goals Dates– Fiscal Years 2021-2025: FDA has updated the dates to be used for purposes of the Over-the-Counter Monograph User Fee Program Performance Goals and Procedures (OMUFA goals letter) to reflect that FY 2021 is the first program year, per the statutory authority for OMUFA fees enacted under the Coronavirus Aid, Relief, and Economic Security (CARES) Act. This updating aligns with language in the OMUFA goals letter stating that although it was drafted under the assumption that FY 2018 would be the first program year, "If the program has a different effective date, goal dates…will need to be adjusted accordingly." The updated goal dates in this document should be referred to in place of the "Summary of Dates of Specified Activities under OMUFA" table on pages 34-37 of the OMUFA goals letter.

Related Information

Contact Us

Questions for the Over-the-Counter Monograph Drug User Fee staff? Email FDAUserFees@fda.hhs.gov or call 301-796-7900.
Questions about refunds? Email FDAUserFees@fda.hhs.gov.
Questions about making a payment or confirming the status of a payment? Email the User Fee Helpdesk at userfees@fda.gov or call 301-796-7200.
Questions about Pay.gov? Email pay.gov.clev@clev.frb.org or call 800-624-1373.
Questions about registration and listing of drug products? Email the eDRLS team at edrls@fda.hhs.gov.

In the rare instance where you are unable to submit an electronic request, you may mail your request, via the carrier of your choice, to FDA, Division of User Fee Management, 10903 New Hampshire Ave, Bldg. 32, Room 4245, Silver Spring MD 20993.