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

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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 March 2, 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 “User Fee Lists” tab.
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).

Facility User Fee Rates	FY 2025	FY 2026
Monograph Drug Facility (MDF) Fee	$37,556	$19,188
Contract Manufacturing Organization (CMO) Fee	$25,037	$12,792

OMOR Fee Rates	FY 2025	FY 2026
Tier 1	$559,777	$587,529
Tier 2	$111,955	$117,505

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)

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 payment procedures can be found in the Federal Register notice, “Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026” issued in March 2026.

Information about OMOR fee payment procedures can be found in the Federal Register notice, "Over-the-Counter Monograph Drug User Fee Amendments – OTC Monograph Order Request Fee Rates for Fiscal Year 2026" issued in December 2025.

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 2026 facility fees.

When is the facility fee due?
The facility fee is due annually.

When are OMUFA facility fees due for FY 2026?
OTC monograph drug facility fees for FY 2026 are due on Monday, June 1, 2026.

How were OTC monograph drug facility fees for FY 2026 calculated?
The statute mandates that facility fee rates shall be established to generate a calculated total facility fee revenue amount, which for FY 2026 is equal to $16,885,000 (rounded to the nearest thousand dollars). FDA calculated the number of fee-liable OTC monograph drug facilities of each type (MDF and CMO) using registration information from the Electronic Drug Registration and Listing System (eDRLS) and 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 2026 facility fees can be found in the Federal Register notice issued on March 18, 2026, “Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026.”

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.

How were OTC monograph drug facility fees for FY 2026 calculated?
The statute mandates that facility fee rates shall be established to generate a calculated total facility revenue amount, which for FY 2025 is equal to $36,467,000 (rounded to the nearest thousand dollars). FDA calculated the number of fee-liable OTC monograph drug facilities of each type (MDF and CMO) using data that included registration information from the Electronic Drug Registration and Listing System (eDRLS) and 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 2025 facility fees can be found in the Federal Register notice issued on March 20, 2025, “Over-The-Counter Monograph Drug User Program - Facility Fee Rates for Fiscal Year 2025”

Why did facility fees decrease in FY 2026?

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 Organizations (CMO), and 3) increases in the total target revenue due to inflation and other adjustments.

This year’s facility fee reflects a decrease of 49% compared to the FY 2025 fee amount. This decrease is largely due to a downward operating reserve adjustment.
Please see the FRN titled “Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026” for a detailed explanation of the methodology utilized in calculating OMUFA facility fee rates for FY 2026.

Does the FY 2025 OMUFA facility fee apply to facilities that only manufactured or processed hand sanitizer products during the COVID-19 public health emergency?
Consistent with the January 12, 2021, HHS Federal Register notice (HHS FRN) and FDA’s subsequent Federal Register notices published on March 26, 2021, March 16, 2022, March 27, 2023, and March 29, 2024, announcing the FY 2021, FY 2022, FY 2023, and FY 2024 OMUFA fees (respectively), facilities are not identified as an “OTC monograph drug facility” and will not be assessed a FY 2025 OMUFA facility fee if they: (1) were not registered with FDA as OTC drug manufacturers prior to the HHS declaration of the COVID-19 public health emergency (PHE) on January 27, 2020 ; (2) registered with FDA on or after the declaration of the COVID-19 PHE on January 27, 2020; (3) registered for the sole purpose of producing only hand sanitizer products during the COVID-19 PHE; and (4) ceased manufacturing hand sanitizer products and delisted and deregistered in eDRLS before 12 a.m. EST on December 31, 2024. We note that under the FD&C Act, whether an entity is subject to OMUFA fees has no bearing on whether the entity or the entity’s products are subject to other requirements under the FD&C Act. FDA will continue to use its regulatory compliance and enforcement tools to protect consumers, including from hand sanitizers or other drugs that are potentially dangerous or subpotent.

The January 12, 2021, HHS FRN explains that “[t]he Department’s conclusion [that certain hand sanitizer manufacturers are not identified as OTC monograph drug facilities] does not apply to such persons which (1) manufacture, distribute, and sell over-the-counter drugs in addition to hand sanitizer or (2) continue to manufacture (as opposed to hold, distribute, or sell existing inventories) hand sanitizer products as of December 31 of the year immediately following the year during which the COVID–19 public health emergency is terminated. In those cases, the Department may identify such persons as OTC drug manufacturing facilities” (emphasis added). Accordingly, as the PHE expired on May 11, 2023, those facilities which “continue to manufacture” solely hand sanitizer products as of December 31, 2024, are identified as OTC monograph drug facilities and are subject to an OMUFA facility fee for FY 2025. Conversely, if such facilities ceased manufacturing hand sanitizer products and delisted and deregistered to reflect that before 12 a.m. EST on December 31, 2024, they are not identified as an OTC monograph drug facility and would not be considered fee liable for purposes of FY 2025 OMUFA facility fees. FDA communicated this deadline to stakeholders on multiple occasions, including in the FY 2024 OMUFA Facility Fee FRN, presentations to industry and OMUFA listserv emails.

Does the FY 2026 OMUFA facility fee apply to my facility?
The FD&C Act defines which facilities are subject to an OMUFA fee. The OMUFA FY 2026 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 Facility Fee Rates for Fiscal Year 2026” issued on March 18, 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 2026 OMUFA facility fee does not apply to the facilities and entities detailed below:

Those facilities that only manufacture the active pharmaceutical ingredient (or 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, 2025, 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 2026. 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 2026 facility fee, please contact CDERCollections@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

For information about FDA’s regulation of OTC monograph drugs, please visit OTC Monographs @ FDA
For information about OMUFA policy and to find general information about monograph reform, please visit OTC Monographs @ FDA
May 20, 2025, OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration
June 18, 2024, OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration
June 18, 2024, OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration
May 16, 2023, OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration Webinar
June 3, 2021 OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar
Over-the-Counter (OTC) | Nonprescription Drugs
User Fees
OMUFA Financial Reports
OMUFA Performance Reports

Contact Us

Questions for the Over-the-Counter Monograph Drug User Fee staff? Email CDERCollections@fda.hhs.gov or call 301-796-7900.
Questions about refunds? Email CDERCollections@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.