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.

Federal Register Documents

• Over-the-Counter Monograph Drug User Fee Program – OTC Monograph Order Requests (OMORs) Fee Rates for Fiscal Year 2024 
• Over-The-Counter Monograph Drug User Fees Rates for Fiscal Year 2023
• Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2022
• Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021

Guidances

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

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

1. Facility fees
2. OTC Monograph Order Request (OMOR) fees

When will OMUFA fees be due for fiscal years after FY 2021?
For fiscal years after FY 2021, OMUFA facility fees will be due on the later of (a) the first business day of June of each 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, as described in section 744M(a)(1)(D)(ii) of the FD&C Act. The facility fee amounts will be set in advance of the due date through a Federal Register Notice, in accordance with the process specified under the statute.

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 fee payment procedures can be found in the Federal Register Notice issued on March 24, 2023, “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2023.”

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

The OTC Monograph User Fee program does not assess a facility fee for human OTC drug products that are produced under an approved drug application. The Federal Register Notice referenced above will provide more information about FY 2023 facility fees.

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

When are OMUFA facility fees due for FY 2023?
OTC monograph drug facility fees for FY 2023 are due on June 1, 2023.

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:

1. 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;
2. 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
3. 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 2023 calculated?
The statute mandates that facility fee rates shall be established to generate a calculated total facility revenue amount, which for FY 2023 is equal to $25,421,000 (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 registrations from the Electronic Drug Registration and Listing System (eDRLS) and the breakdown of facilities that paid FY 2022 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 and assumptions.

More information about the calculation of FY 2023 facility fees can be found in the Federal Register Notice issued on March 24, 2023, “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2023.”

Why did facility fees increase in FY 2023?
To calculate 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. 

Please see the FRN titled “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2023" for the methods utilized in calculating OMUFA fee rates for FY 2023.

Does the FY 2023 OMUFA facility fee apply to facilities that manufactured or processed hand sanitizer products during the COVID-19 public health emergency?
No. Consistent with the Department of Health and Human Services’ (HHS) Notice published on January 12, 2021, and FDA’s OMUFA fee rate notices for FYs 2021-2022, FDA will not assess OMUFA facility fees for FY 2023 upon those firms that first registered with FDA on or after the January 27, 2020 declaration of the COVID-19 public health emergency (PHE) solely for purposes of manufacturing OTC hand sanitizer products during the PHE. Although FDA’s March 13, 2023 FRN explained that the PHE is expected to expire on May 11, 2023, this will not impact FY 2023 fee liability (i.e., will not create a fee obligation).  FDA intends to provide further information regarding facility fees and such hand sanitizer manufacturers that will remain on the market going forward. 

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 potentially dangerous or sub-potent hand sanitizers.  

Does the FY 2023 OMUFA facility fee apply to my facility?
The FD&C Act defines which facilities are subject to an OMUFA fee. As stated above, the OMUFA FY 2023 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 2023” issued on March 24, 2023. 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 as part of annual establishment registration under FD&C Act section 510.

The FY 2023 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
• OTC monograph drug facilities that had ceased all activities related to OTC monograph drugs prior to December 31, 2021, and had updated their registration with FDA to reflect that change (see section 744M(a)(1)(B)(i) of the FD&C Act); or
• entities that first registered with FDA on or after the January 27, 2020 declaration of the COVID-19 public health emergency (PHE), solely for purposes of manufacturing hand sanitizer products during the PHE.

Although FDA’s March 13, 2023 FRN explained that the PHE is expected to expire on May 11, 2023, this will not impact FY 2023 fee liability (i.e., will not create a fee obligation).  FDA intends to provide further information regarding facility fees and such hand sanitizer manufacturers that will remain on the market going forward.

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 2023. 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 2023 facility fee, please contact [email protected].

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).

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.

• Other OMUFA Fee-Related Questions
• OMUFA Facility Arrears List (PDF - 361 KB)
• OMUFA Facility Arrears List (XLSX - 64 KB)

• OMUFA Reauthorization for Fiscal Years 2026 - 2030
• Public Meeting on the Reauthorization of the Over-the-Counter Monograph Drug User Fee Program (OMUFA) - 09/28/2023

• For information about OMUFA policy and to find general information about monograph reform, please visit OTC Monographs @ FDA
• 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 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.
• Over-the-Counter (OTC) | Nonprescription Drugs
• User Fees
• OMUFA Financial Reports
• OMUFA Performance Reports 

• Questions for the Over-the-Counter Monograph Drug User Fee staff? Email [email protected] or call 301-796-7900.
• Questions about refunds? Email [email protected].
• Questions about making a payment or confirming the status of a payment? Email the User Fee Helpdesk at [email protected] or call 301-796-7200.
• Questions about Pay.gov? Email [email protected] or call 800-624-1373.
• Questions about registration and listing of drug products? Email the eDRLS team at [email protected].

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, 10001 New Hampshire Ave, Silver Spring, MD 20993.