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 Drug 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 provides more information about FY 2025 facility fees.

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

When are OMUFA facility fees due for FY 2025?
OTC monograph drug facility fees for FY 2025 are due on Monday, June 2, 2025.

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 2025 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 increase in FY 2025?
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 an increase of 10% compared to the FY 2024 fee amount. This increase is largely due to the additional dollar amount of $3 million (as specified in the statute) and the inflation adjustment of $1.2 million used to determine the FY 2025 target revenue to be generated from facility fees, pursuant to the statutory calculations. Please see the FRN titled “Over-the-Counter Monograph Drug User Fee Program – Facility Fee Rates for Fiscal Year 2025” for the methodology utilized in calculating OMUFA facility fee rates for FY 2025.

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 2025 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 2025 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 Program – Facility Fee Rates for Fiscal Year 2025” issued on March 20, 2025. 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 2025 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, 2023, 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 registered with FDA during the Coronavirus Disease 2019 (COVID-19) pandemic whose sole activity with respect to OTC monograph drugs during the pandemic consisted of manufacturing OTC hand sanitizer products and had ceased manufacturing hand sanitizer products and delisted and deregistered in eDRLS accordingly before 12 a.m. EST on December 31, 2024.

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 2025. 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 2025 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).