Over-The-Counter Monograph User Fee Program (OMUFA)
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On Friday, March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and ease the economic impact of COVID-19. In addition to the COVID-19 response efforts, the CARES Act includes an important legislative initiative that reforms and modernizes the way certain nonprescription, over-the-counter (or OTC) drugs are regulated in the United States. These drugs, known as OTC monograph drugs, may be marketed without an approved drug application under section 505 of the Federal Food, Drug, and Cosmetic (FD&C Act) if they meet the requirements of section 505G of the FD&C Act, as well as other applicable requirements.
Section 744M of the FD&C Act, as added by the CARES Act, establishes an OTC monograph drug user fee program, under which FDA will assess and collect fees from submitters of OTC Monograph Order Requests (OMORs) as well as facility fees from certain manufacturers of OTC monograph drugs, to support the agency's OTC monograph drug activities. As with our other user fee programs, we anticipate that this new user fee program will provide additional resources to help the agency conduct these important regulatory activities in a timely manner and ultimately help provide the public with access to innovative OTC monograph drugs.
FDA plans to publish a Federal Register Notice (FRN) to establish fees with respect to OTC monograph drug facilities and OMORs for FY 2021. This FRN will be published after an appropriation for these fees is enacted as part of an FY 2021 appropriations act for FDA. OTC monograph drug facility fees for FY 2021 will be due 45 days after publication of this FRN.
FDA will collect two types of user fees under OMUFA: Facility Fees and OTC Monograph Order Request (OMOR) fees.
Fiscal Year (FY) 2021 user fee rates
| FY 2021 Facility User Fee Rates | |
|---|---|
| Facility Fee | Facility fees will be published in a Federal Register notice |
| FY 2021 OMOR Fee Rates | |
|---|---|
| Tier 1 | $500,000 |
| Tier 2 | $100,000 |
On March 27, 2020, the President signed into law “the Coronavirus Aid, Relief, and Economic Security Act” (or the “CARES Act”). Division A of the CARES Act includes an important legislative initiative, detailed in subtitle F of title III, that reforms and modernizes the way certain nonprescription, over-the-counter (or OTC) drugs are regulated in the United States. These drugs, known as OTC monograph drugs, may be marketed without an approved drug application under section 505 of the Federal Food, Drug, and Cosmetic (FD&C Act) if they meet the requirements of section 505G of the FD&C Act, as well as other applicable requirements. Under this OTC monograph reform legislation, FDA will also assess and collect user fees dedicated to OTC monograph drug activities.
The new user fee program, which we refer to as the Over-the-Counter Monograph User Fee Act (or "OMUFA"), is modeled after the successful Prescription Drug User Fee Act (PDUFA). For OMUFA purposes, industry-paid fees will help fund a portion of FDA’s regulatory activities for OTC monograph drugs and FDA agreed to adhere to performance goals, including to review submissions within specific time frames. As with PDUFA, FDA anticipates that this user fee program will provide additional resources to help the agency conduct these important regulatory activities in a timely manner and ultimately help provide the public with access to innovative OTC monograph drugs.
OMUFA is authorized under sections 744L and 744M of the FD&C Act, as added by the CARES Act, under which FDA will assess and collect fees from submitters of OTC Monograph Order Requests (OMORs), other than OMORs for certain safety changes, as well as from qualifying manufacturers of OTC monograph drugs, to help fund the agency's OTC monograph drug activities.
What is an OTC monograph drug?
An OTC monograph drug is a nonprescription, over-the-counter (or OTC) drug that may be marketed without an approved drug application under section 505 of the FD&C Act if it meets the requirements of section 505G of the FD&C Act, as well as other applicable requirements.
What is an OTC monograph?
Simply stated, an OTC monograph is a "rule book" for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, route of administration, labeling, and testing under which an OTC drug is generally recognized as safe and effective (GRASE).
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
| FY 2021 Facility User Fee Rates | |
|---|---|
| Facility Fee | Facility fees will be published in a Federal Register notice |
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 2021 facility fees.
When is the facility fee due?
The facility fee is due annually.
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.
| FY 2021 OMOR Fee Rates | |
|---|---|
| Tier 1 | $500,000 |
| Tier 2 | $100,000 |
- "Monograph Reform is Here" webinar presentation from May 29, 2020
- 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 - September 6, 2016 Stakeholder Webinar – Meeting Summary
- FDA and Industry Discussions
- June 10, 2016 public meeting: Over-the-Counter Monograph User Fees
- Frequently Asked Questions on Potential OTC Monograph User Fee Program
- OTC Drug Monograph Process
- Over-the-Counter (OTC) | Nonprescription Drugs
- User Fees