FDA OTC Monograph Drug Facility Fees 2027
FY 2027 OMUFA Fees - FDA Registration Fees
The FDA OTC Monograph Drug User Fee (OMUFA) for fiscal year 2027 is $47,891 for a Monograph Drug Facility (MDF) and $31,927 for a Contract Manufacturing Organization (CMO) facility. These rates were published in the Federal Register on July 30, 2026, and apply to the period January 1, 2026, through September 30, 2026.
What Is OMUFA?
Under the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA), the FDA is authorized to assess and collect annual facility fees from qualifying manufacturers of OTC monograph drugs for fiscal years 2026 through 2030. The fees support the FDA's OTC monograph drug program. There are two facility types:
- MDF (Monograph Drug Facility): a facility that manufactures or processes OTC monograph drugs and whose owner (or an affiliate) sells those products directly to wholesalers, retailers, or consumers in the U.S.
- CMO (Contract Manufacturing Organization): a facility that manufactures OTC monograph drugs but where neither the owner nor any affiliate sells the product directly to wholesalers, retailers, or consumers in the U.S. By statute, the CMO fee is set at two-thirds of the MDF fee — which is why $31,927 is two-thirds of $47,891.
Who Is Liable for the FY 2027 Fee?
OTC monograph drug facilities that were registered with the FDA at any point from January 1, 2026, through September 30, 2026 are liable for the FY 2027 OMUFA facility fee. Liability is tied to being identified as a qualifying OTC monograph drug facility during that period, based on FDA's drug registration and listing data.
When Are the FY 2027 Fees Due?
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. Facilities that fail to pay by the due date risk being placed on the FDA's public arrears list. A facility owing fees in arrears faces additional consequences until the outstanding fees are paid—including the denial or cancellation of OTC monograph order requests (OMORs) and related submissions, products being deemed misbranded, and the issuance of warning letters.
FDA Fees for OTC Monograph Drug Facility Registration for Fiscal Year 2027
| Type of Registration / Application | MDF Facility | CMO Facility |
|---|---|---|
| OTC Monograph Drug Facility (OMUFA) Fee | $47,891 | $31,927 |
| Type of Application | OMOR Fee |
|---|---|
| OMOR Fee Tier 1 | $614,608 |
| OMOR Fee Tier 2 | $122,921 |
The FY 2027 OMUFA fee does not apply to the below facilities
- 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 the FD&C Act.
- OTC monograph drug facilities that had ceased all activities related to OTC monograph drugs prior to December 31, 2024, and had updated their registration with the FDA to reflect that change.
Understanding OTC Monograph Terms
- An OTC monograph drug (OTC Drug) is a nonprescription drug without an approved new drug application.
- An OTC monograph drug facility (MDF) is 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.
- A contract manufacturing organization (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
- The term “OTC monograph order request” (or OMOR) is defined in section 744L(7) of the FD&C Act and refers to a request for FDA to issue an administrative order under section 505G of the FD&C Act.
Frequently Asked Questions
Who must pay OMUFA fees?
Are OMUFA fees paid to FDA directly?
What is the OMUFA fee for 2027?
Questions About OTC Drug Fees?
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