FDA 发布 2027 财年 OTC 专论药品用户费项目（OMUFA）设施费说明：总额 36,972,000 美元，分两期缴纳

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 2027 facility fees.

When are OMUFA facility fees due for FY 2027?
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.

How were OTC monograph drug facility fees for FY 2027 calculated?
The statute mandates that facility fee rates shall be established to generate a calculated total facility fee revenue amount, which for FY 2027 is equal to $36,972,000 (rounded to the nearest thousand dollars). FDA calculated the number of fee-liable OTC monograph drug facilities of each type (Monograph Drug Facilities (MDF) and Contract Manufacturing Organizations (CMO)) using registration information from the Electronic Drug Registration and Listing System (eDRLS) and considering 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 2027 facility fees can be found in the Federal Register notice issued on July 29, 2026, Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027.

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.

Why did facility fees increase for FY 2027?
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 Organization (CMO) facilities, and 3) increases in the total target revenue due to inflation and other adjustments.

This year’s facility fee reflects an increase of 149% compared to the FY 2026 fee amount. This increase is largely attributable to a downward operating reserve adjustment that was applied in FY 2026. Historically, OMUFA facility fees were due late in the FY (e.g., June 1), requiring FDA to retain sufficient carryover to sustain its statutorily-required OTC monograph drug activities until receipt of annual facility fee funding in the 3rd fiscal quarter. With the transition to an October 1 due date planned for FY 2027, the additional 35-week continuity set-aside utilized under OMUFA I was no longer necessary in setting FY 2026 fees and was omitted from fee calculations for FY 2026, resulting in a significant, one-time downward adjustment that year.

For a detailed explanation of the methodology used to calculate OMUFA facility fee rates for FY 2027, please refer to the Federal Register notice titled "Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027."

Does the FY 2027 OMUFA facility fee apply to my facility?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines which facilities are subject to an OMUFA fee. The OMUFA FY 2027 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 2027” issued on July 29, 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 2027 OMUFA facility fee does not apply to the facilities and entities detailed below:

• Those facilities that only manufacture the active pharmaceutical ingredient (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, 2026, 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 2027. 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 2027 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).