The over-the-counter monograph drug facility (OTC MDF) fees for FY 2025 are effective on October 1, 2024, and fees will be due on June 2, 2025.
There are two types of facility fees for OTC drug manufacturing facilities:
- An OTC 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 MDF 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.
These facilities are further defined in the statute and outlined in the Federal Register (FR) notice here. An OTC MDF pays a full fee and an OTC CMO pays two-thirds of the full facility fee. The FY 2025 fees for each type of facility are:
- MDF facility: $37,556
- CMO facility: $25,037
The FR notice provide further information on who must pay and who may be exempt if they no longer manufacture OTC products of various types and they have delisted those products appropriately and in accord to the timelines identified in the notice. The FR notice also provides a discussion of how the fees are calculated.
Please note that the OTC MDF facility fees only apply to OTC products marketed under an appropriate OTC monograph and do not apply to OTC manufacturing facilities for products that are approved through an NDA or ANDA as these products may be subject to various other fee structures.
