The OTC Monograph drug user fee program (OMUFA) is the user fee paid by OTC monograph drug manufacturers and contract manufacturers.
OTC Monograph drug facility is defined as a foreign or domestic establishment that satisfies the requirements below.
- Under one management and at one geographic location that manufactures or process finished dosage form of an OTC monograph drug
- It also includes the finished dosage form of the drugs manufactured under contract.
- It does not include the drug used for clinical research supplies, testing, and creating multiple packing.
OTC Monograph Drug facilities registered with FDA from January 1, 2025, through December 31, 2025, are liable for the FY 2026 FDA fees.
| Type of Registration / Application | MDF Facility | CMO Facility |
| OTC Monograph Drug Facility (OMUFA) Fee | $19,188 | $12,792 |
FDA will send invoices to establishment directly and the fees must be paid within 20 calendar days of the original due date. Failure to do so will result in following.
- Establishment name will be published on FDA publicly available arrear list.
- OTC monographs drug manufactured in such facility will be considered misbranded.
- OTC monographs order request submitted by a person will not be accepted for filings until all fees that are due will be paid fully.
- Person who owes the fees to FDA shall be considered ineligible for OTC monograph drug meetings until they pay the fee in full.
As part of the transition in FY 2027, facility fees will be assessed in two installments: 50 percent will be due on October 1, 2026, and the remaining 50 percent will be due on February 1, 2027.
Liberty Management Group Ltd, a leading FDA consulting group provides assistance with OMUFA PIN creation, API drug establishment registration, Drug establishment registration and listing renewals and US agent service to foreign countries.
Sudha S
Regulatory Consultant
Email: Office@libertymanagement.us