OTC Monograph Archives - Lachman Consultant Services, Inc.

Over-the-Counter Monograph Drug User Fee Program—Facility Fee Rates for FY 2025

By Bob Pollock Mar 20, 2025 OTC Monograph

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 […]

Aug

OMUFA FY 2025 User Fees - Lachman Consultants

OMUFA FY 2025 User Fees Announced

By Rebecca Welton Aug 01, 2024 OTC Monograph User Fees

Rounding out the User Fee announcements, the Over-the-Counter Monograph Drug User Fee Program (OMUFA) announced its FY 2025 fees on July 31, 2024. The Federal Register Notice announcing the new fees can be found here. The update was only to the OTC Monograph Order Request (OMOR) fee rates – it did not include an update for the […]