FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: OVER-THE-COUNTER MONOGRAPH DRUG USER FEE AMENDMENTS-OTC MONOGRAPH ORDER REQUEST FEE RATES FOR FISCAL YEAR 2026

WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Over-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026.

The notice was published in the Federal Register on Dec. 29 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as "OMUFA II"), authorizes the Food and Drug Administration (FDA, the Agency, or we) to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMOR)s fo...