FDA's OTC monograph facility fee just rose 149% — up to $47,891 per facility, with the first installment due October 1, 2026. Answer a few questions and see exactly where your facility stands.
Fee amounts and due dates are drawn from FDA's Federal Register notice Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027 (91 FR 48118, July 30, 2026) and FDA's OMUFA program page (fda.gov, content current as of July 30, 2026). FY 2027 rates: MDF $47,891 · CMO $31,927, payable in two equal installments due October 1, 2026 and February 1, 2027 (FD&C Act §§ 744L–744M). FDA considers relabelers and repackagers to be OTC monograph drug facilities subject to OMUFA facility fees.
This tool is provided for general informational purposes only and does not constitute regulatory or legal advice, and no client relationship is formed by its use. Fee liability depends on facility-specific facts, including eDRLS registration status and business operations during the fee-liable period. Confirm your facility's status before making payment decisions.