New Fees Hit OTC Drug Makers for 2026
Published Date: 3/18/2026
Notice
Summary
Starting October 1, 2025, companies that make or submit requests for over-the-counter (OTC) drug products will pay new facility fees for fiscal year 2026. These fees help the FDA keep OTC drugs safe and effective. If you own or run an OTC drug facility, get ready for these updated charges that last through September 30, 2026.
Analyzed Economic Effects
5 provisions identified: 0 benefits, 3 costs, 2 mixed.
FY2026 OTC Facility Fee Amounts
If you own an OTC monograph drug manufacturing facility (MDF), you will be charged a facility fee of $19,188 for the period October 1, 2025 through September 30, 2026. If your facility is a contract manufacturing organization (CMO), the fee for FY2026 is $12,792 (two-thirds of the MDF fee).
Who Is Assessed Fees (Fee-Liability Window)
Facilities identified as OTC monograph drug facilities during the fee-liable period from January 1, 2025 through December 31, 2025 will be assessed an FY2026 facility fee. A full fee is assessed for each MDF and a reduced fee (two-thirds) is assessed for each CMO facility.
Which Facilities Are Exempt or Excluded
Facilities that ceased OTC monograph drug activities and updated their FDA registration to that effect before January 1, 2025 are exempt from FY2026 facility fees. Also excluded from being OTC monograph drug facilities (and thus not assessed fees) are facilities whose only activities are manufacture of active pharmaceutical ingredient (API), production of clinical research supplies, testing, or placement of outer overpackaging on already-final packaged products. By contrast, relabelers and repackagers are treated as fee-subject OTC monograph drug facilities.
Payment Timing, Methods, and Consequences
FY2026 facility fees are due on June 1, 2026 (the later of June 1 or the first business day after an appropriations Act) and invoices will be issued in April 2026. Payments must be in U.S. currency drawn on a U.S. bank and are accepted online via Pay.gov (ACH/eCheck) or credit card (credit card payments allowed only for balances under $25,000); full payments only (no partial online payments). Unpaid fees will be treated as claims of the U.S. Government and referred to collection.
Change in Fee Due Date Starting FY2027
OMUFA II transitions facility fee due dates so that, starting in FY2027, facility fees will be due the first business day in October; for FY2027 specifically, fees will be due in two equal installments on the first business day of October and the first business day of February. This changes the prior timing when fees were due in the third fiscal quarter (June).
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