Dear Colleague,
This message pertains to the July 30, 2026, Food and Drug Administration Federal Register notice (FRN) titled “Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027.”
The first installment of 50 percent of the fiscal year (FY) 2027 Over-the-Counter (OTC) monograph facility fees are due today, October 1, 2026. If you are a qualifying owner of an OTC monograph drug facility, as described in sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act, please visit FDA’s payment portal to submit your payment.
For more information on fee-qualifying OTC monograph drug facilities, as well as fee payment options and procedures, please refer to the aforementioned FRN. For more information on the OTC Monograph Drug User Fee Program (OMUFA), please visit the OMUFA user fee website.
FDA issued FY 2027 OMUFA facility fee invoices on August 20, 2026, for the first installment of 50 percent of the facility fees. The second installment of 50 percent of FY 2027 facility fees will be issued in December 2026 and will be due on February 1, 2027.
If you have already submitted your first installment payment prior to receiving this message, thank you for your prompt attention, no further action is required at this time.
If you have any questions regarding this notice, please contact the OMUFA User Fee Staff at FDAUserFees@fda.hhs.gov.
Respectfully,
Division of User Fee Revenue Management
Office of Operations | Office of Finance, Budget, and Acquisitions | Office of User Fees
U.S. Food and Drug Administration