FDA Hikes OTC Drug Facility Fees for FY 2025
Published Date: 3/21/2025
Notice
Summary
Starting October 1, 2024, the FDA is updating the fees that drug makers and facilities pay to support over-the-counter (OTC) drug safety and review. If you own or run a place that makes OTC drugs, these new fees will apply through September 30, 2025. This helps the FDA keep your favorite OTC medicines safe and effective without breaking the bank!
Analyzed Economic Effects
9 provisions identified: 5 benefits, 4 costs, 0 mixed.
FY2025 OTC facility fees set
If you own or run an OTC monograph drug manufacturing facility identified for the fee-liable period (January 1, 2024 through December 31, 2024), you must pay a facility fee for the period October 1, 2024 through September 30, 2025. The fee amounts are $37,556 for a monograph drug facility (MDF) and $25,037 for a contract manufacturing organization (CMO) facility.
Exemption if ceased before Dec 31, 2023
If you stopped OTC monograph drug activities and updated your FDA registration to show that before December 31, 2023, your facility is exempt from FY2025 OMUFA facility fees (the fees that apply October 1, 2024 to September 30, 2025).
COVID-era hand sanitizer registrants can avoid FY2025 fees
If you registered during the COVID-19 pandemic solely to make OTC hand sanitizer and you ceased making hand sanitizer and delisted/deregistered in FDA's eDRLS before 12:00 a.m. Eastern Time on December 31, 2024, your facility is not identified as fee-liable for FY2025 and will not be assessed an OMUFA facility fee.
Hand sanitizer makers still operating face fees
If you continued to manufacture solely hand sanitizer products as of December 31, 2024, you are identified as an OTC monograph drug facility and are subject to the FY2025 OMUFA facility fee for the October 1, 2024 through September 30, 2025 period.
CMO fee is two‑thirds of full fee
Contract manufacturing organization (CMO) facilities are charged a reduced fee equal to two‑thirds of the MDF fee; for FY2025 that results in the CMO fee of $25,037 compared with the MDF fee of $37,556.
API‑only manufacturers excluded from fees
If your facility only manufactures the active pharmaceutical ingredient (API) of an OTC monograph drug, your facility does not meet the statutory definition of an OTC monograph drug facility and therefore is not assessed an OMUFA facility fee for FY2025.
Certain limited activities are fee‑excluded
Facilities whose only OTC-related activities are (1) production of clinical research supplies, (2) testing, or (3) placing outer overpackaging on already final-packed products are not identified as OTC monograph drug facilities and will not be assessed FY2025 OMUFA facility fees.
Relabelers and repackagers are fee‑liable
If your business relabels or repackages OTC monograph drugs (relabelers and repackagers), FDA considers you to be an OTC monograph drug facility and you are subject to the FY2025 OMUFA facility fee.
Payment timing and methods for FY2025 fees
FY2025 OMUFA facility fees are due on June 2, 2025. Payments must be made in U.S. currency by electronic check (ACH/eCheck) or wire transfer via FDA's user‑fee systems (Pay.gov/User Fees Payment Portal); credit card payment is available only for balances under $25,000. Online payments accept only full (no partial) payments.
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