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OTC Monograph Drug Facility Fees Past Due

OTC Monograph Drug Facility Fees

The deadline to pay OTC Monograph Drug Facility Fees under the Over-the-Counter Monograph User Fee Program (OMUFA) was June 3rd, 2024. This applies to qualifying owners of OTC monograph drug facilities, as defined in the Federal Food, Drug, and Cosmetic Act.

Generally a 20-day grace period is offered by the FDA for late payments. However, facilities that miss their payment will be placed on the OTC arrears list after the grace period. This means any OTC product manufactured at their facilities could be considered misbranded.

If you need assistance with OMUFA fees, please contact us today!

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