FDA Releases OTC Monograph Drug User Fees for Fiscal 2021

December 30, 2020

The FDA has announced its rates for over-the-counter (OTC) monograph drug user fees for fiscal 2021.

The agency has set fees for OTC monograph order requests at $500,000 for Tier 1 requests and $100,000 for Tier 2. Tier 1 requests involve adding a new ingredient or indication for an OTC monograph drug, while Tier 2 requests relate to lesser changes, such as reordering existing information in a drug facts label.

For facility fees, the agency will charge $14,060 for monograph drug facilities and $9,373 for contract manufacturing organization facilities.

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