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Home » FDA Releases OTC Monograph Drug User Fees for Fiscal 2021
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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