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# FDA Republishes OTC Monograph Fee Rates
- URL: https://www.fdaweb.com/fda-republishes-otc-monograph-fee-rates/
- Published: 2021-03-25T12:00:00.000Z
- Updated: 2026-09-14T16:52:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148965

FDA is republishing fee rates for the over-the-counter (OTC) monograph drug user fee program. A *Federal Register* [notice](https://www.federalregister.gov/public-inspection/2021-06361/fee-rates-under-the-over-the-counter-monograph-drug-user-fee-program-for-fiscal-year-2021?ref=fdaweb.com) says the rates were authorized under the 3/2020 Coronavirus Aid, Relief, and Economic Security Act to support the modernization of the OTC monograph program.

After the fees were initially published in a 12/29/20 *Federal Register* notice, FDA determined that they should not be applied to companies that first entered the OTC market on or after 1/27/20 solely to produce hand sanitizer during the Covid-19 public health emergency. FDA says the initial notice has been withdrawn and the rates are now being republished.

CDER acting director **Patrizia Cavazzoni** says FDA is aware that because some hand sanitizer companies will not be paying facility fees, other firms will see an increase in the FY 2021 fees they will pay compared to those in the withdrawn fee notice. “However,” she says, “by supporting OTC monograph reform efforts, these fees will aid in improving the efficiency, timeliness, and predictability of the review process for OTC monograph drugs.”