FDA Releases Update on OTC Monograph Drug User Fee Program Implementation

The CARES Act, enacted in March 2020, amended the Federal Food, Drug, and Cosmetic Act to provide FDA authority to assess and collect annual facility fees from owners of qualifying OTC monograph drug facilities (in addition to fees for OTC monograph order requests). FDA announced these fees in a December 29, 2020 Federal Register Notice (FRN) titled "Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021." The December 29, 2020 FRN was subsequently withdrawn by the Department of Health and Human Services (HHS). The withdrawal means this FRN and the fees it announced are no longer in effect.

On January 8, 2021, HHS issued a new notice stating that facility fees do not apply to those companies that first entered the over-the-counter drug market only to produce hand sanitizer during the COVID-19 public health emergency. Accordingly, FDA will not assess facility fees on such hand sanitizer manufacturers. FDA remains committed to working with all parties to ensure an adequate supply of this important public health tool to help all Americans practice good hygiene.

FDA intends to continue implementation of the OTC monograph drug user fee program enacted by Congress in an appropriate and transparent manner, including with respect to facility fees, and in accordance with the HHS notice. We will provide additional updates on this work as soon as we are able on FDA’s OMUFA webpage.