HHS asks FDA to cancel annual fees for OTC monographs

Release time:

2021-01-07 14:14

On December 29, 2020, the FDA issued a fee standard for OTC monograph drugs. On January 4, 2021, HHS(Department of Health and Human Services) canceled the newly released policy of levying annual drug fees. This is undoubtedly good news for manufacturers of hand sanitizer and disinfectant wipes registered by FDA OTC in China.

Event review:

On March 27, 2020, the United States signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to help respond to jobs and mitigate the economic impact of the COVID-19. In addition to COVID-19 response efforts, the CARES Act includes an important legislative initiative to reform and update the way certain over-the-counter (or OTC) drugs are regulated in the United States. These drugs, known as OTC monograph drugs, may be marketed under section 505 of the Federal Food, Drug, and Cosmetic Act (FD & C Act) without approval if they meet section 505 of the FD & C Act and other applicable requirements.

According to section 744M of the FD & C Act, the OTC monograph drug user charging plan is established. According to the plan, FDA will evaluate and collect the fees of the author of OTC monograph order requests (OMORs) and the facility fees of certain OTC monograph drug manufacturers to support the agency's OTC monograph drug activities.

Annual Fee Details:

Brand: 14060 USD
OEM工厂：9373 USD

The planned OTC drug facility fee for fiscal year 2021 will be paid within 45 days of the release of this FRN. The FDA also expects that the FRN will estimate the number of OTC monograph drug facilities registered in the eDRLS system as of December 30, 2020 to set the fee.

OTC drug plant and OMOR fees are not required to be paid to FDA until further notice from HHS or FDA. New Angrun Consulting provides professional FDA\EPA consulting services to escort enterprises.

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