FDA Re-Releases Official Annual Fee Standard for OTC Enterprises in Fiscal Year 2021

Release time:

2021-04-12 14:26

On March 25, the U.S. Food and Drug Administration (FDA) reissued the OTC User Fee Act OMUFA(The Over-the-Counter Monograph User Fee Act)2021 the official annual fee. At the end of last year, FDA issued a high official annual fee for OTC enterprises, causing great dissatisfaction among many enterprises exporting hand sanitizer, disinfectant wipes and disinfectant to the United States. The original announcement was revoked by the U.S. Department of Health and Human Services (HHS) on January 6, 2021. This re-release will also have a greater impact on OTC companies exporting to the United States.

The FDA decided that hand sanitizer manufacturers-who registered during the COVID-19 Public Health Emergency (PHE) and only produced hand sanitizer during the outbreak-will not be required to pay OMUFA facility fees.
The rates for fiscal year 2021 are shown in the table below:

The OTC monograph drug facility fee for fiscal year 2021 will expire on May 10, 2021, that is, 45 days after the FN bill is issued. Relevant enterprises are requested to pay the relevant fees as soon as possible. You can also contact Xinanrun Consulting to assist in paying your fees.

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