FDA Releases First-Ever OTC Monograph Facility Fees For 2021, exempting some hand sanitizer makers

On March 27th, the FDA released the new OTC Monograph Facility Fees. The new rates are for the period of October 1st, 2020 through September 30, 2021. The facility fees will be 45% higher than the FDA’s previous assessment made in December 2020.

New fees are due on May 10th, 2021.

I. Exempt Facilities

According to FDA, “The FY 2021 OMUFA facility fee does not apply to the facilities and entities detailed below:

    • those facilities that only manufacture the active pharmaceutical ingredient (or API) of an OTC monograph drug do not meet the definition of an OTC monograph drug facility (see section 744L(10)(A)(i)(II);
    • OTC monograph drug facilities that had ceased all activities related to OTC monograph drugs prior to December 31, 2019 and had updated their registration with FDA to reflect that change (see section 744M(a)(1)(B)(i) of the FD&C Act); or
    • entities that registered with FDA on or after the January 27, 2020 declaration of the COVID-19 public health emergency (PHE), solely for purposes of manufacturing hand sanitizer products during the PHE.”

This means that facilities registered after January 27, 2020 will be exempt from facility fees if they manufacture antiseptic rubs or wipes. The exemption is limited to the period during which the COVID-19 public health emergency remains in effect.

II. OTC Facility Fee Increase

The significant increase in the fee amounts, as stated in FDA’s press release, is a result of the facilities now considered exempt. FDA states that Congress requires that they match the amount they must collect ($23.3 million), but with less manufacturers to collect from, the rates had to be raised.

*This article is an update from our January 2021 article on these fees. At that time, the FDA decided to remove those fees and has now decided to re-instate.

For more information, see the FDA’s Federal Register Notice.