In March 2020, provisions were added to the Federal Food, Drug, and Cosmetic Act by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which authorize FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. The fees are to support FDA’s OTC monograph drug activities including review and inspection of facilities associated with such products.

Does this apply to your company?

The facility fee for 2021 applies to any foreign or domestic facility engaged in manufacturing or processing a finished dosage form of an OTC monograph drug to be sold in the USA during the period between January 2020 and December 2020. This includes all facilities that perform the following business operations: finished dosage form manufacture, label, manufacture, pack, relabel, or repack. It also applies to submitters of an OTC Monograph Order Request (OMOR), except for those which request certain safety-related changes with respect to an OTC monograph drug. If your facility is solely manufacturing OTC hand sanitizer products, such a facility is not subject to the OTC Monograph Drug user fee program facility fee.

How much do you owe and when?

If you are an OTC monograph drug facility (MDF) – USD 20,322

If you are a contract manufacturing organization (CMO) – USD 13,548

If you submit a Tier 1 OMOR – USD 500,000

If you submit a Tier 2 OMOR – USD 100,000

Note: The above fees are for the period from Oct. 1, 2020 through Sep. 30, 2021.

Payment is due no later than May 10, 2021.

If you need assistance with determining whether the FDA OTC Monograph Drug user fee program applies to your company or you have any questions relating to payment options, please do not hesitate to contact us.