US FDA Announces OTC Monograph Drug User Fees

Dec. 30 2020

The U.S. Food and Drug Administration (FDA) has announced the over-the-counter (OTC) monograph drug user fee program (OMUFA) facility fee rates for fiscal year 2021. As part of the Over-the-Counter Drug Monograph, Safety, Innovation, and Reform bill enacted in March 2020, the FDA was authorized to collect user fees from certain manufacturers of OTC monograph drug products. Companies that manufacture or process finished dosage forms of an OTC monograph drug product (known as a Monograph Drug Facility or MDF) will have to pay the full facility fee of $14,060. “A contract manufacturing organization (CMO) facility [that] is an OTC monograph drug facility where neither the owner nor any affiliate of the owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States” will have to pay a facility fee of $9,373.

Facility fees are due within 45 days of the Federal Register posting and are effective as of October 1, 2020 and will remain in effect through September 30, 2021. However, “OTC monograph drug facilities are exempt from the Fiscal Year 2021 facility fees if they ceased OTC monograph drug activities, and updated their registration with the FDA to that effect, prior to December, 2019.”

Click to view the Federal Register posting.

Background
On March 27, 2020, as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the Over-the-Counter Drug Monograph Safety, Innovation, and Reform Bill was signed into law. The bill is intended to modernize OTC drug monograph review, which should speed up the approval of new monographs and changes to existing monographs.

Click to view the OTC Monograph Reform Bill newsbyte for additional information.

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