FDA-TRACK: Over-The-Counter Monograph Drug User Fee Program Performance OTC Monograph Order Requests

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OTC Monograph Order Request Submissions

Procedural Notifications and Responses

Meeting
Management

• • Current Performance
• • Historical Performance
• • Goals Summary

• • Current Performance
• • Historical Performance
• • Goals Summary

• • Current Performance
• • Historical Performance
• • Goals Summary

Relevant Links:

1. • OMUFA II Commitment Letter - FY 2026 to FY 2030
2. • OMUFA I Commitment Letter - FY 2021 to FY 2025
3. • OMUFA Performance Goals and Procedures
4. • Over-The-Counter Monograph Drug User Fee Program
5. • Coronavirus Aid, Relief, and Economic Security Act
6. • FDA-TRACK: OMUFA Performance Reports

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136) was signed into law.  In addition to aiding the COVID-19 response efforts, the CARES Act amended the FD&C Act to include statutory provisions that (1) reform and modernize the way over-the-counter (OTC) monograph drug products are regulated in the United States and (2) authorize the U.S. Food and Drug Administration (FDA or Agency) to assess and collect user fees from qualifying manufacturers of OTC monograph drug products and submitters of OTC monograph order requests.

Download OTC Monograph Order Request Submissions Dataset

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Footnotes:

•   ^ FY 2024 includes preliminary performance as of 9/30/2025.
•   * FY 2025 and FY 2026 includes preliminary performance as of 12/31/2025.

• ** Does not include Tier 1 Safety or Tier 1 GRASE OMORs, as those are reported separately. 

  ~ Beginning in OMUFA II, Tier 1 OMORs and Tier 2 OMORs are reported separately, and FDA is reporting on filed OMORs.  

  †† FDA did not receive any applicable OMOR submissions.