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  6. Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act
  1. Over-the-Counter OTC | Nonprescription Drugs

Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act

Information about Over-the-Counter (OTC) Monograph Reform

About OTC Monograph Reform

On Friday, March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law to aid response efforts and ease the economic impact of COVID-19. In addition to the COVID-19 response efforts, the CARES Act includes statutory provisions that reform and modernize the way OTC monograph drugs are regulated in the United States. Specifically, the CARES Act replaces the rulemaking process with an administrative order process for issuing, revising, and amending OTC monographs. The CARES Act also provides FDA the authority to assess and collect user fees dedicated to OTC monograph drug activities. FDA anticipates that this user fee program will provide additional resources to help the agency conduct these important regulatory activities in a timely manner and ultimately help provide the public with access to innovative OTC monograph drugs. On March 26, 2021, FDA updated and reissued the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2021 in a Federal Register Notice (FRN) titled “Fee Rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021.”

In support of the law, the Over the Counter Monograph User Fees Program Performance Goals and Procedures document was drafted to specify FDA and industry mutually agreed upon timelines. FDA has updated the dates (See Updated Over-the-Counter Monograph User Fee Program Performance Goals Dates– Fiscal Years 2021-2025) to be used for purposes of the Over-the-Counter Monograph User Fee Program Performance Goals and Procedures (OMUFA goals letter) to reflect that FY 2021 is the first program year, per the statutory authority for OMUFA fees enacted under the Coronavirus Aid, Relief, and Economic Security (CARES) Act. This updating aligns with language in the OMUFA goals letter stating that although it was drafted under the assumption that FY 2018 would be the first program year, "If the program has a different effective date, goal dates…will need to be adjusted accordingly." The updated goals dates should be referred to in place of the "Summary of Dates of Specified Activities under OMUFA" table on pages 34-37 of the OMUFA goals letter.

OTC Monographs@FDA

OTC Monographs@FDA will provide the public with the ability to search for proposed and final administrative orders that add, remove or change conditions for an OTC drug monograph. OTC Monographs@FDA will also provide the public with an opportunity to submit comments and data to proposed administrative orders.

FDA anticipates OTC Monographs@FDA to available to the public in fiscal year 2021.

Recent Communications

Presentations

Meetings

User Fees

FY 2021 OMOR Fee Rates
Tier 1 $500,000
Tier 2 $100,000
FY 2021 Facility User Fee Rates
Monograph Drug Facility (MDF) Facility Fee $20,322
Contract Manufacturing Organization (CMO) Facility Fee $13,548
 

Frequently Asked Questions, by topic


General Information


Administrative Orders and OTC Monograph Order Requests (OMOR)


User Fees

FY 2021 OMOR Fee Rates
Tier 1 $500,000
Tier 2 $100,000
FY 2021 Facility User Fee Rates
Monograph Drug Facility (MDF) Facility Fee $20,322
Contract Manufacturing Organization (CMO) Facility Fee $13,548
 

Meetings


Status of Existing OTC Monograph Products


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