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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 President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) 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.

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. [Note: Dates of commitments will be updated to reflect the date of passage of the legislation.] 

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

Upcoming Events

None

Presentations

User Fees

Frequently Asked Questions, by topic

General Information

Administrative Orders and OTC Monograph Order Requests (OMOR)  

User Fees

FY 2021 Facility User Fee Rates 

Facility Fee

Facility fees will be published in a Federal Register notice

FY 2021 OMOR Fee Rates

Tier 1 

$500,000 

Tier 2 

$100,000 

Meetings

Status of Existing OTC Monograph Products

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