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  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

Latest News

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.” On March 16, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022 in a Federal Register Notice (FRN) titled “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2022.”

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

FDA created a new public facing web-portal, OTC Monographs@FDA, that provides the public with the ability to view OTC monographs and proposed and final administrative orders that add, remove, or change conditions for an OTC monograph.

OTC Monographs@FDA also facilitates the submission of comments and data from stakeholders for proposed administrative orders. 

To access the proposed and final administrative orders, go to OTC Monographs@FDA. Under the “Administrative Orders” banner, click on the desired link under the “Order ID” heading and follow the prompts.

To access the OTC Monographs, under the “OTC Monographs” banner, click on the desired link under the “OTC Monograph ID” heading and follow the prompts.

Annual Forecast

On October 1, 2021, FDA posted the first Annual Forecast for Planned Monograph Activities. The Annual Forecast is a nonbinding list, issued each year, of planned monograph activities that FDA intends to address over the upcoming three years.  
More information is available in the FAQs section below.

Recent Communications

Presentations

Meetings

User Fees

FY 2022 Facility User Fee Rates
Monograph Drug Facility (MDF) Facility Fee $24,178
Contract Manufacturing Organization (CMO) Facility Fee $16,119
 
FY 2022 OMOR Fee Rates
Tier 1 $507,021
Tier 2 $101,404

Frequently Asked Questions, by topic


General Information


Administrative Orders and OTC Monograph Order Requests (OMOR)


Deemed Final Orders


User Fees

FY 2022 Facility User Fee Rates
Monograph Drug Facility (MDF) Facility Fee $24,178
Contract Manufacturing Organization (CMO) Facility Fee $16,119
 
FY 2022 OMOR Fee Rates
Tier 1 $507,201
Tier 2 $101,404

Meetings


Annual Forecast for Planned Monograph Activities


Status of Existing OTC Monograph Products


Contact Us

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