Overview:

On December 28, 2020 , the U.S. Food and Drug Administration ( FDA) announced the rates for over the counter (OTC) monograph drug user fees for fiscal year (FY) 2021. The Federal Register Notice (FRN) establishes fees with respect to OTC monograph drug facilities and OTC Monograph Order Requests (OMORs) for FY 2021. The FRN includes information about facility fee calculations, OMOR fee calculations, fee due dates, and fee payment options and procedures.

OTC monograph drug facility fees for FY 2021 will be due 45 days after publication of the FRN. These fees are effective as of October 1, 2020 and will remain in effect through September 30, 2021.

OTC FY2021 Fees

Calculation of OTC Monograph Drug Fees depend on both the Facility Classification; either Monograph Drug Facility (MDF) or a contract manufacturing organization (CMO) and also based on whether the OMOR at issue is a Tier 1 or Tier 2 OMOR.

 For FY 2021, the OMUFA fee rates are as follows:

  • Tier 1 OMOR fees ($500,000),
  • Tier 2 OMOR fees ($100,000),
  • MDF facility fees ($14,060),
  • CMO facility fees ($9,373).

Regulatory Corner:

On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). 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.

Section 744M of the Federal Food, Drug, and Cosmetic Act, as added by the CARES Act, establishes an OTC monograph drug user fee program, under which FDA will assess and collect fees from submitters of OMORs as well as facility fees from certain manufacturers of OTC monograph drugs, to support the agency’s OTC monograph drug activities.

What is an OTC monograph Drug?

An OTC monograph drug is a nonprescription drug without an approved new drug application which is governed by the provisions of section 505G of the FD&C Act ((21 U.S.C. 355h); see section 744L(5) of the FD&C Act);

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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