The United States Food and Drug Administration reforms the Over the Counter (OTC) process under the CARES Act signed by Congress in March ’20 to provide emergency relief affected by the COVID-19 pandemic.

Regulatory Pathways to market OTC drugs:

  1. NDA/ANDA: The application is submitted to the FDA for safety and efficacy review. Once approved, the drug can be marketed. This is product specific.
  2. OTC Monograph: No approval is needed for marketing. However, the drug should comply with Section 505(g) of the FD&C Act.

OTC process Prior to the Cares Act:

Prior to the CARES Act, drugs were designated as GRASE or NOT GRASE, established under therapeutic drug class in OTC monographs. The act results in 2 conclusions for OTC products,

  • Obtaining FDA review of the OTC ingredients for active ingredients in the sunscreens which are subject to their own review but can now transfer review.
  • Clarify the regulatory status of OTC products, whether to follow the final monograph or are subject to NDA approval process.

What the CARES ACT Changes:

The CARES act introduces 2 new aspects of drug review process:

  1. Provides the FDA the right to collect user fees
  2. Provides 18 months exclusivity period for the new OTC drugs that are approved the administrative order process.

OTC Monograph Drug Regulation Before and After CARES Act:

What Stays the same?

What new?

 Ingredient Based Review

 Administrative order process

APIs grouped by therapeutic action

OTC order request

GRASE category determination

OTC monograph User fees

Drugs that comply with OTC monograph can be marketed without FDA approval

 Clarification of status of previously monograph drugs falling under the category of TFM and ANPR


 Exclusivity period of monograph drugs

OTC User Fees Program (OMUFA):

FDA establishes OTC User Fees Program (OMUFA) through which it will collect fees from the manufacturers. FDA will collect 2 types of fees:

Facility Fee

  • Annual fees
  • Starts in 2021
  • Due on the later of the first business day of July 2020 or 45 calendar days after the notice of federal register

OTC Monograph Order Request (OMOR) fees

These are due on submission of OMOR and are of 2 types:

Tier 1
  • A fee of $500,000 (adjusted for inflation) of OTC monograph order request
  • Tier 1 is any request not determined to be Tier 2 request
Tier 2
  • A fee of $100,000 (adjusted for inflation) of OTC monograph order request
  • Tier 2 requests includes,
  • Changes to drug facts labels;
  • Standardization of the concentration or dose of a specific finalized ingredient within a finalized monograph;
  • A change to ingredient nomenclature to align with nomenclature of a standards-setting organization; or
  • Addition of an interchangeable term in accordance with 21 C.F.R. §330.1. 

Regulatory Corner:

OTC Drug Product Characteristics:

OTC Product can be adequately labeled such that;

    • The consumer can self-diagnose, self-treat, and self-manage the condition being treated
    •  No health practitioner is needed for the safe and effective use of the product
    •  Drug has low potential for misuse and abuse
    •  Safety margin is such that the benefits of OTC availability outweigh the risks

What does GRASE mean?

GRASE = Generally Recognized As Safe and Effective

What is a User Fee?

  •  Not a tax
  • The payor of a user fee receives a benefit for having paid the fee
  • There is a direct relationship between the amount of total fee revenue and FDA’s total cost of providing the service
  • The fee defrays the cost of a government service; the government does not make a profit

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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