FDA – OTC Monograph Reform under the CARES Act – What to Know?

FDA – OTC Monograph Reform under the CARES Act – What to Know?

August 6, 2020 By

In the US, drugs may either be prescription drugs, requiring a prescription by an authorized health care provider, or they may be over-the-counter (OTC) drugs, which are purchased directly by a consumer without a prescription. Each drug category has a different path to market, and the process demonstrating the safety and efficacy differs between prescription drugs and OTC drugs.

Prescription drugs require submission of a new drug application (NDA) to the FDA for approval for the safety and efficacy of the drug for its intended use/s, prior to going to market. On the other hand, for the most part, OTC drugs do not require approval or a licence. Instead, OTCs come to the market via the OTC monograph pathway. In a number of cases, some drugs do not fully align with an OTC parameter and are required to receive approval via the NDA pathway prior to marketing the drug.  Importantly, OTC drugs are considered by the FDA to be safe and effective for consumer use as per the label directions and warnings for the intended use and are specified for medical conditions that consumers may self-diagnose. Due to the self-diagnosis of such drugs, OTCs have a higher margin of safety, compared to a prescription or new drug. OTC monographs cover ~ 800 active ingredients for over 1400 uses and authorizing over 100,000 drugs. There have recently been some significant changes to this pathway, which originally established in the 1970s by the US FDA with the OTC review process.

On March 27th 2020, the President signed the Coronavirus Aid, Relief and Economic Security (CARES) Act into law (HR 748).1 The CARES Act contains important legislative initiatives for Over-The-Counter (OTC) Monograph Reform to modernize the way in which OTC monograph drugs are regulated in the US. This reform replaces the rulemaking with new administrative orders, improves efficiency, timelines and predictability of the OTC monograph process, and expeditiously addresses safety, and establishes user fees to implement this new process.

The main changes to the OTC monograph reform under the initiatives are outlined here:

  • The Administrative order process rulemaking revisions – these will allow the FDA to issue an administrative order to revise an OTC drug monograph (adding, removing, or changing the conditions of use in order to ensure the drug is Generally Recognized As Safe and Effective, GRASE), in an expedited process, with set timelines, and can be initiated by the FDA or by the industry (abbreviated OMOR, for OTC monograph order request).
  • OTC monograph User Fees (OMUFA) – these include facility fees and an OTC monograph Order Request fee (for the person who submits an OTC monograph order request). These fees will fund the OTC monograph oversite and approval process.2
  • Formal meetings – the industry will be able to request formal meetings with the FDA.
  • Exclusivity period – 18 months of exclusivity for a new OTC drug (may also be for cases when new clinical study data prompts an administrative order for changes in conditions of use).
  • There will be a process for minor changes in dosage forms; for example, the FDA is scheduled to issue solid oral dosage forms order/guidance pair by April 1, 2025.
  • Clarification of status of an existing OTC drug, (which includes drugs that were previously subject to Tentative Final Monographs (TFMs) and Advance Notice of Proposed Rulemaking (ANPRs) – these are not final monographs).  

A few processes will remain the same for the OTC monograph reform, namely:

  • The OTC monograph processes – will remain as an ingredient-based review (especially in terms of grouping for therapeutic categories).
  • The GRASE determination remains the same.
  • Drugs may be marketed without FDA approval so long as they comply with the OTC and other applicable requirements.
  • The process includes a public comment period before the final order.

Over the coming months, the FDA will be providing more updates on the OTC Monograph Reform.  Various guidance resources will be provided under this new process, and the timelines for when to anticipate guidelines will be laid out in the goals document that serve to communicate performance goals.

For assistance in confirming that your product meets the FDA requirements set forth under the OTC monograph, contact dicentra today.


  1. https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process
  2. https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa