Bringing OTC Drugs to Market

Over-the-counter (OTC) drugs, products that can be used without a prescriber’s authorization, are developed under the OTC Monograph Process.  This three-phase process was established to ensure that OTC drugs were safe and effective for use by the general public.  One of the most important aspects of this process is what you define as and how the FDA considers your products intended use.

Your products intended use(s) is very important because it can affect how your product will be regulated and whether it will be regulated as a prescription or OTC drug.  The FDA determines your product’s intended use by its labeling claims that are including on your website, advertising, and oral and written statements by manufacturers and sponsors.

In general, the characteristics of an OTC drug are the following:

  1. There is a safety margin that is acceptable and considered safe to the general public
  2. There is a low abuse and misuse potential
  3. It can be used safely without the need for a healthcare professional to be involved
  4. It is adequately labelled

As with any FDA approval process, we highly suggest you work with a regulatory consultant to understand the specific nuances of your product and subsequent processes you must undertake.  But to get a general overview, here is an outline of the phases of OTC drug regulation process.

Phase 1: Review panels determine if the active ingredients of your drug can be safe and effective for use in self-treatment

Phase 2: Review of each active ingredient by the FDA, public comments, and any new data that has become available since Phase 1 concluded

Phase 3: Publication of conclusions from review process and subsequent regulations

Free ebook download: Learn the 4-step process that simplifies the site  budgeting process.

Additional FDA resources to help you in OTC drug development processes

Development and Regulatory issues:

Briefly describes OTC approval through a NDA application or through the monograph process. Also has contact info for FDA personnel to help with labelling and marketing questions.

Drug Applications:

Provides a general overview of the monograph process and additional resources for the application process.

FAQ on the regulatory process:

Provides answers to frequently asked questions; mostly on the monograph system and labelling.

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