U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Bringing an Over-the-Counter (OTC) Drug to Market
OTC vs. Prescription
OTC Drug

An OTC drug is considered safe and effective for use by the general public without a prescriber's authorization.

Necessary characteristics for OTC drugs include:

  1. The product has an acceptable safety margin.
  2. The product has low misuse and abuse potential under conditions of widespread availability.
  3. A healthcare practitioner is not needed for the safe and effective use of the product.
  4. The product has adequate labeling.

In addition, consumers must be able to self-diagnose, self select the medication, self-treat, and self-manage the condition for which the OTC drug is intended.

A useful tip for identifying whether the condition(s) for which your product is intended are amenable to OTC use is to check and to see if the condition(s) are addressed under the OTC Drug Review (i.e., the OTC monographs), which is discussed in a later module.

Note that FDA's OTC Drug Review usually does not cover prescription drug products.

Select the hyperlinked text to learn more.

Bottle with pink liquid; dosing cup with pink liquid, an OTC drug with the words (does not require prescriber's authorization)
Click NEXT to continue.
Page 12 of 16
Back Button
Next Button