Over the Counter

Over-the-counter” redirects here. For the securities trading method, see Over-the-counter (finance).

OTC medication with child-resistant packaging (cap) and tamper-resistant carton and innerseal

Photo of the packaging of four medicines showing their Product Licence Numbers and symbols denoting if they are Prescription Only Medicine (POM) or Pharmacy Medicine (P)

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional.

As opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription.

In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician’s care.

OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products.
By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.

In the United States, the manufacture and sale of OTC substances are regulated by the Food and Drug Administration.

The FDA requires that all “new drugs” obtain a New Drug Application (NDA) before entering interstate commerce, but the act exempts any drugs generally recognized as safe and effective (GRAS/E).

To deal with the vast number of OTC drugs that were already on the market before the requirement that all drugs obtain an NDA, the FDA created the OTC monograph system to review classes of drugs and categorize them as GRAS/E after reviewing by expert panels.

Certain classes of OTC drugs would not be required to obtain an NDA and could remain on the market if they conformed to the monograph guidelines for doses, labeling, and warnings finalized in the Code of Federal Regulations