There are two types of drugs in the U.S.: prescription and nonprescription (OTC). Both must be safe and effective for their intended use and approved by FDA. OTC medicines differ from Rx drugs in the following ways:
Margin of safety: Since their intended use is not supervised by a doctor or other prescriber, OTCs need to have a wider margin of safety than Rx drugs.
Labeling: By law, OTC medicine labeling must include all the information that an ordinary consumer needs for the safe and effective use of the product. Drug Facts is the name given to the type of label format on the majority of OTCs.
Advertising: FDA oversees Rx medicine advertising. In contrast, the U.S. Federal Trade Commission (FTC) has authority over OTC medicine advertising, just as it does for other consumer products.
Distribution: The majority of OTC medicines can be sold in any of the approximately 750,000 retail outlets in the United States—supermarkets, mass merchandisers, pharmacies, etc.—unlike Rx drugs which are limited to roughly 55,000 pharmacies.
