Over-the-Counter

Over-the-counter (OTC) medications are drugs that are available to a consumer without a prescription from a healthcare professional. This differs from prescription drugs, which require the purchaser to obtain a valid prescription from a provider.

In the United States, the Food and Drug Administration (FDA) regulates the manufacture and sale of OTC substances. Under the Federal Food, Drug, and Cosmetic Act, all new drugs or drug ingredients must obtain approval though a New Drug Application (NDA).

Drugs that have been market for years before the NDA requirements are evaluated differently. The regulation of the active ingredients in OTC drugs, not the final product, is referred to as OTC monographs. By regulating active ingredients instead of specific drug formulations, the government allows manufacturers the freedom to develop proprietary mixtures, by formulating ingredients.

While the FDA regulates the advertising of prescription medications, the U.S. Federal Trade Commission (FTC) regulates OTC drug advertising. The FDA regulates product labeling of OTC products. To make the labels consistent and easier for the consumer to read, the FDA issued a regulation requiring that all OTC product labels must comply with a standard format. The “Drug Facts” label must include: active ingredients, uses, warnings, directions and inactive ingredients.

The FDA classifies OTC drugs in over 80 categories including: allergy medications, cold relievers and cough suppressants, pain relievers, sleep aids, diet aids, and anti cough/cold medications, pain relievers, antacids, laxatives, sleep aids, and antibacterial drugs.