Over the counter

Over the Counter (OTC) refers to the sale of pharmaceutical drugs directly to a consumer without a prescription from a healthcare professional, as opposed to prescription drugs, which may be sold only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are ingredients that are safe and effective when used without a physician's care.

Regulation

OTC drugs are usually regulated by active pharmaceutical ingredients (APIs), not 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.

Availability

The availability of OTC drugs varies from country to country. In the United States, the manufacture and sale of OTC substances is 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 this exemption, the FDA established the OTC monograph system to review classes of drugs and to categorize them as GRAS/E after review by expert panels.

See also

• Prescription drug
• Pharmacy
• Food and Drug Administration

References

Over the counter Resources
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