OTC

OTC or Over-the-Counter refers to the drugs, medicines, or other medical products that can be bought without a prescription. These are typically used for self-treatment and are safe and effective when used as directed.

Overview

OTC drugs are available for purchase by the general public without needing a prescription from a healthcare professional. This is in contrast to prescription drugs, which require a prescription from a doctor or other healthcare professional and are regulated by the Food and Drug Administration (FDA). OTC drugs are regulated by the FDA through the OTC Drug Review.

History

The concept of OTC drugs has been in existence since the establishment of modern pharmacy regulations in the late 19th century. The Durham-Humphrey Amendment of 1951 formally established the legal basis for the distinction between prescription and OTC drugs in the United States.

Regulation

In the United States, the Food and Drug Administration (FDA) is responsible for regulating OTC drugs. The FDA's Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving new OTC drugs.

OTC drugs are categorized into different classes based on their therapeutic effect. These include analgesics, antacids, antihistamines, and cough suppressants, among others.

Safety and Risks

While OTC drugs are generally safe for use, they can pose risks if not used correctly. It is important for consumers to read and follow the drug facts label on the packaging. Some OTC drugs may interact with other drugs, have side effects, or be unsafe for use in certain populations.

See Also

• Prescription drug
• Food and Drug Administration
• Durham-Humphrey Amendment