Over-the-counter

Over-the-counter (OTC) refers to the sale of pharmaceutical drugs that can be bought without a prescription. These drugs are considered safe and effective for use by the general public without needing the direct supervision of a healthcare professional. The availability of OTC drugs provides individuals with a convenient and less expensive means of treating common or minor ailments.

Regulation

OTC drugs are 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.

In the United States, the Food and Drug Administration (FDA) is responsible for regulating OTC drugs. The FDA requires that all new drugs obtain a New Drug Application (NDA) before entering the market. However, certain drugs are recognized as safe and effective under the conditions of use described in the labeling, and thus are permitted to be marketed OTC.

Classification

OTC drugs are typically divided into three categories:

• General items, which may be sold without a prescription, like analgesics.
• Pharmacy medicines, which may be sold without a prescription but must be kept in a locked container.
• Schedule 1 pharmacy medications, which must be sold in a pharmacy by a pharmacist.

Safety

While OTC drugs are deemed safe for public consumption, there are risks involved with their use. These include potential misuse, adverse reactions, drug interactions, allergic reactions, and overdoses. It is important for individuals to read and understand the drug facts label before use.

See also

• Prescription drug
• Pharmacy
• Food and Drug Administration

Over-the-counter Resources
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