Over-the-counter drug

Over-the-counter (OTC) drugs are medicines that may be sold without a prescription drugs. The name "over-the-counter" is somewhat confusing to some, since these items can be found on the shelves of stores and bought like any other packaged product in some countries or in others may be bought "over the counter" from the pharmacy, while prescription drugs are sold at a pharmacy counter. The term likely dates back to before self service shopping became common, when most goods were obtained by requesting them from a clerk at a sales counter; while prescription drugs required a visit to the doctor first, these drugs could be purchased "over the (sales) counter" just like other goods. Some medicines considered safe in general terms may be available in general stores, supermarkets, gas stations etc. The rules vary considerably from country to country.

Regulation by country

United States

In the United States, the manufacture and sale of OTC substances is regulated by the New Drug Application ("NDA") prior to entering interstate commerce, but the act exempts any drugs generally recognized as safe and effective ("GRAS/E") from this requirement. In order to fit the vast amount of OTC drugs that were already on the market prior to the requirement that all drugs obtain an NDA, the FDA created the OTC monograph system to review classes of drugs and categorize them as GRAS/E by regulation. This meant that certain classes of OTC drugs were not required to obtain an NDA and could remain on the market.

Thus, manufacture must be done either pursuant to an FDA monograph, which specifies types of OTC drugs, active ingredients and labeling requirements, or pursuant to a coal tar, and other topical products with a therapeutic effect.

The Federal Trade Commission regulates advertising of OTC products. This is in contrast to prescription drug advertising, which is regulated by the FDA.

United Kingdom

In the United Kingdom, medication will fall into one of three categories:

1. Prescription medication.
2. Medication dispensed only under the supervision of a pharmacist.
3. Unrestricted medication, available off the shelf.

Medication available only with a prescription is marked on the back of the box/container with [PoM] in a small box. Over-the-counter medicines are marked with [P] in a small box. A prescription is not required for these medicines and pharmacy sales assistants with the correct training can dispense such medicines, but the pharmacist must be nearby to be able to intervene in the sale if necessary. Some medication available in supermarkets and petrol stations is sold there only in smaller packet sizes. Larger packs will be marked [P] and available only from a pharmacy.

Non-drug OTC products

In the US, medical devices may also be considered OTC. For example, most diabetic management supplies are available OTC. The category of medical devices includes electronic blood glucose monitors, monitor test strips, and lancets. In some areas insulin syringes may also be available OTC; some areas have classified all syringes as limited OTC products as a measure of drug addiction harm reduction.

Switches between prescription and OTC

As a general rule, over-the-counter drugs have to be primarily used to treat a condition that does not require the direct supervision of a doctor and must be proven to be reasonably safe and well-tolerated. OTC drugs are usually also required to have little or no abuse potential, although in some areas drugs such as aspirin.

Over time, drugs that prove themselves safe and appropriate for self-medication, may be switched from prescription to OTC. An example of this is ibuprofen (Herron Blue/Nurofen®) in Australia.

It is somewhat unusual for an OTC drug to be withdrawn from the market as a result of safety concerns, rather than market forces, though it does happen occasionally, phenylpropanolamine being one example.

Recently many U.S. drugstores have begun moving products containing pseudoephedrine in the United States is restricted and the identity of the purchaser is required to be obtained and recorded. In addition, pseudoephedrine itself is a mild stimulant- somewhere between caffeine and ephedrine. Nonetheless, these products are still considered OTC since no prescription is required.

See also

• Pharmacy
• Medical prescription
• Regulation of therapeutic goods
• Generic drug