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Over-the-counter drugs are medicines that may be sold without a prescription and without a visit to a medical professional, in contrast to prescription only medicines (POM).
In the United States, the manufacture and sale of OTC substances is regulated by the FDA. 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 New Drug Application (NDA), for products which do not fit within a specific monograph. Because an NDA is extremely expensive to obtain, due primarily to testing requirements, most OTC substances produced in the USA are manufactured pursuant to the applicable monograph. Typical OTC products manufactured pursuant to an FDA monograph are sunscreens, anti-microbial and anti-fungal products, external and internal analgesics such as lidocaine and aspirin, psoriasis and eczema topical treatments, anti-dandruff shampoos containing coal tar, and other topical products with a therapeutic effect.
In the United Kingdom, items may be restricted to sale only under the supervision of a pharmacist in a registered pharmacy — called (P) medicines — or may be sold in any general retail outlet without any professional supervision — called GSL (General Sales List) items. Restrictions apply both to which items may be sold (P) or GSL and to the quantities that may be purchased, such as for paracetamol.
The name "over-the-counter" is somewhat confusing, since GSL items are found on the shelves of stores and bought like any other packaged product.
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, lancets and insulin. 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 POM 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 codeine are available OTC (usually in strictly limited formulations or requiring paperwork or identification to be submitted during purchase). One of the oldest OTC drugs is aspirin.
Over time, drugs that prove themselves safe and appropriate for self-medication, may be switched from POM to OTC. An example of this is diphenhydramine (Benadryl®) which once required a prescription but now is available OTC nearly everywhere. More recent examples are cimetidine and loratadine in the United States.
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 US drugstores have begun moving products containing pseudoephedrine into locations where customers must ask a pharmacist for them. A prescription is not required; the change is being made in an effort to reduce methamphetamine production. Many US states have now passed laws requiring both location behind the counter, submission of identification and recordation of purchases.
See also
External links
OTC-Arzneimittel | Médicament de comptoir | Zelfzorgmedicijn | OTC | OTC | OTC | 非处方药
"Over-the-counter drug"