Over-the-counter (OTC) drugs are medicines that may be sold without a prescription, in contrast to prescription drugs. Medication, also referred to as medicine, can be loosely defined as any substance intended for use in the diagnosis cure mitigation treatment or prevention of disease A prescription (℞ is a health-care program implemented by a Physician or other medical practitioner in the form of instructions that govern the plan of care for an individual A prescription drug is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained 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. Self service is the practice of serving oneself usually when purchasing items 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.
|U.S. drug regulation|
In the United States, the manufacture and sale of OTC substances is regulated by the FDA. The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction A prescription drug is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained Over-the-counter (OTC drugs are medicines that may be sold without a prescription, in contrast to Prescription drugs The name "over-the-counter" The Federal Food, Drug, and Cosmetic Act requires that all "new drugs" are required to obtain a 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. The United States Federal Food Drug and Cosmetic Act (abbreviated as FFDCA FDCA or FD&C is a set of laws passed by Congress in 1938 giving authority to the The New Drug Application (NDA is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale 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 New Drug Application (NDA), for products which do not fit within a specific monograph. The New Drug Application (NDA is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale Because an NDA is extremely expensive to obtain, due primarily to testing requirements, most OTC substances produced in the USA 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. Lidocaine ( INN) (ˈlaɪdoʊkeɪn or lignocaine (former BAN) (/ˈlɪgnoʊkeɪn/ is a common Local anesthetic and antiarrhythmic drug Aspirin, or acetylsalicylic acid (ASA (əˌsɛtɨlsælɨˌsɪlɨk ˈæsɨd is a Salicylate drug, often used as an Analgesic to relieve Psoriasis (səˈraɪəsɪs ( suh-RI-uh-sus) is a non-contagious disorder which affects the Skin and Joints It commonly causes red scaly Eczema (from Greek έκζεμα) is a form of Dermatitis, or Inflammation of the Epidermis. Dandruff (also called scurf and historically termed Pityriasis capitis) is due to the excessive shedding of dead skin cells from the Scalp. Coal tar is a brown or black liquid of high Viscosity, which smells of Naphthalene and Aromatic hydrocarbons Coal tar is among the by-products when coal
The Federal Trade Commission regulates advertising of OTC products. The Federal Trade Commission ( FTC) is an independent agency of the United States government, established in 1914 by the Federal Trade Commission Act This is in contrast to prescription drug advertising, which is regulated by the FDA.
In the United Kingdom, medication will fall into one of three categories:
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.
In the US, medical devices may also be considered OTC. For example, most diabetic management supplies are available OTC. Diabetes mellitus (ˌdaɪəˈbiːtiːz or /ˌdaɪəˈbiːtəs/ /məˈlaɪtəs/ or /ˈmɛlətəs/ often referred to simply as diabetes ( Ancient Greek: grc The category of medical devices includes electronic blood glucose monitors, monitor test strips, and lancets. A medical device is an object which is useful for diagnostic or therapeutic purposes Blood sugar, used in a physiological context is a misnomer and misleading 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. A syringe is a simple piston Pump consisting of a plunger that fits tightly in a tube Drug addiction is widely considered a pathological state. The disorder of addiction involves the progression of acute Drug use to the development of drug-seeking Harm reduction is a Philosophy of Public health, intended to be a progressive alternative to the prohibition of certain potentially dangerous
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). Codeine ( INN) or methylmorphine is an Opiate used for its Analgesic, antitussive and antidiarrheal properties One of the oldest OTC drugs is aspirin. Aspirin, or acetylsalicylic acid (ASA (əˌsɛtɨlsælɨˌsɪlɨk ˈæsɨd is a Salicylate drug, often used as an Analgesic to relieve
Over time, drugs that prove themselves safe and appropriate for self-medication, may be switched from prescription to OTC. An example of this is diphenhydramine (Benadryl) which once required a prescription but now is available OTC nearly everywhere. Pharmacological action Diphenhydramine (dye fen hye' dra meen works by blocking the effect of histamine at H1 receptor sites Diphenhydramine is a deliriant, nevertheless, most recreational drug users find its effects uncomfortable rather than exciting. More recent examples are cimetidine and loratadine in the United States, and ibuprofen (Herron Blue/Nurofen) in Australia. Cimetidine ( INN) (sɨˈmɛtɨdiːn/ /saɪ- is a histamine H2-receptor antagonist that inhibits the production of acid in the Stomach. Loratadine is a drug used to treat allergies, and marketed for its non-sedating properties The United States of America —commonly referred to as the Ibuprofen ( INN) (ˌaɪbjuːˈpɹəʊfɛn (from the now outdated nomenclature i so- bu tyl- pro panoic- phen olic acid is a Non-steroidal For a topic outline on this subject see List of basic Australia topics.
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. Phenylpropanolamine (PPA is a drug ingredient of the Phenethylamine family used as a Decongestant in prescription and nonprescription (over the counter
Recently many U. S. drugstores have begun moving products containing pseudoephedrine into locations where customers must ask a pharmacist for them. Pseudoephedrine (commonly abbreviated as PSE is a sympathomimetic Amine commonly used as a Decongestant. A prescription is not required; the change is allegedly being made in an effort to reduce methamphetamine production. Since the passage of the Methamphetamine Precursor Control Act, the purchase of pseudoephedrine in the United States is restricted and the identity of the purchaser is required to be obtained and recorded. Pseudoephedrine (commonly abbreviated as PSE is a sympathomimetic Amine commonly used as a Decongestant. The United States of America —commonly referred to as the 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.