Over-the-counter drug
In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care.
OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) and strengths of final products.
[5][6][7][8] By 2018, the prevalence of use by adults in the U.S. as first-line treatment for minor illnesses had reached 81%: however, there is some debate as to whether this figure relates to an actual improvement of health.
The lack of a legal definition for OTC drugs has led to this US$4 billion market segment being effectively unregulated.
The drugs are usually on the shelves, and the store also sells items like toys, gadgets, perfumes and homeopathic products.
In the United States, the manufacture and sale of OTC substances are regulated by the Food and Drug Administration.
Examples of OTC substances approved in the United States 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.
[19] An ill-defined third category of substances is products having over-the-counter status from the FDA while being simultaneously subject to other restrictions on sale.
After initial attempts to control methamphetamine use (by requiring documentation of sale with government issued ID as well as limits on the quantity an individual could purchase) failed to realize meaningful reductions in methamphetamine use and production, Mississippi passed House Bill 512 in the State Senate on February 2, 2010 "to require a prescription from a licensed medical professional to purchase over-the-counter medicines with pseudoephedrine, ephedrine, or any other precursor chemical that can readily and illicitly be converted into methamphetamine, methcathinone or any active/scheduled analogs of phenylethylamines/amphetamine.
However, on February 25, 2014, the FDA approved generic one-pill emergency contraception products for unrestricted sale on the shelf.
Such drugs are sold without a prescription but are subject to record-keeping rules and quantity and/or age restrictions, and they must be dispensed by a pharmacy.
[22] Finally, pharmacies frequently require a prescription for Schedule V drugs as a matter of policy, despite their OTC status according to applicable laws and regulations.
No [POM], [P] or [GSL] products that are stocked in a pharmacy can be sold, dispensed, or pre-made until a responsible pharmacist is signed in and on the premises.
Frequently, customers buying larger-than-usual doses of [P] medicines (such as DXM, promethazine, codeine or Gee's Linctus) will be queried, due to the possibility of abuse.
[24] As a general rule, over-the-counter drugs have to be used primarily 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.
[28] Ranitidine was suspended in multiple markets due to concerns over the presence of the carcinogen N-nitrosodimethylamine (NDMA).
[29][30][31][32] In the United Kingdom, it was announced in February 2007 that Boots the Chemist would try over-the-counter sales of Viagra in stores in Manchester, England (previous available as prescription only).
