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07-SEPTEMBER-2008 03:17:44 - Over-the-counter drug This article or section has multiple issues. Please help improve the article or discuss these issues on the talk page. It does not cite any references or sources. Please help improve it by citing reliable sources. Tagged since February 2008. It may not present a worldwide view of the subject. Tagged since February 2008. Over-the-counter OTC drugs are medicines that may be sold without a prescription, in contrast to 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. Contents 1 Regulation by country 1.1 United States 1.2 United Kingdom 2 Non-drug OTC products 3 Switches between prescription and OTC 4 See also 5 References Regulation by country United States U.S. drug regulation Prescription drugs Over-the-counter drugs Law Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption Government agencies United States Department of Health and Human Services Food and Drug Administration Drug Enforcement Administration National Institutes of Health Center for Drug Evaluation and Research Process Drug development New drug application Investigational new drug Clinical trial Phase I, II, III, IV Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval International coordination International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs Non-governmental organizations Institute of Medicine Research on Adverse Drug events And Reports This box: view talk In the United States, the manufacture and sale of OTC substances is regulated by the FDA. 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. 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. 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. 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: Prescription Only Medication, which is only available with a valid prescription from a doctor. A pharmacist has to be on the premises for POM medicines to be dispensed, required by law. The medicine has been specifically prescribed for the patient holding the prescription, so it is considered safe for only the recipient to take. POM Pharmacy Only Medication, containing chemicals, strengths or sizes which require more information, personal to the person taking the medication. The pharmacist will determine whether the medicine is safe for the particular customer based on their responses to a set of questions. P General Sale License, available off the shelf with no pharmacy training required to sell. Generally considered safe for most people when taken correctly. GSL Medication available only with a prescription is marked somewhere on the box/container with POM. Over-the-counter medicines are marked with P. A prescription is not required for P medicines and pharmacy sales assistants are required by law to ask certain questions, most of all, whether the patient is taking other medication, before selling these. It is with this information that the pharmacist can halt the sale, if need be. Some medication available in supermarkets and petrol stations is sold there only in smaller packet sizes. Often, larger packs will be marked as P and available only from a pharmacy. Frequently, customers buying larger than usual doses of P medicines such as Paracetamol will be queried, due to the possibility of abuse. 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 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 prescription to OTC. An example of this is diphenhydramine Benadryl which once required a prescription but now is available OTC nearly everywhere. 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. 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 into locations where customers must ask a pharmacist for them. 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. 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 Child-resistant packaging References Retrieved from http://en..org/wiki/Over-the-counter_drug Categories: Drugs | Pharmaceuticals policyHidden categories: Articles lacking sources from February 2008 | All articles lacking sources | Articles with limited geographic scope Views Article Discussion this page History Personal tools Log in / create account Navigation Main page Contents Featured content Current events Random article Search Go Search Interaction Community portal Recent changes Contact Donate to Help Toolbox What links here Related changes Upload file Special pages Printable version Permanent link Cite this page Languages العربية Deutsch Español Français Nederlands 日本語 Polski Svenska ไทย 中文 This page was last modified on 23 August 2008, at 21:15
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