What OTC drugs

OTC (Over-The-Counter) drugs, also known as non-prescription drugs, FDA has acknowledged that the term "counter purchase of drugs." Drugs sold in the United States nearly 40O, OOO, of which more than 300,000 of OTC drugs. Access to medicines in the United States, there are two main channels: either according to the prescribed prescription drugs, or to consumers directly purchase 0TC drugs.

care costs increase, and the United States safer and more effective OTC appearance, prompting the patient to self-treat disease, which in the past can not be non-recourse to professional medical care. This trend makes the access to prescription drugs used to increase the chances, because these sections have been included in the prescription drugs non-prescription drugs range. These non-prescription drugs to provide consumers a wider choice and opportunity.

the United States issued the first drugs designed to manage major federal regulations in 1906, "Federal Food and Drugs Act," but until 1938, adopted the "Federal Food, Drug, and Cosmetic Regulations" was From a legal limit on the safety of drugs. Since 1933, this new law, legislation has been considered. Just as people used this recently sold toxic solvent diethylene glycol mix of dapsone sulfanilamide elixir, resulting in 100 deaths, many of which are children. This incident eventually led to the formation of laws and regulations. 1938 "Federal Food, Drug and Cosmetic Act" requirements, the market in 1938 after all the drug product should be confirmed before the sale is safe for human use, often referred to as the original under the terms of the requirements in 1938 The products listed are not new drug application (NDA) Terms and Conditions. However, some current sales of OTC drugs, such as aspirin, still the impact of the provision, in addition, FDA review of OTC drugs, has accredited all OTC drug safety, efficacy and labeling, whether on sale The date is when. In the U.S. the new drug application process, prescription drugs can be re-classified as OTC drugs, and to retain its status of new drugs. OTC drugs can also be directly approved new drug application (not reclassified), such as different T phenylpropionate 2OOmg (never used the prescription dose). When a new drug used for many years by many patients, it can be seen as a generally recognized safe and effective. Through the FDA review of OTC drug, you can get all the recognition status. Review is completed, all new drugs are not approved as OTC drugs will be attributed to OTC drug monograph (see "OTC monograph meaning"). drugs,drugs question and answers

1972 OTC drug review began before, FDA is not a specific subordinate unit to deal with our existing sales of OTC drugs. At first, drug officials to help sell the advisory review panel reviewed the ingredients of OTC drugs, labels, and warning and announced the resulting federal document file. 1977, including the Medicines Evaluation and Research fair to (CDER) of the Ministry of OTC drug review, including a larger, more formal organization was set up. However, when the majority of drug related issues (including re-classification and applications) is in the drug evaluation and research department in the center of a drug rather than by the OTC drug department.

OTC Medicines Evaluation Division was reorganized in 1991 as the OTC drug review office. It is responsible for fulfilling the new drug application and evaluation of new drugs prescription drugs conversion work of the department. It includes a monograph review staff, a medical examination and a drug policy staff. They are assigned the same time raised the issue of OTC drugs, OTC drugs such as prescription drugs eleven conversion, the new OTC drugs, international coordination, as well as health care costs for the necessary monitoring.
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2. Since 1981, the final dissolution of OTC drug advisory group, advisory group has no specific routine examination OTC issues. Sometimes, prescription drug care by a permanent inter-group review of OTC ingredients.

1991 The FDA announced the establishment of the Advisory Committee of non-prescription drugs, OTC drug review and evaluation of safety and effectiveness, and as a convert to all kinds of prescription drugs non-prescription drugs when the exchange of views on the place. Set up a 10-member with extensive experience and expertise of the core committee members are internal medicine, obstetrics and gynecology, dermatology, epidemiology, medicine, clinical pharmacology, pediatrics and related fields knowledgeable experts. On a topic to discuss when the central committee can absorb other FDA committees with expertise on the issue of experts participate in the discussion. For example, consider topical agents, then I can invite a number of skin disease experts. The new committee also includes a consumer representative and one non-voting industry liaison. December 1992 held its first meeting to consider the pharmacy OTC products in the role of alcohol, provision of drugs for the smaller oral dose.
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OTC: Over The Counter
refers to non-prescription drugs!

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