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Created with Fabric.js 1.4.5 Drug Regulations 1820 Eleven doctors set up the U.S. Pharmacopoeia and record the first list of standard drugs. 1848 Drug Importation Act passed by Congress requires U.S. Customs Service inspection tostop entry of tainted, low quality drugs from overseas. 1905 The American Medical Association (AMA) begins a voluntary program of drug approvalthat would last until 1955. In order to advertise in the AMA and related journals, drugcompanies must show proof that the drug will treat what they claim. 1937 Elixir Sulfanilamide, contain the poisonous liquid, diethylene glycol, kills 107 persons,many of whom are children, dramatizing the need to establish drug safety beforemarketing and to pass the pending food and drug law. 1938 Congress passes The Federal Food, Drug, and Cosmetic (FDC) Act of 1938, whichrequires that new drugs show safety before selling. This starts a new system of drugregulation. The Act also requires that safe limits be set for unavoidable poisonous matterand allows for factory inspections 1941 Nearly 300 deaths and injuries result from the use of sulfathiazole tablets, an antibiotic,tainted with the sedative, phenobarbital. In response, FDA drastically changesmanufacturing and quality controls. These changes lead to the development of goodmanufacturing practices (GMPs). 1951 Congress passes the Durham-Humphrey Amendment, which defines the kinds of drugsthat cannot be used safely without medical supervision. The amendment limits sale ofthese drugs to prescription only by a medical professional. All other drugs are to beavailable without a prescription. 1966 FDA contracts with the National Academy of Sciences/National Research Council tomeasure the effectiveness of 4,000 marketed drugs approved on the basis of safetyalone between 1938 and 1962. 1995 FDA declares cigarettes to be "drug delivery devices." Limits are issued on marketingand sales to reduce smoking by young people. 2002 The Best Pharmaceuticals for Children Act, in exchange for studying the drug inchildren, the drug maker gets six months of selling their product without competition. 2005 The Drug Safety Board is formed, consisting of FDA staff and representatives from theNational Institutes of Health and the Veterans Administration. The Board advises theDirector, Center for Drug Evaluation and Research, FDA, on drug safety issues andworks with the agency in sharing safety information to health professionals and patients. 1995
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