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美国的药品管理历史与大多数发达国家相似,并且反映了政府越来越多的参与进去,努力保证只有安全有效的药物才能在市场上流通,并且确保都是使用了合理的制造和销售方式。初期的美国法律,为了应对当时假冒伪劣食品和药物在市场上的猖獗情况,1906年通过了《纯净食品和药品法》(Pure Food and Drug Act)。但是这一法律仅仅给予了联邦政府从市场上撤除任何伪造或者假冒产品的权利。但是联邦政府负有证明其假冒或者伪造的义务。
The history of drug administration in the United States is similar to that in most developed countries and reflects the increasing involvement of the government in trying to ensure that only safe and effective drugs are available in the market and that they are made using sound manufacturing and marketing methods. Initial U.S. law passed the Pure Food and Drug Act of 1906 in response to the prevailing market conditions of counterfeit food and drugs at that time. However, this law only gives the federal government the right to remove any counterfeit or counterfeit products from the market. But the federal government has an obligation to prove its counterfeit or forgery.