联邦食品、药品和化妆品法案 參考資料 导航菜单75-717S. 5Food, Drug, and Cosmetic Law Research GuideHomeopathic Drugs, Royal Copeland, and Federal Drug RegulationASHP Website : News Article存檔

美國法律食品法健康照護品質


美国国会美国食品药品监督管理局Royal S. Copeland磺胺二甘醇




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联邦食品、药品和化妆品法案

美国官方大纹章

缩写
（通俗）

FFDCA, "FD&C Act"
制定者
75届美国国会
参考文献
公法
75-717
法律汇编（英语：United States Statutes at Large）
52 Stat. 1040
法案编纂
法案废除
纯净食品及药品法案（英语：Pure Food and Drug Act）
法卷修订
美国法典第21篇（英语：Title 21 of the United States Code）

法典创建
第9章第301节及以下
立法历程


  • 参议院提案：S. 5， Royal Copeland (D–NY)， 1938年3月5日


  • 委员会审核：美国众议院能源及贸易委员会（英语：United States House Committee on Energy and Commerce）


  • 众议院通过：1938年6月1日（修改后同意）


  • 参议院通过：1938年6月2日（否决）


  • 联合委员会听证：1938年6月11日 众议院同意通过： 1938年6月15日（同意） 参议院同意通过：1938年6月15日（同意）


  • 总统签署生效：富兰克林·罗斯福，1938年6月25日


主要修正案


  • 1951 Food, Drug, and Cosmetics Act Amendments, PL 82–215, 65 Stat 648


  • 1962 Food, Drug, and Cosmetics Act Amendments, PL 87–781, 76 Stat 780


  • Fair Packaging and Labeling Act, PL 89–755, 80 Stat 1296


  • Medical Device Regulation Act, PL 94–295, 90 Stat 539


  • Radiation Control for Safety and Health Act, PL 90-602, 82 Stat 1173


  • Drug Price Competition and Patent Term Restoration Act of 1984, PL 98-471, 98 Stat 1585


  • Nutrition Labeling and Education Act (1990), PL 101-535, 104 Stat 2353


  • Safe Medical Device Amendments of 1990, PL 101-629, 104 Stat 4511


  • Food and Drug Administration Revitalization Act (1990), PL 101-635, 104 Stat 4583


  • Dietary Supplement Health and Education Act (1994), PL 103-417, 108 Stat 4332


  • Food and Drug Administration Modernization Act of 1997, PL 105-115, 111 Stat 2296


  • Food and Drug Administration Amendments Act of 2007, PL 110-85, 121 Stat 823[1]

美国联邦食品、药品和化妆品法案（常缩写为FFDCA，FDCA，或FD&C）是美国国会在1938年通过的一系列法案的总称，赋予美国食品药品监督管理局（FDA）监督监管食品安全、药品、及化妆品的权力。该法案主要是由Royal S. Copeland写成，其为一三年期的纽约州参议员。[2]该法案通过后又历经多次修改。


催生该法案的主要原因之一是因为一种磺胺药物中所使用的溶剂二甘醇导致100多名病人死亡。[3]这部法案诞生后取代了1906年通过的纯净食品及药品法案（英语：Pure Food and Drug Act）。



參考資料




  1. ^ "Food, Drug, and Cosmetic Law Research Guide," Georgetown Law Library


  2. ^ Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation


  3. ^ ASHP Website : News Article 互联网档案馆的存檔，存档日期2007-09-27.








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