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drug laws

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Term
Definition
Food and Drug Act (1906)   Outlaws states from buying and selling food, drinks, and drugs that have been mislabeled and tainted.  
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Sherley Amendment (1912)   Outlaws labeling drugs with fake medical claims meant to trick the buyer.  
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FDA (1930)   Food and Drug Administration is named.  
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Federal Food, Drug, and Cosmetic (FDC) Act of 1938   Requires new drugs to be proven safe prior to marketing; starts a new system of drug regulation; requires safe limits for unavoidable poisonous substances; and allows for factory ispections.  
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Durham-Humphrey Amendment (1951)   Defines the types of drugs that cannot be used safely without medical supervision and limits the sale to prescription only by medical professionals.  
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Kefauver-Harris Drug Amendments (1962)   Requires manufacturers to prove that their drugs are effective prior to marketing.  
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Over-the-Counter Drug Review (1972)   Nonprescription medications must be safe, effective and appropriately labeled.  
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Tamper-Resistant Packaging Regulations (1982)   Makes it a crime to tamper with packaged products and requires tamper-proof packaging.  
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Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) ( 1984)   Allowed FDA to approve generic versions of brand-name drugs without repeating research to prove safety and efficacy; allowed brand-names to apply for 5 years of additional patents for new drugs to make up for lost time while going through FDA approval  
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Prescription Drug Marketing Act (1988)   Designed to eliminate diversion of products from legitamate channels of distribution and requires wholesalers to be licensed.  
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Food and Drug Administration Modernization Act (1997)   Expands scope of agency activities and moves agency to the Department of Health and Human Services (DHHS)  
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Medicare Prescription Drug Improvement and Modernization Act of 2003   Includes Medicare Part D which increases access to medications through private insurers.  
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