Chapter3_Spring2011

Chapter3_Spring2011 - Drug Use, Regulation, and the Law...

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Drug Use, Regulation, and the Law Chapter 3
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Guidelines for Controlling Drug Development and Marketing Society has the right to protect itself from the damaging impact of drug use. Society has the right to demand safe and effective drugs.
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Patent Medicines The term patent medicines signified that the ingredients were secret, not patented. The patent medicines of the late 1800s and early 1900s demonstrated the problems of insufficient regulation of the drug industry.
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The 1906 Pure Food and Drug Act Required manufacturers to include on labels the amounts of alcohol, morphine, opium, cocaine, heroin, or marijuana extract in each product Marked the beginning of involvement by the government in drug manufacturing Did not prohibit distribution of dangerous preparations
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The Sherley Amendment in 1912 Accuracy of manufacturers’ therapeutic claims was not controlled by the Pure Food and Drug Act. The Sherley Amendment in 1912 was passed to strengthen existing laws and required that labels should not contain “any statement. ..regarding the curative or therapeutic effect. ..which is false and fraudulent.”
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Food, Drug, and Cosmetic Act All non-narcotic drugs were available OTC prior to World War II. The sale and use of Elixir Sulfanilamide led to a tragic accident that killed over 100 people. Companies required to file applications with the government showing that new drugs were safe.
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Food, Drug, and Cosmetic Act (continued) Defined drugs to include products that affect bodily structure or function even in the absence of disease Drug label had to list all ingredients, as well as provide instructions regarding correct use and warnings about its dangers
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Durham-Humphrey Amendment Made formal distinction between prescription and nonprescription drugs
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Chapter3_Spring2011 - Drug Use, Regulation, and the Law...

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