Drug Regulation
Quiz yourself by thinking what should be in
each of the black spaces below before clicking
on it to display the answer.
Help!
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| Food and Drug Act of 1906 | prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. Government pre-approval of drugs is required
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| 1911 Sherley Amendment | It prohibits false and misleading claims about the therapeutic effects of a drug
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| 1938 Food, Drug and Cosmetic (FDC) Act | requires new drugs be shown to be safe before marketing
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| 1950 Alberty Food Prducts v. U.S. | the purpose for which a drug is to be used must be included in the label
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| 1951 Durham-Humphrey Amendment | defines what drugs require a prescription by a licensed practitioner and requires them to include this legend: "Caution: Federal law prohibits dispensing without a prescription"
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| 1962 Kefauver-Harris Amendment | requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug
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| 1966 Fair Packaging and Labeling Act | requires all consumer products in interstate commerce to be honestly and informatively labeled
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| 1970 Poison Prevention Packaging Act | requires child-proof packaging on all controlled and most prescription drugs
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| 1970 Controlled Substances Act (CSA) | classifies drugs that may be easily abused and restricts their distribution
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| 1976 Medical Device Amendment | requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices
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| 1983 Orphan Drug Act | provides incentives to promote research, approval and marketing of drugs needed for the treatment of rare diseases
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| 1987 Prescription Drug Marketing Act | restricts distribution of prescription drugs to legitimate commercial channels and requires drug wholesalers to be licensed by the states
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| 1990 Omnibus Budget Reconciliation Act (OBRA) | requires pharmacists to offer counseling to Medicaid patients regarding medications
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| 1996 Health Insurance Portability and Accountability Act (HIPAA) | protects patients' right to privacy
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