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15 Cards in this Set
- Front
- Back
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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
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Requires all consumer products in interstate commerce to be honestly and informatively labeled
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1970 Controlled Substances Act (CSA)
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Classifies drugs that may be easily abused and restricts their distribution. Enforced by the DEA w/in Justice Dept
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1987 Prescription Drug Marketing Act
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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)
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Requires pharmacists to offer counseling to Medicaid patients regarding meds
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1970 Poison Prevention Packaging Act
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Requires child-proof packaging on all controlled and most prescription drugs despensed by pharmacies
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1976 Medical Device Amendment
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Requires pre-market approval for safety and efectiveness of life-sustaining and life-supporting medical devices
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1983 Orphan Drug Act
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Provides incentives to promote research, approval and marketing of drugs needed for treatment of rare diseases
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1996 Health Insurance Portability and Accountability Act (HIPAA)
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Defines scope of health info that may and may not be shared among health care providers w/out patient consent and provides stringent regulations to protect patients 'right to privacy'
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Food and Drug Act of 1906
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Prohibits interstate commerce in adulterated or misbranded food, drinks, and drugs. Government pre-approval of drugs is required
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1927 Food, Drug and Insecticide Administration
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Law enforcement agency renamed in 1930 as FDA
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1950 Alberty Food Products v. US
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US Court of Appeals rules that the purpose for which a drug is to be used must be included on the label
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1911 Sherley Amendment
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Prohibits false and misleading claims about the "therapeutic" effects of a drug
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1938 Food, Drug and Cosmetic (FDC) Act
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In response to fatal poisoning of 107 people, mostly children, by an untested sulfanilamide concoction, this law requres new drugs be shown to be safe before marketing
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1951 Druham-Humphrey
Amendment |
Law that 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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