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15 Cards in this Set

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  • Back
1962 Kefauver-Harris
Amendment
Requires drug manufacturers to provide proof of both safety and efectiveness before marketing the drug
1966 Fair Packaging and Labeling Act
Requires all consumer products in interstate commerce to be honestly and informatively labeled
1970 Controlled Substances Act (CSA)
classifies drugs that may be easily abused and restricts their distribution. Enforced by the DEA w/in Justice Dept
1987 Prescription Drug Marketing Act
Restricts distribution of prescription drugs to legitimate commercial channels and requires drug wholesalers to be licensed by the states
1990 Omnibus Budget Reconciliation Act (OBRA)
requires pharmacists to offer counseling to Medicaid patients regarding meds
1970 Poison Prevention Packaging Act
requires child-proof packaging on all controlled and most prescription drugs despensed by pharmacies.
1976 Medical Device Amendment
requires pre-market approval for safety and efectiveness of life-sustaining and life-supporting medical devices
1983 Orphan Drug Act
provides incentives to promote research, approval and marketing of drugs needed for treatment of rare diseases
1996 Health Insurance Portability and Accountability Act (HIPAA)
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'
Food and Drug Act of 1906
prohibits interstae commerce in adulterated or misbranded food, drinks, and drugs. Government pre-approval of drugs is required
1927 Food, Drug and Insecticide Administration
law enforcement agency renamed in 1930 as FDA
1950 Alberty Food Products v. US
US Court of Appeals rules that the purpose for which a drug is to be used mus be included on the label
1911 Sherley Amendment
prohibits false and misleading claims about the "therapeutic" effects of a drug
1938 Food, Drug and Cosmetic (FDC) Act
in response to fatl poisoning of 107 people, mostly children, by an untested sulfanilamide concoction, this law requres new drugs be shown to be safe before marketing
1951 Druham-Humphrey
Amendment
law that defines what drugs require a prescription by a licensed practitioner and requires them to include this LEGEND: "Caution: Feeral Law prohibits dispensing without a prescription