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Drug Regulation

TermDefinition
Food and Drug Act of 1906 prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. Government pre-approval of drugs is required
1911 Sherley Amendment It prohibits false and misleading claims about the therapeutic effects of a drug
1938 Food, Drug and Cosmetic (FDC) Act requires new drugs be shown to be safe before marketing
1950 Alberty Food Prducts v. U.S. the purpose for which a drug is to be used must be included in the label
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"
1962 Kefauver-Harris Amendment requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug
1966 Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled
1970 Poison Prevention Packaging Act requires child-proof packaging on all controlled and most prescription drugs
1970 Controlled Substances Act (CSA) classifies drugs that may be easily abused and restricts their distribution
1976 Medical Device Amendment requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices
1983 Orphan Drug Act provides incentives to promote research, approval and marketing of drugs needed for the treatment of rare diseases
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 medications
1996 Health Insurance Portability and Accountability Act (HIPAA) protects patients' right to privacy
Created by: hsjanstjd