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drug laws

TermDefinition
Food and Drug Act (1906) Outlaws states from buying and selling food, drinks, and drugs that have been mislabeled and tainted.
Sherley Amendment (1912) Outlaws labeling drugs with fake medical claims meant to trick the buyer.
FDA (1930) Food and Drug Administration is named.
Federal Food, Drug, and Cosmetic (FDC) Act of 1938 Requires new drugs to be proven safe prior to marketing; starts a new system of drug regulation; requires safe limits for unavoidable poisonous substances; and allows for factory ispections.
Durham-Humphrey Amendment (1951) Defines the types of drugs that cannot be used safely without medical supervision and limits the sale to prescription only by medical professionals.
Kefauver-Harris Drug Amendments (1962) Requires manufacturers to prove that their drugs are effective prior to marketing.
Over-the-Counter Drug Review (1972) Nonprescription medications must be safe, effective and appropriately labeled.
Tamper-Resistant Packaging Regulations (1982) Makes it a crime to tamper with packaged products and requires tamper-proof packaging.
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) ( 1984) Allowed FDA to approve generic versions of brand-name drugs without repeating research to prove safety and efficacy; allowed brand-names to apply for 5 years of additional patents for new drugs to make up for lost time while going through FDA approval
Prescription Drug Marketing Act (1988) Designed to eliminate diversion of products from legitamate channels of distribution and requires wholesalers to be licensed.
Food and Drug Administration Modernization Act (1997) Expands scope of agency activities and moves agency to the Department of Health and Human Services (DHHS)
Medicare Prescription Drug Improvement and Modernization Act of 2003 Includes Medicare Part D which increases access to medications through private insurers.
Created by: mstevenson
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