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Pharmacy law

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 act of 1938 1938- requires new drugs to be proven safe prior to markerting. starting a new system of drug regulation. requires safe limits for unavoidable poisonous substances and allows for factory inspections
durham-humphrey amendment 1951- defines the type of drugs that cannot be used safely without medical supervision and limits the sale to prescription only by medical professionals
kefauver-harris drug amendment 1962- requires manufacturers to prove that thier drugs are effective prior to marketing
over the counter drug review 1972- nonprescription medications must be safe effective and appropriatly labeled
tamper resistant packaging regulations 1982- makes it a crime to tamper with packaged produtcs and requires tamper-proof packaging
drug price competition and patent term restoration act hatch-waxman act 1984-
prescription drug marketing act 1988- designed to elminated diversion of products from legitmate channels of distribution and requires wholesalers to be licensed
food and drug administration modernization act 1997- expands scope of agency activites and moves agency to the department of health and human services
medicare prescription drug improvement and modernization act of 2003 2003- includes medicare part d which increases access to medications through private insurers
Created by: 2402sp



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