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Ch 2

Study Guide

Question/ PurposeActYear
Outlaws labeling drugs with fake medical claims meant to trick the buyer Sherley Amenment 1912
Food and Drug Administration is named FDA 1930
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 inspections Federal Food, Drug, and Cosmetic (FDC) Act iof 1938 1938
Defines the type of drugs that cannot be used safely without medical supervision and limits the sale to prescription only by medical professionals Durham-Humphrey Amendment 1951
Requires manufacturers to prove that their drugs are effective prior to marketing Kefauver- Harris Drug Amendments 1962
Nonprescription medications must be safe, effective, and appropriately labeled Over the counter drug review 1972
Makes it a crime to tamper with packaged products and requires tamper-proof packaging Tamper-Resistant Packaging Regulations 1982
Allowed FDA to approve generic version of brand-name drugs without repeating research to prove safely and efficacy; allowed brand- name drugs to apply for up to 5 years of additional patent protection for new drugs to make up for the lost while there prod Drug price Competition and patent Term Restoration Act 1984
Designed to eliminate diversion of products from legitimate channels of distribution and requires wholesalers to be licensed Prescription Drug Marketing Act 1988
Expands scope of agency activities and moves agency to the department of Health and Human Services (DHHS) Food and Drug Administration Modernization Act 1997
Includes Medicare Part D which increases access to medications through private insurers Medicare Prescription Drug Improvement and Modernization Act 2003 2003
Outlaws states from buying and selling food, drinks, and drugs that have been mislabeled and tainted Food and Drug Act 1906
Created by: elyr83
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