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Pharm 1 Test 2

Regulations

QuestionAnswer
Sherley Amendment of 1912 Prevented the use of fraudulent therapeutic claims
Food, Drug, and Cosmetic Act of 1938 Prevented new drugs from being marketed before being properly tested for saftey. Drug labels must be accurate and complete.
Federal Food and Drug act of 1906 First US law passed to protect the public from adulterated and mislabled drugs. Required to list presence of 11 drugs that were dangerous or addictive. Many loopholes.
Durham-Humphrey Amendment of 1952 Distinguished more clearly between drugs that can be sold with or without a prescription and those that cannot be refilled.
Harris-Kefauver Amendment of 1962 Required proof of both safety and efficacy before it was approved for use. All drugs had to be tested. New drug testing procedures.
Controlled substance act of 1970 Categorized controlled substances on the basis of their potential for abuse.
Drug Regulation Refore Act of 1978 Shortened the drug investigation process to release drugs sooner to the public
Orphan Drug Act of 1983 Allowed drug companies to take tax deductions for about 3/4 of the cost of maufacture of drugs for those with rare diseases
Food and Drug Administration Modernization Act of 1997 Fast track for AIDs and CA drugs. 6 month notice for drug companies who plan to stop making a drug. Drug testing in children. Experimental drugs. Off-label use info to health care providers.
Black box warning most serious type of warning label by FDA
Created by: Keller_KI
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