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Drug Legislation

QuestionAnswer
1906 Federal Food, Drug, and Cosmetic Act -USP and NF set as Nat'l standards -Fed gov't given authority to enforce standards -Purity and strength standards
1912 Shirley Act Prohib fradulent drug claims by manf
1914 Harrison Narcotic Act -1st Narc act -Est word narcotic as a legal term
1938 Federal Food, Drug and Cosmetic Act - Prep must be FDA approved - Toxicity tests on lab animals prior to seeking approval -Drug labels: Content, name of drug, warnings, manf, directions, NO misleading or false info
1945 Amendment of Federal Food, Drug and Cosmetic Act of 1938 Allowed FDA to test each batch of preparation
1952 Durham-Humphrey Amendment -Rx req before pharm can dispense certain drugs - No refill w/o Rx -Rx label must include "Caution: Federal law prohibits dispensing w/o Rx"
1962 Kefauver Harris Ammendment -Increased FDA control over drug safety -FDA Req'd proof of drug efficacy -FDA established official drug names -Drug ads must be truthful -Evidence to support new drug must be established -Manf must report Ad rxn immediatedly
1970 Controlled Substances Act -5 categories/schedules of drugs based on abuse potential --> Lower schedule# = higher abuse potential -Increased research in drug abuse prevention and tx
Schedule I -All nonresearch forbidden -Ex. Heroin, cocaine
Schedule II -No telephone rx -No Refills -Ex. Morphine, amphetamines, secobarbital
Schedule III -Renew rx after 6 months or 5 refills -Ex. Tylenol 3
Schedule IV -Renew Rx after 6 months or 5 refills -Less abuse potential then SIII Ex. Valium, librium
Schedule V - May be dispensed without Rx - Ex. Lomitil, immodium
1978 Drug Regulation and Reform Act -Speeds up new drugs to public -Dec research time
1984 Drug Price Competition and Patent Term Restoration Act -Allows generic companies to mkt generic drugs -Grants longer patent protection on new drugs
Created by: alli725
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