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Federal law takes precedence over state law unless...
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The state Law is STRICTER than the federal Law.
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A Law enacted in 1906 to prohibit the interstate tranportation or sale of adulerated and misbranded food or drugs
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PURE FOOD AND DRUG ACT OF 1906
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The FDA was created under this act and required that all new drug apliications be filed with the FDA. Also defined adulteration and misbrading.
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FOOD, DRUG AND COSMETIC ACT OF 1938 (FDCA - 1938)
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What is aduleration?
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To make impure by adding extraneous, improper, or inferior ingredients.
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What is MIsbranding according to the the FDCA of 1938?
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NUTSHELL: 1) Labeling that is FALSE or MISLEADING. 2) packaging that does not Man., distributor, or accurate quantity3) Fails to carry "warning sign - habbit forming" 4) Fails to give directions5) Dangers to Health
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An amendment to FDCA act of 1938 that required all products to have adquate direction for use unless they contain federal legand. (ie OTC products)
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DURHAM-HUMPHERY ACT OF 1951
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What were the 3 specific changes that the DURHAM-HUMPHERY ACT of 1951 enacted?
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1) Separated drugs into two categories: OTC and LEGAND 2) Allows verbal Rx's over the phone 3) Allows refills to be called in from a physicain's office.
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What was the purpose of the KEFAUVER -HARRIS ACT OF 1963?
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The Kefauver- Harris act required that medication on the U.S. market be pure, safe and effective.
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Which Act place more control on drug abuse? What Year?
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COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT OF 1970.
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What agency wa created from the Comprehensive drug and abuse act of 1970
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DEA - DRUG ENFORCEMENT AGENCY which is under supervision of the department of justice
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What are scheule I drugs?
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Drugs with NO exceptable medical uses. example: Hashish, Hash oil , Mescaline, Opium , Peytote, Psilocybin
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Which has more strick regulations Scedule I < IV?
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I > II > III > IV > V (most to least)
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Which Schedule drug may leas to phychological or physical dependance?
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Schedule II
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Every pharmacy that dispense controlled substances must be registered with the DEA and renew this every ____ years.
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3 years
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Adderall
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Amphetamine/dextroamphetamine Schedule II
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