chapter 2 part 2
Quiz yourself by thinking what should be in
each of the black spaces below before clicking
on it to display the answer.
Help!
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| the food & drug act of 1906, prohibits interstate commerce in | adulterated/misbranded consumables that must be gov't pre-approved
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| the harrison tax act of 1914, says that narcotic prescribers/manufacturers/importers must be | licensed & pay taxes
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| the durham-humphrey amendment of 1951, is the law that tells what drugs should be prescribed by | licensed practitioners by having "rx only" labels
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| the kefauver-harris amendment of 1962 requires manufacturers to | prove safety & effectiveness pre-marketing
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| the fair packaging & labeling act of 1966, requires all consumer products in interstate commerce to have | honest/informative labels
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| the controlled substance act (CSA) of 1970, classifies | 5 controlled drug levels
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| the csa of '70 also started the drug enforcement administration (DEA) which is a | justice department division to enforce laws & regulations reguarding controlled drugs
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| the poison prevention packaging act of 1970, requires | childproof caps on all controlled & most rx's except for non-childproof requests
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| the medical device amendment of 1976' requires pre-market approval for | safety/effectiveness of medical devices
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| the orphan drug act of 1983 provides incentive to promote | research, approval, & marketing of rare disease treatment drugs
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| the drug price competition & patent term restoration act (hatch-waxman) of 1984, allows drug patent terms | extensions & quicker intro of lowercost generics
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| the rx drug marketing act of 1987, restricts distribution of rx drugs to | legitimate commercial channels & requires licensed drugs whole salers
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| the ominus budget reconciliation act (OBRA) of 1990, says that pharmacists should | offer council to all patients as administered by the health care financing agency (HCFA)
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| the health insurance portability & accountability act of 1996 defined health info on what health care providers don't share | without pateint's consent & provided for broad & stringment regulations to protect patient's right to privacy
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| the accutane law of 2002, doesn't allow refills on | accutane rx's & must be handwritten by md & dispensed within 7 days
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| the combat methamphetamine epidemic act of 2005, sets daily/monthly restriction on | "ephedra" & requires photo id for purchase while the retailers keep records within 2yrs. of purchase
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| a new drug application is the process through which drug sponsors formally propose that the fda | approves a new drug to market in the u.s.
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| the fdc act expanded the definition of | adulterated/misbranded drugs
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| the durham-humphrey amendment act of 1951 established the distinction between | rx & non-rx drugs
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| the durham-humphrey amendment act of 1951, authorized | verbal rx's allowing refills
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| the kefauver-harris amendment of 1962, passed in response to | thalidomide which caused birth deffects
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| the kefauver-harris amendment of 1962 required drugs to be | effective as well as safe
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| the kefauver-harris amendment of 1962, made drugmakers | file investigational nda's
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| the kefauver-harris amendment of 1962, extended marketing time which was balanced by | patent protection for drugmakers
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| the comprehension drug abuse prevention & control act of 1970, was also called | CSA & was created to combat drug abuse
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| schedule I or CI drugs are | hospital use only drugs and are not legally dispensed
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| schedule II or CII drugs | have no refills
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| schedule III-V or CIII-V drugs have | limited refills
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| child resistance/proof containers can't be opened by | 80% of children & 10% of adults
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| child proof containers are made to | resist accidental ingestion as started by the poison prevention packaging act of '70
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