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pht 100-2

chapter 2 part 2

the food & drug act of 1906, prohibits interstate commerce in adulterated/misbranded consumables that must be gov't pre-approved
the harrison tax act of 1914, says that narcotic prescribers/manufacturers/importers must be licensed & pay taxes
the durham-humphrey amendment of 1951, is the law that tells what drugs should be prescribed by licensed practitioners by having "rx only" labels
the kefauver-harris amendment of 1962 requires manufacturers to prove safety & effectiveness pre-marketing
the fair packaging & labeling act of 1966, requires all consumer products in interstate commerce to have honest/informative labels
the controlled substance act (CSA) of 1970, classifies 5 controlled drug levels
the csa of '70 also started the drug enforcement administration (DEA) which is a justice department division to enforce laws & regulations reguarding controlled drugs
the poison prevention packaging act of 1970, requires childproof caps on all controlled & most rx's except for non-childproof requests
the medical device amendment of 1976' requires pre-market approval for safety/effectiveness of medical devices
the orphan drug act of 1983 provides incentive to promote research, approval, & marketing of rare disease treatment drugs
the drug price competition & patent term restoration act (hatch-waxman) of 1984, allows drug patent terms extensions & quicker intro of lowercost generics
the rx drug marketing act of 1987, restricts distribution of rx drugs to legitimate commercial channels & requires licensed drugs whole salers
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)
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
the accutane law of 2002, doesn't allow refills on accutane rx's & must be handwritten by md & dispensed within 7 days
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
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.
the fdc act expanded the definition of adulterated/misbranded drugs
the durham-humphrey amendment act of 1951 established the distinction between rx & non-rx drugs
the durham-humphrey amendment act of 1951, authorized verbal rx's allowing refills
the kefauver-harris amendment of 1962, passed in response to thalidomide which caused birth deffects
the kefauver-harris amendment of 1962 required drugs to be effective as well as safe
the kefauver-harris amendment of 1962, made drugmakers file investigational nda's
the kefauver-harris amendment of 1962, extended marketing time which was balanced by patent protection for drugmakers
the comprehension drug abuse prevention & control act of 1970, was also called CSA & was created to combat drug abuse
schedule I or CI drugs are hospital use only drugs and are not legally dispensed
schedule II or CII drugs have no refills
schedule III-V or CIII-V drugs have limited refills
child resistance/proof containers can't be opened by 80% of children & 10% of adults
child proof containers are made to resist accidental ingestion as started by the poison prevention packaging act of '70
Created by: frescah



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