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chapter 2 part 3

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Answer
the drug listing act of 1972 gave the fda authority to   compile a list of currently marketed drugs that have ndc's  
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NDC means   nat'l drug code  
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a database of drugs kept by the fda is by   use, manufacturer, & ingredients  
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the orphan drug act of 1983, is for rare disease treatment drugs that are   approved by the fda which is prohibitively expensive to make & market  
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the orphan drug act of 1983, encourages their development by   giving tax incentive, granting exclusive license, & allowing expedited review & approval  
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the brand name is the   trade name under which the manufacturer markets the drug  
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a generic name sometimes denotes a drug   unprotected by trade mark  
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the drug price competition & patent restoration act of 1984 responded to pressure to   reduce drug costs, encouraged need for generics, & extended patent license to allow manufacturers to recoup research & development costs  
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brand & generics are compared by   form, safety, strength, quality, & performance  
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generics must demonstrate   bioequivalent to brand name product  
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over 60% of rx's are filled with   generics in community pharm]  
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the rx drug marketing act of 1987, keeps non-manufacturers from   re-importing drugs into the u.s.  
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the rx drug marketing act of 1987, responded to safety & competition issues & has major issues as   seniors go to canada for rx's or mail orders them  
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the anabolic steroid act of 1990, identifies steroids as   a CIII drug  
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steroids are   synthetic testosterone which gives serious effects when abused.  
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the omnibus budget act of 1990 requires   state standards of practice for drug use reviews  
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pharmacists must screen for   therapeutic duplications, drug disease contraindication, drug to drug interactions, incorrect dosage/duration of treatment, & clinical abuse/misuse  
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possibility of medicaid reimbursement loss   used to enforce rules  
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the omnibus budget reconciliation act of 1990, requires pharmacists to discuss with patients the   interactions & therapeutic contraindications such as the way to prevent them & what to do if they happen  
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the omnibus budget act of 1990, also wants pharmacists to tell patients how to   self-monitor drug therapy,refill info, proper storage, directed usage, & warnings  
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dietary supplement health & education act of 1994 says that manufacturers don't have to   prove safety, effectiveness, or standardization of products  
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Created by: frescah
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