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JURISPRUDENCE QUESTIONS WITH COMPLETE ANSWERS.
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JURISPRUDENCE QUESTIONS WITH COMPLETE ANSWERS.
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JURISPRUDENCE QUESTIONS WITHCOMPLETE ANSWERS
Our ssR&D ssteam ssrecently sscompleted ssseveral ssstudies ssusing sscompound ssRZ43
ssthat ssrevealed ssbeneficial sseffects sson ssblood sspressure ssin ssrats. ssWhat ssis ssthe
ssnext sslegal ssstep ssin ssorder ssto ssperform sstesting ssin sshumans? ss- ssAnswer
ssInvestigational ssnew ssdrug ss(IND) ssapplication
What ssmust ssbe ssapproved ssby ssthe ssFDA ssbefore sswe ssmay sslegally ssdistribute ssthe
ss"new ssdrug" ssin ssinterstate sscommerce ssfor sspatient ssuse? ss- ssAnswer ssNew ssdrug
ssapplication ss(NDA)
RZ43 sswas ssapproved ssby ssthe ssFDA ssfor sshypertension. ssFurther ssrat ssstudies
ssshow ssthat ssthe ssdrug ssalso ssshows sspromise ssin sslowering sscholesterol. ssCan sswe
ssadd ssthis ssas ssan ssindication? ss- ssAnswer ssNo, ssbecause ssa ssnew ssindication
ssmakes ssit ssa ssnew ssdrug.
Fast ssforward ss20+ ssyears ssfrom ssthe ssdate ssthe sspatent ssfor ssRZ43 sswas ssoriginally
ssfiled. ssA sscompetitor sscompany sswould sslike ssto ssmanufacturer ssa ssgeneric ssversion
ssof ssRZ43. ssWhat sstype ssof ssapplication ssmust ssthey ssfile sswith ssthe ssFDA? ssWhat
ssmust ssthey ssprove ssin ssthis ssapplication? ss- ssAnswer ssAbbreviated ssnew ssdrug
ssapplication ss(ANDA), ssonly sshave ssto ssprove ssbioequivalence ssto ssinnovator ssdrug
Your sscompany ssultimately sswins ssthe sspatent ssinfringement sstrial ssbecause ssthe
ssgeneric sscompany ssdid ssnot sswait ssuntil ssthe sspatent sson ssyour sstablet sscoating
ssprocess ssexpired. ssYour sscompany sswants ssto ssmaximize ssRZ43's sstime sson ssthe
ssmarket ssso ssit ssproduces ssan ss"authorized ssgeneric" ssof ssRZ43 ssunder ssa ssprivate
sslabel. ssWhat ssis ssthe ssbenefit ssof ssdoing ssthis? ss- ssAnswer ssIts ssthe ssbrand ssname
sscompany ssmaking sstheir ssown ssgeneric, ssdont sshave ssto ssfile ssan ssANDA ssbecause
ssits ssthe sssame ssdrug
Up ssuntil ssrecently ssyour sscompany sshas ssnot ssworried ssabout sscompetition ssfrom
ssgeneric sscompanies, sshowever ssin ss2010 ssthe ssAffordable ssCare ssAct sscreated ssan
ssabbreviated sslicensure sspathway ssfor ssbiological ssproducts ssthat ssare ssdemonstrated
ssto ssbe ss"biosimilar" ssto ssor ss"interchangeable" sswith ssan ssFDA-licensed ssbiological
,ssproduct. ssWhat sswas ssthis ssact? ss- ssAnswer ssBiologics ssPrice ssCompetition ssand
ssInnovation ssAct ssof ss2009 ss(BPCI ssAct)
The ssFDA's ss"____________ ssbook" sslists ssapproved ssbiological ssproducts sswith
ssbiosimilarity/interchangeability ssevaluations ss- ssAnswer ssPurple
True/False: ssBiosimilar ssproducts ssmeans ssthey ssare ssinterchangeable ss- ssAnswer
ssFalse, ssmust ssbe ssbiosimilar ssto ssan ssapproved ssFDA ssreference ssproduct ssAND
ssmeet ssadditional ssstandards ssfor ssinterchangeability.
After ssdispensing ssa ssbiologic ssfor sswhich ssan ssinterchangeable ssproduct ssis
ssavailable, ssregardless ssof sswhether ssa sssubstitution ssis ssmade, ssthe sspharmacist
ss(or ssan ssindividual ssdesignated ssby ssthe sspharmacist) ssshall sscommunicate ssto ssthe
ssprescriber ssinformation ssidentifying ssthe ssspecific ssbiological ssproduct ssthat sswas
ssdispensed, ssincluding ssthe ssname ssof ssthe ssbiological ssproduct ssand ssits
ssmanufacturer. ssHow ssmany ssdays ssdo ssthey sshave ssto sscomplete ssthis sstask? ss-
ssAnswer ss5 ssdays
True/False: ssIn ssOhio, sspharmacists sscannot sssubstitute ssinterchangeable ssbiosimilar
ssproducts sswithout ssprescriber ssintervention ss- ssAnswer ssFalse, sslaw sspassed sslast
ssDecember ssallows sspharmacists ssto sssubstitute ssinterchangeable ssproducts ss(even
ssthough sswe sshardly ssever ssdo ssthis)
When ssin ssthe ssdrug ssapproval ssprocess ssmay ssthe ssFDA ssrequire ssa ssREMS
ssprogram? ss- ssAnswer ssbefore ssor ssafter ss(anytime ssreally)
To ssbe sspharmaceutically ssequivalent sswhat ssaspects ssmust ssbe ssthe sssame ssas ssthe
ssinnovator ssdrug? ss- ssAnswer ssActive ssingredient, ssstrength, ssdosage ssform, ss&
ssroute ssof ssadministration ss
(color, ssshape, ssand ssinactive ssingredients sscan ssbe ssdifferent)
What ssmust ssbe ssthe sssame ssfor ssa ssdrug ssto ssbe ssconsidered ssgenerically
ss(bioequivalent) ssequivalent? ss- ssAnswer ssMust ssbe sspharmaceutically ssequivalent
ssAND ssvirtually ssthe sssame ssrate ssand ssextent ssof ssabsorption
A ssbioequivalent ssgeneric ssmust sshave ssa ssrate ssand ssextent ssof ssabsorption sswithin
ss_____ ssto ss_____ ss% ssof ssthe ssinnovator ssdrug ss- ssAnswer ss80 ssto ss125%
True/False: ssbioequivalent ssdrugs ssare ssalso sscalled sstherapeutically ssequivalent ss-
ssAnswer ssTrue
True/False: ssIn ssOhio, ssbioequivalent ssdrugs ssare ssalso ssreferred ssto ssas ssgenerically
ssequivalent ssdrugs. ss- ssAnswer ssTrue
What ssreference ssbook ssdo sspharmacists ssuse ssto ssdetermine ssif ssproducts ssare
ss"generically ssequivalent"? ss- ssAnswer ssThe ssorange ssbook
,In ssthe ssstate ssof ssOhio, ssmay ssa ssprescriber ssindicate ssthat ssthey ssdo ssnot sswant ssa
ssdrug sssubstituted ssby sswriting ss"Do ssnot sssubstitute" sson ssthe ssprescription? ss-
ssAnswer ssNo, ssmust sshand sswrite ssDAW ssor ssdispense ssas sswritten
In ssthe ssstate ssof ssOhio, ssmay ssa ssprescriber ssindicate ssthat ssthey ssdo ssnot sswant ssa
ssdrug sssubstituted ssby sshaving ss2 sssignature sslines ssprinted sson sstheir ssRx sspads ss-
ssone ssline ssfor sssubstitution sspermissible ssand ssone ssline ssthat ssindicates ss"dispense
ssas sswritten"? ss- ssAnswer ssNo, ssmust sswrite ssDAW ssor ssdispense ssas sswritten
If ssa ssprescriber ssindicates ss"DAW" sson ssa ssprescription ssbut ssthe sspatient ssrequests
ssthe ssgeneric, ssmay sswe sslegally ssperform ssthe sssubstitution? ss- ssAnswer ssNo, sswe
sscant sstrump ssthe ssprescribers ssDAW sseven ssif ssthe sspatient sswants ssgeneric
In ssthe ssstate ssof ssOhio, ssif ssthe ssprescriber sswrites ss"lisinopril" sson ssa ssprescription
ssmay ssthe sspharmacist ssdispense ssthe ssbrand ssname ss(Zestril®) ssinstead? ss-
ssAnswer ssYes, sslegally ssyou sscan sspick sswhatever ssyou sswant ssbecause ssthey
sswrote ssfor ssthe ssgeneric.
Which ssof ssthe ssfollowing sscould ssbe ssan sselement ssof ssa ssREMS ssprogram? ss(Select
ssall ssthe ssapply)
A. ssMedication ssguide
B. ssCommunication ssfrom ssmanufacturer ssto sshealthcare ssproviders ssabout
ssassociated ssrisks ssof ssthe ssmedication
C. ssElements ssto ssassure sssafety ssuse, ssfor ssexample ssa ssregistry ssfor ssclozapine
ssprescriptions sswith ssmandatory ssANC ssto ssfill ssprescription
D. ssAn ssimplementation sssystem sswhere ssthe ssmanufacturer ssis ssresponsible ssfor
ssmonitoring ssand ssevaluating ssif sshealthcare ssproviders ssare ssimplementing ssthe
ssregistry sssystem ssmentioned ssabove. ss- ssAnswer ssAll ssof ssthe ssabove ssmay ssbe
sselements ssof ssa ssREMS ssprogram
May ssa sspharmacist ssgenerically sssubstitute ssfor ssa ssbrand ssname ssdrug ssif ssthe
ssgeneric sscosts ssmore ssthan ssthe ssbrand? ss- ssAnswer ssNo.
If ssyou ssget ssan sse-script ssor sstelephone ssprescription ssand ssthe ssMD sssays ssthe
ssbrand ssis ssmedically ssnecessary, ssmay ssyou ssthen ssdispense ssthe ssbrand ssdrug? ss-
ssAnswer ssYes, ssif ssit ssis sselectronic ssor ssoral ssthey sscan ssjust sssay ssits ssmedically
ssnecessary. ssIf ssits sswritten ssit ssmust sssay ssDAW ssor ssdispense ssas sswritten sson ssit.
True/False: ssThe sspharmacist ssmust ssinform ssthe sspatient ssthat ssa ssgeneric ssis
ssavailable ssand ssthey sshave ssthe ssright ssto ssrefuse ssthe ssgeneric. ss- ssAnswer ssTrue
The sspharmacist ssmust ssinform ssthe sspatient ssthey sshave ssthe ssright ssto ssrefuse ssthe
ssgeneric ssexcept ssfor ssin sswhat sspatient sspopulation? ss- ssAnswer ssPatients ssinsured
ssthrough ssany ssagency ssof ssOhio ssor ssif ssthey ssare sspatients ssof sshospital, ssnursing
sshome, ssor sssimilar sscare ssfacility
, Who ssowns ssa ssprescription? ss- ssAnswer ssInformation sson ssa ssprescription ssis ssthe
ssproperty ssof ssthe sspatient ssand ssis ssintended ssto ssauthorize ssthe ssdispensing ssof ssa
ssspecific ssamount ssof ssmedication ssfor ssuse ssby ssthe sspatient. ssThe sspharmacy
ssowns ssthe sshard sscopy ssafter ssit ssis ssfilled
How ssmany ssnon sscontrolled sssubstances ssmay ssbe sson ssthe sssame ssprescription? ss-
ssAnswer ss3
How ssmany sscontrolled sssubstances ssmay ssbe sson ssthe sssame ssprescription? ss-
ssAnswer ss1
True/False: ssPreprinted ssprescriptions ssstill ssrequire ssa ssmanual sssignature ssfrom ssthe
ssprescriber. ss- ssAnswer ssTrue, ssprescribers sssignature sscan't ssbe sspreprinted ssor
ssstamped sswith ssthe ssrest ssof ssthe ssscript
Can ssthe ssfax ssbe sscut ssinto ssthe sssize ssof ssa sstraditional ssprescription ssfor ssstorage
sspurposes? ss- ssAnswer ssYes ss- ssbut ssonly ssif ssthe ssheader ssinformation ssand ssthe
ssfull ssname ssof ssthe ssprescriber's ssagent ssthat sssent ssthe ssfax ssis ssretained ss- ssthe
ssheader ssis ssrequired ssfor ssit ssto ssremain ssa ssvalid ssprescription.
If ss2 ssproducts sshave ssthe sssame ssdrug ssname, ssstrength, ssdosage ssform, ssand ssare
ssboth ssBC ssrated, ssare ssthey ssinterchangeable? ss- ssAnswer ssNo, ssonly ssproducts
sswith ssthe sssame ss'A' ssrating ss(i.e ssAB, ssAP, ssAN) sscould ssbe ssinterchangeable.
True/False: ssif sstwo ssdrug ssproducts sshave ssthe sssame ss'A' ssrating, ssthe ssFDA
ssconsiders ssthem ssto ssbe sstherapeutically ssequivalent ss- ssAnswer ssTrue
True/False: ssYou ssmay sssubstitute ssan ssAB1 ssproduct ssfor ssan ssAB2 ssor ssAB3
ssproduct ssbecause ssthey ssstill sshave ssthe sssame ssAB ssrating, ssjust sswith ssdifferent
ssnumber sscategories. ss- ssAnswer ssFalse, ssIf ssthey sshave ssa ssnumber ssafter ssthe ssAB
ssrating ssthat ssmust ssmatch ssas sswell ssto ssbe ssgenerically ssequivalent
Dietary ssSupplement ssand ssNonprescription ssDrug ssConsumer ssProtection ssAct
ss(2006) ssrequires ssthe ssmanufacturers ssto ssput sswhat sson ssthe sslabel ssof ssdietary
sssupplements ssand ssOTC ssdrug sslabels? ss- ssAnswer ssThe ssmanufacturer ssor
ssretailers ssdomestic ssaddress ssor ssphone ssnumber ssso ssthey sscan ssreport ssserious
ssadverse ssevents ssthat ssoccur sswhile sstaking ssthat sssupplement/drug
If ssa sspt sscalls ssthe ssnumber sson ssa ssdietary sssupplement ssor ssOTC ssdrug ssand
ssreports ssa sssignificant ssevent, sswhat ssmust ssthe ssmanufacturer ssdo sswith ssthat
ssinformation? ss- ssAnswer ssMust sssubmit ssthe ssinformation sswithin ss15 ssdays ssto ssthe
sssecretary ssof sshealth ssand sshuman ssservices ss(runs ssthe ssFDA)
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