Indiana MPJE Exam With 100% Correct And Verified Answers

Indiana MPJE Exam With 100% Correct
And Verified Answers
Lawi-iCorrectiAnswer-
aiwrittenilawienactedibyitheilegislaturei(congressioril
ocalimunicipalities,igovernor,ipresident)iELECTEDiO
FFICIALS)

T/
FiLAWSiGOiTHROUGHiAiPUBLICiCOMMENTiANDiRE
VISIONiPROCESSi-iCorrectiAnswer-FALSE

Whereiareifederalilawsifound?i-iCorrectiAnswer-
UnitediStatesiCodei(USC)

WhereiareiIndianailawsifound?i-iCorrectiAnswer-
IndianaiCodei(IC)

WhatiisiaiRegulation/Rule?i-iCorrectiAnswer-
havingitheiforceiofiailawiissuedibyianiadministrativeia
gency-iFDA,iDEA,iBOPi(NONiELECTEDi)

Whereiareifederaliregulationsipublished?i-
iCorrectiAnswer-CodeiofiFederaliRegulationsi(CFR)



WhereiareiindianaiRegulationsifound?i-
iCorrectiAnswer-IndianaiAdministrativeiCodei(IAC)



HowiwouldiTitilei21iSectioni353,isubsectionibibeiwrit
teniiniUSC(iunitedistatesicode)?i-iCorrectiAnswer-
21iUSCiss353i(b)




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,Whatiisitheidefinitioniofiaidrug?i-iCorrectiAnswer-
1)iArticlesirecognizedibyiU.S.iPharmacopeiai(USP),iN
ationaliformularyi(NF),iHomeopathiciPharmacopeiai
ofiU.Si(HPUS)
AND
2)iUseditoidiagnose,icure,imitigate,itreat,ioripreventi
diseasei
AND
3)iintendeditoiaffectitheichemicalistructure/
functioniofitheibody

prescriptionidrugsi-iCorrectiAnswer-
aidrugiintendeditoibeiusedibyiman,iwhichi
A-
ibecauseiofiitsitoxicityioriotheripotentialityiforiharmf

ulieffect,iorimethodiofiitsiusei,ioricollateralimeasuresi
necessaryitoiitsiuse,iisinotisafeiforiuseiexceptiunderis
upervisioniofiaipractitionerilicensedibyilawitoiadmini
sterisuchidrug
OR
B-
iisilimitedibyianiapprovediapplicationiunderiseci355io

fithisititleitoiuseiunderitheiprofessionalisupervisioniof
iaipractitionerilicensedibyilawitoiadministerisuchidru

gi(NEWiDRUG)

T/
FiPrescriptionidrugsimustihaveitheisymboli"RXionly"i
onitheiproductilabel?i-iCorrectiAnswer-TRUE

WhatiareiOTCiDrugs?i-iCorrectiAnswer-
drugsithatiareisafeiandieffectiveiwithoutiaiprescriberi
supervisioniforicertainiconditions



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,Theilawispecificallyidefinesicontrolledisubstancesiasi-
i-iCorrectiAnswer-

aidrugioriotherisubstancei,ioriimmediateiprecursor,ii
ncludediinischedulei1-5
aidrugithatihasidependenceiliabilityiand/
oripotentialiforiabuse

Whatiisianiorphanidrug?i-iCorrectiAnswer-
Aidrugiuseditoitreati
A-
airareidiseaseiaffectingifewerithani200,000iAmerican
s
ORi
B-
aiconditionithatiaffectsi>200,000ipeopleiforiwhichith
ereiisinoireasonableiexpectationithatitheicostiofidevel
opingiwillibeirecoveredifromisales.

Whatiisiaidietaryisupplement?i-iCorrectiAnswer-a-
iVitamin

OR
B-imineral
OR
c-Herbi/Botanical
ORi
d-AminoiAcid
OR
E-
iusedibyimaniorisupplementitheidietibyiincreasingithei

totalidietaryiintake
ORi
F-
iconcentrateimetabolite,iconstituent,iextract,ioricom

binationiofiABCDEiabove

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, WhatiisiaiNEWidrug?i-iCorrectiAnswer-
drugithatiisiaidrugithatiisinotigenerallyirecognizediasi
safeiandieffectiveiforitheiconditionioriinitheidosageifo
rmiitiwouldibeiprescribediunderi
OR
iaidrugithatihasibeenirecognizediasisafeiandieffective,i

butihasinotibeeniusediinitheiconditionioriinitheidosag
eiformiforitheisufficientiamountiofitime.

DRUGiTHATiHASiNOTiCOMPLETEDiTHEiPREiMARK
ETiAPPROVALiPROCESS

T/
Fiainewidrugiapplicationiisitieditoiitsidosageiform,iinio
rderitoimakeiaialreadyiestablisheditabletidrugianiinje
ctableiitimustiapplyiforiapprovaliagaini-
iCorrectiAnswer-TRUE



NDAi(NewiDrugiApplication)i-iCorrectiAnswer-post-
clinicalitrialsitoiFDA,iaskingiifiokitoimarket

INDi(InvestigationaliNewiDrugiApplication)i-
iCorrectiAnswer-

Successfulianimalitesting.iPremissioniforihumanitest
ingi(clinicalitrials)

ANDAi(AbbreviatediNewiDrugiApplication)i-
iCorrectiAnswer-

theiprocessibyiwhichiapplicantsimustiscientificallyide
monstrateitoitheiFDAithatitheirigenericiproductiisibio
equivalentiandihasiacceptableimanufacturingipractic
es.



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