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MPJE (Michigan Law) Exam Questions and Answers
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MPJE (Michigan Law) Exam Questions and Answers
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MPJE (Michigan Law) Exam Questionsand Answers
Hatch-Waxman iiAct ii- iiAnswers ii-In ii1984 iithis iiallowed iigreater iiaccess iifor iicompanies
iito iidispense iigeneric iidrugs.
Drugs iicompanies iimust iisubmit iithis iifor iia iigeneric iidrug: ii- iiAnswers ii-Abbreviated
iiNew iiDrug iiApplication ii(ANDA)
ANDA iiprocess ii- iiAnswers ii-Does iinot iirequire iicompanies iito iirepeat iianimal iiand
iiclinical iiresearch iion iiingredients.
ANDA iiProcess iiapplies iito iidrugs iimade iiafter: ii- iiAnswers ii-1962
Generic iidrug iihas iito iimatch iiwith iithe iifollowing: ii- iiAnswers ii-Identity, iiStrength, iiPurity
iiand iiQuality ii(ISPQ)
If iia iidrug iihas iian iiNDC iidoes iiit iiguarantee iidrug iiapproval? ii- iiAnswers ii-NO
Use iiof iian iiunapproved iidrug iisuch iias iiDomperidone iiis: ii- iiAnswers ii-Misbranding
Side iieffects iistatement: ii- iiAnswers ii-States iito iicall iidoctor iifor iimedical iiadvice iiabout
iiSE. iiAlway iimay iireport iiSE iito iiFDA. iiIncluded iiwith iinew iifills iiand iirefills
Does iithe iiside iieffect iistatement iiapply iito iiinpatients iiand iihealth iicare iifacility iiunder
iithe iiorder iiof iia iilicensed iipractitioner? ii- iiAnswers ii-NO
OTC iiSide iiEffect iiStatement: ii- iiAnswers ii-If iinot iistatement, iimust iihave iinumber iito
iireport iiit iito
Font iirequirements iifor iistatements: ii- iiAnswers ii-There iiisn't iia iispecific iirequirement iifor
iimeds iibut iifor iiOTC iimust iibe iia iiminimum iiof ii6 iipoint iibold iiletter.
Anything iitopical iiis iiexempt iifrom iiPoison iiPrevention iiPackaging iiAct iiexcept: ii-
iiAnswers ii-Nasal iiand iilidocaine
What iiis iiexempt iifrom iithe iiPoison iiPrevention iiPackaging iiAct? ii- iiAnswers ii-Samples
iiand iiStarter iiPacks
Any iinose iidrop iiwith iithis iisubstance iineeds iia iiPPPA: ii- iiAnswers ii-Oxymetazolone
, Market iiWithdrawal: ii- iiAnswers ii-A iifirm iiremoves iithe iiproduct iifrom iithe iimarket iito
iicorrect iia iiviolation
Michigan iiSamples ii- iiAnswers ii-Under iiarticle ii17 iia iiphysician iimay iidelegate iito iia
iipharmacist iiin iiwriting iithe iireceipt iiof iia iicomplimentary iistarter iidose iiof iidrugs iiother
iithan iiCS
CS iito iiForeign iiCountries ii- iiAnswers ii-Has iito iibe iiregistered iias iian iiexporter iito iiship
iiCS iiout iiof iicountry.
US iiresident iican iibring iiup iito iihow iimany iiCS iiunits iifrom iioverseas: ii- iiAnswers ii-50
iibut iithey iihave iito iideclare iiit
PI ii(Package iiInsert) iivs iiPPI ii(Patient iiPackage iiInsert) ii- iiAnswers ii-Package iiinsert iiis
iijust iiprofessional iiinformation iiwhere iipatient iipackage iiinsert iiis iirequired iiwith iiall iifills
iiif iimedication iirequires iiit
Michigan iiCounseling ii- iiAnswers ii-MUST iioffer iicounseling iiwith iieach iinew iidrug
iipatient iiis iion
Are iipharmacies iiable iito iicompound iiand iimanufacture iidrugs iiat iithe iisame iilocation? ii-
iiAnswers ii-NO
If iia iipharmacy iiships iimore iithan ii5% iiof iicompounded iidrugs iithey iimust: ii- iiAnswers ii-
Sign iia iimemorandum iiof iiunderstanding iiwith iithe iiFA
Outsourcing iiFacility ii- iiAnswers ii-Has iito iibe iilicensed iiby iithe iistate iiof iiMichigan iias iia
iipharmacy iibut iithe iiFDA iiregistration iiis ii"voluntary"
An iioutsourcing iifacility iican iicompound iicopies iiof iia iimedication iiwhen: ii- iiAnswers ii-It
iiis iion iia iishortage iilist
An iioutsourcing iifacility iihas iihow iimany iidays iito iireport iian iiadverse iievent? ii- iiAnswers
ii-10 iidays
Is iithere iia iilimit iion iithe iiratio iiof iitechnicians iiand iisupport iistaff iito iipharmacists ii-
iiAnswers ii-NO
Pharmacy iiintern iito iiRPH iiratio ii- iiAnswers ii-2:1
Pharmacy iiBoard iiComposition ii- iiAnswers ii-6 iipharmacists, ii4 iipublic iimembers iiand ii1
iitechnician
Term iilength ii- iiAnswers ii-Two iiterms iiof iifour-years iialong iiwith iione iipartial iiterm
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