Exam (elaborations)
MPJE Exam with correct Answers (Graded A)
- Course
- Institution
MPJE Exam with correct Answers
[Show more]
Content preview
MPJE Exam with correct Answerswhat iiis iithe iiorphan iidrug iiact; ii< ii________ iipeople ii- iiAnswers ii-Provides iitax/licensing
iiincentives iifor iimanufacturers iito iidevelop iidrugs/biologicals iifor iitreatment iiof iirare
iicondition/disease iiaffecting ii<200,000 iipeople
NPI iiis iia ii_______________ iiadministrative iisimplification iistandard, ii__ iidigits,
ii________________ iimay iinot iiobtain iia iiNPI iinumber ii- iiAnswers ii-HIPAA
-10
-- iiveterinarians
Voluntary iiaction iitaken iiby iia iicompany iito iiremove iia iidefective iidrug iifrom iimarket. ii
-Class ii1=
--Class ii2=
---Class ii3= ii- iiAnswers ii-Recall
-Situation iiin iiwhich iithere iiis iia iireasonable iiprobability iithat iithe iiuse iiof iior iiexposure iito
iia iiproduct iiwill iicause iiserious iihealth iiconsequences iior iideath
--Use iior iiexposure iimay iicause iitemporary iior iimedically iireversible iiadverse iihealth
iiconsequences, iior iiwhere iiprobability iiof iiadverse iihealth iiconsequences iiis iiremote
---Use iiof iior iiexposure iito iia iiproduct iiis iinot iilikely iito iicause iiadverse iihealth
iiconsequences
Drug iiapproval iiprocess
Steps ii1-3 ii- iiAnswers ii-1. iiPreclinical ii(animal) iitesting
2. iiInvestigational iinew iidrug iiapplication ii(IND) iioutlines iiwhat iisponsor iiof iinew iidrug
iiproposes iifor iihuman iitesting iiin iiclinical iitrials
3. iiPhase ii1 iistudies ii(usually ii20-80 iipeople)
Drug iiapproval iiprocess ii
Steps ii4-6 ii- iiAnswers ii-4. iiPhase ii2 iistudies ii(typically iifew iidozen iito ii300 iipeople)
5. iiphase ii3 iistudies ii(typically iiinvolve iiseveral iihundred iito ii3000 iipeople)
6. iiPre-NDA iiperiod ii(just iibefore iiNDA iiis iisubmitted), iicommon iitime iifor iiFDA iiand iidrug
iisponsors iito iimeet
Drug iiapproval iiprocess
Steps ii7-9 ii- iiAnswers ii-7. iiSubmission iiof iian iiNDA ii(formal iistep iiasking iiFDA iito
iiconsider iia iidrug iifor iimarketing iiapproval)
8. iiAfter iiNDA iiis iireceived, iiFDA iihas ii60 iidays iito iidecide iiwhether iito iifile iiit iiso iiit iican
iibe iireviewed
,9. iiIf iifiled, iian iiFDA iireview iiteam iiis iiassigned iito iievaluate iithe iisponsors iiresearch iion
iithe iidrugs iisafety/effectiveness
Drug iiapproval iiprocess
Steps ii10-12 ii- iiAnswers ii-10. iiFDA iireviews iiinformation iithat iigoes iion iia iidrugs
iiprofessional iilabeling
11. iiFDA iiinspects iithe iifacilities iiwhere iithe iidrug iiwill iibe iimanufactured iias iipart iiof
iiapproval iiprocess
12. iiFDA iireviewers iiwill iiapprove iithe iiapplication iior iiissue iia iicomplete iiresponse iiletter
Drug iicompanies iimust iisubmit iian ii__________________________ iifor iiapproval iito
iimarket iia iigeneric iiproduct ii- iiAnswers ii-Abbreviated iinew iidrug iiapplication ii(ANDA)
To iigain iiFDA iiapproval, iia iigeneric iidrug iimust: ii(6) ii- iiAnswers ii-1. iiContain iisame
iiactive iiingredients iias iiinnovator iidrug
2. iiBe iiidentical iiin iistrength, iidosage iiform, iiand iiroute iiof iiadministration
3. iiHave iithe iisame iiuse iiindications
4. iiBe iibioequivalent
5. iiMeet iithe iisame iibatch iirequirements iifor iiidentity, iistrength, iipurity, iiand iiquality
6. iiBe iimanufactured iiunder iithe iisame iistrict iiFDA iistandards iiof iigood iimanufacturing
iipractice iiregulations
Number iithat iiidentifies iithe iilabeler/vendor, iiproduct, iiand iipackage iisize, iiand iiis
iiassigned iito iieach iidrug iiproduct iilisted iiunder iisection ii510, iifregistration iiof iiproducers
iiof iidrugs iiand iidevices, iiof iithe iifederal iifood, iidrug, iiand iicosmetic iiact ii- iiAnswers ii-
NDC
If iia iiproduct iihas iian iiNDC, iiis iiit iiFDA iiapproved? ii- iiAnswers ii-Does iinot iiguarantee
Three iiways iito iiviolate iithe iiFood iiDrug iiand iiCosmetic iiAct ii(FD&C) ii- iiAnswers ii-1.
iiAdulteration
2. iiMisbranding
3. iiPlacing iiinto iiinterstate iicommerce iian iiunapproved iidrug
Pregnancy iiwarnings: ii(Changing)
Category iiA:
Category iiB: ii- iiAnswers ii-Only iiif iiclearly iineeded ii(Both)
Pregnancy iiwarnings:
Category iiC:
Category iiD:
Category iiX: ii- iiAnswers ii-C: iiOnly iiif iithe iipotential iibenefit iijustifies iithe iipotential iirisk iito
iithe iifetus
D: iiPositive iievidence iiof iidental iirisk iiexists
X: iiMay iicause iifetal iiharm iiwhen iiadministered iito iia iipregnant iiwomen
, The ii___________________ iiinsert iimust iibe iigiven iito iipatient iiwith iieach iidispensing,
iioriginal iiand iirefills ii- iiAnswers ii-Patient iipackage iiinsert
Community iipharmacy iirequired iito iigive iiPP iiwith ii___________________________
Institutions? ii- iiAnswers ii-each iidispensing, iioriginal iiand iirefills
Institution= iiwith iiadministration iiof iifirst iidose iiand iithen iionce iievery ii30 iidays
Consumer iimedication iiinformation ii- iiAnswers ii-Not iirequired iito iibe iigiven iito iipatient.
iiUsually iigiven iiwith iifirst iifill iiif iiit iiis iigiven. iiNot iiregulated iiby iiFDA
Duties iiof iithe iipharmacy iiboard ii- iiAnswers ii-Protection iiof iithe iipublic ii- iihas iiobligation
iito iidiscipline iilicensees iiwho iihave iiadversely iiaffected iithe iipublics iihealth, iisafety, iiand
iiwelfare
-procure iisamples iiand iilimit iior iiprevent iisale iiof iidrugs iiand iidevices iithat iido iinot
iicomply iiwith iithe iilaw
Members iiof iithe iipharmacy iiboard?
___ iitotal ii- iiAnswers ii-11 iitotal
6 iipharmacists
4 iipublic
1 iipharmacy iitechnician
Members iiof iithe iipharmacy iiboard iiare iiappointed iiby ii____________________
-They iihave ii______________ iiterms, iiand iimay iiserve ii__ iiterms iimax ii- iiAnswers ii-the
iigovernor
-4 iiyear iilong, iimax ii2 iiterms ii+ ii1 iipartial iiterm
Disciplinary iisubcommittee ii(DSC) iiof iithe iiboard iicontains ii__________ iimembers ii-
iiAnswers ii-5 iimembers- ii3 iiprofessional iiand ii2 iipublic
DSC: iihow iiis iifinal iidecision iidetermined? ii- iiAnswers ii-majority iivote. iiONE iipublic
iimember iier iihas iito iivote iiwith iithe iimajority, iior iiit iidoes iinot iipass.
DSC iichairperson iiis ii________________________________ ii- iiAnswers ii-a iipublic
iimember iiappointed iiby iithe iichair iiof iithe iifull iiboard
What iiis iithe iiconsumer iiinformation iinotice? ii(CIN)
When iiis iiit iirequired iito iibe iiposted? ii- iiAnswers ii-notice iito iiconsumers iiabout
iiprescription iidrugs
-If iiengaged iiin iithe iibusiness iiof iiselling iidrugs iiat iiretail iiat iieach iicounter iiover iiwith iiRx
iidrugs iiare iidispensed
(*not iirequired iito iibe iiposted iiif iionly iidispenses iidrugs iifor iiinpatient iiuse iiat iia iihealth
iicare iifacility)
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller millyphilip. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $12.49. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
72042 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now