Nebraska MPJE Exam Questions and
Answers A+ Guide
What legistation was created for the provisions for the fast track
review of some NDA submissions to expedite approval of new
drugs used to treat life-threatening conditions? - correct
answers✅✅Food and Drug Administration (FDA) Modernization
Act 1997
What legistation encouraged manufacturers to conduct research
for new uses of drugs and to submit SNDAs for these uses? -
correct answers✅✅FDA modernization act 1997
What act reduced the cose of orphan drugs? - correct
answers✅✅Orphan drug act 1983
What act prohibited the adulteration or misbranding of food and
drugs? - correct answers✅✅Pure Food and Drug Act 1906
What act required tha active ingredients be placed on the label of
a drug's packaging and that drugs couldn't fall below purity levels
established by the USP or National Formulary? - correct
answers✅✅Pure food and drug act 1906
What amendment defined two categories - legend and OTC -
correct answers✅✅Durham-humphrey 1951
What amendment mandated there must be "adequate directions
for use" on the manufacturer's label for OTC's - correct
answers✅✅Durham-Humphrey 1951
,Nebraska MPJE Exam Questions and
Answers A+ Guide
What amendment declared that all new drugs marketed in the
U.S. had to be shown to be safe and effective - correct
answers✅✅Kefauver-Harris 1962
What act was passed to correct the problem of diversion from the
normal distribution channels. Prohibits drug from being re-
imported into the U.S. Except by the manufacturer of said drugs. -
correct answers✅✅Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and maintenance of
appropriate distribution records? - correct
answers✅✅Prescription Drug Marketing Act 1987
What act prohibits sale, purchase, or trade of any drug which was
purchased by a public or private hospital or other health care
entity? - correct answers✅✅Prescription Drug Marketing Act
1987
What act prohibits the sale, purchase, or trade of any drug sample
or drug coupon redeemable for a drug product? - correct
answers✅✅Prescription Drug Marketing Act 1987
To be PIC what are the hourly requirements they must physically
work in a pharmacy? - correct answers✅✅majority of the
hours per week that the pharmacy is open averaged over a 12 -
month period or 30 hours per week
, Nebraska MPJE Exam Questions and
Answers A+ Guide
Who must submit the Pharmacy Quality Assurance Report and
when? - correct answers✅✅PIC and Annually
Who submits the Parkinson's Disease Registry Act to the
Department semiannually? - correct answers✅✅PIC
Who needs to be notified if there's a change in pharmacy
ownersip, address, PIC, or pharmacy closes? - correct
answers✅✅Department of Health and Human Services
Within how many days should the department be notified that a
pharmacy is closing? - correct answers✅✅30 days prior
Within how many days should the department be notified of the
disposition/sale of inventory, prescription records, etc due to
pharmacy closing? - correct answers✅✅15 days
When shold the department be notified of a change in PIC? -
correct answers✅✅Immediately
What information is reported under the Parkinson's disease
registry - correct answers✅✅Report shall include the name,
address, and socical security number of the person for whom the
drugs were prescribed and the name and address of the
prescribing physician
Answers A+ Guide
What legistation was created for the provisions for the fast track
review of some NDA submissions to expedite approval of new
drugs used to treat life-threatening conditions? - correct
answers✅✅Food and Drug Administration (FDA) Modernization
Act 1997
What legistation encouraged manufacturers to conduct research
for new uses of drugs and to submit SNDAs for these uses? -
correct answers✅✅FDA modernization act 1997
What act reduced the cose of orphan drugs? - correct
answers✅✅Orphan drug act 1983
What act prohibited the adulteration or misbranding of food and
drugs? - correct answers✅✅Pure Food and Drug Act 1906
What act required tha active ingredients be placed on the label of
a drug's packaging and that drugs couldn't fall below purity levels
established by the USP or National Formulary? - correct
answers✅✅Pure food and drug act 1906
What amendment defined two categories - legend and OTC -
correct answers✅✅Durham-humphrey 1951
What amendment mandated there must be "adequate directions
for use" on the manufacturer's label for OTC's - correct
answers✅✅Durham-Humphrey 1951
,Nebraska MPJE Exam Questions and
Answers A+ Guide
What amendment declared that all new drugs marketed in the
U.S. had to be shown to be safe and effective - correct
answers✅✅Kefauver-Harris 1962
What act was passed to correct the problem of diversion from the
normal distribution channels. Prohibits drug from being re-
imported into the U.S. Except by the manufacturer of said drugs. -
correct answers✅✅Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and maintenance of
appropriate distribution records? - correct
answers✅✅Prescription Drug Marketing Act 1987
What act prohibits sale, purchase, or trade of any drug which was
purchased by a public or private hospital or other health care
entity? - correct answers✅✅Prescription Drug Marketing Act
1987
What act prohibits the sale, purchase, or trade of any drug sample
or drug coupon redeemable for a drug product? - correct
answers✅✅Prescription Drug Marketing Act 1987
To be PIC what are the hourly requirements they must physically
work in a pharmacy? - correct answers✅✅majority of the
hours per week that the pharmacy is open averaged over a 12 -
month period or 30 hours per week
, Nebraska MPJE Exam Questions and
Answers A+ Guide
Who must submit the Pharmacy Quality Assurance Report and
when? - correct answers✅✅PIC and Annually
Who submits the Parkinson's Disease Registry Act to the
Department semiannually? - correct answers✅✅PIC
Who needs to be notified if there's a change in pharmacy
ownersip, address, PIC, or pharmacy closes? - correct
answers✅✅Department of Health and Human Services
Within how many days should the department be notified that a
pharmacy is closing? - correct answers✅✅30 days prior
Within how many days should the department be notified of the
disposition/sale of inventory, prescription records, etc due to
pharmacy closing? - correct answers✅✅15 days
When shold the department be notified of a change in PIC? -
correct answers✅✅Immediately
What information is reported under the Parkinson's disease
registry - correct answers✅✅Report shall include the name,
address, and socical security number of the person for whom the
drugs were prescribed and the name and address of the
prescribing physician
