1 | Page
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NEBRASKA MPJE 2025 UPDATED
ACTUAL EXAM WITH CORRECT
SOLUTIONS.
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
| | | | | | | |
answer- Food and DrugAdministration (FDA) Modernization Act
| | | | | | |
1997
|
What legistation encouraged manufacturers to conduct
| | | | |
research for new uses of drugs and to submit SNDAs for these
| | | | | | | | | | | |
uses? - correct answer- FDA modernization act 1997
| | | | | | | |
What act reduced the cose of orphan drugs? - correct answer-
| | | | | | | | | |
Orphan drug act 1983
| | | |
What act prohibited the adulteration or misbranding of food and
| | | | | | | | |
drugs? - correct answer- 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
| | | | | | | | |
,2 | Page
| | | | | |
levels established by the USP or National Formulary? - correct
| | | | | | | | |
answer- Pure food and drug act 1906
| | | | | | |
What amendment defined two categories - legend and OTC -
| | | | | | | | |
correct answer- Durham-humphrey 1951
| | | |
What amendment mandated there must be "adequate directions
| | | | | | |
for use" on the manufacturer's label for OTC's - correct answer-
| | | | | | | | | | |
Durham-Humphrey 1951
| |
What amendment declared that all new drugs marketed in the
| | | | | | | | |
U.S. had to be shown to be safe and effective - correct answer-
| | | | | | | | | | | |
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 answer- Prescription Drug Marketing Act 1987
| | | | | | | |
What act requires proper storage of drugs and maintenance of
| | | | | | | | |
appropriate distribution records? - correct answer- Prescription
| | | | | | |
Drug Marketing Act 1987
| | | |
,3 | Page
| | | | | |
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 answer- 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 answer-
| | | | | | | | | | |
Prescription Drug Marketing Act 1987
| | | | |
To be PIC what are the hourly requirements they must physically
| | | | | | | | | |
work in a pharmacy? - correct answer- majority of the hours per
| | | | | | | | | | | |
week that the pharmacy is open averaged over a 12 - month
| | | | | | | | | | | |
period or 30 hours per week
| | | | | |
Who must submit the Pharmacy Quality Assurance Report and
| | | | | | | |
when? - correct answer- PIC and Annually
| | | | | | |
Who submits the Parkinson's Disease Registry Act to the
| | | | | | | |
Department semiannually? - correct answer- PIC
| | | | | |
, 4 | Page
| | | | | |
Who needs to be notified if there's a change in pharmacy
| | | | | | | | | |
ownersip, address, PIC, or pharmacy closes? - correct answer-
| | | | | | | | |
Department of Health and Human Services
| | | | | |
Within how many days should the department be notified that a
| | | | | | | | | |
pharmacy is closing? - correct answer- 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 answer- 15 days
| | | | | | |
When shold the department be notified of a change in PIC? -
| | | | | | | | | | |
correct answer- Immediately
| | |
What information is reported under the Parkinson's disease
| | | | | | |
registry - correct answer- 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
|
How long must a pharmacy maintain inventory records - correct
| | | | | | | | |
answer- 5 years
| | |
| | | | | |
NEBRASKA MPJE 2025 UPDATED
ACTUAL EXAM WITH CORRECT
SOLUTIONS.
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
| | | | | | | |
answer- Food and DrugAdministration (FDA) Modernization Act
| | | | | | |
1997
|
What legistation encouraged manufacturers to conduct
| | | | |
research for new uses of drugs and to submit SNDAs for these
| | | | | | | | | | | |
uses? - correct answer- FDA modernization act 1997
| | | | | | | |
What act reduced the cose of orphan drugs? - correct answer-
| | | | | | | | | |
Orphan drug act 1983
| | | |
What act prohibited the adulteration or misbranding of food and
| | | | | | | | |
drugs? - correct answer- 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
| | | | | | | | |
,2 | Page
| | | | | |
levels established by the USP or National Formulary? - correct
| | | | | | | | |
answer- Pure food and drug act 1906
| | | | | | |
What amendment defined two categories - legend and OTC -
| | | | | | | | |
correct answer- Durham-humphrey 1951
| | | |
What amendment mandated there must be "adequate directions
| | | | | | |
for use" on the manufacturer's label for OTC's - correct answer-
| | | | | | | | | | |
Durham-Humphrey 1951
| |
What amendment declared that all new drugs marketed in the
| | | | | | | | |
U.S. had to be shown to be safe and effective - correct answer-
| | | | | | | | | | | |
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 answer- Prescription Drug Marketing Act 1987
| | | | | | | |
What act requires proper storage of drugs and maintenance of
| | | | | | | | |
appropriate distribution records? - correct answer- Prescription
| | | | | | |
Drug Marketing Act 1987
| | | |
,3 | Page
| | | | | |
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 answer- 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 answer-
| | | | | | | | | | |
Prescription Drug Marketing Act 1987
| | | | |
To be PIC what are the hourly requirements they must physically
| | | | | | | | | |
work in a pharmacy? - correct answer- majority of the hours per
| | | | | | | | | | | |
week that the pharmacy is open averaged over a 12 - month
| | | | | | | | | | | |
period or 30 hours per week
| | | | | |
Who must submit the Pharmacy Quality Assurance Report and
| | | | | | | |
when? - correct answer- PIC and Annually
| | | | | | |
Who submits the Parkinson's Disease Registry Act to the
| | | | | | | |
Department semiannually? - correct answer- PIC
| | | | | |
, 4 | Page
| | | | | |
Who needs to be notified if there's a change in pharmacy
| | | | | | | | | |
ownersip, address, PIC, or pharmacy closes? - correct answer-
| | | | | | | | |
Department of Health and Human Services
| | | | | |
Within how many days should the department be notified that a
| | | | | | | | | |
pharmacy is closing? - correct answer- 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 answer- 15 days
| | | | | | |
When shold the department be notified of a change in PIC? -
| | | | | | | | | | |
correct answer- Immediately
| | |
What information is reported under the Parkinson's disease
| | | | | | |
registry - correct answer- 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
|
How long must a pharmacy maintain inventory records - correct
| | | | | | | | |
answer- 5 years
| | |
