Nebraska MPJE Exam QUESTIONS AND
ANSWERS 100% RATED CORRECT
WITH 100% SURE PASS|GRADED A+
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
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
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
How long must a pharmacy maintain inventory records - CORRECT ANSWERS 5 years
Within how many days should a copy of the initial CS inventory, annual inventory, and/or CS inventory
take pursuant to change in PIC be forwarded to the Department? - CORRECT ANSWERS
Within 30 days after completion
In the event of a pharmacy closing what documents must be returned to the Department - CORRECT
ANSWERS Pharmacy license, pharmacy's DEA registration, all unused DEA 222 Forms
If CS inventory is transferred to another pharmacy, how long must those transfer records be
maintained? - CORRECT ANSWERS 2 years
How often does a consult pharmacist have to physically be in the public health clinic? - CORRECT
ANSWERS 30 days
May a pharmacy intern transfer CS? - CORRECT ANSWERS Yes
May a pharmacy intern conduct DUR? - CORRECT ANSWERS Yes
ANSWERS 100% RATED CORRECT
WITH 100% SURE PASS|GRADED A+
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
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
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
How long must a pharmacy maintain inventory records - CORRECT ANSWERS 5 years
Within how many days should a copy of the initial CS inventory, annual inventory, and/or CS inventory
take pursuant to change in PIC be forwarded to the Department? - CORRECT ANSWERS
Within 30 days after completion
In the event of a pharmacy closing what documents must be returned to the Department - CORRECT
ANSWERS Pharmacy license, pharmacy's DEA registration, all unused DEA 222 Forms
If CS inventory is transferred to another pharmacy, how long must those transfer records be
maintained? - CORRECT ANSWERS 2 years
How often does a consult pharmacist have to physically be in the public health clinic? - CORRECT
ANSWERS 30 days
May a pharmacy intern transfer CS? - CORRECT ANSWERS Yes
May a pharmacy intern conduct DUR? - CORRECT ANSWERS Yes
