NEBRASKA MPJE EXAM QUESTIONS AND ANSWERS.
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? - (ANSWER)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? - (ANSWER)FDA modernization act 1997
What act reduced the cose of orphan drugs? - (ANSWER)Orphan drug act 1983
What act prohibited the adulteration or misbranding of food and drugs? - (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 levels established by the USP or National Formulary? - (ANSWER)Pure food and
drug act 1906
What amendment defined two categories - legend and OTC - (ANSWER)Durham-humphrey 1951
What amendment mandated there must be "adequate directions for use" on the manufacturer's label
for OTC's - (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 - (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. -
(ANSWER)Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and maintenance of appropriate distribution records? -
(ANSWER)Prescription Drug Marketing Act 1987
,NEBRASKA MPJE EXAM QUESTIONS AND ANSWERS.
What act prohibits sale, purchase, or trade of any drug which was purchased by a public or private
hospital or other health care entity? - (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? - (ANSWER)Prescription Drug Marketing Act 1987
To be PIC what are the hourly requirements they must physically work in a pharmacy? -
(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? - (ANSWER)PIC and Annually
Who submits the Parkinson's Disease Registry Act to the Department semiannually? - (ANSWER)PIC
Who needs to be notified if there's a change in pharmacy ownersip, address, PIC, or pharmacy closes? -
(ANSWER)Department of Health and Human Services
Within how many days should the department be notified that a pharmacy is closing? - (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? - (ANSWER)15 days
When shold the department be notified of a change in PIC? - (ANSWER)Immediately
What information is reported under the Parkinson's disease registry - (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 - (ANSWER)5 years
, NEBRASKA MPJE EXAM QUESTIONS AND ANSWERS.
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? - (ANSWER)Within 30 days after
completion
In the event of a pharmacy closing what documents must be returned to the Department -
(ANSWER)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? - (ANSWER)2 years
How often does a consult pharmacist have to physically be in the public health clinic? - (ANSWER)30
days
May a pharmacy intern transfer CS? - (ANSWER)Yes
May a pharmacy intern conduct DUR? - (ANSWER)Yes
May a pharmacy intern oversee technicians? - (ANSWER)No
May a technician receive an oral medication order? - (ANSWER)No
May a technician Drug Product Select? - (ANSWER)No
May a technician counsel or provide any professional consultations? - (ANSWER)No
May a technician clarify a medical order? - (ANSWER)No
Can supervision and/or verification be fulfilled via real-time audiovisual cmmunication? - (ANSWER)Yes,
for verification only if patient is resident of a facility
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? - (ANSWER)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? - (ANSWER)FDA modernization act 1997
What act reduced the cose of orphan drugs? - (ANSWER)Orphan drug act 1983
What act prohibited the adulteration or misbranding of food and drugs? - (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 levels established by the USP or National Formulary? - (ANSWER)Pure food and
drug act 1906
What amendment defined two categories - legend and OTC - (ANSWER)Durham-humphrey 1951
What amendment mandated there must be "adequate directions for use" on the manufacturer's label
for OTC's - (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 - (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. -
(ANSWER)Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and maintenance of appropriate distribution records? -
(ANSWER)Prescription Drug Marketing Act 1987
,NEBRASKA MPJE EXAM QUESTIONS AND ANSWERS.
What act prohibits sale, purchase, or trade of any drug which was purchased by a public or private
hospital or other health care entity? - (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? - (ANSWER)Prescription Drug Marketing Act 1987
To be PIC what are the hourly requirements they must physically work in a pharmacy? -
(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? - (ANSWER)PIC and Annually
Who submits the Parkinson's Disease Registry Act to the Department semiannually? - (ANSWER)PIC
Who needs to be notified if there's a change in pharmacy ownersip, address, PIC, or pharmacy closes? -
(ANSWER)Department of Health and Human Services
Within how many days should the department be notified that a pharmacy is closing? - (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? - (ANSWER)15 days
When shold the department be notified of a change in PIC? - (ANSWER)Immediately
What information is reported under the Parkinson's disease registry - (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 - (ANSWER)5 years
, NEBRASKA MPJE EXAM QUESTIONS AND ANSWERS.
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? - (ANSWER)Within 30 days after
completion
In the event of a pharmacy closing what documents must be returned to the Department -
(ANSWER)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? - (ANSWER)2 years
How often does a consult pharmacist have to physically be in the public health clinic? - (ANSWER)30
days
May a pharmacy intern transfer CS? - (ANSWER)Yes
May a pharmacy intern conduct DUR? - (ANSWER)Yes
May a pharmacy intern oversee technicians? - (ANSWER)No
May a technician receive an oral medication order? - (ANSWER)No
May a technician Drug Product Select? - (ANSWER)No
May a technician counsel or provide any professional consultations? - (ANSWER)No
May a technician clarify a medical order? - (ANSWER)No
Can supervision and/or verification be fulfilled via real-time audiovisual cmmunication? - (ANSWER)Yes,
for verification only if patient is resident of a facility
