Nebraska MPJE UPDATED Study
Guide QUESTIONS AND
CORRECT 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? - 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
Guide QUESTIONS AND
CORRECT 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? - 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
