NEBRASKA MPJE | 176 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? - correct
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? - 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
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
,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
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
Within how many days should a copy of the initial CS inventory,
annual inventory, and/or CS inventory take pursuant to change
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? - correct
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? - 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
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
,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
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
Within how many days should a copy of the initial CS inventory,
annual inventory, and/or CS inventory take pursuant to change
