NEBRASKA MPJE WITH COMPLETE SOLUTIONS
GUARANTEED PASS
What legislation 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 legislation 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
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
Within how many days should a copy of the initial CS inventory,
annual inventory, and/or CS inventory take pursuant to change
GUARANTEED PASS
What legislation 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 legislation 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
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
Within how many days should a copy of the initial CS inventory,
annual inventory, and/or CS inventory take pursuant to change
