Nebraska MPJE Q&A with complete solution.
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 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
