Nebraska Mpje Exam With 176
Questions And Correct Verified
Answers ||Graded A+
,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
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
Questions And Correct Verified
Answers ||Graded A+
,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
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
