Nebraska MPJE/ 176 Questions with Definitive
Solutions.
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
Page 1 of 24
,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
Page 2 of 24
, 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
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Solutions.
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
Page 1 of 24
,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
Page 2 of 24
, 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
Page 3 of 24
