Nebraska MPJE Exam/ 396 Questions with Certified Ans.| 2025 LATEST
UPDATED
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? -
(answers)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? - (answers)FDA modernization act 1997
What act reduced the cose of orphan drugs? - (answers)Orphan drug act 1983
What act prohibited the adulteration or misbranding of food and drugs? - (answers)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? -
(answers)Pure food and drug act 1906
What amendment defined two categories - legend and OTC - (answers)Durham-humphrey 1951
,What amendment mandated there must be "adequate directions for use" on the manufacturer's
label for OTC's - (answers)Durham-Humphrey 1951
What amendment declared that all new drugs marketed in the U.S. had to be shown to be safe
and effective - (answers)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. -
(answers)Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and maintenance of appropriate distribution records? -
(answers)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? - (answers)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? - (answers)Prescription Drug Marketing Act 1987
, To be PIC what are the hourly requirements they must physically work in a pharmacy? -
(answers)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? - (answers)PIC and
Annually
Who submits the Parkinson's Disease Registry Act to the Department semiannually? -
(answers)PIC
Who needs to be notified if there's a change in pharmacy ownersip, address, PIC, or pharmacy
closes? - (answers)Department of Health and Human Services
Within how many days should the department be notified that a pharmacy is closing? -
(answers)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? - (answers)15 days
When shold the department be notified of a change in PIC? - (answers)Immediately
UPDATED
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? -
(answers)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? - (answers)FDA modernization act 1997
What act reduced the cose of orphan drugs? - (answers)Orphan drug act 1983
What act prohibited the adulteration or misbranding of food and drugs? - (answers)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? -
(answers)Pure food and drug act 1906
What amendment defined two categories - legend and OTC - (answers)Durham-humphrey 1951
,What amendment mandated there must be "adequate directions for use" on the manufacturer's
label for OTC's - (answers)Durham-Humphrey 1951
What amendment declared that all new drugs marketed in the U.S. had to be shown to be safe
and effective - (answers)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. -
(answers)Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and maintenance of appropriate distribution records? -
(answers)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? - (answers)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? - (answers)Prescription Drug Marketing Act 1987
, To be PIC what are the hourly requirements they must physically work in a pharmacy? -
(answers)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? - (answers)PIC and
Annually
Who submits the Parkinson's Disease Registry Act to the Department semiannually? -
(answers)PIC
Who needs to be notified if there's a change in pharmacy ownersip, address, PIC, or pharmacy
closes? - (answers)Department of Health and Human Services
Within how many days should the department be notified that a pharmacy is closing? -
(answers)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? - (answers)15 days
When shold the department be notified of a change in PIC? - (answers)Immediately
