Nebraska MPJE exam with correct
answers
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? - ** VERIFIED 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? - ** VERIFIED ANSWERS **✔✔FDA modernization act 1997
What act reduced the cose of orphan drugs? - ** VERIFIED ANSWERS **✔✔Orphan drug act 1983
What act prohibited the adulteration or misbranding of food and drugs? - ** VERIFIED 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? - ** VERIFIED
ANSWERS **✔✔Pure food and drug act 1906
What amendment defined two categories - legend and OTC - ** VERIFIED ANSWERS
**✔✔Durham-humphrey 1951
What amendment mandated there must be "adequate directions for use" on the manufacturer's label
for OTC's - ** VERIFIED 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 - ** VERIFIED 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. - **
VERIFIED ANSWERS **✔✔Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and maintenance of appropriate distribution records? - **
VERIFIED 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? - ** VERIFIED 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? - ** VERIFIED ANSWERS **✔✔Prescription Drug Marketing Act 1987
To be PIC what are the hourly requirements they must physically work in a pharmacy? - **
VERIFIED 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? - ** VERIFIED ANSWERS
**✔✔PIC and Annually
Who submits the Parkinson's Disease Registry Act to the Department semiannually? - ** VERIFIED
ANSWERS **✔✔PIC
Who needs to be notified if there's a change in pharmacy ownersip, address, PIC, or pharmacy
closes? - ** VERIFIED ANSWERS **✔✔Department of Health and Human Services
Within how many days should the department be notified that a pharmacy is closing? - ** VERIFIED
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? - ** VERIFIED ANSWERS **✔✔15 days
, When shold the department be notified of a change in PIC? - ** VERIFIED ANSWERS
**✔✔Immediately
What information is reported under the Parkinson's disease registry - ** VERIFIED ANSWERS
**✔✔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 - ** VERIFIED ANSWERS **✔✔5 years
Within how many days should a copy of the initial CS inventory, annual inventory, and/or CS
inventory take pursuant to change in PIC be forwarded to the Department? - ** VERIFIED
ANSWERS **✔✔Within 30 days after completion
In the event of a pharmacy closing what documents must be returned to the Department - **
VERIFIED ANSWERS **✔✔Pharmacy license, pharmacy's DEA registration, all unused DEA 222
Forms
If CS inventory is transferred to another pharmacy, how long must those transfer records be
maintained? - ** VERIFIED ANSWERS **✔✔2 years
How often does a consult pharmacist have to physically be in the public health clinic? - **
VERIFIED ANSWERS **✔✔30 days
May a pharmacy intern transfer CS? - ** VERIFIED ANSWERS **✔✔Yes
May a pharmacy intern conduct DUR? - ** VERIFIED ANSWERS **✔✔Yes
May a pharmacy intern oversee technicians? - ** VERIFIED ANSWERS **✔✔No
May a technician receive an oral medication order? - ** VERIFIED ANSWERS **✔✔No
answers
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? - ** VERIFIED 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? - ** VERIFIED ANSWERS **✔✔FDA modernization act 1997
What act reduced the cose of orphan drugs? - ** VERIFIED ANSWERS **✔✔Orphan drug act 1983
What act prohibited the adulteration or misbranding of food and drugs? - ** VERIFIED 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? - ** VERIFIED
ANSWERS **✔✔Pure food and drug act 1906
What amendment defined two categories - legend and OTC - ** VERIFIED ANSWERS
**✔✔Durham-humphrey 1951
What amendment mandated there must be "adequate directions for use" on the manufacturer's label
for OTC's - ** VERIFIED 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 - ** VERIFIED 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. - **
VERIFIED ANSWERS **✔✔Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and maintenance of appropriate distribution records? - **
VERIFIED 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? - ** VERIFIED 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? - ** VERIFIED ANSWERS **✔✔Prescription Drug Marketing Act 1987
To be PIC what are the hourly requirements they must physically work in a pharmacy? - **
VERIFIED 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? - ** VERIFIED ANSWERS
**✔✔PIC and Annually
Who submits the Parkinson's Disease Registry Act to the Department semiannually? - ** VERIFIED
ANSWERS **✔✔PIC
Who needs to be notified if there's a change in pharmacy ownersip, address, PIC, or pharmacy
closes? - ** VERIFIED ANSWERS **✔✔Department of Health and Human Services
Within how many days should the department be notified that a pharmacy is closing? - ** VERIFIED
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? - ** VERIFIED ANSWERS **✔✔15 days
, When shold the department be notified of a change in PIC? - ** VERIFIED ANSWERS
**✔✔Immediately
What information is reported under the Parkinson's disease registry - ** VERIFIED ANSWERS
**✔✔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 - ** VERIFIED ANSWERS **✔✔5 years
Within how many days should a copy of the initial CS inventory, annual inventory, and/or CS
inventory take pursuant to change in PIC be forwarded to the Department? - ** VERIFIED
ANSWERS **✔✔Within 30 days after completion
In the event of a pharmacy closing what documents must be returned to the Department - **
VERIFIED ANSWERS **✔✔Pharmacy license, pharmacy's DEA registration, all unused DEA 222
Forms
If CS inventory is transferred to another pharmacy, how long must those transfer records be
maintained? - ** VERIFIED ANSWERS **✔✔2 years
How often does a consult pharmacist have to physically be in the public health clinic? - **
VERIFIED ANSWERS **✔✔30 days
May a pharmacy intern transfer CS? - ** VERIFIED ANSWERS **✔✔Yes
May a pharmacy intern conduct DUR? - ** VERIFIED ANSWERS **✔✔Yes
May a pharmacy intern oversee technicians? - ** VERIFIED ANSWERS **✔✔No
May a technician receive an oral medication order? - ** VERIFIED ANSWERS **✔✔No
