Nebraska MPJE Correct Questions &
Answers(RATED 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
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
What information is reported under the Parkinson's disease registry - ANSWER 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 - ANSWER 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? -
ANSWER Within 30 days after completion
In the event of a pharmacy closing what documents must be returned to the Department
- ANSWER 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? - ANSWER 2 years
How often does a consult pharmacist have to physically be in the public health clinic? -
ANSWER 30 days
May a pharmacy intern transfer CS? - ANSWER Yes
May a pharmacy intern conduct DUR? - ANSWER Yes
May a pharmacy intern oversee technicians? - ANSWER No
Answers(RATED 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
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
What information is reported under the Parkinson's disease registry - ANSWER 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 - ANSWER 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? -
ANSWER Within 30 days after completion
In the event of a pharmacy closing what documents must be returned to the Department
- ANSWER 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? - ANSWER 2 years
How often does a consult pharmacist have to physically be in the public health clinic? -
ANSWER 30 days
May a pharmacy intern transfer CS? - ANSWER Yes
May a pharmacy intern conduct DUR? - ANSWER Yes
May a pharmacy intern oversee technicians? - ANSWER No
