Nebraska MPJE Exam 2023 Test Bank 100% Verified
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?
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?
FDA modernization act 1997
What act reduced the cose of orphan drugs?
Orphan drug act 1983
What act prohibited the adulteration or misbranding of food and drugs?
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?
Pure food and drug act 1906
What amendment defined two categories - legend and OTC
Durham-humphrey 1951
What amendment mandated there must be "adequate directions for use" on the
manufacturer's label for OTC's
Durham-Humphrey 1951
What amendment declared that all new drugs marketed in the U.S. had to be shown to
be safe and effective
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.
Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and maintenance of appropriate distribution
records?
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?
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?
Prescription Drug Marketing Act 1987
To be PIC what are the hourly requirements they must physically work in a pharmacy?
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?
PIC and Annually
Who submits the Parkinson's Disease Registry Act to the Department semiannually?
PIC
Who needs to be notified if there's a change in pharmacy ownersip, address, PIC, or
pharmacy closes?
, Department of Health and Human Services
Within how many days should the department be notified that a pharmacy is closing?
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?
15 days
When shold the department be notified of a change in PIC?
Immediately
What information is reported under the Parkinson's disease registry
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
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?
Within 30 days after completion
In the event of a pharmacy closing what documents must be returned to the Department
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?
2 years
How often does a consult pharmacist have to physically be in the public health clinic?
30 days
May a pharmacy intern transfer CS?
Yes
May a pharmacy intern conduct DUR?
Yes
May a pharmacy intern oversee technicians?
No
May a technician receive an oral medication order?
No
May a technician Drug Product Select?
No
May a technician counsel or provide any professional consultations?
No
May a technician clarify a medical order?
No
Can supervision and/or verification be fulfilled via real-time audiovisual cmmunication?
Yes, for verification only if patient is resident of a facility
Requirements to be a pharmacy technician
Must be at least 18 years old, have met the educational requirements of a high school
diploma, never been convicted of any nonalcohol, drug-related misdemeanor/felony,
fulfill training requirements within the first 30 days of employment, apply for registration
w/in 30 days of being hired
Supervision Ratio
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?
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?
FDA modernization act 1997
What act reduced the cose of orphan drugs?
Orphan drug act 1983
What act prohibited the adulteration or misbranding of food and drugs?
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?
Pure food and drug act 1906
What amendment defined two categories - legend and OTC
Durham-humphrey 1951
What amendment mandated there must be "adequate directions for use" on the
manufacturer's label for OTC's
Durham-Humphrey 1951
What amendment declared that all new drugs marketed in the U.S. had to be shown to
be safe and effective
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.
Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and maintenance of appropriate distribution
records?
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?
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?
Prescription Drug Marketing Act 1987
To be PIC what are the hourly requirements they must physically work in a pharmacy?
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?
PIC and Annually
Who submits the Parkinson's Disease Registry Act to the Department semiannually?
PIC
Who needs to be notified if there's a change in pharmacy ownersip, address, PIC, or
pharmacy closes?
, Department of Health and Human Services
Within how many days should the department be notified that a pharmacy is closing?
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?
15 days
When shold the department be notified of a change in PIC?
Immediately
What information is reported under the Parkinson's disease registry
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
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?
Within 30 days after completion
In the event of a pharmacy closing what documents must be returned to the Department
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?
2 years
How often does a consult pharmacist have to physically be in the public health clinic?
30 days
May a pharmacy intern transfer CS?
Yes
May a pharmacy intern conduct DUR?
Yes
May a pharmacy intern oversee technicians?
No
May a technician receive an oral medication order?
No
May a technician Drug Product Select?
No
May a technician counsel or provide any professional consultations?
No
May a technician clarify a medical order?
No
Can supervision and/or verification be fulfilled via real-time audiovisual cmmunication?
Yes, for verification only if patient is resident of a facility
Requirements to be a pharmacy technician
Must be at least 18 years old, have met the educational requirements of a high school
diploma, never been convicted of any nonalcohol, drug-related misdemeanor/felony,
fulfill training requirements within the first 30 days of employment, apply for registration
w/in 30 days of being hired
Supervision Ratio
