ACTUAL EXAM WITH CORRECT

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NEBRASKA MPJE

ACTUAL EXAM WITH CORRECT

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? - correct 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? - correct answer- FDA modernization act 1997

What act reduced the cose of orphan drugs? - correct answer- Orphan drug act 1983

What act prohibited the adulteration or misbranding of food and drugs? - correct 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 1 / 4

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levels established by the USP or National Formulary? - correct answer- Pure food and drug act 1906

What amendment defined two categories - legend and OTC - correct answer- Durham-humphrey 1951

What amendment mandated there must be "adequate directions for use" on the manufacturer's label for OTC's - correct 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 - correct 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. - correct answer- Prescription Drug Marketing Act 1987

What act requires proper storage of drugs and maintenance of appropriate distribution records? - correct answer- Prescription Drug Marketing Act 1987

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What act prohibits sale, purchase, or trade of any drug which was purchased by a public or private hospital or other health care entity? - correct 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? - correct answer- Prescription Drug Marketing Act 1987

To be PIC what are the hourly requirements they must physically work in a pharmacy? - correct 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? - correct answer- PIC and Annually

Who submits the Parkinson's Disease Registry Act to the Department semiannually? - correct answer- PIC

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Who needs to be notified if there's a change in pharmacy ownersip, address, PIC, or pharmacy closes? - correct answer- Department of Health and Human Services

Within how many days should the department be notified that a pharmacy is closing? - correct 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? - correct answer- 15 days

When shold the department be notified of a change in PIC? - correct answer- Immediately

What information is reported under the Parkinson's disease registry - correct 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 - correct answer- 5 years

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