Nebraska MPJE Exam Questions and Answers 100% Pass

Nebraska MPJE Exam Questions and Answers 100% Pass 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 Fo