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Nebraska MPJE | 176 Questions with 100% CORRECT ANSWER s
Question 1: What legislation 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
Question 2: What legislation encouraged manufacturers to
conduct research for new uses of drugs and to submit SNDAs for these uses?
CORRECT ANSWER: FDA Modernization Act 1997
Question 3: What act reduced the cost of orphan drugs?
CORRECT ANSWER : Orphan Drug Act 1983
Question 4: What act prohibited the adulteration or misbranding
of food and drugs?
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CORRECT ANSWER : Pure Food and Drug Act 1906
Question 5: What act required that 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?
CORRECT ANSWER : Pure Food and Drug Act 1906
Question 6: What amendment defined two categories - legend
and OTC?
CORRECT ANSWER : Durham-Humphrey 1951
Question 7: What amendment mandated there must be "adequate
directions for use" on the manufacturer's label for OTCs?
CORRECT ANSWER : Durham-Humphrey 1951
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Question 8: 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
Question 9: 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
Question 10: What act requires proper storage of drugs and
maintenance of appropriate distribution records?
CORRECT ANSWER : Prescription Drug Marketing Act 1987
Question 11: What act prohibits sale, purchase, or trade of any
drug which was purchased by a public or private hospital or other health care entity?
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CORRECT ANSWER : Prescription Drug Marketing Act 1987
Question 12: 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
Question 13: 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
Question 14: Who must submit the Pharmacy Quality Assurance
Report and when?
CORRECT ANSWER : PIC and Annually
Question 15: Who submits the Parkinson's Disease Registry Act
to the Department semiannually?
