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Exam (elaborations)

MPJE – Michigan Questions and Answers Graded A+

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MPJE – Michigan Questions and Answers Graded A+ Misbranding Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adulterated or Misbranded?: False/misleading labeling Misbranded Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug Misbranded Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous and readable Misbranded Adulterated or Misbranded?: Drug has habit-forming substance and label fails to list name and proportion of substance and "Warning—may be habit forming" Misbranded Adulterated or Misbranded?: If established name or mutli-ingredient products don't identify each active ingredient Misbranded Adulterated or Misbranded?: Drug is liable to deterioration and label doesn't warn to that effect Misbranded Adulterated or Misbranded?: Misleading container, imitates another drug or offered for sale under the name of another drug Misbranded Adulterated or Misbranded?: Dosage, frequency, duration or route of admin suggested in the labeling is dangerous Misbranded Adulterated or Misbranded?: Pharmacist dispensed a medication without a refill or prescription Misbranded Adulteration Failure of drug or device to satisfy FDA purity standards Adulterated or Misbranded?: Consists in whole or in part of filthy, putrid or decomposed substance Adulterated Adulterated or Misbranded?: Prepared, packaged or held under unsanitary conditions, whereby it MAY have become contaminated w/ filth or MAY have been rendered injurious to health (don't have to prove, just say it MAY have) Adulterated Adulterated or Misbranded?: Drug is manufactured in facility in violation of cGMPs Adulterated Adulterated or Misbranded?: Container is composed of poisonous or deleterious substance

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Institution
MPJE – Michigan
Course
MPJE – Michigan

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Uploaded on
December 14, 2023
Number of pages
75
Written in
2023/2024
Type
Exam (elaborations)
Contains
Questions & answers

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