Law > QUESTIONS & ANSWERS > Michigan MPJE, Questions and answers. 2022/2023. 100% verified. Rated A (All)
Michigan MPJE, Questions and answers. 2022/2023. 100% verified. Rated A MPJE – Michigan, Exam predictor Questions and answers, 2022/2023. Rated 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 that may render contains injurious to health - ✔✔Adulterated Adulterated or Misbranded?: Bears unsafe color additive for purposes of coloring only - ✔✔Adulterated Adulterated or Misbranded?: Drug labeled in official compendium but strength differs from or quality or purity falls below compendium standards - ✔✔Adulterated Adulterated or Misbranded?: Drug not listed in official compendium and its strength differs from or its quality or purity falls below what is represented on label - ✔✔Adulterated Adulterated or Misbranded?: Any substance mixed w/ the drug to reduce strength, or any substance that has been substituted for the drug - ✔✔Adulterated Adulterated or Misbranded?: Pharmacist dispenses expired products - ✔✔Adulterated Labeling - ✔✔Anything accompanying the product (ex: package insert, med guide, advertisements, physician's desk reference, side effects statement, promotional material, the actual label, etc.) OTC Labeling - minimum font size? - ✔✔Size 6 Federal Food Drug & Cosmetic (FDC) Act - ✔✔-Required new drugs to be shown safe before marketing -Authorized factory inspections Prescription Drug Marketing Act - ✔✔-Bans the sale of samples -Requires drug wholesalers to be licensed by the states -Restricts reimportation from other countries Michigan Board of Pharmacy Members - ✔✔11 members - 6 RPh and 5 Public Michigan Board of Pharmacy Disciplinary Subcommittee - [Show More]
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