MPJE – Michigan Questions and
Answers with Certified Solutions
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
Answers with Certified Solutions
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
