Misbranding - correct answer Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA
Adulterated or
... [Show More] Misbranded?:
False/misleading labeling - correct answer Misbranded
Adulterated or Misbranded?:
Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug - correct answer Misbranded
Adulterated or Misbranded?:
Any word or statement required on label is not prominent, conspicuous and readable - correct answer 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" - correct answer Misbranded
Adulterated or Misbranded?:
If established name or mutli-ingredient products don't identify each active ingredient - correct answer Misbranded
Adulterated or Misbranded?:
Drug is liable to deterioration and label doesn't warn to that effect - correct answer Misbranded
Adulterated or Misbranded?:
Misleading container, imitates another drug or offered for sale under the name of another drug - correct answer Misbranded
Adulterated or Misbranded?:
Dosage, frequency, duration or route of admin suggested in the labeling is dangerous - correct answer Misbranded
Adulterated or Misbranded?:
Pharmacist dispensed a medication without a refill or prescription - correct answer Misbranded
Adulteration - correct answer 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 - correct answer 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) - correct answer Adulterated
Adulterated or Misbranded?:
Drug is manufactured in facility in violation of cGMPs - correct answer Adulterated
Adulterated or Misbranded?:
Container is composed of poisonous or deleterious substance that may render contains injurious to health - correct answer Adulterated
Adulterated or Misbranded?:
Bears unsafe color additive for purposes of coloring only - correct answer Adulterated
Adulterated or Misbranded?:
Drug labeled in official compendium but strength differs from or quality or purity falls below compendium standards - correct answer 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 - correct answer Adulterated
Adulterated or Misbranded?:
Any substance mixed w/ the drug to reduce strength, or any substance that has been substituted for the drug - correct answer Adulterated
Adulterated or Misbranded?:
Pharmacist dispenses expired products - correct answer Adulterated
Labeling - correct answer 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? - correct answer Size 6
Federal Food Drug & Cosmetic (FDC) Act - correct answer -Required new drugs to be shown safe before marketing
-Authorized factory inspections [Show Less]