Adulteration vs. Misbranding Flashcards
Manufacturer does not follow cGMP
Adulteration
Drug contains poisonous substance
Adulteration
If a prescription drug label does not mention about net quantity, then it is considered:
Misbranding
not really sure what “net quantity” means
If a prescription drug label does not mention the number of dosage units, then it is considered:
Misbranded
If drug contains filthy substance, then it is considered:
Adulterated
If a prescription drug label does not mention federal warning of transfer, then it is considered:
Misbranded
If a empty container contains dead ant in it, it is considered:
*Unsanitary
Since it is just container, you cannot interpret that drug is contaminated or not
per practice questions
If drug contains contaminated substance
Adulterated
If a prescription drug label does not mention about special storage instructions
misbranded
If drug mixed with other drug which reduces the strength
adulterated
If a prescription drug label does not mention about manufacturer’s lot number
misbranded
If a drug passes its expiration
adulterated
If a prescription drug label does not mention about expiration date,
misbranded
If drug contains deleterious substance
adulterated
If drug packaged in paper which reduces the quality of drug,
adulterated
If a prescription IV drug label does not mention the route on it, then it is considered:
misbranded
If drug purpots to be a drug in USP and its strength differs from
adulterated
If a drug expires on 01/01/2017 and a pharmacist sells it on 02/01/2017, it is considered:
Adulterated AND misbranding
If a prescription drug label does not contain - Rx Only legend on it
Misbranding
If drug contains decomposed substance
Adulterated
If drug contains putrid substance
Adulterated
If drug contains putrid substance
MISBRANDED
should be descending: highest amount –> lowest
If a prescription drug label does not mention quanitity of active ingredient in each dosage unit
Misbranded
If a prescription drug label does not contain the distributor information
Misbranding
If drug strength differs from what it says on label
Adulterated
If a prescription drug label does not contain drug name
Misbranded
If a prescription drug label does not contain the name of manufacturer
Misbranded
If drug the drug labeling is misleading
Misbranded
If drug held under unsanitary conditions,
Adulterated
If PPI is not provided by a pharmacist
Misbranded
