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