Adulteration vs. Misbranding Flashcards

1
Q

Manufacturer does not follow cGMP

A

Adulteration

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2
Q

Drug contains poisonous substance

A

Adulteration

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3
Q

If a prescription drug label does not mention about net quantity, then it is considered:

A

Misbranding

not really sure what “net quantity” means

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4
Q

If a prescription drug label does not mention the number of dosage units, then it is considered:

A

Misbranded

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5
Q

If drug contains filthy substance, then it is considered:

A

Adulterated

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6
Q

If a prescription drug label does not mention federal warning of transfer, then it is considered:

A

Misbranded

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7
Q

If a empty container contains dead ant in it, it is considered:

A

*Unsanitary

Since it is just container, you cannot interpret that drug is contaminated or not
per practice questions

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8
Q

If drug contains contaminated substance

A

Adulterated

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9
Q

If a prescription drug label does not mention about special storage instructions

A

misbranded

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10
Q

If drug mixed with other drug which reduces the strength

A

adulterated

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11
Q

If a prescription drug label does not mention about manufacturer’s lot number

A

misbranded

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12
Q

If a drug passes its expiration

A

adulterated

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13
Q

If a prescription drug label does not mention about expiration date,

A

misbranded

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14
Q

If drug contains deleterious substance

A

adulterated

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15
Q

If drug packaged in paper which reduces the quality of drug,

A

adulterated

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16
Q

If a prescription IV drug label does not mention the route on it, then it is considered:

A

misbranded

17
Q

If drug purpots to be a drug in USP and its strength differs from

A

adulterated

18
Q

If a drug expires on 01/01/2017 and a pharmacist sells it on 02/01/2017, it is considered:

A

Adulterated AND misbranding

19
Q

If a prescription drug label does not contain - Rx Only legend on it

A

Misbranding

20
Q

If drug contains decomposed substance

A

Adulterated

21
Q

If drug contains putrid substance

A

Adulterated

22
Q

If drug contains putrid substance

A

MISBRANDED

should be descending: highest amount –> lowest

23
Q

If a prescription drug label does not mention quanitity of active ingredient in each dosage unit

A

Misbranded

24
Q

If a prescription drug label does not contain the distributor information

A

Misbranding

25
Q

If drug strength differs from what it says on label

A

Adulterated

26
Q

If a prescription drug label does not contain drug name

A

Misbranded

27
Q

If a prescription drug label does not contain the name of manufacturer

A

Misbranded

28
Q

If drug the drug labeling is misleading

A

Misbranded

29
Q

If drug held under unsanitary conditions,

A

Adulterated

30
Q

If PPI is not provided by a pharmacist

A

Misbranded