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
If drug strength differs from what it says on label
Adulterated
26
If a prescription drug label does not contain drug name
Misbranded
27
If a prescription drug label does not contain the name of manufacturer
Misbranded
28
If drug the drug labeling is misleading
Misbranded
29
If drug held under unsanitary conditions,
Adulterated
30
If PPI is not provided by a pharmacist
Misbranded