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Flashcards in Adulteration And Misbranding Deck (18):
1

What must be present on the label to keep from misbranding?

Manufacturer, packer, or distributors name and place of business

2

What name must be listed for the drug to not constitute misbranding?

The generic name

3

What is it considered if the med doesn't have adequate directions for use?

Misbranding

4

What is it considered if a drug is an imitation of another drug?

Misbranding

5

What is it if a med is a hazardous household substance and it not packaged especially for that?

Misbranding

6

If something is wrong with the outside, it is what?

Misbranding

7

If a drug doesn't meet all USP/NF standards, it is considered what?

Adulterated or misbranded

8

Which kind of recall is the one that causes serious adverse health consequences?

Class 1

9

Which recall is the least serious recall?

Class 3

10

Who is responsible for notifying sellers of the recall?

Manufacturers

11

What is consisting in whole or part of filthy putrid or decomposed substance?

Adulteration

12

What is it when a product is manufacturered under conditions that don't conform to current GMP?

Adulteration

13

When do FDA perform inspections for CGMP?

Each 2 years

14

A drug is what is it is an imitation of another drug?

Misbranded

15

What must accompany a drug product that's needed for safe and effective use of a product by HCP?

Package inserts

16

What is required when a drug may lead to death or serious injury?

Black Box Warning

17

A prescription drug may be dispense pursuant to a prescription if the label contains what five things?

Name of pharmacy
Address of pharmacy
Date of prescription or if it's filing
Serial number of prescription
Name of prescriber

18

If a strength of a drug differs from the labeled representation, is that adulteration or misbranding?

Adulteration