Adulteration And Misbranding

Question 1

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

Answer 1

Manufacturer, packer, or distributors name and place of business

Question 2

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

Answer 2

The generic name

Question 3

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

Answer 3

Misbranding

Question 4

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

Answer 4

Misbranding

Question 5

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

Answer 5

Misbranding

Question 6

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

Answer 6

Misbranding

Question 7

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

Answer 7

Adulterated or misbranded

Question 8

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

Answer 8

Class 1

Question 9

Which recall is the least serious recall?

Answer 9

Class 3

Question 10

Who is responsible for notifying sellers of the recall?

Answer 10

Manufacturers

Question 11

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

Answer 11

Adulteration

Question 12

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

Answer 12

Adulteration

Question 13

When do FDA perform inspections for CGMP?

Answer 13

Each 2 years

Question 14

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

Answer 14

Misbranded

Question 15

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

Answer 15

Package inserts

Question 16

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

Answer 16

Black Box Warning

Question 17

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

Answer 17

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

Question 18

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

Answer 18

Adulteration