Adulteration And Misbranding Flashcards
(18 cards)
What must be present on the label to keep from misbranding?
Manufacturer, packer, or distributors name and place of business
What name must be listed for the drug to not constitute misbranding?
The generic name
What is it considered if the med doesn’t have adequate directions for use?
Misbranding
What is it considered if a drug is an imitation of another drug?
Misbranding
What is it if a med is a hazardous household substance and it not packaged especially for that?
Misbranding
If something is wrong with the outside, it is what?
Misbranding
If a drug doesn’t meet all USP/NF standards, it is considered what?
Adulterated or misbranded
Which kind of recall is the one that causes serious adverse health consequences?
Class 1
Which recall is the least serious recall?
Class 3
Who is responsible for notifying sellers of the recall?
Manufacturers
What is consisting in whole or part of filthy putrid or decomposed substance?
Adulteration
What is it when a product is manufacturered under conditions that don’t conform to current GMP?
Adulteration
When do FDA perform inspections for CGMP?
Each 2 years
A drug is what is it is an imitation of another drug?
Misbranded
What must accompany a drug product that’s needed for safe and effective use of a product by HCP?
Package inserts
What is required when a drug may lead to death or serious injury?
Black Box Warning
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
If a strength of a drug differs from the labeled representation, is that adulteration or misbranding?
Adulteration
