What is drug recall?
Why is it done?
A method of removing misbranded and/or adulterated products from the market to protect the public.
Are drug recalls performed forcibly or voluntarily by the manufacturer?
Can the FDA request drug recall? What happens if ignored
- Voluntarily by manufacturer
- FDA can request & if ignored, seizure or injunction action
Most recalls are voluntary
Can the FDA mandate recalls? What do they have the power to do?
yes, but only 4 products: infant formula,
medical devices, biologic products, and tobacco products
Does the FDA have the power to mandate drug recalls?
No
What are the 3 classifications of recalls
Class I: Reasonable probability
that product will cause serious
adverse health effects or death
Class II: Product may cause
temporary or medically reversible
adverse health effects, but serious
adverse effects are remote
Class III: Product unlikely to cause
adverse health effects
The FDA enforces violations of FD&C Act, what are 4 violations?
adulteration
misbranding
tampering
counterfeit drugs
Define adulteration
containing poisonous, insanitary ingredients or
manufactured without adequate controls
True or false: Filthy, putrid or decomposed product is adulteration
True
True or false: Prepared, packed, or stored under sanitary conditions that comply with CGMP is adulteration
false
True or false: Containing a color additive that is unsafe is adulteration
True or false: Strength, quality, or purity different from the official compendium is adulteration
true
is it adulteration?
True or false: Mixing with or ingredients substituted with another substance
if a Package can contaminate the product, it is adulteration?
All yes
Can cosmetics be adulterated?
yes
is it adulteration
true or false: cosmetics containing any poisonous or deleterious substances, is it adultered?
true or false: cosmetics containing filthy, putrid, or decomposed substance is it adultered
ALL yes
is it adulteration
cosmetics prepared under unsanitary conditions
cosmetics container contains a substance that may contaminate the contents
cosmetics contains unsafe color additives but is not a hair dye containing coal tar
ALL YES
What specific dye that contain coal tar are EXEMPT from the adulteration and color additive provisions of the law.
hair dyes
The label or labeling is false or misleading - is it misbranding?
The label or labeling includes required elements - is it misbranding?
The required label or labeling is not prominently displayed - is it misbranding?
- It is an imitation of another drug - is it misbranding?
Its packaging does not conform to Poison Prevention Packaging Act 1970 - is it misbranding?
yes
no
yes
yes
yes
What approves the exact wording of the label and labeling during the pre-market approval process?
FDA
What does misbranding focus on?
the representations made by the manufacturer on the label or labeling.
When does the FD&C Act deems a cosmetic misbranded?
Must all cosmetics comply with labeling requirements of FD&C and FP&L and regulations from food and drug administration?
- if any word, statement, or label or labeling required by law is not placed with prominence, or if it is not stated in such terms that it is likely to be understood
- yes - whether they are manufactured
here or are imported from abroad
How must ingredients be listed?
Any exceptions?
- descending order of predominance
- exceptions:
Active drug ingredients
* Ingredients with less than 1% concentration
* Color additives
* “And other ingredients”
What does the Federal anti-tampering act define tampering as?
Improper interference with the product for the purpose of making objectionable or unauthorized changes
Federal anti-tampering act
What does the FDA regulations require certain OTC human drugs, cosmetics, and devices be manufactured in?
Is this the same as requiring child-resistant packaging?
- tamper-resistant packaging
- No
What does Tamper-resistant packaging provide?
visible evidence to a
consumer that tampering occurred
