adulteration vs misbranding

[khydroxide]

I am studying several different sources for the ny mpje and i am still kinda confused over adulteration vs misbranding and when it's BOTH. Could someone who has a good understanding of the material post some specific examples of each?

Adulterated: not as labeled, differs in strength, quality or purity from that represented or containing filthy, putrid or decomposed substances.

Misbranded: false label statements about the identity or ingredients of the contained drugs

Are these accurate definitions?
It says adulterated = not as labeled which sounds pretty much like misbranded to me.

Any help would be appreciated. taking my law exam on friday =T

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[motorx]

Hi,
from what I understand

Adulterated is like having junks (not 100% pure) in your products. (intentionally or not). For example, someone intentionally open up an otc 50 tabs aspirin bottle and put in 50 tabs of advils and sell it as a 100tabs of ASA... OR a bottle of Gingko extract is 75% Gingko tabs and 20% Ginger tabs and 5% garbages... That's adulterated or tempered.

Misbranding in other hand, is like putting something in the ingredients list but the bottle containing different ingredients OR making false claims or false statements about your products. For example, the bottle of Gingko claims to cure Alzheimer's. OR, the bottle of fish oil claiming that's its ingredients containing Alaskan King Salmon fish oil but in fact it contain Rock Cod fish oil.

Hope it helps.

 

[Oncopharm2009]

Hi,
from what I understand

Adulterated is like having junks (not 100% pure) in your products. (intentionally or not). For example, someone intentionally open up an otc 50 tabs aspirin bottle and put in 50 tabs of advils and sell it as a 100tabs of ASA... OR a bottle of Gingko extract is 75% Gingko tabs and 20% Ginger tabs and 5% garbages... That's adulterated or tempered.

Misbranding in other hand, is like putting something in the ingredients list but the bottle containing different ingredients OR making false claims or false statements about your products. For example, the bottle of Gingko claims to cure Alzheimer's. OR, the bottle of fish oil claiming that's its ingredients containing Alaskan King Salmon fish oil but in fact it contain Rock Cod fish oil.

Hope it helps.

I guess I could not have explained better than this, that would be the correct definition of Misbranded vs adulterated.

 

[FruitFly]

Adulterating - is to change the actual substance without authorization. Tampering with the product. The original Food and Drug laws came as a response to putrid products.

Misbranding misrepresents the contents of a product- usually in writing and with regards to labeling. Omissions of pertinent information could count as misbranding, as well.

 

[khydroxide]

Adulterating - is to change the actual substance without authorization. Tampering with the product. The original Food and Drug laws came as a response to putrid products.

Misbranding misrepresents the contents of a product- usually in writing and with regards to labeling. Omissions of pertinent information could count as misbranding, as well.

what would be a situation when it would be considered both adulterated and misbranded?

 

[PharmDstudent]

what would be a situation when it would be considered both adulterated and misbranded?

Filthy aspirin tablets in a bottle that says Advil.

 

[J ROD]

what would be a situation when it would be considered both adulterated and misbranded?

Dispensing a drug that has expired....

technically it is misbranded as being in date and adulterated because it is passed its expiration date.

 

[ohiopharmacist]

I am studying several different sources for the ny mpje and i am still kinda confused over adulteration vs misbranding and when it's BOTH. Could someone who has a good understanding of the material post some specific examples of each?

Adulterated: not as labeled, differs in strength, quality or purity from that represented or containing filthy, putrid or decomposed substances.

Misbranded: false label statements about the identity or ingredients of the contained drugs

Are these accurate definitions?
It says adulterated = not as labeled which sounds pretty much like misbranded to me.

Any help would be appreciated. taking my law exam on friday =T

There are only 3 scenarios in which a drug is considered adulterated
1. Unsanitary conditions in which the physical condition of the drug,environment in which they were manufactured are questioned

2. drug leaves the pharmacy and is then re-dispensed

3. Outdated drugs


If at any point during the exam,I had to guess...I would go with misbranding

 

[vanccce]

Bringing up this from the past as my own exam is coming up.

#1 MD writes for: Ibu 800
bottle dispensed says: Ibu 600 (error)
Bottle contains: Ibu 800 (correct strength)

Misbranded, adulterated or both? It isn't what it purports to be but it is the correct strength (per prescription order) so I say Misbranded.

#2 Another example:
MD writes for: Ibu 800
bottle dispensed says: Ibu 600 (error)
Bottle contains: Ibu 400 (wrong str)

Misbranded, adulterated or both? It isn't what it purports to be AND it is the wrong strength (per prescription order) so I say both!

#3 And finally:
MD writes for: Ibu 800
bottle dispensed says: Ibu 600 (error)
Bottle contains: Ibu 600 (wrong str)

Misbranded, adulterated or both? It isn't misbranded, because it is what it purports to be, but it is the wrong strength (per prescription order) so it must be Adulterated.

Let me know if you think those statements are wrong, but this is my current understanding of the letter of the law.

 

[MountainPharmD]

Misbranding - You put Lipitor in a bottle and label it as Simvastatin, ie a misfill.

Aldulteration. You p!ss in a bottle Lipitor and label it as Simvastin.

 

[vanccce]

Misbranding - You put Lipitor in a bottle and label it as Simvastatin, ie a misfill.

Aldulteration. You p!ss in a bottle Lipitor and label it as Simvastin.

Adulteration definition also includes "Wrong Strength" not just putrid products. The full definition is much more inclusive.

 

[tulipsmith]

Is an adulterated product always misbranded?

 

[Modest_anteater]

There are only 3 scenarios in which a drug is considered adulterated
1. Unsanitary conditions in which the physical condition of the drug,environment in which they were manufactured are questioned

2. drug leaves the pharmacy and is then re-dispensed

3. Outdated drugs


If at any point during the exam,I had to guess...I would go with misbranding

Also say a drug comes in that needs to be refrigerator and is left on a shelf for two days. That would be adulterated medication.