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Rehashing misbranded vs both misbranded and adulterated

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neopharma

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I did a search on the old threads but there didn't seem to be a general consensus.

If you fill an rx for the wrong strength, it's for sure misbranded, I get that.

However, would it be BOTH misbranded and adulterated?

The applicable adulteration rules say:


"[SIZE=-1](6) If it purports to be, or is represented as, a drug the name of which is recognized in the official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. The determination as to strength, quality, or purity must be made in accordance with the tests or methods of assay set forth in such compendium, or, when such tests or methods of assay are absent or inadequate, in accordance with those tests or methods of assay prescribed under authority of the federal act. A drug defined in the official compendium is not adulterated under this subsection merely because it differs from the standard of strength, quality, or purity set forth for that drug in such compendium if its difference in strength, quality, or purity from such standard is plainly stated on its label;
(7) If it is not subject to subsection (6) and its strength differs from, or its purity or quality falls below the standard of, that which it purports or is represented to possess;"

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Please correct anything below that is wrong.

So, if you take zyx 75 mg and pour it into a bottle that's labeled for 50 mg, that would be just misbranding
.

However, if you pour in zyx 75 mg and for some reason it has deteriorated to 50 mg, then it would be misbranding AND adulteration.

If you are supposed to compound zyx 75 mg and end up accidentally making and filling 50 mg, misbranding AND adulteration.

If you receive a bottle of zyx 100mg on the label from the manufacturer, but it really contains zyx 75 mg, is that just misbranding, or is it misbranding AND adulteration?

Would love to be done with this concept once and for all! Ahhhh! MPJE is gonna make us all looney.

 
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CaptainPicard

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"[SIZE=-1](6) and its strength differs from, or its purity or quality falls below the standard of, that which it purports or is represented to possess;"

It says nothing about deteriorating. The wrong strength in the bottle is adulteration of the end product, regardless of how the wrong strength came to be.

There is some overlap with adulteration and misbranding, from my interpretation.
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DrWrong

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Not going to be of any help here, as I haven't really started studying in depth yet.

But, why must a pharmacist be able to differentiate between what is adultered and misbranded?

I feel I should just have to know what is wrong and that it has consequences. It's ridiculous.
 

neopharma

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I feel that way about a lot of this stuff :/ I wish the test was based off of more commonly experienced, realistic things...it would make me feel better about MY personal pharmacist, as the patient
 

CaptainPicard

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Both adulteration and misbranding can occur in a pharmacy. They are covered by federal law, so you need to know about them.
 

DrWrong

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Both adulteration and misbranding can occur in a pharmacy. They are covered by federal law, so you need to know about them.


I don't doubt for a minute that they do. I just don't feel I should have to differentiate between the two.
 

all4rx

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Here's the way I learned: Adulterated = Dirty & Wrong Strength ; Misbranded = Lie (Misfilled, Mislabeled)

So the one case I can think of being both adulterated and misbranded is when the pharmacist misfilled something. The drug is in the bottle definitely has a wrong strength (Adulterated) and was filled as to be misleading (Misbranded)
 

TheGoGetter

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The easiest way and best way to remember this for the boards is:

Adulterated is any of the following:
1) Physical conditions of the drugs, environment in which they were manufactured; ANYTHING UNSANITARY
2) If a drug leaves the pharacy and is then RE-DISPENSED
3) OUTDATED/EXPIRED DRUGS

Everything else is MISBRANDED
 
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