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MPJE Misbranding Question

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vpanopoulos

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Can anyone explain why in these 2 scenarios, this isn’t considered misbranding?

1) The concentration of a tetracaine ointment 5% W/W is only 2%.

2) The level of alcohol in the product is 5% V/V but the label states 15% V/V.

Both of these statements seem to not be misbranded and I cannot figure it out. Any help is much appreciated!
 

Jdudley

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I believe in this case it would be both. From the resources I've read if the drug product strength/quality/purity differs from the label this is adulteration because you're selling an "unofficial" product per the official compendium of that product. Both of the main sources I've used has specifically mentioned that there are circumstances where it can both be adulterated and misbranded, and this is one of them. In my opinion, this is ESPECIALLY true if the product is compounded by yourself/pharmacy staff, as you specifically made a "bad" product.

Granted, I take my MPJE tomorrow so I'm literally just answering this to the best of my ability/understanding and trying to refine it down to non-legal terms (offical/unofficial/bad).

Hope this helps :)

Edit: I believe the official reason why its considered adulteration is that the drug has "Strength, quality or purity varying from standards" and/or "reduced in quality or strength by additives", but I still believe it is both.
 
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