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adulterated vs misbranded

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p-rog

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I'm so frustrated! I've been studying this forever and I just can't find a way to keep a straight.

Let's see if you guys can help. This is what I THINK is correct so far:

If you fill:

1. the wrong drug and the label says what the original rx was for = misbranded

2. the wrong strength and the label says the original rx strength = adulterated

3. an expired drug = both adulterated and misbranded

4. a drug w/o a valid rx or with no refills remaining = misbranding


Any corrections?
 

volleychica

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I'm so frustrated! I've been studying this forever and I just can't find a way to keep a straight.

Let's see if you guys can help. This is what I THINK is correct so far:

If you fill:

1. the wrong drug and the label says what the original rx was for = misbranded

2. the wrong strength and the label says the original rx strength = adulterated

3. an expired drug = both adulterated and misbranded

4. a drug w/o a valid rx or with no refills remaining = misbranding


Any corrections?

#2 is wrong. Should be misbranded, just like #1. Any time the contents of the bottle doesn't match the label, it is misbranded. Adulterated means there's something wrong with it, either it was stored improperly, dropped on the floor, thought to be stored improperly, and as you put in #3, and expired drug (on the shelf in the pharmacy or otherwise ready to be used to fill a script).
 

enterprise2004

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So, if a pharmacist follows the "5-second rule" and puts the pill back into the container after it falls onto the dirty floor, it's adulterated!
 

StringTheorist

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#2 is wrong. Should be misbranded, just like #1. Any time the contents of the bottle doesn't match the label, it is misbranded. Adulterated means there's something wrong with it, either it was stored improperly, dropped on the floor, thought to be stored improperly, and as you put in #3, and expired drug (on the shelf in the pharmacy or otherwise ready to be used to fill a script).
that makes sense but when taking practice exams, it always comes up as adulterated. Why? IDK! It's not like it was putrid or filthy, it's just a different strength! This one confused me a lot...
 

MindOverMatter

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that makes sense but when taking practice exams, it always comes up as adulterated. Why? IDK! It's not like it was putrid or filthy, it's just a different strength! This one confused me a lot...

A drug is adulterated when "it contains a drug recognized in official compendia, but it's strength, purity or quality is lower than the official standards."

So if a drug states that it's a 5% cream for instance, but it's really only a 2% cream, it is adulterated. I know it sounds weird because this is a case where the label doesn't match the product, but you just have to suspend your belief about it in this specific case. I always just thought of it as if the drug was expired, and didn't contain the original potency that it should have.

I have no idea what it would be if it was actually stronger than the label. I would assume that would be misbranding, but every example that I saw was always where the drug was lower potency than the label.

I had a lot of misbranding/adulteration on my exam (about 6-7 questions), so you have to know this stuff down cold.
 

garzarx007

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If you thought that was bad - how about knowing who concludes if a product is adulterated if a pharmacy has to close because of flooding - and no electricity for seven days - and all product in pharmacy reaches temperatures above 100 degrees. How do you figure that out ?? I still don't know.
 

p-rog

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If you thought that was bad - how about knowing who concludes if a product is adulterated if a pharmacy has to close because of flooding - and no electricity for seven days - and all product in pharmacy reaches temperatures above 100 degrees. How do you figure that out ?? I still don't know.

Actually I'm pretty sure the board of pharmacy has to come inspect in that case!
 

p-rog

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Ok on page 304 of Reiss and Hall (question # 188): A wrong drug (american ginseng instead of chinese ginseng) is essentially put in the bottle but they called it adulterated (misbranded wasn't an option).

So, is filling a wrong drug both adulterated and misbranded then?
 
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p-rog

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#2 is wrong. Should be misbranded, just like #1. Any time the contents of the bottle doesn't match the label, it is misbranded. Adulterated means there's something wrong with it, either it was stored improperly, dropped on the floor, thought to be stored improperly, and as you put in #3, and expired drug (on the shelf in the pharmacy or otherwise ready to be used to fill a script).

Yeah just like other people said, on EVERY practice question I've seen it always says the answer is adulterated, so I'm just memorizing and not trying to understand it at this point.
 

p-rog

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Actually I'm pretty sure the board of pharmacy has to come inspect in that case!

This is the law for GA:

Within three (3) days following any damage by fire and/or water to a building or storage area in which any of the above said items are stored or retained, written notice shall be forwarded to the Director of the Georgia Drugs and Narcotics Agency (GDNA) at his office, by the person or his agent with custody or control of the said items informing the Director of the GDNA of the circumstances and requesting an immediate inspection of said items.


Within three (3) days from his receipt of such written notice the Director of theGDNA shall cause an inspection to be made of said items for the purpose of determiningtheir suitability for use as intended and within a reasonable time after the completion ofsaid inspection, the Director of the GDNA shall forward to the person from whom hereceived such notice a report of the result of said inspection and an authorization torelease said items for retail sale if the facts so indicate.
 

CgaPharm2011

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What if you have a suspension that calls for reconstitution with 100ml water. However, you got distracted and only added 50ml of water. Is this adulterated or misbranded? Basically, the product being dispensed to the patient will have wrong volume and concentration that is different from what is stated on the label, so would this be misbranded?
 
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