Omeprazole liq compounding Que

Started by Whereismynorco
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Whereismynorco

Full Member
10+ Year Member
hey guys

Can we still compound omeprazole liq or we can not coz they are available now commercially. like Zegerid powder packet or First-Omeprazole.???anyone ?
 
That's a good question. I have heard from other rph that the first-omeprazole is not covered by insurances but the regular compound is covered.
 
maria1oh said:
That's a good question. I have heard from other rph that the first-omeprazole is not covered by insurances but the regular compound is covered.
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But whether or not it is covered has nothing to do with if we are legally allowed to compound it.

In my state we are not allowed to compound anything commercially available.


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yes there was another thread on this, First-omeprazole does not count as a commercially available product because it is merely a kit.
 
Why does the fact that it's a kit make a difference? Do you have any kind of official source on this? I've never seen the terminology "merely a kit" in an pharmacy law I've read


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FarmD711 said:
Why does the fact that it's a kit make a difference? Do you have any kind of official source on this? I've never seen the terminology "merely a kit" in an pharmacy law I've read


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Because they didn't submit a new drug application to the FDA for Omeprazole suspension. To the FDA, such a drug doesn't exist as something that is commercially available. They are simply selling you omeprazole powder and some strawberry flavored, lightly alkaline vehicle together in a box.
 
WVUPharm2007 said:
Because they didn't submit a new drug application to the FDA for Omeprazole suspension. To the FDA, such a drug doesn't exist as something that is commercially available. They are simply selling you omeprazole powder and some strawberry flavored, lightly alkaline vehicle together in a box.
Click to expand...

That's interesting. Definitely fits with what I've seen bc our Medicaid plan rejects the first omeprazole kit saying it's not FDA approved.


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I hate that law. You can't compound anything that's commercially available. What if some company literally stands up and patents every possible compound out there? You're taking away a pastime of the pharmacist in order to feed corporate greed.
 
Just FYI the FDA doesn't enforce the whole not compounding commercially available products. It's like a lot of compounding regulations, no one really enforces them. That is what really lead to the NECC disaster. A lack of enforcement, not a lack of regulation. You can check NECC's LONG list of previous violations of code. Why where they still allowed to compound given their history? A lack of regulatory oversight/enforcement.

The whole commercially available thing is a completely separate issue though.
 
Why not have MD write for something ridiculous like omeprazole 1.95mg/ml? It's not commercially available. Pharmaceutical companies do this nonsense all the time. I remember way back when before Mucinex was OTC, there was a 595 MG guaifenesin tablet. GTFOH!
 
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