Don't Use Dallas Compounding Pharmacy Products..FDA Warns : NBC News

[Stuart G]

http://www.nbcnews.com/health/dont-use-dallas-compounding-pharmacy-products-fda-warns-6C10937607


Maggie Fox , NBC News

Aug. 16, 2013 at 6:24 PM ET

The Food and Drug Administration took an unusual step on Friday, warning patients and health care providers to stay away from sterile products made by a Dallas-based compounding pharmacy called NuVision.


It’s a new twist in an ongoing fight the FDA has had with compounding pharmacies, which are supposed to make individual products to order on a prescription-by-prescription basis. The FDA says these companies often act as large-scale manufacturers, but evade FDA oversight because of glitches in the law.

The FDA says its inspections show the sterility of products made by NuVision cannot be guaranteed, but the pharmacy says it doesn’t have to meet FDA standards.

The FDA forced a showdown in a battle that almost perfectly illustrates the agency’s complaints that it doesn’t have the powers it needs to regulate such pharmacies.
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This story suggests that FDA may have some power that it claims it does not have. Further down, it tells that hundreds of people
were infected as a result of a similar situation with a New England company. Sad indeed that the FDA cannot stop these crooks....

I don' ever recall reading about this from that story:...
.....
"FDA has redoubled efforts to check on compounding pharmacies after an outbreak of fungal infections linked to a single Massachusetts pharmacy last year killed 63 people. So far, 749 people in 20 states have been sickened in that outbreak, the worst cases with meningitis or stroke, with some local abscesses and similar infections as well."....

You would think that some company that "killed 63 people" would get huge nation wide coverage. I don't remember a word..

Here is a link from Boston.com..but this appears to be somewhat obscure..(also there is no date to this article..although comments on it seem to be from last February..:

http://www.boston.com/whitecoatnotes/2013/02/05/just-massachusetts-compounding-pharmacies-passed-surprise-health-inspections/zFT7FKklNPfj6EdW4tYu1L/story.html

[Ilsa]

1. Don't they execute CEOs in China for doing

stuff like this (remember the baby formula case?)? Too bad we ca aren't putting these assholes in prison for life, or executing them for mass murder.

[magical thyme]

2. it was all over the news...

I remember tracking it while at work. We had a patient visiting from an effected state with pain in her arm at injection site for some time after the injection. IIRC, it was my first order for a fungus culture.

[Gormy Cuss]

3. It was also posted on DU . n/t

[TxDemChem]

4. I remember both cases, but I think the

Dallas company was on my radar since I work in Dallas. As a matter of fact, I did a little research into why these companies seem to not be required to follow GMP protocols and standards.

It's insane that any company that handles pharmaceuticals would not be required to be GMP-compliant.

[Defectata]

5. The New England pharmacy also had a facility in Tennessee.

These were in the news nationally. I remember them because I am from Tennessee.

[marble falls]

6. Nothing like less regulation and smaller government when one is dealing in public health.

[blkmusclmachine]

7. .

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