Showing posts with label We’re All at Risk While Drug Compounders Fight Regulation; One Person Doesn't Like the Odds. Show all posts
Showing posts with label We’re All at Risk While Drug Compounders Fight Regulation; One Person Doesn't Like the Odds. Show all posts

Wednesday, August 28, 2013

We’re All at Risk While Drug Compounders Fight Regulation; One Person Doesn't Like the Odds

on August 27, 2013
The expected backlash to attempts by the FDA to crackdown on compounding pharmacies has begun, threatening public safety.
Dallas, TX compounder NuVision is refusing to voluntarily recall its sterile products, thumbing its nose at FDA requests following safety concerns stemming from a federal inspection of its production facilities this spring. In response, the FDA has issued two public alerts to health care providers not to use any sterile NuVision products and to “quarantine” any supplies in stock.
Shockingly, the FDA has no authority to require a compounding pharmacy to recall any products, even if inspectors have observed lax procedures that could endanger patients. Currently, compounding pharmacies, many of which began as small family-owned operations, are not considered “manufacturers.” But as compounders have flourished, many have become national, high-volume producers. A lapse in sterile procedures at one of these companies has the potential to endanger hundreds, if not thousands, of patients.

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