Under a new settlement with the federal government, a Texas compounding pharmacy will be allowed to stay in business under certain conditions after it allegedly made an eye injection that partially blinded at least 68 patients.in September, the patients say that the company, Guardian Pharmacy Services, made a faulty, knock-off version of a drug called TriMoxi, which was injected into their eyeballs as part of routine cataract surgeries in late 2016 and early 2017.
“We have 60-plus people with a blind eye. If you go around and poke 60 people in the eye, you’d be in a lot of trouble. But apparently if you’re just going to inject them with a toxic chemical, that’s okay.”said that the settlement demonstrated the FDA’s commitment to regulating compounding. The DOJ’s findings of wrongdoing may also bolster Sommerman’s clients’ lawsuit, which is expected to go to trial later this year, he said.
Compounding pharmacies customize drugs to specific patient needs — like a pill in liquid form — when those drugs aren’t sold by pharmaceutical companies. Unlike pharmaceutical companies, however, compounders are not required to demonstrate that their products are safe, effective, and FDA-approved.
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Fonte: CNN - 🏆 4. / 95 Consulte Mais informação »