Friday, March 29, 2013

FDA cites contamination issues in Delta compounding phamacy Mississippi State strengthening safety requirements

In the wake of contaminated steroid shots at New England Compounding Center linked to a deadly meningitis outbreak, the Food and Drug Administration has discovered problems at a Mississippi Delta compounding pharmacy.
Mississippi is now strengthening safety requirements. “We’re beefing up our compounding rules,” said Frank Gammill, executive director for the state Board of Pharmacy.
The FDA has accelerated inspections of compounding facilities across a dozen states. Last month, it visited the Cleveland facility run by the Illinois-based PharMEDium and reported that procedures designed to prevent contamination of drug products failed to include adequate validation of the sterilization process.
PharMEDium officials say patient safety is their highest priority and that none of the company’s products has been linked to a patient’s death. The New England center’s contamination is linked to 50 deaths.
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