Pharmaceutical manufacturers press for stricter control of compounding pharmacies

On October 10th, 2012, posted in: Rx Returns by

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A national fungal meningitis outbreak linked to contaminated vials of steroid injectables from a Massachusetts compounding operation has reignited the debate over the safety of compounded drugs and the need for stiffer FDA regulation of these activities. Last week, the Centers for Disease Control and Prevention (CDC) reported 7 deaths and 91 ill, with the numbers rising daily. Thousands of individuals have been exposed to some 17,000 vials of methylprednisolone acetate produced by the New England Compounding Center (NECC) and shipped to 23 states in recent months.

Such a large volume of drug compounding and marketing to such a broad geographic area runs counter to FDA policy, especially for a drug that is available from regulated manufacturers. Compounded sterile injectables have been associated with serious adverse events, and NECC has been cited by FDA and state regulators for a range of violations in recent years. In April 2012, FDA and the CDC warned against use of a contaminated product used in eye surgery from Franck’s Pharmacy in Florida. FDA inspectors found fungus in several NECC lots last week; the firm instituted a broad recall and shut down operations. Read Entire Article


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