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Potentially Contaminated Medication From NECC

October 2012, Vol 5, No 7

On October 4, 2012, the FDA and the US Centers for Disease Control and Prevention (CDC) recommended that all healthcare professionals cease use and remove from pharmaceutical inventory any product produced by the New England Com­pounding Center (NECC). The FDA and CDC issued the health advisory after a multistate outbreak of Aspergillus meningitis among patients who received an epidural steroid injection of preservative-free methylprednisolone acetate suspension prepared by NECC.

On October 6, NECC announced a voluntary recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts, stating that it was taking this action “out of an abundance of caution due to the potential risk of contamination, and in cooperation with an investigation being conducted by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Massachusetts Board of Registration in Pharmacy.”

The situation with NECC has focused attention on the regulation of pharmaceutical compounding companies. Currently, the FDA has limited authority over the operations of compounding pharmacies, which are mainly regulated at the state level. According to the International Academy of Compounding Pharmacists, there are approximately 7500 pharmacies in the United States that specialize in advanced compounding services, with approximately 3000 providing sterile compounding.

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