The FDA has formed a new advisory committee to deal with issues related to compounded medications. Problems with individually compounded prescriptions attracted national attention in 2012 after tainted preservative-free methylprednisolone acetate for injection, made by the New England Compounding Center (NECC) of Framingham, Mass., was tied to dozens of deaths from meningitis nationwide. The government put the final death toll at 64. In November 2013, Congress passed the Drug Quality and Security Act which created an optional FDA certification for “outsourcing facilities” like large-scale compounders. The law also created a national “track-and-trace” system that requires manufacturers, suppliers, and pharmacies to scan drug packages as they change hands to ensure a dispensed drug’s authenticity. The 14 committee members come from a variety of disciplines, including pharmaceutical compounding and manufacturing, pharmacy, medicine, and pharmaceutical regulation.
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