Bipartisan Federal Legislation Advances to Put Compounding Pharmacies Under FDA Oversight

摘要

The US Senate was expected to vote this summer-possibly as early as July 2013-on a bill that would require compounding pharmacies to be regulated by the FDA.The proposed legislation was drafted in response to the outbreak of fungal meningitis in 2012 traced to New England Compounding Center (NECC) vials of methylprednisolone that had been injected into patients to treat back pain. The tainted vials sickened 745 people in 20 states and led to the death of 58 patients.On May 22, 2013, the US Senate Health, Education, Labor and Pension Committee unanimously approved legislation that would, if passed by the full Congress, increase federal oversight of compounding pharmacies that sell drugs across state lines.