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Senate committee approves drug compounding, 'track and trace' bill

May 22, 2013

The Senate Health, Education, Labor and Pensions Committee today approved legislation to improve the safety of compounded drugs by clarifying the oversight responsibilities of state and federal authorities. The legislation distinguishes between traditional compounding pharmacies and “compounding manufacturers,” which make sterile products without or in advance of a prescription and sell them across state lines. Traditional compounding would continue to be regulated primarily by state pharmacy boards, while compounding manufacturers would be regulated by the Food and Drug Administration. Health systems that engage in sterile compounding would be considered traditional compounders, regulated by the states as they are now, even if they ship interstate for dispensing within their system. The approved bill (S. 959) incorporates “track and trace” legislation (S. 957) to increase the safety and security of the nation’s drug distribution system by requiring interoperable, electronic unit-level product tracing within 10 years. According to a report released by the committee today, large-scale drug compounders continue to pose a serious risk to public health since last year’s fungal meningitis outbreak involving the New England Compounding Center.