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House holds hearing on 'track and trace' drug distribution bill

April 25, 2013

The House Energy and Commerce Committee today heard testimony from the Food and Drug Administration, drug makers, distributors and others on draft legislation to increase the safety and security of the nation’s drug distribution system. Among other provisions, the “track and trace” proposal by Reps Bob Latta (R-OH) and Jim Matheson (D-UT) would establish lot-level tracing requirements for manufacturers, wholesale distributors, pharmacies and repackagers based on changes in ownership, and establish a collaborative process between FDA and stakeholders to better understand how and when to move to unit-level traceability. Committee Chairman Fred Upton (R-MI) said he expects the committee to mark up the legislation in May with the goal of final passage before the August recess. Last week, leaders of the Senate Health, Education, Labor and Pensions Committee released for stakeholder feedback through tomorrow a discussion draft of “track and trace” legislation that would require “interoperable, electronic unit-level product tracing” within 10 years.