Key members of the Senate Health, Education, Labor, and Pensions Committee have released a bipartisan draft legislative proposal intended to improve drug distribution security. The legislation addresses, among other things: lot-level product tracing requirements for “downstream” pharmaceutical supply chain members (drug manufacturers, repackagers, wholesale distributors, and dispensers); a requirement that manufacturers serialize prescription drugs at the unit level; national licensure standards for wholesale distributors and third-party logistics providers; a requirement that members of the supply chain only transact with registered or licensed entities; and preemption of state product tracing requirements, including paper or electronic pedigree systems. The lawmakers will accept comments on the draft legislation until April 26, 2013. In a related development, the House Energy and Commerce Subcommittee on Health has scheduled an April 25 hearing on "Securing Our Nation's Prescription Drug Supply Chain,” which will focus on a House companion version of the draft “track and trace” legislation intended to secure pharmaceutical distribution.
Update: On May 8, 2013, the House Energy and Commerce Health Subcommittee approved by voice vote an amended version of its “track and trace” legislation intended to secure pharmaceutical distribution.