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Addressing Serialization and e-Pedigree Mandates
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Ensuring the security and traceability of healthcare shipments is of growing importance, especially as the counterfeiting of healthcare products continues to rise. An important step is for the U.S. to adopt legislation that creates uniform national standards and enforcement for serialization and licensing (to preempt a patchwork of state-level regulations). While it has been a slow process, progress is being made on the legislative front.

In thinking about policy, especially at the federal level, it is important to focus on: “What problem are we trying to solve?” In this situation, it is ensuring access to safe medicines and preventing counterfeit drugs from reaching consumers.

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