US-wide track-and-trace called for to pre-empt state laws

Published on 20 April 2011

Pharma, distributors and dispensers have all called for a single, US-wide track-and-trace standard that pre-empts state laws.

Concerns about the lack of a nationwide standard were communicated to the US Food and Drug Administration (FDA) after its public workshop. Without pre-emptive federal legislation companies may have to adopt track-and-trace on a state-by-state basis, beginning with California in 2015.

In the absence of clarity regarding federal pre-emption, many companies…must begin funding their plans to develop line designs, system architecture and new business processes to meet requirements for California”, said AstraZeneca.

Other players in the biopharm supply chain, such as distributors and pharmacies, expressed similar concerns. Overall, the fear is that without pre-emptive federal legislation all parts of the supply chain will face unnecessary costs as they attempt to comply with an unworkable system.

Many respondents also commented on data ownership and visibility. “A track-and-trace system must maintain the proprietary nature of each entity’s data”, said AstraZeneca, “by appropriate security controls to limit data entry and access to relevant authorised parties”.

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