Which act established the clear timeline for phasing in unit-level tracking for the US drug supply chain?

Answer

The Drug Supply Chain Security Act (DSCSA)

The Drug Supply Chain Security Act (DSCSA) served as the primary legislative catalyst for the widespread, mandatory adoption of unit-level serialization within the United States drug supply chain. Enacted in late 2013, this legislation did not create serialization from scratch but rather set a firm, non-negotiable schedule requiring trading partners to implement unit-level tracking and exchange transactional information using specific product identifiers. This regulatory pressure transformed serialization from an optional pilot program or siloed internal project into a necessary operational requirement enforced by law, primarily aimed at combating issues like counterfeiting, diversion, and adulteration of prescription drugs. Before the DSCSA, efforts were often localized or voluntary, but this act created the necessary market demand for universally interoperable unit tracking.

Related Questions

Which act established the clear timeline for phasing in unit-level tracking for the US drug supply chain?What mechanism electronically links serialized units, like individual blister packs, to their next level of packaging, such as an outer carton?What fundamental requirement distinguishes modern supply chain serialization from earlier tracking methods like batch or case tracking?Which individual is cited as being instrumental in defining the scope of modern supply chain thinking that preceded serialization?What key characteristic ensures that a manufacturer's serialized data can communicate successfully with a wholesaler's system, regardless of software vendor?What is the typical 2D barcode format utilized to encode the serialized National Drug Code and associated data on individual pharmaceutical containers?Beyond mitigating counterfeit risk, what long-term operational benefit does precise unit serialization enable for managing product recalls?What crucial element must be present on a pharmaceutical unit alongside the unique serialized NDC for regulatory tracking purposes?What operational constraint necessitates significant scaling of IT infrastructure when moving to high-volume unit verification?Which global regulatory framework, implemented in regions like the European Union, required track-and-trace based on unique product identifiers?

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