What crucial element must be present on a pharmaceutical unit alongside the unique serialized NDC for regulatory tracking purposes?

Answer

A serial number, lot number, and expiration date.

True unit-level serialization for regulated products, such as prescription drugs, requires more than just a unique identifier tied to the National Drug Code (NDC). To ensure complete traceability and manage product viability, the affixation to the saleable unit must also include three other critical pieces of information: the specific serial number (which makes the NDC unique for that instance), the lot number (linking it to a specific production run), and the expiration date (critical for patient safety). This comprehensive data package, often encoded via a 2D matrix, provides the necessary context for regulatory verification and ensures that logistical data like storage conditions (e.g., cold chain requirements) can be managed effectively for that singular product container.

What crucial element must be present on a pharmaceutical unit alongside the unique serialized NDC for regulatory tracking purposes?

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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