US DSCSA · §582 repackager obligations · new SNI assigned, linked to the original manufacturer's identifier · in force.
A repackager breaks the manufacturer's package and creates a new one — which means DSCSA hands it the chain's hardest identity job: assign a new serialized identifier to every repackaged unit while maintaining the documented link back to the original. Break that link once and every downstream trace dead-ends at your facility.
Each repackaged unit gets its own product identifier — NDC, serial, lot, expiry in a GS1 DataMatrix — as if you were the manufacturer, because for that package you are.
The new identifier must be associated with the original manufacturer's identifier in your records — the transformation event is the hinge of the whole chain.
Verification requests, suspect-product handling, FDA 3911 notifications, six-year records — repackagers carry the manufacturer obligation set, not a lighter one.
Repackaged units into cases into pallets: aggregation errors here propagate downstream as everyone else's exceptions, with your name on them.
Repackager duties are in force. The 2033 NDC-12 transition doubles the workload: both the original and the new identifier formats change, and the linkage records must survive the migration.
Capture the old-to-new identifier mapping as a structured EPCIS transformation event at the line — reconstruction later is where linkage dies.
Sample cases against their declared contents weekly. Your downstream partners are already measuring you; measure yourself first.
Your records reference two identifier namespaces. Build the crosswalk for both, and dual-read years before 2033.
Aeroz writes the repackaging transformation as an EPCIS 2.0 event binding chip-verified identity on the new unit to the original's record — so lineage is machine-provable, not a mapping table in a drawer. Downstream verifications resolve in seconds, and your facility stops being where traces go to die.
Yes — a repackager applies its own product identifier to each repackaged unit, under its own NDC, while maintaining the documented association with the original manufacturer's identifier.
Records must connect the new identifier to the original product's identifier, so a downstream trace can pass through the repackaging step back to the manufacturer. It is the single most-broken link in DSCSA tracing.
Yes — like manufacturers, they must respond to verification requests for product bearing their identifiers, and handle suspect and illegitimate product with quarantine, investigation and FDA notification.
Twice: the original NDCs you record and the NDCs you assign both migrate to the 12-digit format by 7 March 2033, and your linkage records must remain valid across the change.
A fixed-fee Aeroz audit maps your products against dscsa for repackagers requirements and returns a written readiness assessment, a data-mapping review, and a scoped pilot plan with cost and timeline.