US DSCSA · 3PLs recognized as a distinct licensed category · custody without ownership · data pass-through in force.
DSCSA carved third-party logistics providers into their own category: entities that take custody of drugs without taking ownership. Licensure and reporting are the floor; the real test is operational — a 3PL sits inside its clients' data flows, and every serialization exception that happens in your building is a client relationship problem the same day.
3PLs are licensed (state or federal facility reporting) as their own category — operating unlicensed ends the pharma business line.
Product in your custody must remain traceable: receipts, holds, ships, all reconcilable to the owner's serialized records at unit level.
TI/TS flows between your clients and their partners through your operations — your WMS touching the flow must never orphan a serial.
When physical product and EPCIS data disagree on your dock, you are the first to know and contractually the first to answer.
3PL duties are in force, and pharma clients now write serialization performance into logistics contracts — exception rates and verification turnaround are becoming commercial terms, not compliance footnotes.
Daily reconciliation of physical inventory against clients' serialized records — sampling, not wall-to-wall counts — catches drift before clients do.
Receiving and shipping should verify serialized identity as product moves, writing events your clients' systems consume without manual touch.
A 3PL that can prove clean custody at unit level wins pharma contracts on exactly that proof. Make the metric visible to prospects.
Aeroz gives 3PLs dock-speed verification: chip-read identity checks on receipt and dispatch, custody events appended to an EPCIS 2.0 log your clients can audit. Exceptions surface at the door instead of in a client's reconciliation, and 'we never lose a serial' becomes a claim with a log behind it.
Yes — DSCSA defines third-party logistics providers as entities providing warehousing and distribution services without taking ownership, with their own licensure and reporting track.
The ownership-holding partners exchange TI/TS, but the data describes product physically moving through the 3PL — so the 3PL's operations must keep physical and data flows aligned, and many contracts route the data through 3PL systems.
Unit-level custody integrity, fast verification support during suspect-product events, and low exception rates — increasingly written into SLAs with penalties.
The NDC-12 transition reformats the identifiers inside every barcode and record a 3PL touches; WMS parsing and client integrations all migrate, ideally years early.
A fixed-fee Aeroz audit maps your products against dscsa for 3pls requirements and returns a written readiness assessment, a data-mapping review, and a scoped pilot plan with cost and timeline.