Pharmaceutical Chain of Custody
Records that move with the unit, not just the shipment.
The DSCSA sets out an interoperable, electronic way to identify and trace prescription drugs at the package level. Records move between trading partners. Proof that the unit itself was present at the handoff does not.
NOANE is designed to add that proof to custody handoffs, alongside the records you already keep.
Direct Answer
What NOANE does for pharmaceutical custody.
NOANE is a patented custody protocol designed to add physical possession proof to pharmaceutical handoffs. Custody is designed to advance only when the unit and the authorized receiving party both take part, so a distributor, dispenser or investigator can check that the unit tied to a transaction record was actually present. It is designed to complement DSCSA product identifiers, EPCIS events and transaction records, not to replace them.
The Exposure
Records can move without the unit.
Trading partners exchange transaction data. Units move through distributors, repackagers, returns and dispensers. When a record and a unit separate, investigations start from claims.
Diversion
A unit can leave its authorized channel while its records still look complete.
Saleable returns
A returned unit has to be confirmed as the unit that was sold before it goes back into stock.
Suspect product
When product is suspect, every handoff becomes a question. Trading partners must notify FDA within 24 hours of determining a product is illegitimate.
Tracing says where a record went. Custody asks whether the unit was there.
Traced vs Held
Traced is not the same as held.
Transaction records describe what was shipped and to whom. Custody is a different question: was this unit present, and was the party receiving it authorized to take it.
Transaction records today
Custody, as NOANE is designed
NOANE adds possession proof to the records the DSCSA already requires. It does not replace them.
Designed for Every Trading Partner
Who it is for.
Capabilities the protocol is designed to enable. Not all are built today.
Manufacturers and repackagers
Identity provisioned at packaging. A custody record that starts at the source.
Wholesale distributors
Confirm the unit received is the unit invoiced. Gate custody on authorized receivers.
Dispensers and pharmacies
Check a unit at receipt or return with a phone tap.
Logistics and cold-chain carriers
Handoffs that record who held the unit and when.
Quality and compliance teams
A signed custody event to attach to release, quarantine and investigation workflows.
Investigators and recall teams
Narrow an investigation or recall to the units that were actually touched.
On the Record
A unit's life on the record.
How the protocol is designed to follow a unit from packaging to dispensing.
01
Register
The unit receives its identity at packaging.
02
Bind
That identity is bound to a custody record.
03
Ship
Custody moves with the unit, not just the shipment.
04
Receive
The receiver and the unit both sign the handoff.
05
Return
A returned unit is checked against its record before restocking.
06
Dispense
The final handoff is recorded.
07
Retire
The record closes when the unit is dispensed or destroyed.
Pharmaceutical handoffs use continuous custody mode: every transfer is designed to require both signatures before custody changes. No deferred settlement.
Limits
What NOANE does not do.
NOANE does not replace DSCSA product identifiers, transaction information or verification systems, and it is not a temperature sensor. A chip signature is not proof that a product is safe or legitimate. NOANE is designed to supply custody evidence those programs can use.
There is no pharmaceutical deployment today. This page describes the protocol design and the scope we are developing toward.
FAQ
Frequently asked.
Does NOANE make us DSCSA compliant?
No. NOANE is designed to add custody evidence alongside your DSCSA records. Compliance stays with your existing systems and processes.
Does this replace product identifiers?
No. Product identifiers and transaction records stay as they are. NOANE is designed to add a possession check at the handoffs that need one.
Does every unit need a chip?
Not necessarily. A secure chip costs more than a printed code, so it fits where a unit's value or risk justifies it. Scoping that is part of a pilot.
What about personal data?
The record is designed to bind units, roles and organizations without collecting unnecessary personal data.
More answers on the FAQ and in the Glossary.
Sources: US FDA, Drug Supply Chain Security Act (opens in new tab).
BIND IT.
Bring your category into the design cohort.
Research: NOANE Infrastructure Response Paper V2 · SSRN (opens in new tab) · DOI: 10.2139/ssrn.6736141 (opens in new tab)