Plain-English definitions for the standards, mandates, and concepts behind the Digital Product Passport, DSCSA, and unit-level authentication. If a regulation, data carrier, or acronym appears in a compliance brief, it is defined here — clearly, and without the jargon.
The US Drug Supply Chain Security Act. It requires unit-level serialization, electronic package-level tracing, verification, and suspect-product handling for prescription drugs. Enhanced Section 582 requirements are enforceable November 27, 2026.
Under DSCSA, product that may be counterfeit, diverted, stolen, or otherwise unfit for distribution. Trading partners must quarantine it, investigate, and notify the FDA (Form 3911) if a product is confirmed illegitimate.
Under DSCSA, a manufacturer, wholesaler, dispenser, or repackager that holds a valid license or registration. Trading partners may only buy from and sell to authorized trading partners.
The FDA's uniform 12-digit National Drug Code in a 6-4-2 format, finalized in 2026 and effective 7 March 2033 after a transition period. It re-issues every US drug label in a consistent, 2D-carrier-ready code.
A structured, machine-readable and human-accessible record of a product's identity, materials, origin, and lifecycle, bound to the physical item via a unique identifier and data carrier. In the EU it is mandated under the ESPR.
The EU Ecodesign for Sustainable Products Regulation, Reg. (EU) 2024/1781. It makes the Digital Product Passport mandatory, rolled out product group by product group through delegated acts — phased 2027–2030.
A Digital Product Passport for batteries under EU Regulation 2023/1542 (Article 77), mandatory from 18 February 2027 for EV, industrial (over 2 kWh), and LMT batteries.
A UN/CEFACT specification for issuing verifiable Digital Product Passports and conformity credentials using W3C Verifiable Credentials and decentralized identifiers — the cross-border interoperability layer for DPPs.
The data carrier · chip under the label
Assigning a unique identifier to each saleable unit so it can be individually tracked and verified. It proves the data about a unit moved correctly — but not that the physical unit in hand is genuine.
A GS1 standard that turns a product identifier into a web address, so a single QR code connects a product to all of its data — including its Digital Product Passport. The resolver standard the EU and CIRPASS converge on.
A 2D barcode that carries a serialized identifier using GS1 Application Identifiers. It is the common data carrier for pharmaceutical serialization and 2D product labeling (including AI(715) for NDC-12).
The international standard for capturing and sharing supply-chain event data — what, when, where, and why. It is the interoperable chain-of-custody record behind traceability and DPP systems.
A cryptographically signed, tamper-evident digital statement whose authorship and integrity can be independently verified. UNTP uses Verifiable Credentials to issue Digital Product Passports.
The layer that lets a physical product identify and authenticate itself anywhere, combining a secure physical anchor with a verifiable digital record. It is the category Aeroz builds.
The verifiable, tamper-evident link between a physical item and its digital record — which prevents a passport or serial number from simply being copied onto a counterfeit.
Aeroz's provisioning workflow where tags arrive ready with nothing written to the chip — removing the per-unit encoding step and leaving nothing on the chip to clone.
A structured, machine-readable and human-accessible record of a product's identity, materials, origin, and lifecycle, bound to the physical item through a unique identifier and data carrier. In the EU it is mandated under the ESPR (Reg. (EU) 2024/1781).
It phases in from 2027 to 2030. Delegated acts set DPP requirements category by category; batteries apply from 18 February 2027, with textiles among the first ESPR product groups.
The US Drug Supply Chain Security Act. Its enhanced Section 582 requirements — unit-level traceability, verification, and authorized-trading-partner rules — are enforceable November 27, 2026.
Serialization proves the data about a unit moved correctly. Authentication proves the physical unit itself is genuine — a cloned code fails when identity is bound to the item with a tamper-evident anchor.
The layer that lets a physical product identify and authenticate itself anywhere, combining a secure physical anchor with a verifiable digital record. It is the category Aeroz builds.
A fixed-fee, 14-day Aeroz audit maps your products to DSCSA, the EU Digital Product Passport, and the Battery Passport — with a written gap analysis and no commitment to proceed.