What Is DSCSA?
The Drug Supply Chain Security Act (DSCSA) is a US federal law enacted in 2013 as part of the Drug Quality and Security Act. It establishes requirements to secure the pharmaceutical supply chain, ensuring prescription drugs are safe and traceable as they move through the distribution chain, from manufacturer to dispenser.
What the DSCSA Requires
The DSCSA mandates that pharmaceutical manufacturers, repackagers, wholesale distributors and dispensers provide and capture transaction information for each product sold, including lot number, transaction date and shipment date. Its endpoint is an interoperable electronic system that traces prescription drugs at package level throughout the US supply chain.
Obligations differ by role: manufacturers implement serialisation and tracing and meet product identifier requirements; distributors maintain accurate transaction records and verify identifiers to ensure authenticity; pharmacies and dispensers capture transaction information and verify the legitimacy of received products. Implementation costs, system interoperability and ongoing compliance are the main challenges for all three.
Key Features of the DSCSA
Implications for Stakeholders
The Act reshapes obligations across the pharmaceutical chain:
- Protects consumers from counterfeit and adulterated medicines
- Makes drugs traceable from manufacturing to dispensing
- Standardises transaction records across trading partners
- Enables fast detection and removal of illegitimate products
- Reduces regulatory risk for compliant stakeholders
- Creates package-level accountability across the US supply chain
How Acviss Supports DSCSA-Style Compliance
Acviss supports DSCSA-style compliance with unit-level serialisation, unique 2D identifiers and verification systems that confirm authenticity at every handover.
Origin provides the transaction-level traceability, audit trails and recall workflows regulators expect, while integration with ERP and LIMS keeps serialisation data consistent across systems.
Build Regulatory-Grade Traceability with Origin
Serialisation, verification and package-level tracing aligned with DSCSA-style regulation. Built for brands and manufacturers.
Book a Free DemoFrequently Asked Questions
The Drug Supply Chain Security Act, a US federal law enacted in 2013 under the Drug Quality and Security Act, which sets requirements for tracing, serialising and verifying prescription drugs as they move through the distribution chain.
Product tracing (transaction information at every sale), serialisation (a unique 2D Data Matrix identifier on each package), verification of identifiers, notification and response processes for illegitimate products, licensing for third-party logistics providers and interoperable electronic data exchange.
Manufacturers (serialisation and tracing), repackagers, wholesale distributors (accurate transaction records and identifier verification) and pharmacies or dispensers (capturing transaction information and verifying received products).
Each package and homogeneous case of prescription drugs must carry a unique product identifier encoded in a 2D Data Matrix barcode, applied by manufacturers and repackagers, enabling package-level verification and tracing.
Implementation costs of serialisation and electronic tracking, interoperability between different stakeholders' systems, and continuous monitoring to keep pace with evolving requirements.
