Achieve DSCSA Compliance and Add Business Value with TraceLink
The rollout of the Drug Supply Chain Security Act (DSCSA) in the United States is in full swing with pharmacies across the country—from large retail chains to those serving healthcare systems and hospitals—striving to meet new sets of requirements ahead of 2020 and 2023 deadlines.
Hospital and retail pharmacies—collectively known as dispensers under DSCSA—are assessing their strategies and making plans to comply with new serialization requirements in 2020, followed by full supply chain digitalization in 2023. While the new DSCSA regulations pose complex challenges for many life sciences industry companies, they also represent a fresh opportunity for pharmacies to digitally transform business operations and add business value.
TraceLink helps retail pharmacies achieve DSCSA compliance while increasing operational efficiency and reducing waste in their supply chain ecosystem. The combination of serialized receiving and TraceLink’s powerful network of more than 275,000 pharma supply chain companies ensures connectivity with upstream and downstream trading partners. It also provides the scalability and supply chain visibility needed to optimize operational efficiency.
For hospital and healthcare system pharmacies, serialized receiving with TraceLink ensures compliance with DSCSA. But it also lays a foundation that enables pharmacies to address longstanding challenges, from improving inventory management to enabling new technical processes like digital recalls that ultimately increase patient safety.
From large retail chains to small independent and hospital-based pharmacies, TraceLink enables all dispensers to achieve DSCSA compliance while embracing a value-based business mindset and streamlining operations.
Three stages of DSCSA
DSCSA was enacted in 2013 to protect the public from drugs that may be counterfeit, contaminated, or harmful in some other way. The law ultimately calls for drug manufacturers, distributors, and pharmacies to build a digitalized and interoperable system to track and trace pharmaceuticals as they move through the supply chain. Three key stages of the rollout affect pharmacies directly, including:
- Lot-level traceability
The first wave of DSCSA requirements became law in 2015. Stage 1 ushered in lot-level traceability requirements, mandated that pharmacies only do business with ized trading partners, and mandated that covered prescription products be accompanied by T3 documentation.
- Transition to serialization and 2D barcodes
The deadline for compliance with stage 2 is November 2020. By then, all pharmacies are required to receive only serialized products from their suppliers. This means that each unit of purchase must include a Global Trade Item Number (GTIN), a serial number, a lot number, an expiration date, and a 2D data matrix barcode, which enables these data fields to be easily scanned. Stage 2 also includes new verification requirements for serialized products.
- Full supply chain digitalization
The final phase of DSCSA, which goes into effect in 2023, requires electronic data exchange across the entire supply chain, including retail and hospital pharmacies.
TraceLink offers a full set of capabilities designed to generate new business value and support the compliance needs of US-based hospital and retail pharmacies going into 2023 and beyond.
Transform your business practices with TraceLink
Every day, thousands of hospital and retail pharmacy locations in the US and the EU rely on the TraceLink network to exchange and validate transaction documentation, protect patients from counterfeit drugs, and adhere to legal requirements. TraceLink solutions enable these pharmacies to:
- Store information connected to every drug received
- Maximize the value of 2D scanning data
- Consolidate multiple sources of compliance data
- Receive real time product master data updates
- Instantly receive verification responses
- Provide visibility for the entire enterprise
- Quickly identify recalled products for removal from inventory
TraceLink is the world's largest integrated supply network, enabling digitalization and compliance strategies across the life sciences supply chain, from manufacturers to distributors to hospitals and pharmacies. Contact the TraceLink sales team to learn more.