An Overview of DSCSA Compliance, Reports, Regulations & Timeline

DSCSA Compliance

DSCSA Compliance

The United States has been taking initiatives to discourage the introduction and distribution of counterfeit drugs. With that goal in mind during November 2013, the Drug Quality and Security Act (DQSA) was introduced. DQSA is a federal framework to address supply chain security. The Drug Supply Chain Security Act (DSCSA) outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S.

The DSCSA compliance laws aim to facilitate the exchange of information at the individual package level about where a drug has been in the supply chain to:

  • Enable verification of the legitimacy of the drug product identifier down to the package level
  • Enhance detection and notification of illegitimate products in the drug supply chain
  • Facilitate more efficient recalls of drug products

Serialization for the US is centered on the Standardized Numerical Identifier (SNI). The SNI is a national registration and serial number for the medicinal product and each pack. Each unit must also carry the lot number and expiry date as a mandatory requirement. All data is a 2D data matrix code and printed on the pack. The serialization data are reported to the parties involved so that the flow of goods in the supply chain can be re-traced.
rfxcel Traceability Platform is designed according to the internationally accepted ANSI/ISA S95 standard. Meaning, an efficient track-and-trace solution should integrate with the packaging equipment, line controllers, and Central Repository via standard interfaces for seamless communication. This architecture ensures seamless information exchange in both directions. It is flexible enough to catch errors before unacceptable product accrue. For example, production can be stopped in instances of missing or inconsistent data to avoid manufacturing unusable (i.e. incorrectly serialized) products.

The DQSA affects:

  • Manufactures
  • Wholesale distributors
  • Repackagers
  • Third-party logistics
  • Pharmacies

DSCSA compliance implementation phases
Lot-level management
Started on January 1, 2015, for manufacturers, wholesalers, and repackagers, and July 1, 2015, for pharmacy (hospitals and retail): Share the 3T’s: Transaction Information (TI), History (TH), and Statements (TS) at the Lot (or Batch) level of identification.

Item serialization
Mid-term (2017–2019): Manufacturer/repackagers serialize packages of drug products using a product identifier (GS1 Global Trade Item Number® (GTIN®) or NDC), serial number, lot number, and expiration date.

Serialized item-level traceability
By November (2023), make available information that would allow supply chain partners to trace the ownership back to the initial manufacturer or repackager.

The DSCSA compliance transactions or changes in ownership includes the following elements:

1. Transaction information (TI)‐includes the name of the product, strength and dosage form, NDC, container size, number of containers, lot number,
transaction date, shipment date and the name and address of the businesses previous and subsequent owner.
2. Transaction history (TH)‐ an electronic statement that includes the transaction information for each prior transaction back to the manufacturer.
3. Transaction statement (TS)‐electronic confirmation by the entity transferring ownership of the product.

Each business is required to provide the TI, TH, and TS to the subsequent owner for each transaction. Each party, buyer or seller, must capture and maintain the TI, TH, and TS for each transaction for six years.

Transaction statement confirms that the product is authorized under the DSCSA compliance laws and received the product from an authorized party.

  • TI and TS from the previous seller are received
  • Shipping only legitimate product
  • Systems and processes to perform verification
  • Did not knowingly provide false transaction information
  • Did not alter the transaction history

How can rfxcel help?
With over 14 years in the traceability business, rfxcel understands the need to fulfill these regulatory requirements. Pharmaceutical and biopharmaceutical companies need a reliable track-and-trace solution to have a strong process workflow.

rfxcel provides the following solution requirements:

  • DSCSA compliance with international anti-counterfeiting requirements
  • Support of GS1 labeling information
  • Management and randomization of serialization numbers in operations
  • Management of modular aggregation for item, bundle, pallets
  • Integration with centralized track-and-trace repositories
  • Verified product that is EPCIS certified
  • Handling of packaging orders and batch information
  • Dialogs to create, discard, aggregate, and disaggregate units and hierarchies
  • User management, including rights management & audit trail
  • Recording and reconciliation of used and unused serialization numbers

The industry trusts rfxcel Traceability Platform for its scalability and reliability. rfxcel meets the needs of serialization, DQSA compliance requirements, business value and competitive advantage.

rfxcel Traceability Platform offers:

      • rfxcel Integration Server – an integration engine to merge external systems with rfxcel products. These external systems can include ERP Systems (e.g. SAP, Oracle, IBS), Packaging Systems and Edgeware (e.g. Optel), Country-specific Drug Data Repositories and more
      • rfxchange – the ecosystem that connects formatted and mapped data to DQSA hub and any other global repository
      • Data processing and validation ensures no bad data gets into the hubs
      • Scan: scanning capabilities, shipping, receiving
      • Seamlessly data exchange and formatting for DSCSA requirements
      • Collaboration and integration with all partners, customers, and other solution providers
      • Works with multiple file formats (XML, SAP iDoc, PML, EDI, or any custom data types and file formats)

Contact us for a 20-30 minute demo.


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