US FDA Drug Supply Chain Security Act (DSCSA)

Kallik minimizes the impact of staying compliant with current and forthcoming pharmaceutical regulations.

What is the DSCSA?

The DSCSA mandates full supply chain traceability for prescription drugs dispensed in the US.  Serialization data contained on product labeling and packaging must be both machine and human readable and include its National Drug Code (NDC) and Standardized Numerical Identification (SNI) being the serial number plus lot number and expiry date. A 2D data matrix is required on all packages whilst cases can carry either a linear or 2D barcode.

How does Kallik help with the DSCSA?

Kallik helps medical device manufacturers ensure their products are correctly labelled in accordance with both the FDA’s DSCSA and global serialization requirements for device identification, manufacturer, safety and re-use requirements. 

  • Improves transparency and traceability by managing all fixed and variable product and production data within one global platform.
  • Establishes a single source of labelling ‘truth’ that all market-facing product information and materials flow from
  • Increases vigilance of label layouts and content and ensures messaging is aligned across increasingly diverse product portfolios and distribution channels
DSCSA

Timeline of Updates

November 2013: DQSA Enacted by Congress

Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlined steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This enhanced FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

January 2015: Requirement for Lot Numbers

Since January 2015, dispensers, manufacturers, re-packagers and wholesale distributors in the drug supply chain have needed to print lot numbers on packaging for all prescription drugs and exchange information about a drug and who handled it each time it is sold in the U.S. market.

November 2018: Unique Serial Numbers Required on Packaging

DSCSA required pharmaceutical manufacturers and re-packagers to include unique serial numbers and expiration dates on prescription drug packaging. This had to be in a human-readable format and GS1 barcodes and included in 2D codes (Data Matrix Codes). Manufacturers and re-packagers also had to capture and store transaction information (TI), transaction history (TH), and transaction statements (TS) in their databases for at least six years.

November 2019: DSCSA Enforcement

All non-exempt, non-grandfathered drug packages flowing through the supply chain are now serialized, encoded into a 2D barcode, between the manufacturer and the dispenser. Homogeneous cases of those same drugs are also serialized, encoded into either a set of linear barcodes or a 2D barcode on their label. Pharma wholesalers are also required to authenticate and verify prescription drugs before reselling them.

November 2020: Dispenser Authentication

This deadline will affect dispensers, who will also need to have processes in place to authenticate and verify all the medicines they buy before selling them to consumers. They will need to store all TI, TH, and TS data for product tracking and tracing.

November 2023: Full DSCA Compliance

By the end of 2023, the entire supply chain must be DSCSA compliant. Complete unit-level traceability, including aggregation, will be mandatory.

How to be compliant

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Ensure consistency and robustness

Establish a global source of labeling truth backed up by digital signatures and comprehensive audit trails to ensure that every product throughout the supply chain contains a serial number, lot number, expiration date, and GS1 and 2D barcodes.

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Embrace Cloud Technologies

Eliminate multiple siloed systems by moving to a centralized cloud-based solution will improve visibility, control and co-ordination making it easier to identify and updated impacted labels whilst demonstrating compliance.

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Improve Insights

Identify opportunities to maximize operational gains across multiple contract manufacturing and supply chain partners by standardizing content and layout for multiple packaging processes and graphic elements.

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Harmonize Your Processes

Unite dispersed teams and eliminate disjointed processes resulting from use of spreadsheets, documents, emails and localized desktop solutions that otherwise make identification of all future impacted labels an almost impossible task.

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Future-Proof Your Compliance

Be better prepared for further world adoption of serialization and track and trace regulations by implementing a scaleable, robust and transparent solution to secure your supply chain and deliver globally compliant labeling.

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Optimize Print and Packaging

Ensure the quality, format and positioning of linear and 2D serialization barcodes contained within multiple types of print and packaging labeling are detectable to the range of optical and scanning devices used throughout the supply chain.