Drug supply chain security act (DSCSA) Labeling

About DSCSA

The Drug Supply Chain Security Act (DSCSA) aims to build an electronic, interoperable system to accurately trace prescription drugs throughout the supply chain as they are distributed in the United States. Its goal is to verify legitimate products, detect suspect and illegitimate products, and better facilitate drug product recalls protecting consumers from counterfeit, contaminated, or otherwise harmful products.

 

The FDA has outlined tiered compliance deadlines for DSCSA implementation, beginning with prescription drug manufacturers by November 27, 2017. Repackagers were required to reach compliance by November 27, 2018, followed by wholesale distributors by November 27, 2019, and dispensers by November 27, 2020. The final deadline for serialization and traceability for DSCSA was November 27, 2023. The FDA announced a one-year delay in enforcing the electronic tracking requirement under the DSCSA. The enforcement of an interoperable package-level electronic data exchange has now shifted to November 27, 2024. 

 

DSCSA requires a unique product identifier at the prescription drug package level that consists of:

• • National Drug Code (NDC)
  • Serial number
  • Lot number
• • Expiration date
  • Product identifier in 2D barcode format

 

By November 27, 2024, the pharmaceutical industry must serialize DSCSA product identifiers at the unit level for the ability to track products securely throughout the supply chain. Partners must exchange all transaction information in a secure, interoperable, and electronic manner. With the new ability to track products, pharmaceutical manufacturing, packaging, and distribution will have new and improved serialized data and more product traceability, keeping counterfeit products out of the pharmaceutical supply chain.

Pharmaceutical manufacturing, distribution, dispensers, and packaging industries must meet the following requirements no later than November 27, 2024.

 

• Interoperable exchange: Trading partners must exchange transaction information in a secure and electronic manner with the DSCSA product identifier on all individual packages.
• Interoperable verification: Partners are required to verify the product identifier on packages and electronically validate shipments. For example, scanning a barcode to confirm reliability at the unit level.
• Interoperable tracing: All items must be able to be tracked at any time throughout the supply chain, and the product identifier must include expiration dates, lot numbers, and a standardized numerical identifier. DSCSA serialization is mandatory.

 

Trading partners must meet the above requirements, as well as provide transaction statements that include the product identifier for each package in the transaction. If companies fail to comply, they could risk fines, loss of licenses, loss of business to competitors, and operational delays until fully compliant.

 

To prepare, be sure to communicate and plan effectively with your organization. Update your barcode labeling software if it doesn’t meet the requirements, check that the barcodes on your products are readable and scannable, and invest in new hardware such as new barcode scanners and RFID readers. Barcode labeling and compliance are crucial steps for data exchange and traceability in supply chains. Take a step towards DSCSA compliance with CODESOFT, and use advanced serialization on your barcode labels with variable counter functions.

 

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