2D Vaccine Barcoding - For Manufacturers

Vaccine manufacturers play a key role in affixing 2D barcodes on vaccine vials and syringes. The following resources discuss the implications, opportunities, and challenges of implementing 2D barcoding technology on vaccine products and provides guidance on requirements and general specifications to-date. Also included is historical information on the 2012 CDC vaccine manufacturer forum.

2D Barcoding Resources

The Drug Supply Chain Security Act and 2D Vaccine Barcodes

This report evaluates the Drug Supply Chain Security Act (DSCSA) from the perspective of 2D vaccine barcode scanning. This law aims to enhance the FDA’s ability to protect consumers by identifying and removing counterfeit and dangerous medicines/products from the U.S. pharmaceutical supply chain and calls for the implementation of an electronic interoperable system by 2023. More information about this law is available at the FDA web site: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-implementation-planexternal icon.

Vaccine Manufacturer’s Forum

On January 26, 2012 CDC held a 2D Barcode Vaccine Manufacturers Forum to engage the vaccine manufacturing community. It included vaccine product manufacturers, their distributors, and trading partners in presentations and discussions on the implications, opportunities, and challenges of implementing 2D barcoding technology on vaccine products.

The goals and objectives of the Forum were to:

  • engage the vaccine manufacturing community in the discussion of the benefits, impacts, and challenges of implementing 2D barcoding,
  • understand the regulations and standards landscape in more detail, and
  • explore the options and considerations for moving the industry forward toward the implementation of 2D barcoding of vaccine products.

Speakers discussed implementation issues and standards related to 2D barcoding technology for vaccine products. A working session during the forum divided attendees into smaller groups to discuss topics related to opportunities and challenges regarding 2D barcode implementation.

Forum Attendees

It was attended by over 60 industry stakeholders including 26 representatives from 10 vaccine manufacturing companies. In addition to the manufacturers, the Forum was attended by representatives of retail pharmacy supply chain, standards organizations, and trade associations. Regulatory and global agencies including World Health Organization (WHO), the Food and Drug Administration (FDA), and CDC participated in the event, providing a rare opportunity for the industry and regulators to connect and discuss the changing requirements and standards for vaccines.

Forum Summary Documents

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Page last reviewed: January 1, 2020