Vaccine 2D Barcoding for Manufacturers
View which manufacturers have added 2D barcodes to the UoU in the List of Vaccines Shipping with 2D Barcodes.
Vaccine manufacturers play a key role in affixing 2D barcodes on vaccine products. The Drug Supply Chain Security Act, enacted in 2013, mandated 2D barcodes on the secondary packaging, or unit of sale (UoS). An increasing number of manufacturers have added 2D barcodes to the unit of use (UoU) packaging (e.g., vials, syringes) for the purpose of scanning upon vaccine administration as well.
The following resources discuss the implications, opportunities, and challenges of implementing 2D barcode technology on vaccine products and provide guidance on requirements and general specifications to-date. Also included is historical information on the 2012 CDC Vaccine Manufacturers Forum.
- AAP and GS1 Guidance for Manufacturers and Suppliers (GS1R DataMatrix Barcodes to Vaccines for Point of Care) [25 pages]external icon
This “Application Guideline” developed in collaboration between the American Academy of Pediatrics (AAP) and GS1 Healthcare US, a barcode standards development organization, provides specification for creating GS1 DataMatrix 2D barcodes at the point-of-care or primary vaccine package.
- Guidance for Industry: Bar Code Label Requirements – Questions and Answers pdf icon[14 pages]external icon, August 2011
This guidance from the Food and Drug Administration (FDA) provides questions and answers relating to how the bar code label requirements apply to specific products or circumstances. This guidance finalizes the draft guidance entitled “Guidance for Industry: Bar Code Label Requirements – Questions and Answers (Question 12 Update)” dated August 2010, and supersedes the guidance entitled “Guidance for Industry: Bar Code Label Requirements – Questions and Answers” dated October 2006.
- GS1 General Specifications pdf icon[6.18 MB, 478 pages]external icon, Release 20.0, Ratified, Jan 2020
The foundational GS1 standard that defines how identification keys, data attributes and 2D and other barcodes must be used in business applications.
- GS1 Healthcare GTIN Allocation Rules pdf icon[1.1 MB, 26 pages]external icon, Release 10.0, Ratified, Jun 2020
Includes information on the Global Trade Item Number (GTIN) Allocation Rules for the Healthcare Sector.
This one-page brief pdf icon[1 page] provides a description of vaccine 2D barcodes and the benefits of scanning them during mass vaccinations.
This two-page brief pdf icon[2 pages]describes the background and challenges of different vaccine lot numbers on the unit of sale vaccine product (package or salable box) and the unit of use vaccine product (e.g., vial, syringe). The brief includes current tools, ongoing efforts, and plans to update information related to this issue.
The Drug Supply Chain Security Act and 2D Vaccine Barcodes pdf icon[15 pages] report evaluates the Drug Supply Chain Security Act (DSCSA) from the perspective of vaccine 2D 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 chains and calls for the implementation of an electronic, interoperable system by 2023. More information about this law is available at the FDA web siteexternal icon.
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.
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 chains, 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 unique opportunity for the industry and regulators to connect and discuss the changing requirements and standards for vaccines.
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.
The goals and objectives of the Forum were:
- 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.
- Explore the options and considerations for moving the industry forward toward the implementation of 2D barcoding of vaccine products.
- Two-Dimensional (2D) Vaccine Barcoding Manufacturers Forum Final Report pdf icon[32 pages]
- CDC 2D Vaccine Barcode Pilot-Manufacturers Forum Outcome pdf icon[2 pages]