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.
- 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 barcoding 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 Answerspdf 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 This guidance finalizes the draft guidance entitled “Guidance for Industry: Bar Code Label Requirements – Questions and Answers (Question 12 Update)” dated August 2010, and supersedes the guidance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, Version 14 Issue 1, Jan-2014
The core standards document describing how barcodes and identification keys should be used to comply with GS1 standards.
- GS1 Healthcare GTIN Allocation Rules pdf icon[1.1 MB, 26 pages]external icon, Release 9.0.2, Ratified, Dec 2015
Includes information on the GTIN Allocation Rules for the Healthcare Sector.
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.
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.
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
- Two-Dimensional (2D) Vaccine Barcoding Manufacturers Forum Final Report pdf icon[32 pages]
Summarizes the content presented at the Manufacturer’s Forum and includes questions and answers from attendees as well as a summary of the working sessions and meeting follow up.
- CDC 2D Vaccine Barcode Pilot-Manufacturers Forum Outcome pdf icon[2 pages]
An article summarizing the highlights and outcomes of the January 2012 Vaccine Manufacturer’s forum.