Industry guidance aims to help manufacturers adhere to bar coding requirements

Regulatory NewsRegulatory News | 18 April 2022 |  By 

The Healthcare Distribution Alliance (HDA) on Monday issued a guide to help the pharmaceutical industry in formatting and placing bar code labels on their products to comply with Drug Supply Chain Security Act (DSCSA) requirements for tracking products through the supply chain.
DSCSA was signed into law in November 2013 and outlines the necessary steps necessary to build and electronic, interoperable system to identify and trace prescription drugs distributed in the US to ward off drug counterfeiting.
The law specifies that manufacturers affix a product identifier to each package and case that moves through the supply chain. Such identifiers must include the National Drug Code (NDC), serial number, lot number and expiration date. These product identifiers must be embedded in linear barcodes and affixed to each product and to homogeneous case of products.
The 66-page document covers how to configure the NDC in bar codes, the components of the product identifier; the standards to follow in using two-dimensional (2D) bar codes, affixing bar codes on very small packaging configurations and on larger units and using bar code scanners.
The document revises an earlier version from 2017, and it includes information on the following topics:
  • Clarification on abbreviation and expiration date formats based on industry practice;
  • FDA’s final guidance issued in June 2021 on product identifiers, including human readable NDC;
  • Requirements for four data elements of a product identifier mandated by DSCSA;
  • Updated images and figures to display current recommendations for serialized and non-serialized products
The guidance recommends that manufacturers and labelers “rely on the unique GS1 Global Trade Item Number (GTIN) identifier associated with each drug at each packaging level in their catalogs and on price lists.” Omitting the GTIN “may violate the DSCSA and could create difficulties for downstream trading partners and potentially even compromise patient safety.”
The guideline also recommends adding a label on the outside of the shrink wrap or using a stretch wrap to ensure that labels can be read through the wrap.
The update was developed by HDA’s bar code task force and reflects “strong industry consensus across major stakeholder segments.” The first bar coding guidance was issued in 1993.
HDA says the update “builds on lessons learned from implementation over the past four years,” and “provides detailed guidance’s on shipping case bar code label format, marking and placement, and it serves as a resource for more detailed primary and secondary sources of information on standards for bar codes to be used in the U.S. pharmaceutical supply chain.”
The group said that efforts were made to maintain the “logical foundation” of previous editions.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you