This comprehensive guideline, developed by the distribution-sector experts of HDA’s Bar Code Task Force, provides specifications for bar coding and labeling healthcare products.

The 2022 revision serves as an industry-wide voluntary resource on the use of globally accepted GS1 system data structures and symbologies to comply with the Drug Supply Chain Security Act (DSCSA) to convey the required serialized data in product identifier, along with presenting options for non-serialized products.

Primarily building on the lessons learned from DSCSA implementation over the past four years, this revision includes detailed guidance on shipping case bar code label format, inner packs as well as incorporates new FDA and USP guidance and industry best practices for marking and placement of bar codes to be used in the U.S. pharmaceutical supply chain.

For questions or issues, contact Jaidalyn Rand, Director, Industry Relations.