From next November individual drug boxes must be marked with barcodes carrying a serial number, a lot number and an expiration date under the US Drug Supply Chain Security Act (DSCSA), which is part of the Drug Quality and Security Act (DSQA) signed into law in 2013.
The rules – like similar but albeit subtly different regulations being introduced in Europe – are designed to secure supply chains and ensure drugs can be traced from source to pharmacy.
Several observers have raised concerns about the scale of the challenge that drug manufacturers face trying to comply with the new requirements with some even suggesting drug shortages are a possibility.
Greg Bylo, vice president of healthcare standards at GS1 US told us the situation has improved, explaining that: “The pharma industry is focused on being compliant by the November 2017 deadline.”
“Already a small portion of the industry has already begun shipping products with the new Data Matrix symbol with the accompanying data.”
However, there is still work to do according to Bylo.
“The largest concerns are the data quality and symbol quality of the Data Matrix symbols as the industry transitions to the new format.”
To address this “GS1 requires that manufacturers “verify” the bar code is accurate which requires a special bar code verification equipment. The verification grade needs to be Grade C or better in order for the bar code to meet GS1 specifications.”
GS1 US also recently launched a revised version of its implementation guidelines focused on helping drug companies move from a lot-based to a serialized approach.
According to Bylo the new “guideline focuses on the use of serialized GTINs, GLNs, and the use of EPCIS as a single industry protocol” and is “aligned with the new “1.2 implementation guideline for EPCIS” which was just published by GS1 Global.”
The document also provides drug manufacturers with worst case scenarios, which will help them manage expectations Bylo said.
“What happens if something does not occur perfectly, how would a trading partner handle this issue? The work group spend many months identifying the various business scenarios and how to handle each one of them.”