Last week was the FDA held a Drug Quality and Security Act (DQSA) supply chain stakeholder’s call. One caller asked a particularly interesting question—in light of the 2D barcode requirement in the DQSA, would packaging still be required to accommodate 1D barcodes? Since drug packages are often quite small in size, it can be difficult to include both.
Currently, 1D barcodes are required on pharmaceuticals, and 2D barcodes are being added since they become an official requirement in 2017. Those in the pharmaceutical industry feel that, “Requiring the new 2D barcode without removing the linear barcode requirement would be the worst possible outcome because it will take up more real estate on drug packages and will delay the use of the 2D barcode which will delay the benefits to the industry and to patients.”
While barcodes in the pharmaceutical industry were already examined a few years back for track and trace regulations, those in the industry are urging for the elimination of the 1D barcode.
In order to ensure the safety of pharmaceuticals around the world, most governments are requiring serial number. And while pharmaceutical companies can obtain a serial number from the GS1 (a Global Trade Item number, or GTIN), this number can not be added to a standard UPC barcode commonly used on most items.
Since the UPC-A symbology does not support the addition of the other information, such as a serial number, some have decided to go with Code-128, which can embed more characters, rather than two separate barcodes. However, this barcode is extremely lengthy, and not well suited for the small packaging in the pharmaceutical industry.
The obvious solution would be to move towards a 2D barcode. However, currently, the U.S. requires that drugs sold into the U.S market be identified with their serial number in the form of a linear barcode, leaving Code-128.
But, based on the recent call, it appears that the FDA may be open to reexamining the barcode dilemma in the pharmaceutical industry.
However, it is important to consider that there are still a lot of companies throughout the pharmaceutical supply chain who are still only capable of scanning 1D barcodes.