Ode to the Code

On April 26, 2006, manufacturers (and repackagers and relabelers) will need to comply with FDA regulations for barcoding, drafted two years prior. Essentially, the regulations stipulate that, by that date, prescription and OTC products must bear linear bar codes. (Click here for an electronic version of the guidance.) There is some debate as to whether the April deadline applies to packages leaving the plant, or those that are already at the consumer. If the latter, that means that drugs shipped from the plant well before the deadline will need to be coded, in order to be considered compliant upon reaching hospitals and pharmacies. Regardless, the regulations are a long time coming, and have been welcomed by manufacturers, most of which have been barcoding for years, prompted by wholesalers and the need to monitor and control stocks. Pfizer, for instance, has been barcoding all of its retail packages since 1992. The new regulations put the focus of barcoding where it should be — as a means of ensuring product safety, and consumer well-being. With all the incessant talk about RFID and its potential to revolutionize track and trace, one would think an “old” technology such as barcoding had nothing new to offer. Not so. It is far from a mature technology. There’s still no consensus as to how it should be used, and manufacturers are just beginning to tap its true value in securing the supply chain and optimizing logistics.Along with RFID, barcoding will help establish electronic pedigrees — a critical issue as states take matters into their own hands and enforce pedigree requirements. It also has the potential to facilitate recalls, as long as hospitals and pharmacies obtain the readers necessary to quickly decipher and use the National Drug Codes (NDCs) and lot numbers found on barcoded labels. Recently, pharmacists in England and Wales who were equipped with two-in-one barcode/RFID scanners as part of an Aegate Consulting pilot project found themselves key participants in aiding the recent recall of a batch of counterfeit Lipitor — but only because Aegate had provided the equipment to make it all work.Bar code quality is hardly homogenous and can be advanced, especially in terms of print quality and accuracy. Many labels suffer from legibility issues due to inadequate inks. (Click the Download Now button below to access Quint Co.’s primer — a 4-page PDF — on bar code verification.) FDA’s regulations will help, as they mandate that the print quality of barcodes meet ANSI standards of grade C or better. Still, there will always be challenges. Last May, Roche Diagnostics had to recall several batches of bar code labels because some contained duplicate barcode numbers. In these days of Moore’s Law and the desire for tomorrow’s technologies today, we might be tempted to look past barcoding as a relevant, robust track and trace solution and move right on to RFID. If only the cost of RFID would come down, we say. Well, for many applications, barcoding matches RFID as an effective mass serialization tool, and does so much more cheaply. Let’s give it its due, and support efforts to improve quality and usefulness.