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Serialization is about maintaining the integrity of the drug supply and the safety of patients, says Kennedy. “Basically it means that every individual unit in the drug supply chain can be traced back through every point to origin,” he says. “In the near future, when you go to a pharmacy to have a prescription filled, the pharmacist will scan a 2D barcode on a bottle of pills and know with certainty that the contents are what they are supposed to be and that the bottle he is holding was properly moved through every point along the supply chain.”
Regulations driving serialization began in California and, most recently, were updated in the Drug Quality and Safety Act of 2013, which applies national regulations to the pharmaceutical industry and changes the timeline for compliance. The federal law pushes full compliance to 2023, though there are phased-in rules to be met along the way, Kennedy says. In 2017, for example, every unit level of a drug will be required to display a 2D barcode, which by 2023 will be used for end-to-end tracking and tracing.
Complying with this law will mean a lot of changes for logistics facilities handling affected products. “The entire infrastructure of the warehouse will have to be rethought and, in some cases, retrofitted with serialization in mind,” says Kennedy. “It will affect every package line, every label design, and systems and procedures will have to be changed, so it is pervasive. I have seen reports suggesting that drug companies are looking at having to invest a minimum of $10m, and up to $70m for the big guys.”
While changes will be required, the drug industry has the advantage of dealing with a mature and proven technology, Kennedy says. He notes that when serialization was first discussed the assumption was that it would need RFID labels, but pilot programs with RFID delivered inconsistent results. “So the standard was pushed to the 2D barcode, which has been around a long time and used in many applications. There will be challenges in terms of getting a 2D barcode on very small drug bottles, but these challenges will be solved.”
The drug supply chain always has had a problem with theft and counterfeiting. “By serializing and creating a pedigree for each drug through its life cycle, we will be able to eliminate most, if not all, of those problems,” says Kennedy.
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