Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain. Let me explain.
In my last essay I touched on the use of Product Identifier Authentication, or PIA, as an alternative to the collection and distribution of aggregation data to allow wholesale distributors and repackagers to meet the verification requirements of the Drug Supply Chain Security Act (DSCSA). Starting in November of 2018 for repackagers and in November of 2019 for wholesalers, the DSCSA will require these companies to verify that the standardized numerical identifier (SNI)—commonly referred to as “the serial number”—corresponds with one that the manufacturer originally applied to drugs that are found to be suspect, and for any returned drug that will be resold.
As I pointed out in my previous essay (see “The Aggregation Hoax and PIA”), manufacturers and repackagers may be able to choose to pass on aggregation information that would allow wholesale distributors to meet their requirements, or they might choose to offer a PIA service that would allow these companies to check the authenticity of one or more SNIs via a web service. Continue reading Product Identifier Authentication (PIA)→
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