DSCSA: Congress Should Have Mandated Randomization

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. The text of the Drug Supply Chain Security Act (DSCSA) was developed last year

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2 thoughts on “DSCSA: Congress Should Have Mandated Randomization”

  1. I do not want to rattle any cages but, I do not think Randomization helps in any way. I have a patent pending great way to randomize alpha numeric strings but I do not believe in Randomization helping much because of its inherent requirement of having a server ready to authenticate the product 24/7, and the flaw of not defining who pays when counterfeit is identified. I am already working on a system being available 24/7 but I know how impractical its to have a system owned by Government to be running 24/7. I am not a great fan of UniqueID system where details which are already printed on the package are stored in a 2D barcode .
    To create a counterfeit in a Randomized system what all the counterfeiter needs is one correct number and they can create and send in Counterfeits before the original is dispensed. After the original is dispensed who will pay for the cost of the counterfeit held up at the dispensing points? Yes you guessed it right.
    I support what FDA is doing because they got it partially right. FDA’s system will track the item from Manufacture to dispense and easily identify where the counterfeit got into the supply chain. Its right for the party where the counterfeit got included into the supply chain to pay for the inclusion.
    I am sure this reply of mine will not be posted after review like the previous ones of mine but I will keep my voice being heard until someone gets it right.

  2. Just wanted to post the demo URL of generating 99.99% Random strings here so as to show that Alpha numeric Randomization is possible and not that complicated as many think.
    FDA’s recent guidelines mention use of numeric or alpha numbers and do not specify if they have to be serial or random. Manufacturers can choose between Random and sequential numbers as per their convenience.
    Here is an URL where you can generate limited Random numbers to your liking. I do not know if URL posting is allowed. Please feel free to delete if it is not allowed.
    http://www.upitag.com/apps/nurans_generator.weml
    Raja

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