DSCSA: Transaction Information

In the new U.S. Drug Supply Chain Security Act (DSCSA) enacted last November as part of the Drug Quality and Security Act (DQSA), “Transaction Information” (TI) is one of three primary sets of data that supply chain sellers of drugs must provide to the buyers beginning January 1 of next year.  I will discuss “Transaction

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One thought on “DSCSA: Transaction Information”

  1. I dont see any hardship in the TI soft/hard copy generation/delivery/validation if appropriate data is maintained. We already do more than that in our patent pending SCM solution. Its basically a shipping/packing list/delivery manifest with lot more detail as mentioned by the author of the post Mr. Rodgers.

    I further dont see any hardship in the data to be included in the TI/TH/TS. The from and to address can mention the Shipper, recipient address and also the shipped,received dock address. These are just 2 additional pieces of information which are already being maintained in any Supply Chain Management system (SCM). Similarly all the other data mentioned are already maintained in any SCM.

    Just requires usage of better software systems and phasing out the manual systems. The main complexity I see from a software point of view is the size of data to be maintained. It will just become expensive for smaller business to own systems maintaining such data. May be they can use cloud based services with recurring smaller costs and over come the issue.

    I will try to put my idea of how the process of generating/delivering/validating TI/TH/TS will happen in non-programmer language as best as possible.
    The TI/TH/TS can be a Text/?ML/Soap transfer based on a web pull/push on request/response over http/https/ftp/SFTP/SCH or pdf transfer on demand/response. Once the technology is defined, I dont see why it would be complicated to auto validate the TI/TH. FDA is already accepted suggestions from parties on how it can be done and processing the suggestions.

    I can keep writing on what each part of the data should be and how it can be derived but this is not the place and time.

    I understand there are issues as with any law which comes into place and they will be sorted out in the free market as they should be. I have seen solutions providers already announce that they are DQSA compliant. There are solutions out there, just the matter of finding the right one.

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