When Will The DSCSA Ever Require Investments In Aggregation?

I have been outspoken on the question of whether or not the Drug Supply Chain Security Act (DSCSA) requires companies in the supply chain to provide their customers with serial number-based aggregation data prior to 2023.  In my view, it does not, but others disagree, saying that there are requirements in the law that lead

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7 thoughts on “When Will The DSCSA Ever Require Investments In Aggregation?”

  1. Smart businesses wanting to provide service beyond the script directly to patients have already understood the commercial value in understanding exactly what patient has what product. Serialization enables service oppprtunities. Service opportunities present especially with specialty pharma. Specialty is growing. For many reasons specialty is moving toward home administration. Serialization of connected drug delivery devices is already a reality. SEE: Internet of things and first mover advantages.

  2. “But after that date, for anyone selling drugs within the supply chain, they will need to know exactly which unit-level serial numbers are contained in their shipments so they can include those serial numbers in their TIs.”

    At what point does the inferred drugs get verified?

    1. Anonymous,
      We won’t know how and when inference will be allowed by the FDA until they make a lot of progress on their understanding of aggregation and inference and their implications. But in my view, all use of inference should be resolved, with the units involved in the inference being verified, at some point before a patient is dispensed the drug. This might happen when the wholesale distributor ships the product, or it might occur when a large dispenser unpacks a manufacturer’s case. Whichever company opens the manufacturer-packed case should be responsible for “closing” the inference that has occurred prior to that point in the supply chain by verifying that the aggregation data provided matches the contents of the shipment. But, again, this will need to be the subject of industry negotiation with the FDA as part of the public meeting(s) surrounding this important topic.

      Dirk.

  3. Sorry Dirk, but this statement is incorrect.
    “But the biggest reason this theory is nonsense is that it is based on a misreading of the DSCSA itself.”

    That section reads
    alternative methods of compliance with “any” of the requirements set forth in paragraph (1), including establishing timelines for small businesses…..

    Thank you for your perspective.

    1. Anonymous,
      Your interpretation of just the few words you cut and pasted from the law is probably correct. But you have to read the whole section to realize that Congress was specifically talking about the alternative methods only for small pharmacies. I’m referring to the fact that the provision requires the FDA to take into consideration the assessment required in subsection 582(g)(3) when they consider those “alternative methods”. You will find that the assessment is to determine the feasibility of small pharmacies conducting interoperable, electronic tracing of products at the package level. I suppose it is at least possible that the FDA could interpret the section you quote to mean that they can allow alternative methods for any provision of the EDDS requirements, but it would be a real stretch, and I don’t think they are likely to use this provision that way.

      Dirk.

  4. I have always wondered how aggregated hierarchical data will be tracked in the supply chain with so many logistical complexities/hurdles. All I hear is vendors/providers talking about the “Happy Path” scenarios. Unless there is a clear understanding on inference and how the data will be captured upon shipment and receipt, this is all a consulting ‘cash cow’.

    I am also an active member of the track and trace solution implementer, but it always bothers me when the end game is not in sight.

    Authentication at the time of dispensing makes the most sense to me with what we know so far. Without proper manpower/technology, tracking in the supply chain seems unrealistic.

    I would like to hear industry comments on this from the experts.

    Thanks,
    SK

    1. Sunil,
      Thanks for commenting. I share your concern about how the industry groups in GS1 and elsewhere always seem to stop after working on the “happy path”. Obviously, if an industry solution only works when nothing goes wrong, or, if that’s the only well-documented situation, we’re in for a catastrophe when that system is implemented. I know GS1 US and HDMA have both been spending a lot of time working on exception handling and my hope is that they have worked out how to deal with all possible exceptions, not just the happy one.

      Dirk.

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