Emerging US DSCSA and wholesaler timelines and their implications

Emerging US DSCSA and wholesaler timelines and their implications

As I have discussed previously, the US DSCSA legislation has a number of key dates for manufacturers who must serialise products:
  • November 2019 to serialise the smallest saleable units and homogeneous cases, but notably no aggregation
  • November 2023 to communicate this information to customers.

However, the wholesalers also have a key deadline of November 2019, at which point they need to authenticate returns, which in turn has an impact on manufacturers. In order to perform this authentication activity, the wholesalers will need serialisation information about the product from the manufacturers.

The HDA, the wholesale distributor industry organisation, are currently running pilots to determine workable options for them to meet these authentication requirements and we will need to wait until these have concluded before the details of how things will need to work are clear.

However, indications from wholesalers to our clients suggest that the wholesalers will be looking for communication of serialisation information from the beginning of 2019.

This has a number of implications that, for many Pharma companies, effectively bring the 2023 customer reporting deadline forward to the end of 2018, or earlier, if you consider supply chain lead times and the risks of delayed go-live. Let me explain why…

The logic goes like this:

  • Wholesalers need serialisation information on the products that have been sent to them, so…
  • For commercial reasons, manufacturers will only want to send wholesalers data on product that has been sent to them, so…
  • Manufacturers will need the capability to pick serialised deliveries to wholesalers, in order to segregate the information flow to them, so…
  • Manufacturers’ distribution locations, often 3PLs, will need to be serialisation-enabled, and…
  • In order to make picking of serialised product practical, aggregation of at least saleable items to cases will be required, so…
  • Packing lines will need to be enabled for full aggregation, and…
  • A manufacturer will need an enterprise serialisation system to coordinate serialisation information between supply chain nodes.

Having said all of this, many companies recognise the additional cost and risk of a phased implementation, particularly as the EU goes live in this timeline and the market is already very capacity constrained. So many are aggregating from day one.

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me at Stephen.McIndoe@be4ward.com.

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