Takeaways from the “DSCSA 2023 stabilization period” webinar

Oct 9, 2023
By Brittany Santiago

Last week I attended the DSCSA stabilization period webinar to gain some perspective from the industry on the recent FDA announcement. The panel discussed the importance of moving full speed ahead. They provided reinforcement that this absolutely is not a delay. The date is still the date.

Gregg Gorniak of Cencora emphasized the word of the law—specifically the word, “intent”. The FDA worded the stabilization period very clearly noting that they do not intend to take any action on the enforcement of the law. This means the FDA will still be knocking on doors, checking up on things and making sure that our systems and processes are in place and turned on in November.

It is vital that everyone in the ecosystem from manufacturers to dispensers take this time to, “get it right.” At the top of the list, evaluating how to handle exceptions and what to do in the case of data no product or product with no associated data. The reality is trucks will be lined up at the docks sitting with the product if we don’t get it right. Products will be stuck in quarantine.

Gregg mentioned that the number of pharmaceutical transactions that are going to take place over the next year in the US supply chain is in the billions. Imagine 1% of that product being quarantined due to data discrepancies? That has a HUGE impact on patient care.

Even with the amount of education out there, there are still trading partners who lack understanding of the regulation. Here are few suggestions I heard from this discussion:

  • Turn your systems on. Share the data.
  • Make sure you have the hardware and software that can get you to compliance.
  • You need systems in place that enable you to get to the root of your data issues, your physical product issues, your connectivity issues and your partner issues.
  • Understand your role—many supply chain partners play a dual role.
  • Keep your foot on the gas!

Ultimately this stabilization period is necessary. Now it’s on all of us to utilize the gift of time we’ve been granted.

Watch the recording for more insights on this along with some interesting Q&A and more!


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