FDA to Host Public Meeting on DSCSA 2023 Requirements

FDA to Host Public Meeting on DSCSA 2023 Requirements

Date: November 16, 2021

Time: 9:00 AM - 4:00 PM ET

The FDA has announced a public meeting to allow stakeholders to provide further feedback on the Enhanced Drug Distribution Security provisions of DSCSA.

Info and sign-up here

While the industry has made significant strides to establish the foundations of DSCSA in serialized barcode labeling and data exchanging, there is still significant work remaining for interoperability. You can see some of the differences in area by reviewing our recent blog post summarizing comments to FDA Draft Guidance. Much of the remaining work is around ensuring that all stakeholders are capable of receiving, storing and sharing the required transactional data from manufacturer through to dispenser. There is also need to align and create updated and new standards on enhanced verification, enhanced product tracing along with ensuring state and federal agents are able to interact with the interoperable system as outlined in the law.

PDG and GS1 US Healthcare are organizations that have done substantial joint work in advancing these areas and continue to work on building consensus and alignment. It is crucial for the industry to understand that interoperability becomes exponentially more difficult as the number of approaches grows especially for any approaches not following a widely adopted path.  We feel that PDG is providing the flexibility for industry stakeholders to have some variations in perspectives, chose from a variety of solution providers or develop their own solutions and still be able to innovate in the area of business-to-business interactions. For example, there are leading single tenant, multi-tenant, blockchain and federated solutions that are members and showing active engagement in following their blueprint, GS1 standards and guides. These solutions allow willing participants to further advance interoperability and take advantage of evolving value beyond compliance without impacting the core industry direction on foundational compliance.

We recommend reviewing this announcement including these questions provided by the FDA which can be used to ensure your organization has the right representative as well as networking with your peers and industry trade groups working on DSCSA alignment.

FDA Questions to Consider:

  1. How is implementation of the 2023 enhanced system requirements progressing for your organization?
  2. What challenges is your organization facing?
  3. Are the proposed recommendations in FDA’s guidance on enhanced drug distribution security at the package level helpful to achieve compliance with 2023 enhanced system requirements? If not, what additional information would be useful?
  4. Are there areas in which FDA could provide more clarity?

We remain encouraged by the industries efforts to address these historically challenging areas and work to put differences aside in the effort to truly secure the US drug supply chain through smarter interoperability and efficiently managed transparency.


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