Due to some "incomplete marketing messaging" out in the industry, there are many who are asking if DSCSA requires buying a digital credential?

The short answer is "No" and was stated well by the FDA in an industry seminar earlier this year, when asked they reminded there is no requirement for a digital credential in the law and no plans to pursue such a path.

‍"The Main Thing, is To Keep The Main Thing, The Main Thing!"

Stephen Covey

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While trading partners may one day choose to utilize such a technical solution as the industry determines how this might work in partial adoption, it is important to be clear that the majority of DSCSA transactions are covered by existing direct connections, digital certificates, and what PDG outlines as the KYS/KYC approach.

Don't let a marketing campaign replace understanding the requirements of the law and understanding what your trading partners are leveraging.

Here are some questions you can ask:

1. Will this solution allow me to interoperate with those who are not paying for such a mechanism and utilizing existing PDG KYS/KYC approaches?
2. Who governs this credential and how are good/bad actors determined?
3. Is there a budget adjustment if we find their is no adoption or usage by trading partners?

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The main point is that the industry has significant hurdles to work through to simply ensure data is flowing and exceptions are handled downstream to ensure product can continue to safely move. Digital credentials are a limited use case mechanism that need time for core integrations and processes to normalize before they should be considered.

The only industry discussed use cases for digital credential are on electronic interactions with indirect trading partners on product verifications and product traces. These are already being managed in limited volume through manual processes and will have time for automation to be considered after better established.

Digital credentials are checking the ATP status of a trading partner (do they have a single valid license or registration anywhere)and are not the same as a license check for a specific facility that is required for drug movement and trading partner license monitoring.

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National Association of Boards of Pharmacy (NABP), as a not-for-profit (NFP) focused on helping it's member board of pharmacies ensure a safe supply chain, explained the issue well and provides the focus the industry needs today.

See this article:

https://nabp.pharmacy/resource/an-interoperable-pathway-to-dscsa-authentication-and-credentialing/

As always, we welcome your questions at info@tencountconsulting.com

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