Are you concerned over DSCSA implementation and supply chain disruption?

© Envato and Spherity

This blog post features an expert contribution from David Kessler, President at our partner, Legisym, offering insights into DSCSA regulation for the U.S. pharmaceutical supply chain.

If you have been keeping up with industry news, you have likely read about various letters being sent to FDA seeking a two-year delay in DSCSA tracking rules over concerns of supply chain disruption. The focus of these concerns centers around final Enhanced Drug Distribution Security (EDDS) requirements of manufacturers, distributors, and dispensers to electronically capture and share interoperable data at the individual package level by November 27, 2023.

While the readiness for a complete EDDS system by November 27th is in question, other sections of DSCSA are NOT awaiting FDA comment.

4 Major DSCSA Violation Observations Recently Made by FDA

1. Authorized Trading Partner
   Failure to verify that trading partners of the company had also reported licensure information to the FDA and then proceeding to conduct transactions with these partners who were not authorized (FD&C Act Section 582(c)(3)).
2. Product Verification: Failure to have systems in place to enable compliance with the verification requirements of the DSCSA (FD&C Act Section 582(c)(4)(A) & (B)).
3. Product Investigation: Failure to maintain records of suspect product investigations (FD&C Act Section 582(c)(4)(A)(iii)).
4. Illegitimate Product: Failure to respond to a notification of illegitimate product (FD&C Act Section 582(c)(4)(B)(iii)).

The warning issued by FDA confirms not prioritizing any of the DSCSA requirements will not slip in their inspections.

We’re here to support you

Good news, there ARE solutions that ARE ready for you to start using today to resolve #1 and #2 of the violations above. The Legisym-Spherity partnership drives a trusted, automated solution for:

• verifying all of your trading partners (direct and indirect) have valid state licensing
• verifying all of your suppliers reported licensure information to FDA
• ensuring data exchange in VRS/Product Verification transactions are only with Authorized Trading

The time for addressing DSCSA Authorized Trading Partner requirements is now, whether FDA comments on delaying specific EDDS requirements or not.

Get a demo today to learn more about Spherity-Legisym’s reliable, secure, and production-ready solution for Authorized Trading Partner requirements.