An earlier version of this article by Legisym’s David Kessler was originally published on Medium.

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.