The HDA Traceability Seminar opened with a packed house and a key message running through presentations: the DSCSA EDDS guidance that FDA dropped Friday, Aug. 25, 2023, is not to be looked at as simply enforcement discretion but as a stabilization period through Nov 27, 2024.
As FDA's Leigh Verbois said in her co-presentation with Connie Jung, “Let me just be really clear, we want to make sure that this time is used to implement, troubleshoot, and mature systems for trading partners and processes while supporting the continued availability of products. With the compliance policies in this new guidance, we want to focus on November 2023 and beyond.”
Jung, FDA senior advisor for policy, reiterated the message. “This does not mean to stop doing anything. We want you to continue to implement, we expect you to continue to implement because if you don't, you will never get there,” she said. “Our expectation is that we want you to test and exchange electronic data before the date. This is what we were saying about November 2023—now, it's before November 2024, you need to be exchanging that data electronically.”
While some may still view this as a pause, Tish Pahl, principal, Olsson Frank Weeda Terman Matz PC, highlighted a section of the guidance which is actually underlined in the EDDS guidance:
"This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements."
As Pahl noted, "FDA doesn't use typographical arts in the way that others might... so the fact that they underlined this is actually really unusual and very important." She suggested that when dealing with companies that are calling up and canceling their contracts, show them this verbiage.
