For the past two weeks, the pharmaceutical industry has been processing the FDA’s announcement of a one-year “stabilization period” for DSCSA starting November 27, 2023 – the date that also marks the beginning of enforcement and the 10-year anniversary of the law’s enactment. To understand the announcement’s implications, it’s helpful to follow key statements by FDA officials and industry leaders at the recent HDA Traceability Seminar in Washington, D.C. (as detailed by Healthcare Packaging).
The FDA’s guidance release took great care to keep anyone in the industry from reading the recommendation as a delay to DSCSA enforcement, or a reason to put off implementing compliance systems and procedures: "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."
FDA's Dr. Leigh Verbois, speaking at the conference, further defined the stabilization period as a time to make sure processes work well, saying the administration seeks “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,” adding, “With the compliance policies in this new guidance, we want to focus on November 2023 and beyond."
As FDA's Dr. Connie Jung put it, the announcement “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.” This has indeed been a worry for businesses at all points in the pharmaceutical supply chain: that their trading partners would wait until it was too late to act on DSCSA, impacting their own ability to comply due to the necessarily collaborative nature of forming an interoperable data connection. And in recent months, with November 2023 drawing nearer, fears began to circulate that any changes to the deadline would prompt such companies to put the entire effort off until the same period the following year, solving very little in the process.
This is why the FDA took such pains to clarify that the stabilization period is not enforcement discretion, and that companies who don’t have systems for compliance in place by November 27, 2023 and fail to make progress after that date, put themselves at risk of regulatory penalties. In short, FDA warned that the year to November 27, 2024 is only additional time if it’s used in good faith. It’s an exceptionally important point for FDA to make, and it’s easy to see why it was made with such urgency: to avoid even the smallest implication that they’d be ready to tolerate delays to compliance, when the intent of reserving time for stabilization is to ensure patients are protected from any impacts during the transition.
Our CEO, Riya Cao, called attention to the fact that too many trading partners have already been misinformed about the demands of DSCSA implementation, and could be vulnerable to further misinformation. “I think a lot of people are still implementing, and then more are not even implementing yet. We’re very concerned about companies lagging behind. [...] Companies are just reading that [enforcement] discretion headline and making the decision not to work on this for another year.” She also noted that those who are ahead of the game on DSCSA still have much to learn – indicating that those who have yet to begin have a steeper challenge than they’re anticipating. “For those of you that are fortunate enough to go into stabilization, there's so much work ahead,” she said. “You have to really get into the daily operations to uncover the scenarios you never thought about. Every day we're learning new things.”