Breaking news from FDA: Stay the course on DSCSA — don't give regulators an excuse to audit your business.

August 30, 2023
"Stopping or slowing efforts to get into compliance with 582(g)(1) puts a trading partner at risk of FDA enforcement."

FDA officials: Don't wait to complete DSCSA implementation

Speaking at the HDA Traceability Seminar in Washington, D.C., Dr. Connie Jung and Dr. Leigh Verbois made clear that all pharmaceutical trading partners need to push forward with progress on DSCSA implementation. The time between November 27, 2023 and the same date in 2024 is a stabilization period: "additional time to implement, troubleshoot, and mature systems and processes while supporting the continued availability of products to patients."

In short, FDA expects all trading partners to make full use of the time remaining in 2023 and 2024 for DSCSA compliance. This stabilization period does not push back the deadline; it grants the time needed to complete implementations that are (or should be) already underway and make sure they work well. Importantly, State Boards of Pharmacy can still enforce DSCSA requirements, and may undertake audits to ensure that businesses have systems in place as of November 27, 2023.

Slowing down on DSCSA compliance is a regulatory risk

The presentation made clear that enforcement is ongoing:

"This is a stabilization period, not enforcement discretion."
"All current DSCSA requirements continue as a condition of FDA's non-enforcement."
"Stopping or slowing efforts to get into compliance with 582(g)(1) puts a trading partner at risk of FDA enforcement."

Trading partners who don't make progress on DSCSA, or reverse course on serialization, are at explicit risk of FDA and State Board of Pharmacy action. It's vital to understand that, even with this one-year stabilization period, the law will be enforced for any pharma business that isn't making progress to comply.

This brings the very design of DSCSA into focus: it's a project that requires collaboration across trading partners at all levels. An organization that holds back compliance endangers itself as well as the very partners it relies on daily, and delays rules that protect patients. That's why manufacturers and wholesale distributors are already urging trading partners to regard DSCSA as a core business requirement, and expect production systems to include serialization.

Stay on top of the DSCSA timeline

The presentation included an updated timeline, outlining expectations for the time period through the 2023 deadline, through 2024 and beyond:

The message here is direct: DSCSA is already in its final enforcement stages, with the Enhanced Security requirements being the final pieces to fall into place. This stabilization period is time for you to refine and polish your systems, and work out any last kinks in the process. (And if your solution provider isn't getting the job done, find one who will.)