Key Takeaways
- DSCSA enforcement deadlines are phasing in through 2025, with wholesalers and repackagers already required to comply as of May 27, and wholesale distributors facing an August 27 deadline—provided they show active progress on data connections.
- Despite past delays and exemptions, industry stakeholders report significant progress, with data connectivity between manufacturers and distributors improving markedly and success rates reaching 90%–95%.
- Uncertainty remains about full industry readiness, even with optimism from experts and phased deadlines; the focus is now shifting to how remaining players will meet upcoming compliance requirements.
Pharmaceutical Commerce has been at the forefront of delivering the latest Drug Supply Chain Security Act (DSCSA) coverage in an effort to provide our readers with updates to this legislation every step of the way.
Stakeholders are aware that this federal law—enforced by the FDA and originally enacted in 2013 as a way to help bolster security and traceability of products passing through the pharma supply chain—has seen its share of delays and exemptions over the years. The most recent enforcement delay came Oct. 9, 2024—seven weeks before the one-year stabilization period was set to end. Intended for “eligible trading partners,” the duration of the exemption varies by the type of partner.
In fact, wholesalers and repackagers had until May 27, 2025 (following this day, full-unit traceability would be mandatory), a date that has officially passed. Next on the docket are wholesale distributors, who have until Aug. 27 of this year to meet the requirements, as long as they are making documented efforts to finalize data connections, of course.
However, the elephant in the room remains—is the industry ready? Earlier this year, I spoke with Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, who had been on the heels of attending the Healthcare Distribution Alliance’s Distribution Management Conference at the time. He was cautiously optimistic about stakeholder preparedness.
“ …Most of the distributors and manufacturers were saying, 'we’re fully connected with most, if not all, of our customers, and that data is actually moving,' so the pipes have been made. Data is moving through the pipes. Generally, the sense is that—not a formal survey—the success rate seems to be around 90% to 95%, so it’s not only that data is moving, but it’s moving at a much higher quality than what we saw this time last year. The amount of improvement has been tremendous."
Rowe went on to describe the broader sentiment as being one of slight relief as well.
“We’ve got the delays that we needed," he said. "We have this phased exemption period moving throughout 2025; it’s how do we now deal with the upcoming deadline? A 90% to 95% success rate is good on paper."
We’ll have to wait and see how stakeholders continue to respond.
Nicholas Saraceno is Pharmaceutical Commerce's Editor. He can be reached at [email protected].
