The response has been fairly muted for FDA’s decision to postpone enforcement of the next phase of the Drug Supply Chain Security Act (DSCSA) from November 2017 to a year later. It had been widely recognized that, while Big Pharma had many serialization projects in place, 100% compliance (in this case, the ability to put a unique identifier on each package of saleable product coming off a packaging line) was a work in progress. At smaller pharmacos, and at contract manufacturers, the capital projects to install the necessary labeling and inspection equipment was just getting started. Several vendors, notably Optel Vision, Systech International, Antares Vision and a few others, had been marketing various “quick start” programs to get packagers onboard; now they can add 12 months to their schedules.
Adents, a hardware-agnostic serialization software provider, says that the delay gives packagers time to think through their installations more carefully. “With the postponement, companies who have not yet completed the serialization process stand to gain the most,” said Christophe Devins, CEO of Adents, “what remains a muddied landscape, desired systems will likely trend toward … serialization solutions that can adapt or scale up to meet future track & trace mandates, as well as help improve business practices.”
But TraceLink, another traceability software provider, cautions that it’s not clear sailing between now and November 2018, offering its opinion that “Because the law will take effect on November 27, 2017, companies could be penalized should an incident occur in the supply chain that requires an investigation and the FDA finds that a company’s negligence to comply with the law on time has contributed to the incident. In other words, companies are still liable for actions that have legal consequences.”
GS1 US Healthcare, which has been laboring for over a decade on standards for pharma serialization (as well as in other industries), believes that the delay is no change from “business as usual,” as Peter Sturtevant, senior director, industry development, pharmaceutical, puts it. The GS1 Healthcare US Initiative facilitated a barcode assessment this spring of actual product delivered at actual wholesalers. The assessment revealed that only “a handful” of products were serialized with all four of the product identifiers needed to meet the Phase 2 DSCSA serialization requirement. Full results of that study will be published by GS1 next month.