Pharma packagers prepare for US serialization mandate

Pack Expo showcases IT and system vendor offerings, while industry awaits new FDA guidance

With Pack Expo going in full swing in Chicago this week, it’s perhaps appropriate that a lot of the attention industry is paying to the Drug Supply Chain Security Act (DSCSA) is focused on equipment to generate serial numbers and barcodes on packaging lines. But having those barcodes on item-level packages and cases is just to first step to meeting the longer-term requirements of the DSCSA; come January, manufacturers (or their providers of contract packaging and distribution) will need to be able to generate “TI, TH and TS” (Transaction Information, History and Statement) information for their customers, at the lot level. Come July, those customers—typically retail pharmacies—will need to be able to show that data to FDA inspectors. But all this is contingent on guidance that FDA is required to publish on Nov. 27, the one-year anniversary of the passage of DSCSA. It’s a tall order.

Major pharma manufacuturers have been preparing for the DSCSA deadline for some time; DSCSA itself was energetically negotiated between industry groups, FDA and Congressional staffs leading up to its passage. Many of the most experienced companies in pharma traceability, including Acsis, (Marlton, NJ), TraceLink (Woburn, MA), Optel Vision (Quebec City), Axway (Phoenix) rfXcel (San Ramon, CA) ROC IT Solutions (Pittsford, NY) and Systech (Cranbury, NJ) have announced updates to their systems to incorporate TI, TH and TS capability. A recently arrived player in the US market, Xyntek-Antares (Yardley, PA) is unveiling its update, Antares Tracking System 3.0, at Pack Expo.

Most of these vendors are reporting double-digit growth in business over the past year; the scramble is on to line up resources to aid in implementations. (The industry scuttlebutt is that, given the tight deadline between the Nov. 27 guidance and Jan. 1, as long as manufacturers show an earnest effort to get ready for DSCSA, FDA will not bring down a hammer on their operations, but of course, that remains to be seen.) Evidence of how the field is expanding can be seen by the arrival of new entrants: one that recently popped up is Adents International (Palaiseau, France), with a warehouse-to-enterprise traceability offering.

Meanwhile, there is a drive to educate more participants in the pharma supply chain beyond manufacturers and distirbutors in the requirements of DSCSA. The Healthcare Distribution Management Assn (HDMA; Arlington, VA) is holding a Traceability Seminar (Nov 10-12), in Arlington; and the GS1 organization (Lawrenceville, NJ) has announced a series of free webinars between now and December 3 on “Preparing for DSCSA.”