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HDMA members gather to discuss track-and-trace technicalities, even while Congress almost--again--passes the Drug Quality and Security Act
Attendees at the HDMA Track and Trace Seminar, held this week in Arlington, VA, were keeping one eye on their smartphones while listening to the range of presentations and case studies HDMA organized. But the anticipated celebration of the passage of the Drug Quality and Security Act (H.R.3204) would have to await next week (Nov. 18) at the earliest, as various parliamentary motions were thrashed through in the US Senate. As this legislation, in various forms, has been debated, brought up and turned aside for 10 or more years, the anticipation of its passage could only turn into a shrug of the shoulders during the meeting.
A quick recap of activities pertaining to this law in recent months: after the RxTec Act, an industry-written version of a law to regulate pharmaceutical distribution at the national level, was shot down in 2012, a new approach was undertaken last spring. The Senate bolted another piece of legislation, on drug compounding, to their bill (S. 959) and made it essentially ready for passage (but did not formally vote on it). The House approved a bill that covered primarily the track-and-trace aspects, but initially expected to consider drug compounding separately, Following intense committee-staff work in late summer, the House passed H.R. 3204, now called the Drug Quality and Security Act, in September. That bill fairly closely tracks the Senate legislation, and Senate Majority Leader Harry Reid has essentially been urging passage ever since. A Nov. 12 vote on cloture (to close debate and vote the legislation through) passed by 97-1, but that one vote (from David Vitter, R-LA) has added a week at least to the time to passage.
Item level, or not?
A key part of the legislation—and a change from how drug serialization had been approached up to last year—is that recording and transmitting product data at the item level will be delayed for upwards of 10 years. But HDMA seminar attendees heard a slightly different take on this. A panel discussion representing the Big Three wholesalers encouraged manufacturers to begin item-level serialization now, even if it will be years before a regulation is in place. For one thing, manufacturers will have to ensure that the appropriate lot number (on a package) matches the lot number specified on a carton or pallet of product. For another, most vendors of serialization equipment are designing their systems (and are being evaluated on the basis of) providing item-level data.
Whether or not the item-level serialization is built in now, several speakers advised manufacturers to schedule sufficient time to rework product labels for serial numbers. Both linear and 2D-datamatrix barcodes are specified in the GS1 barcode standards that most companies are contemplating using; additionally there is a requirement for “human understandable” forms of the codes (which include things like expiration dates). All this means allocating sufficient space for the codes on product labels, as well as to coordinate the placement of the codes with the automated inspection and packaging equipment on a typical packaging line. “Give yourself at least a year to work through all these artwork changes,” said Michael McBride, EDI administrator at Hi-Tech Pharmacal (Amityville, NY), which presented a case study on their serialization work of the past year. “A serialization project on behalf of a brand owner can take six to nine months to set up,” said Justin Schroeder, executive director, marketing development services, at Packaging Coordinators Inc. (Rockford, IL), the former Anderson Packaging contract packager. He noted the case of one client, whose single product is supplied in 85 configurations, for national and international markets; each configuration calls for its own label, and each label needs to be evaluated for how to incorporate the serialization data.
(photo credit: Cognex Corp.)