FDA proposes 'serialized NDC' codes for item-level pharmaceutical packaging

Give FDA’s Office of Regulatory Affairs credit for keeping to a timetable for meeting a requirement of the FDA Amendments Act of 2007 (FDAAA): The agency has published draft guidelines to meet Section 913 of that law, by which Congress ordered the agency to “develop standards for identification, validation, authentication and tracking and tracing of prescription drugs.” To that end, FDA held a public comment period last spring to solicit recommendations. Now, it has issued a proposed “Guidance for Industry” on one part of that mandate—the choice of a serialization system, to be called “serialized NDC” (sNDC), and is inviting comments through the next 90 days.

By itself, sNDC is fairly innocuous: FDA is recommending combining existing National Drug Code (NDC) numbers, which have 10 digits, with a unique eight-digit number, resulting in the 18-digit sNDC. The sNDC could then be incorporated into a barcode label, possibly with a human-readable code alongside it. The code is defined only for item-level packages, not cases or pallets, and this part of the Guidance does not cover tracking methods or authentication, which will presumably come later.

But behind the sNDC guidance is a much bigger goal: a national standard for encoding and tracking drug shipments, at the item level. This would replace (or at least align) the pedigree systems now in place in over half of the U.S. states. The lack of national uniformity has long been a complaint of industry and distributors since the pedigree systems began to come into force earlier this decade. A uniform serialization system, combined with track-and-trace IT communications, in fact subsumes pedigree systems and opens up many

possibilities

in more-efficient supply-chain processes.

GS1 alignment

One other notable element: Without explicitly stating so, the guidance implies an eventual compliance with the product coding and data structures of the international GS1 organization, whose GS1 Healthcare Group has been has been working on standardized systems for identifying products, locations and supply chain functions. “[U]se of sNDC is compatible with, and may be presented within, a serialized Global Trade Item Number”—which is part of the evolving GS1 structure, says FDA.

FDAAA orders FDA to develop a uniform serialization system for package- through pallet-level shipments, along with recommendations for validation and authentication processes, by March 2010. Meanwhile, various efforts to write a law specifying a tracking system, along with a schedule for implementing it, were part of the past Congress, and are expected to reappear in the new Congress.