Serialization: It's Back On!
FDA’s just-released guidance on standardized numerical identification (SNI) for prescription drugs doesn’t set a timeline for implementation, and California’s initial electronic pedigree deadline is well over four years away.
But waiting to serialize drug packages may no longer be prudent. More standards are on the way, so the sooner your company grows adept at serializing saleable package units, the better prepared you will be for further guidance or possible rules. In addition, you’ve got some tricky moves to master, such as producing the SNI in both machine-readable and human-readable formats and capturing all this data on the packaging line. Your lessons could then be shared with FDA to help guide its future standards.
For the SNI, FDA recommends the use of a serialized National Drug Code (sNDC) consisting of the NDC and a serial number up to 20 characters long. The serial number can be numeric or alphanumeric, but it should not include an expiration date, lot, or batch code. And while the agency does not recommend a specific data carrier, it does urge coding that supports both electronic and human reading.
FDA believes that its recommended SNI will help with standards and systems development because it allows for “the unique identification of specific prescription drug packages,” explains Crystal Rice, a spokesperson for FDA’s Center for Drug Evaluation and Research (CDER). “This unique number will facilitate tracking and tracing a specific prescription drug through the supply chain in order to determine who was involved in the distribution history of the product. This would help to protect the product by providing accountability throughout the supply chain for the legitimate partners in the supply chain, and it may allow for illegitimate entities and products to be detected more easily.”
With the basic code in place, you can begin tackling the issues of adding the sNDC to your packages. You’ve got choices here, but you’ve also got existing FDA rules to satisfy. FDA “is not recommending a specific data carrier at this time,” says Rice. However, a linear bar code encoding the NDC is currently required for drugs packaged for hospitals. Given FDA’s suggested sNDC, you will have to decide whether the linear bar code will also be able accommodate the sNDC. If not, you’ll have to decide whether to add a separate bar code or whether to package drugs for hospitals differently from those packaged for retail pharmacies. Two bar codes on one package could result in confusion in the healthcare setting. FDA declined to answer whether it would change its Bar Code Rule to allow for the use of one 2-D bar code to offer a more practical bar coding solution than the mandated linear code.
RFID also remains a possibility. “The SNIs described in this guidance are compatible with, and flexible for, encoding into a variety of machine-readable forms of data carriers, such as 2-dimensional bar codes and radio-frequency identification (RFID), leaving options open as technologies for securing the supply chain continue to be identified,” FDA states in the guidance.
James Mannion, Solutions Marketing Director, and Sue Hutchinson, Director of Industry Adoption, for EPCglobal US and GS1 US, welcome such flexibility, saying that it demonstrates an appropriate focus on the data itself. “FDA is more concerned with how data are exchanged than the carrier itself,” notes Hutchinson. “FDA is concerned with the common language and a common way for supply chain partners to speak to each other.”
Adds Mannion: “You cannot have item visibility unless you speak the same language.”
You’ve also got to look at your labeling space. Even if you can just print the space-saving 2-D Data Matrix or employ RFID tags, you’ve got to accommodate more human-readable information and ensure its legibility. FDA is “not specifying a location on the package where an SNI should be place,” the guidance reads. “If the NDC is already printed on the package in human-readable form, then the serial number could be printed in human-readable form in a non-contiguous manner elsewhere on the product package.”
You have also got to equip your packaging lines with inspection systems ready to verify all printed serial codes and/or preserialized label placement or to add tunnels for reading RFID tags. You also have to be ready to track it all, even those serialized items rejected on the packaging line.
Also, FDA mentions GS1's GTIN standard in the guidance but no other system, such as that from the HIBCC. “GS1's GTIN standard was highlighted because it was one example that is compatible with the recommended serialized NDC in the guidance,” Rice states. Your company will have to decide whether to adopt GS1 standards or investigate whether other approaches can accommodate the sNDC.
FDA did not say whether it was waiting for industry to implement the SNI in order to witness real-market challenges before it issues future guidances or regulations. But Rice did explain that “many aspects of implementation of package-level identification will take shape in the future as standards that make use of the SNI are developed.”
FDA does not offer any specifics on whether its next steps will be guidance or regulation, nor does it give a specific timeline for these steps. However, “this guidance is an initial step in the development of standards and systems for identification, tracking and tracing, authentication, and validation of prescription drug packages,” explains Rice.
When asked whether FDA is waiting for further legislation, such as the rumored reintroduction of the Buyer-Matheson act, before it mandates the SNI or issues further guidance or regulations, Rice stated that “FDA would be happy to work with Congress on legislation to further strengthen the security of our nation's drugs supply.”
FDA’s SNI complies with California’s electronic pedigree law, says Virginia Herold, executive officer of the California State Board of Pharmacy. “Hopefully it will help enable serialization projects to move forward,” she says.
The state of California is eager for the federal government to take the lead. “We would like to see a national model,” says Herold. “Laws in 50 different states would make it very difficult to do business in the United States. We support federal legislation in this area, and any federal rule would take precedence over the California deadline of 2015.”
And such federal activity seems likely. While “FDA supports CA efforts to improve the supply chain,” says Rice, “FDA will continue to work on federal standards development for identification, authentication, and track and trace.”
So what will happen if you don’t implement the SNI? Today, not much. We asked FDA what would happen, but the agency declined to answer.
The long-term risks to your own operations, however, could be more serious than you think. FDA is moving ahead with its plans for further standards, and at some point, it may seek your input, either through workshops or a further draft guidance. Or it may be watching a number of pilots or simulation programs, like GS1’s 2015 Readiness Program (http://www.pmpnews.com/news/simulating-serialized-chain), for details on how to proceed with further standards and systems.
If you don’t understand item-level serialization and its challenges, you won’t be able to provide FDA with real-life information. Your company will then have little say in future standards development, and the resulting standards could be based on experiences very different from yours.
Hutchinson of EPCglobal US and GS1 US notes, “Standards development very much is like a living organism. As companies get comfortable with coding items, the healthcare products community will understand the appropriate roles of lot, batch, or serial numbers and work out the use cases. The community is taking the lead in defining the business cases. And that user community controls the pace by which we work to develop standards.” Interestingly, FDA calls itself an “active observer and participant in GS1 standards development related to healthcare and drug products.”
As a member of that community, are you preparing to evaluate SNI’s role in your own business cases?
Daphne Allen
Editor |
