Last Friday, the FDA published the long awaited guidance on their Standardized Numeric Identifier (SNI) for prescription drug packages. This was right on time since the FDA Amendments Act of 2007 gave the agency 30 months to develop a standard for SNI and they published, almost to the day, 30 months later. Well done.
The published guidance is not radically different from the draft guidance that the agency published under the same name in January of 2009. In fact, in my view, the only really important difference is how the serial number portion of the sNDC is defined. The obvious difference is an increase in length from 8 to 20 characters, but more subtle and significant changes are that the serial number has changed from a proposed fixed length to a variable length field, and from numeric-only to optionally alphanumeric.
These are important changes because, taken together, they result in bringing the FDA sNDC into full alignment with the GS1 definition of a product serial number using Application Identifier (AI) 21, and an SGTIN in RFID tags. This change also technically results in a mis-alignment in the name “Standardized Numeric Identifier” since the serial number doesn’t have to be numeric anymore, but I’ll forgive the authors for not changing the name.
This alignment with SGTIN was a common recommendation in the many comments submitted in response to the FDA’s Request for Comments that was issued at the same time the draft SNI guidance was published last year. The FDA no doubt appreciated these comments and they retained a reference to the GS1 SGTIN as their justification for fulfilling the FDAAA requirement that the SNI “…be harmonized…with internationally recognized standards for such an identifier.” The final guidance points out that “…use of an sNDC is compatible with, and may be presented within,…a serialized GTIN (sGTIN)…”. Clearly this a just an example and not necessarily the only FDA-sanctioned way to represent an NDC-based sNDC. That is, I don’t think the FDA is mandating the use of GS1’s SGTIN. On the other hand, I am in the camp of those who hope that it is the only one we’ll see in actual use within the supply chain.
It’s important to include here another characteristic of the final SNI guidance, for no other reason than to remind everyone that the sNDC is not the only SNI that the supply chain will need to deal with. The FDA officially refers to “other recognized standards, such as ISBT 128”, the standard of the ICCBBA for the uniform container labeling and identification of blood and blood components (blood, tissue and organ products), as the SNI for those products. It’s really the only reason we still need the term “SNI”. SNDC is only one of the two primary forms of SNI.
The SNI Guidance is not a mandate that all drugs be serialized. At the top of each page they’ve included the header “Contains Nonbinding Recommendations“. It’s just a standard that can now be used in subsequent regulations. And companies who plan to serialize pharmaceuticals for California pedigree compliance can now be confident that their efforts will be in compliance with any future federal regulations that may end up requiring serialization. That confidence may result in more companies being willing to invest in serialization of drug products.
As I recall, the development of an SNI standard was the only action in the set of things related to track and trace standards that the FDAAA of 2007 required the FDA to do that had a date tied to it. I’d say that the development of the SNI was probably the easiest of all of those things to complete. The document just published includes the statement, “This guidance is intended to be the first of several guidances and regulations that FDA may issue to implement section 505D of the Act, and its issuance is intended to assist with the development of standards and systems for identification, validation, authentication, and tracking and tracing of prescription drugs.” Congress has consider adding to the FDA’s requirements along these lines in the past and may again in the future.
The FDAAA of 2007 also required the FDA to develop a Unique Device Identification (UDI) standard, but there was no particular deadline specified. We can look forward to the development of that guidance sometime in the future.