Last week, FDA released its anticipated final guidance, “Standards for Securing the Drug Supply Chain—Standardized Numerical Identification for Prescription Drug Packages.” The aim of the guidance is to lend support to industry efforts to establish end-to-end supply chain security and realize the benefits of the myriad track and trace technologies currently available. This guidance is just a start, the Agency indicates. As the intro states, “FDA is identifying package-level SNIs, as an initial step in FDA’s development and implementation of additional measures to secure the drug supply chain.”

We reached out to Scott Dicks, a practice manager for Maxiom Group, for his initial interpretations of the document. (For more from Dicks and a look at manufacturers’ current struggles with electronic pedigree and supply chain security, read “The Path to Epedigree: Manufacturers Chart Their Course”.)

A few points of interest, according to Dicks:

• This guidance seems very limited in its scope and is a finalization of a draft guidance of the same title dated January 16, 2009 (74 FR 3054). I think the last paragraph of the “scope” section says it all: “This guidance does not address how to link a repackager SNI to a manufacturer SNI, nor does it address standards for prescription drug SNI at levels other than the package-level including, for example, the case- and pallet-levels. Standards for track and trace, authentication, and validation are also not addressed in this guidance because this guidance only addresses the standardized numerical identifier itself and not implementation or application issues.”
• FDA has changed serial number specifications from 8 unique numbers to 20 unique numbers. Ultimately, this makes little difference, as I think 8 numbers beyond an NDC offers enough digits to serialize most, if not all, products (certainly for the life of most branded pharma products). However, we’re still well within the realm of 2D barcode capacity at 20, so I think it’s of little consequence (unless the packaging has very little available space already). And, in addition, I think that the number is now variable (see below) so 8 digits can still be used if packaging space is a consideration.
• Dirk Rodgers, from RxTrace.com, commented recently: “These [increase in length from 8 to 20 characters, fixed length serial to variable length, and numeric-only to optionally alphanumeric] 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.” [Here are Rodgers’ full comments.) I concur with what he wrote. The alignment with s-GTIN from GS1 is important as many companies that have moved forward used s-GTIN as the basis for their serialization (at least at the item level).
• As I said in a recent blog post ("Pharmaceutical Track-and-Trace Makes It Big") and have said before, I hope this leads to additional guidance and legislation on serialization and track and trace at the federal level. State-by-state regulation/compliance is problematic for many reasons and I believe that a single national (or international) standard would promote industry action and, ultimately, lead to safer drugs.  

More from Dicks and more on the impact of FDA’s guidance in the coming months.

--Paul Thomas