Posts Tagged ‘SGTIN’

Back in 2007 the U.S. Congress passed the Food and Drug Administration Amendments Act (FDAAA) and it was signed into law by President Bush.  One of the provisions of that law was an instruction to the FDA to “…develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs”, and “…develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs.”

The FDA fulfilled these instructions for one of the specific standards that the law identified when the agency published their Standardized Numerical Identifier (SNI) standard back in 2010.  That standard was fairly high level and for the vast majority of drugs, use of GS1’s Serialized Global Trade Item Number (SGTIN) (or “GTIN plus serial number”) for drug package identification would comply with it.  The text of the FDA’s standard says as much.

By defining the SNI in this way did the FDA surrender the development of the real SNI standard to GS1 (at least the sNDC portion of it)?  I don’t think so.  In my essay about the SNI standard I described it as the FDA “aligning” with GS1’s SGTIN (see my essay “FDA Aligns with GS1 SGTIN For SNDC”).  Alignment shouldn’t be confused with surrender.  The choice of alignment with SGTIN was good for the FDA, good for patients and good for the industry.

WHAT WE GOT WHEN THE FDA ALIGNED THEIR SNI STANDARD WITH GS1’S SGTIN TECHNICAL STANDARD

In the case of the SNI aligning with GS1’s SGTIN we got the following things: Read the rest of this entry »

That’s right.  And it comes from an economic reality that was evident even six years ago.  That was when a small group of people with various pharmaceutical supply chain backgrounds had an informal discussion of the relative costs and impacts that each of the three primary business segments in the supply chain would face in a full deployment of Radio Frequency IDentification (RFID).  As I recall, this conversation may not have even been part of the official proceedings of the project we were assembled to work on at the time.  It may have actually occurred during one of the social hours after a day of meetings, but it stuck with me.  Ever since that time I kept meaning to get around to creating the graphs that we envisioned at that time but have never gotten around to it, until now. Read the rest of this entry »

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 Read the rest of this entry »