Dear FDA: Eight is (Not) Enough

As you may know, the Food and Drug Administration Amendments Act of 2007 requires the FDA to establish technology standards for the pharmaceutical supply chain by 2010. The FDA requested comments and information earlier this year – see the links in The FDA and EC Dive into Supply Chain Security.

The U.S. Food and Drug Administration recently provided guidance on the use of Standardized Numerical Identifiers (SNIs) for prescription drug packages. The guidance document can be accessed here: http://www.fda.gov/oc/guidance/drugsupplychain.html

One of my clients – an executive in the corporate supply chain organization at a big pharma company – pointed out a possible limitation about the FDA’s proposed eight-digit serial number. Perhaps inspired by your friendly neighborhood Drug Channels blogger, his comments were inspired by the inestimable Dick van Patten. His reference is admittedly much classier than my proposed title “Length Matters."

Since he wants to remain anonymous, I’ll let you read his thoughts directly. Feel free to post any comments below.
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“The serialized National Drug Code (sNDC) is comprised of the 10-digit NDC code followed by an 8-digit serial number. One issue not mentioned previously is the length of this serial number.

• An 8-digit number provides for 99,999,999 serial numbers, or to round-up, 100 million numbers. This is probably not an issue for most NDC codes but what about high volume SKUs? Wouldn't vaccines need greater capacity? High-volume generics?
• Any single SKU that has sales of more than 10 million units per year will have less than 10 years' worth of numbers. Perhaps peak sales cannot be sustained for that period but why push it?
• Any additional serialization features that manufacturers would like to pursue, such as step-increments to the numbers or other algorithms to make it more robust, will be virtually impossible with only 8-digits available to utilize.
  

Fortunately, the SNI can be incorporated into a serialized Global Trade Identification Number (sGTIN), which allows for serial numbers of up to 20 digits in length. This is the approach that our serialization program will take in order to maintain consistency with the GS1 Global Standards organization. While the FDA’s proposal for a new number construct is puzzling, at least progress is being made. It does not negatively impact those of us who are embracing GS1 standards.

Sorry Dick Van Patten – Eight is NOT Enough!”