Tag Archives: 11-digit NDC

Human Readable Text Controversy

This example shows a compromise alternative to print both the NDC and the GS1 GTIN in the DSCSA Product Code human readable, following the GS1 General Specifications healthcare human readable guidelines in section 4.14.1

I was a little surprised at how heated the discussion was at the breakfast table back during last year’s Healthcare Distribution Alliance (HDA) Traceability Seminar.  I chose an open seat at a table with people from multiple drug manufacturers and someone from GS1 US.  Our conversation at the table started out typically—the weather, the previous day’s speakers—the usual.  I had recently been thinking about the human readable portion of the Product Identifier mandated by the Drug Supply Chain Security Act (DSCSA) (see “The DSCSA Product Identifier On Drug Packages”), so I asked everyone what their company was planning to do? Continue reading Human Readable Text Controversy

An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon

Dear FriendDear FDA,

Thanks for inviting me to your DSCSA Pilot Party this week.  I look forward to visiting you at your Silver Spring home so we can catch up on what’s been happing in our lives recently.  I’m glad you are thinking more about the Drug Supply Chain Security Act (DSCSA) lately.  I am too.

In fact, I’ve been thinking about how nice it would be if you would fix the broken National Drug Code (NDC) as part of the implementation of the DSCSA.  It’s really not very hard to do.  You already laid out and tested the path that needs to be followed when you implemented the Unique Device Identification (UDI) numbering system for medical devices a few years ago.

Remember how happy that made me?  Remember, I called it “revolutionary” (see “FDA Proposed UDI: A Revolution In Number Assignment”), and it was!  But before I get to how you could do it for pharmaceuticals, let me explain why you should do it as clearly as I can. Continue reading An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon