Tag Archives: GS1 US

DSCSA

Human Readable Text Controversy

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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 →

DSCSA

Wholesalers Find Troubling Results In DSCSA Barcode Assessment

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Last month GS1 US published the results of an assessment of the implementation progress by drug manufacturers of the Drug Supply Chain Security Act (DSCSA) serialization requirements.  It contains troubling indications of the next problem the industry will face in its quest for DSCSA compliance:  too many unusable barcodes.

Big deal, you say?  That kind of complacency could come back to haunt you later this year.  Now is the time to look at your own packages and address any deficiencies.  Here is a look at what GS1 US found in their assessment. Continue reading Wholesalers Find Troubling Results In DSCSA Barcode Assessment →

Blockchain, DSCSA

Blockchain Reigns At GS1 Connect 2017

Maybe I’m just hyper sensitive to all things blockchain right now, but it sure seemed like the topic of blockchain permeated the sessions and the halls at last week’s GS1 Connect conference, GS1 US’s annual membership event.  Oddly, all of the official blockchain content was outside the Healthcare track.  The technology is certainly applicable in all industries and apparently there is interest in it outside of the healthcare vertical within GS1 US.  But what I observed there leads me to think we are very close to an important tipping point. Continue reading Blockchain Reigns At GS1 Connect 2017 →

GS1 U.S.

New Must-Read DSCSA Resource

Last week, GS1 US published a free DSCSA resource that every RxTrace reader must have.  It’s called “Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA” and it can be downloaded free after registration.  Do it now, then come back and finish reading this essay.

The document is 42 pages in PDF form and it Continue reading New Must-Read DSCSA Resource →

DSCSA

DSCSA Serialization: What Wholesalers Expect

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Image of McKesson's sign on their corporate headquarters building in San Francisco, CARecently, several of the larger U.S. wholesale distributors have sent letters to their suppliers to review what they expect from them relative to the Drug Supply Chain Security Act (DSCSA).  You may recall that these companies have provided requirements in advance of earlier DSCSA deadlines (see “U.S. Drug Wholesale Distributors Provide Direction To Manufacturers“).  These expectations are aimed at the November 27, 2017 serialization requirements and beyond. Continue reading DSCSA Serialization: What Wholesalers Expect →

NDC

NDC Nearing Its End, Afflicted by ‘Identifier Failure’

business-executive-and-his-energy-level-concept-vector-cartoon-i-507717540_4911x3472Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing.  My mother and my mother-in-law both suffered from heart failure during their decline.  Analogous to heart failure in humans is a condition of an identifier system that is near the end of its useful life that we can call “identifier failure”.  At the end of November, a new FDA final guidance called “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” went into effect.  Buried deep within this 200+ page document is the official announcement that signaled the National Drug Code (NDC) identifier system is now afflicted with this end-stage condition.  The NDC won’t last long now, and there is no longer any excuse for inaction.  The need for a replacement is now urgent. Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’ →