The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations

HDA logoThe Healthcare Distribution Alliance (HDA) (formerly HDMA) published their highly anticipated “Guidelines for Bar Coding in the Pharmaceutical Supply Chain, Quick Start Guide” a few weeks ago.  Do yourself a favor and stop reading this essay right now, click on the link and download your copy and read it.  It is free, and it is essential reading for manufacturers and solution providers who expect to develop and deploy solutions that ship serialized units and cases of prescription drugs to U.S. wholesale distributors.  This includes solutions that meet the U.S. Drug Supply Chain Security Act (DSCSA) as well as the FDA (linear) barcode rule from 2006.  It is 12 pages of densely packed guidance that is fresh.  The older version from 2014 is now out-of-date.

According to the HDA website, the new version includes key updates on:

  • “The recommendation of a wrap-around case label;

  • Moving the placement of the 2D GS1 DataMatrix away from the outer edges of the label;

  • No longer including AI(30) in the 2D DataMatrix; and,

  • New guidance on inner-pack and partial-case labels.”

When I heard that the HDA planned to update the Quick Start Guide before they updated their full barcode guidance document I was skeptical.  The Quick Start Guide is used to contain the core recommendations and requirements without much explanation.  That’s what I mean by the word “dense”.    The full guideline contains the same recommendations, but it also takes the time and space to provide more examples and more detail behind the recommendations, the standards and the technology involved.  By publishing the update Quick Start Guide before the full guidance, readers may not be able to find the full explanations that might be necessary for full understanding. The Quick Start Guide says that the full guideline will be published later this year so at least we won’t have too long to wait.  We’ll see if they can fulfill that commitment.


The HDA still uses the phrase “bar code” instead of “barcode”.  I find that a little antiquated.  Even GS1 and GS1 US have switched to the term “barcode”.  I have always used that term.  On the other hand, the International Organization for Standards (ISO) and GS1 expert Ken Traub both favor the phrase “bar code”. 

I believe there is a subtle but important difference between these two terms.  The term “bar code” means a code that is distinguished from other codes by being primarily composed of bars.  That English interpretation comes from the space separating the two words“bar” and “code”.  In this case “bar” is an adjective that describes the noun which is “code”.

The term “barcode” is a noun.  Its etymology is obviously from the phrase “bar code”, but because it is a single word we are freed from applying the rules of English in its definition.  From years of usage, it clearly defines a single concept that is a code that is represented graphically.  Even though the letters “b-a-r” precede the letters “c-o-d-e”, the single term can be defined more generally than just the combination of the definitions of the two individual words. 

This isn’t really a relevant issue until you start talking about a 2D barcode, such as a Datamatrix barcode.  There is no such thing as a “Datamatrix bar code” (it is a code composed of squares, or “dots” rather than “bars”), but there is such a thing as a “Datamatrix barcode”.  

Maybe the HDA should update their terminology in the next version of the full guidance.


One thought on “The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations”

  1. Pages 10 and 11 of the quick Start guide concerning case labels confuses me. There are two examples provided: (1) homogeneous full case label and (2) partial case label. Am I correct in interpreting this as meaning that for every batch of pharmaceutical product produced, I will deploy 2 different case labels (All labels but one in one serialized GTIN format, and 1 in an SSCC format)?
    If so – I’ve got to figure out how to handle this in my serialization system line recipes/formats (multiple label formats at one rank for a Production Order)

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