HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain

It has been six years since the Healthcare Distribution Alliance (HDA) updated their full barcode guidelines (see “Updated HDMA Bar Code Guidance: A Must Read”).  They just updated it again with major changes over the 2011 version.  The new document is called “HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain” and it is available on HDA’s website here.  With the passage of the Drug Supply Chain Security Act (DSCSA) in November of 2013, an update was long overdue.

You are forgiven if you thought the HDA updated the barcode guidelines only one year ago (see “The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations”).  In fact, the barcode guideline they published last year was the “Quick Start Guide”, which contains a subset of this newer, full update.  The focus of both documents is to provide guidance to drug manufacturers when labeling their packages, cases and pallets to comply with the DSCSA so that they can be processed efficiently by wholesale distributors.  So, if you already have the Quick Start Guide, do you really need this new document?

According to the Introduction to the new document, it supersedes all previous versions, including last year’s “Quick Start Guide”.  That’s a clue that the new document might contain recommendations that are different from last year’s “Quick Start Guide”.  The odd thing about that is, the HDA still offers the “Quick Start Guide” for download.  That might encourage people to use out-of-date information.  I recommend you get the new document and discard all older copies.

The HDA barcode guidelines are voluntary, but if you are marketing drugs in the United States, I strongly recommend that you study this document and make sure you follow them as closely as you can.  That will ensure that the wholesale distributors can handle your products as efficiently as possible, which will help you in the long run.  Don’t just assume you are already following their guideline since the large wholesalers have not complained about your barcodes.

From my observations when working at one of the large wholesale distributors, most drug manufacturers with more than one NDC have some products that are barcoded better than some of their other products.  That is, most companies have a hard time setting a barcoding standard and ensuring all of their products meet it.  Now that new barcodes are necessary for compliance with the DSCSA, that’s not going to work very well.  All drug manufacturers—whether large or small—must pay very close attention to their labeling to stay compliant with the law, but also to ensure their products move through the supply chain smoothly.  Going forward, there is really no excuse for not following these new HDA guidelines on all supply chain labeling.  It is in your own best interest.

All of the barcodes HDA’s guideline discusses are GS1 barcodes.  GS1’s barcode standards will tell you how to construct their barcodes, but HDA’s guideline goes much further by explaining exactly what information should be encoded in them, and minimum size and readability requirements.  There is a large amount of background information on the NDC and FDA requirements.  Despite its title, HDA’s barcode guideline goes beyond just the barcode to explain parameters of the human readable information and other characteristics of case and pallet labeling, beyond what would normally not be found in the GS1 standards.  All of HDA’s recommendations are proper applications of GS1 standards.

Here is the high-level table of contents of the 51-page book:

  • SUMMARY OF REVISIONS
  • INTRODUCTION
  • FOOD AND DRUG ADMINISTRATION (FDA) REQUIREMENTS AND GUIDANCE IMPACTING BAR CODING OF PHARMACEUTICALS
  • CONFIGURING THE NDC IN BAR CODES
  • THE PRODUCT IDENTIFIER
  • TWO DIMENSIONAL (2D) BAR CODE
  • LINEAR BAR CODES
  • BAR CODES ON VERY SMALL PACKAGING CONFIGURATIONS
  • BAR CODING ON PACKAGING CONFIGURATIONS LARGER THAN INDIVIDUAL SALEABLE UNITS
  • SPECIFYING SYMBOL SIZE: X-DIMENSION VS. MAGNIFICATION
  • NON-PHARMACEUTICAL PRODUCTS: UPC NUMBERING SCHEME, UPC SYMBOLOGY
  • TECHNOLOGY CONSIDERATIONS
  • APPLICATION SOFTWARE DESIGN ISSUES: ISO/IEC SYMBOLOGY IDENTIFIERS
  • SCANNER AND DATA–COLLECTION HARDWARE ISSUES
  • HDA BAR CODE TASK FORCE RECOMMENDATIONS

Look me up at the FDA DSCSA Public Meeting, and then the IQPC Pharmaceutical Traceability Forum this week.

Dirk.

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