From:             Michael E. Coughlin, President and CEO, ScriptPro
Date:              July 26, 2002
Re:                 Food and Drug Administration (FDA), HHS, Public Meeting

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Barcode Label Requirements for Human Drug Products
July 26, 2002, from 9 a.m. to 5 p.m.
Natcher Auditorium, Building 45
National Institutes of Health, Bethesda, MD

 

RECOMMENDATIONS FOR THE DEVELOPMENT OF A REGULATION ON BARCODE LABELING FOR HUMAN DRUG PRODUCTS, INCLUDING BIOLOGIC PRODUCTS

APPENDIX K - TWO DIFFERENT DRUGS APPEAR AS ONLY DIFFERENT PACKAGE SIZES

1.  The example below shows the following:

a.  The field labeled NDC is the 11-digit drug identifier provided by FirstDataBank, Inc. in its National Drug Data File (NDDF).  Most pharmacy computer applications use the NDDF to perform Drug Utilization Reviews and adjudicate prescription claims.  The NDDF is also used by payors to pay prescription claims.

b.  The three drug entries (see picture below) appear from their numbers to be three different package sizes for the same drug.  This is because the numbers are identical except for the last two characters, which designate package size.

c.  However, as listed in the GNN (Generic Name) column, the third entry is a completely different drug.

d.  This problem was discovered simply by chance in developing the data for this report.  We believe that the source of the problem is an error in the placement of the zero in order to expand the 10-digit NDC to 11 digits.  For the third entry, the additional zero probably should have been placed in front of digits 32 instead of behind them.

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