From: Gross, Mary
Sent: Thursday, August 08, 2002 12:10 PM
To: Butler, Jennie C
Subject: FW: Bar code meeting in July

Importance: High



-----Original Message-----
From: Laurence.Edzenga@gsk.com [mailto:Laurence.Edzenga@gsk.com]
Sent: Wednesday, July 17, 2002 2:36 PM
To: GrossM@cder.fda.gov
Cc: dbc2644@gsk.com
Subject: RE: Bar code meeting in July
Importance: High


Mary,

I plan to speak briefly VISI team on bar coding July 26, 2002.  My summary
of remarks are as follows:

 VISI Position to Standardize Identification of Vaccine/Biologic Products
       in and Effort to Reduce Medication Errors by Using Bar Codes

     VISI aligns with PhRMA Statement, as a co-contributor to the
development of the document.

     VISI has researched bar code technology available in the market today
and supplier capabilities to meet the    very small available print area
for vaccine label applications at high production speeds . VISI concludes
     the reduced space symbology required for these small vaccine labels is
the 2 dimensional code DataMatrix.       There is a very limited number of
vaccine base labels where space is available to fit RSS-14 code. There is
no available space for bar coding 2 or 3 part tear-off portions of vaccine
labels without relief from the Agency    to eliminate copy,  i.e.,
company address, company name.

     Present scanning technology allows scanners to be programmed to read
both RSS-14 and DataMatrix
     codes. This technology meets VISI objective for standard bar code
identification for vaccines by users.

     Concerns: Public Health Organizations and physician offices use of bar
codes provided on labeling
     by industry. Government agencies will need to educate and 'pull' the
medical health community for
     appropriate use to meet the objectives bar code are intended.

     VISI wants to continue our work with the CDC, the Agency and
healthcare stakeholders of this process
     in the effort to reduce medication errors.

      Laurence Edzenga
     VISI Team Representative for
     Avantis, Chiron, GlaxoSmithKline, Merck and Wyeth Labs