From: ReconnUSA@aol.com
Sent: Wednesday, May 14, 2003 1:59 PM
To: fdadockets@oc.fda.gov
Cc: LTKontnik@Reconnaissance-Intl.com
Subject: Docket No. 02N-0204-Comments-Bar Code

FDA Docket Management Branch (HFA-305)

Docket No. 02N-0204

Bar Code Label Requirements for Human Drug Products and Blood

http://www.fda.gov/dockets/ecomments


Dear Sirs:


Reconnaissance International is an authority of product counterfeiting and 

diversion, with special focus on the security of pharmaceuticals (please see

www.Pharma-AntiCounterfeiting.Info). We are also a subcontractor in the FDA 

supported Product Surety Program (see: www.ProductSurety.Org).


From our experience in the anticounterfeiting area, we do (as a private 

company) have the following general comments on the above titled proposed 

rules.


1) Consider other related activities in the finalization of the bar code 

rules.


While medical errors and compliance are the main focus of the current 

rulemaking effort, there are other important public health objectives that 

could be advanced (or frustrated) by the current rules.


Authentication and traceability of drugs subject to counterfeiting (and/or 

terrorist attack) is one of those objectives. Over the past two years, 

counterfeits of approximately a dozen different drugs have entered the US 

drug supply. Product unit labeling and track and trace technologies are a 

main potential tool for fighting this problem and for adding security to the

drug supply. I strongly urge you to examine the work being done by the 

Product Surety project and to consider this information as part of you final

rulemaking process. 

One of the specific concerns with the proposed UCC linear codes and the 
stacked 

linear codes such as RS 114 is the limitation of alphanumeric characters

precludes inclusion of lot number, expiration date and serial numbers.  Those 
additional characters could be used for product authentication, as the US 
treasury at some level uses serial numbers to authenticate currency.  Space 
for these additional

characters are already included in the 2-D codes used as standards by the 
aerospace, automotive, and electronic industry. 


2) Do not foreclose current and future bar coding and product identity 

technologies.  

The currently proposed regulations specify the use of the

"National Drug Code (NDC) number in a linear bar code." While this 
information is important, the health care community should not be prevented 
from adopting other 

technologies, containing more information that could be useful in business 

operations and in securing the drug supply against counterfeits and

terrorist attacks. Specifically, 2D bar codes and the developing MIT AutoID 
EPC codes 

should be allowed in addition to the linear codes. 

Not to do this would cut off the FDA and the medical community from using the 
best technology that exists and is being implemented today. We should not 
freeze the system into using old technologies and prevent the introduction of 
current technologies.


Language that looks to the future might also mitigate future obsolescence 
complaints by hospitals, in that their purchasing decision for bar code 
readers would consider using modern design CCD camera and adaptable software 
driven readers, rather than simple linear reader with 1980s technology. 


Foreclosing new technologies would not serve the public health, business

efficiency or administrative effectiveness.

Thank you for the opportunity to comment on these proposed rules.

Sincerely yours,
Lewis T. Kontnik
Principal
Reconnaissance Intl
5650 Greenwood Plaza Blvd #225K
Greenwood Village, CO 80111
USA
303 779 1096
Fax 303 779 3647
www.pharma-anticounterfeiting.info
www.productsurety.org
www.holopackholoprint.info
www.Reconnaissance-Intl.com


ACP SOLUTIONS USA - June 10-13, 2003

Crowne Plaza Ravinia, Atlanta, GA

ACP SOLUTIONS EUROPE - September 8-11, 2003

Radisson SAS Hotel, Dusseldorf, Germany

www.acpsolutions.info