2005D-0202
  

  
Guidance for Industry on Bar Code Label Requirements; Questions and Answers
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC7
  



  

  
Submitter : 
  

  
Mr. Taehyun Baek
  

  
Date & Time: 
  

  
12/15/2006 08:12:09
  



  

  
Organization : 
  

  
Booyoung Eng.
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear: 



I would like to ask A 12 to Q 12 which is below my question about RFID. 

I am involved in building a pharmaceutical warehouse.  



Our team plans to apply RFID (Radio Frequency Identification) chip on the pallets used around the warehouse, so that the logistics flow should be controlled automatically in the warehouse management system and process management system. Thus, is it against FDA Regulations to use RFID for pallets? 



And in the process of production, is it also against FDA Regulations to apply RFID to the containers? 



For the last, if the use of RFID is permitted, could you please let me know some strategies on System Validation Approach. 



Thanks for your time to read my questions and provide me with your comments. 



Sincerely Yours, 

Baek, Taehyun 





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Q12: Can a firm use another automatic identification technology such as a radio frequency identification chip or a two-dimensional symbology, instead of a linear bar code? 



A12: No. The final rule requires the use of a linear bar code to encode the NDC number on most prescription drug products and certain OTC drug products. However, we do not intend to object if firms voluntarily encode lot number and expiration date information, and we recognize that some firms might use other technologies to encode that additional information (response to comment 35,69 FR 9120 at 9134-9135).



    In addition, we stated in the preamble to the final rule that we will consider revising the rule to accommodate new technologies and may begin examining other automatic identification technologies by April 2006 (69 FR 9120 at 9138).