Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -28

Accepted - Volume 13

Comment Record
Commentor Dr. Robert Begliomini Date/Time 2003-04-18 10:27:32
Organization Lehigh Valley Hospital
Category Health Professional

Comments for FDA General
Questions
1. General Comments We have recently instituted bedsided barcode verification of medications prior to administration to the patient. This has proven to be a valuable tool for reduction of errors. Manufacturers must place a barcode on all products and cannot exclude vials < 5ml. Most of the injectable products used at the bedside are of this size and verification of these is a must. If they are not mandated to do this it will require a hospital pharmacy to apply a sticker with a barcode which leads to potential for error. A) Pharmacy personnel can place an incorrect barcode on a product B) the sticker that is placed may cover important information for the end user c) there is a cost involved with this technology in a hospital. Furthermore, Lot and expiration must be part of the barcode. If barcodes can be placed on packs of gum and other candy certainly the patients of this country should expect it on pharmaceutical products. Thanks for listening. Robert Begliomini Pharm D, Director of Pharmacy Lehigh Valley Hospital.




EC -28