Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -30

Accepted - Volume 13

Comment Record
Commentor Dr. Mark Hofstetter Date/Time 2003-04-18 18:44:47
Organization St. Lukes Regional Medical Center
Category Health Professional

Comments for FDA General
1. General Comments I am writing to you as a practicing pharmacist. I have over 26 years of experience ranging from retail pharmacy, hospital pharmacy, home infusion pharmacy and oncology clinic pharmacy. I have over 22 years as a director of pharmacy at vaious institutions. I feel that it is very important that bar coding of drug products be implimented. This will help with safety and reduce the potential for dispensing errors. I feel that all drug products / containers / vials and ampules should be bar coded. The potential for errors are great, and with many simular looking products it is very easy for a wrong medication to be dispensed or administered to a patient. The bar code should also contain the products lot number and expiration dating. This will make it easier to track items that have been recalled, and to follow-up with and contact any patients who may be involved. Although the manufacturers will want to say that this is difficult to do and will cost money, I feel they are a little self-serving in their desires to stop or dilute this regulation. There are some manufacturers who currently bar code all of their products, including each one of their unit-dose tablets and capsules. The primary objective is to help people with diseases to be cured or made better. One way to assure that the right drug is given to the right patient for the right treatment is having a safety check such as would be provided by bar-coding. Thank you very much, sincerely, Mark A. Hofstetter, Pharm.D. Oncology Pharmacist St. Lukes Region Medical Center / Mountain States Tumor Institute Boise/Nampa, Idaho (208) 463-6045

EC -30