Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -17

Accepted - Volume 7

Comment Record
Commentor Mr. Darin Roark Date/Time 2003-04-07 14:31:06
Organization Advocate Health Care
Category Health Professional

Comments for FDA General
1. General Comments While we celebrate and completely support the proposed requirement to add bar codes to medications, we are asking for federal guidance with regards to bar code scanners that are being placed into intravenous infusion pump systems. For example, our hospital system recently commenced a review of the patient controlled analgesic (PCA) devices available on the market. Abbott has a new device known as the PCA Plus III. The device has a bar code reader that only reads vials of medication that are manufactured by Abbott. In another example, an intravenous infusion pump that is manufactured by B Braun only reads bar codes that are printed from a label maker that is manufactured by B Braun. Without the proper regulation of the infusion devices, hospitals will be forced to purchase specific prescription drugs from the same manufacturer as their infusion devices. This potentially places financial hardships on hospital systems as the manufacturer of the medication would then be able to monopolize the marketplace. The only alternative is for the hospital to re-label medications in-house so that the bar code reader on the device can interpret the code. This would eliminate many of the benefits of the legislation (please see II. A page 12503 of the proposed rule). Please take these issues into consideration when arriving at final decisions regarding this very important piece of legislation.

EC -17