Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -24

Accepted - Volume 13

Comment Record
Commentor Mr. Bradley Haupt Date/Time 2003-04-17 11:49:06
Organization Rapid City Regional Hospital
Category Health Professional

Comments for FDA General
1. General Comments Bar codes need to be placed on the individual unit of use package no matter what the size. If this is not part of the FDA's requirements every hospital pharmacy will become a large scale repackager. The ruling is to enhance patient safety, and if every pharmacy is using its own system to repackage there will be no standardization in the unit of use bar codes. Instead of having an automated standardized process, each pharmacy will have a manual process with human error build in. This may lead to more serious errors occurring on larger number of patients because everyone will believe the bar code/packaging is correct and not question who checked to make sure the correct product, strength, dosage form were placed in the package. The greatest fear I'm hearing from other pharmacy professionals is that because of cost many MFG's will simply stop manufacturing unit of use packaging. The above senerio is played out again. I truly believe that pharmacy professionals are willing to spend more for unit of use packaging. But are patients willing to do the same?

EC -24