Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -18

Accepted - Volume 13

Comment Record
Commentor Mr. Christopher York Date/Time 2003-04-09 10:19:35
Organization Tompkins Associates
Category Individual

Comments for FDA General
1. General Comments It is unfortunate that with the majority of deaths attributed to mistakes made within hospitals that the FDA chose the NDC (without lot and expiration date) for the proposed regulation. The hospital groups spend untold millions each year re-packaging and labeling drugs for their use within the hospital, when it would be easier and less costly to the industry as a whole to package and label drugs correctly at the point of manufacture. Some hospital buying groups have said they would even pay a price premium and give preferetial contract considerations to suppliers that can provide single dose packaged drugs that are labeled with the NDC, lot and expiration date. We strongly recommend the FDA consider the greater good in reducing patient deaths and require lot and expiration date be part of the regulation.

EC -18