Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -5

Accepted - Volume 8

Comment Record
Commentor Mr. Reggie Labat Date/Time 2003-03-15 13:04:09
Organization St. Anne General Hospital
Category Individual

Comments for FDA General
1. General Comments Putting a bar code on a bottle of 100 tabs will not help in hospitals. The bar codes must be on unit dose packages. Many products do not come in manufactured unit dose packages resulting in hospital pharmacy personnel having to package the drug themselves leading to more possible errors. More drugs need to be packaged by the manufacturer in unit dose with the bar codes already printed by the manufacturer. According to the language, all a manufacturer has to do is put a bar code on a bottle of 100 tab. No one sends a patient a whole bottle of 100 tabs to a patient. Thanks

EC -5