Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -38

Accepted - Volume 13

Comment Record
Commentor Ms. Shelly Morvay Date/Time 2003-04-22 14:14:28
Organization Children's Hospital
Category Health Professional

Comments for FDA General
1. General Comments Requiring manufacturers to include bar codes on all medications is an excellent step toward reducing medication errors. Rumor has it that some organizations would like to see an exemption for vials and ampuls of 5 mL or less. This exemption should NOT be allowed since it will not protect pediatric patients from medication errors involving most injectables (the volume is nearly always less than 5 mL). This requirement must protect all patients, and especially pediatric patients who are at higher risk for serious adverse events due to errors since most manufacturers do not make medications in unit dose sizes that are appropriate for pediatrics. Thank you for your consideration.

EC -38