Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -46

Accepted - Volume 13

Comment Record
Commentor Mr. James Carpenter Date/Time 2003-05-02 10:44:46
Organization Legacy Health System
Category Health Professional

Comments for FDA General
Questions
1. General Comments Legacy Health System is fully in favor of the placement of bar codes on immediate containers for pharmaceutical product. There is concern that industry pushback will diminish the number of medications that are packaged in unit-dose packaging, a proven error-reducing method of drug product packaging and institutional drug delivery. For this reason, the FDA is encouraged to consider examining the effect of this new legislation on the rate of unit dose packaging of medications by manufacturers. Concern is, of course, that if the number of unit-dose packaged drugs decreases significantly, the burden of repackaging into bar-code compliant packaging will rest on the institution, possibly potentiating repackaging medication errors and a significant step away from industry GMP's. Jim Carpenter, RPh, MS Legacy Health System Portland, OR




EC -46