Bar code final rule
Bar code label requirements for human drug products and biological products; Final rule
Federal Register. Vol. 69, No. 38, Thursday, February 26, 2004.
The U.S. Food and Drug Administration (FDA) is issuing a new rule that requires certain human drug product labels and biological product labels to have bar codes. The bar code for human drug products and biological products (other than blood and blood components) must contain the National Drug Code (NDC) number in a linear bar code. The rule will help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. The rule also requires the use of machine-readable information on blood and blood component container labels to help reduce medication errors.
- Barcode final rule (2/16/04)
- Draft Guidance for Industry: Bar Code Label Requirements - Q & A June 2005
- Premier's statements on healthcare industry bar coding and UDI
- FDA fact sheets and information on the 2004 bar code rule