On June 3, 2011, we announced, as part of the Department of Health and Human Services (HHS) retrospective review plan, that the first of our regulations to be reviewed under this EO would be the “Bar Code Rule.” You can see the HHS plan in its entirety at http://www.hhs.gov/open/execorders/13563/index.html. The Bar Code regulation, which was finalized in 2004, requires certain human drugs and biological products to have a linear bar code on the label so health care professionals can use bar code scanning equipment to verify that the right drug (in the right dose and route of administration) is being given to the right patient at the right time.
In the seven years since this regulation was issued, there have been advances in alternative technologies. In addition, it has become increasingly clear from industry, health care providers, and other FDA initiatives, that certain FDA-regulated products present unique bar coding concerns. For example, the Agency has since learned that certain vaccines present unique challenges in the bar coding context, particularly with respect to compliance with recordkeeping and mandatory adverse event reporting requirements that are specific to the administration of childhood vaccines.