FDA Transparency Blog

If you’ve been following this blog you know that earlier this year, President Obama issued Executive Order (EO) 13563 and outlined his plan to create a 21st-century regulatory system that is simpler and smarter and that protects the health and safety of the American people in a pragmatic and cost-effective way.  One of the goals of EO 13563 is to target rules already on the books and revise regulations that are out-of-date, unnecessary, excessively burdensome, or in conflict with other rules.

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.

We are pleased to announce that today FDA issued a Federal Register notice seeking public input on the Bar Code rule.  You can see this notice at http://www.gpo.gov/fdsys/pkg/FR-2011-10-26/pdf/2011-27657.pdf.  We are requesting comments and supporting information on Bar code labeling standards for drugs and biological products and the identification of current alternative technologies for use by industry and others.

To facilitate this discussion with you, in the notice we have included some questions for you to consider.  These questions, which are not meant to be exhaustive, are provided to stimulate public comments that will help us evaluate the Bar Code rule and the accommodation of alternative technologies to the linear bar code requirement.  You are encouraged to address these and/or other related questions, so please review the notice at http://www.gpo.gov/fdsys/pkg/FR-2011-10-26/pdf/2011-27657.pdf and submit your comments to our docket.  We look forward to hearing your thoughts and ideas.

Stay tuned as we continue reviewing our regulations at FDA.

Leslie Kux

Assistant Commissioner for Policy

And

Clark Nardinelli, FDA Chief Economist