Home > Transparency Posts > Update on Retrospective Review of FDA Regulations

Update on Retrospective Review of FDA Regulations

October 26, 2011 Leave a comment Go to comments

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  One of the goals of EO 13563 is to target rules already on the books and revise regulations that are out-of-date, unnecessary, excessively burdensome, or in conflict with other rules.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


Clark Nardinelli, FDA Chief Economist

  1. October 27, 2011 at 2:04 pm

    I, so far, have not dealt with the bar code issue but I think it is good when the FDA recognizes an area that needs study or change. Blind regulations oblivious to the unintended consequences can be a severe burden on business. From what I am reading the FDA is following the mandate to serve the people.

  2. Bob
    October 27, 2011 at 2:05 pm

    Brilliant post I hope to see more, keep at it.

  3. October 28, 2011 at 6:17 am

    I have a small question regarding the bar code issue. I run a small business, I want to know how bar code will help my business.

  4. November 7, 2011 at 4:32 pm

    This is a very progressive step.Contrary to popular opinion,pharmacists make mistakes to read the prescription of doctor,which might be fatal.Hopefully,linear bar code fix this issue.

  5. November 7, 2011 at 8:14 pm

    This is nice article

  6. Radarwarner
    November 18, 2011 at 1:17 am

    Great post! greets from Radarwarner TEAM Germany

  7. Radarwarner
    November 18, 2011 at 1:21 am

    Greets also from Radarwarner TEAM Germany

  8. idomovie
    November 23, 2011 at 3:25 am

    Brilliant post I hope to see more, keep at it.

    Thanks for good content ^^

  9. Seo
    November 25, 2011 at 4:52 pm

    Great movement forward

  10. Maloja
    November 26, 2011 at 9:02 pm

    good content! keep on!

  11. baileyz
    November 28, 2011 at 3:26 am

    It is always nice to see that the government is taking steps to protect the American public. Creating a ”21st-century regulatory system that is simpler and smarter” is something that we greatly need and would be of great benefit to the people. As we become more and more technologically advanced so should our ways of regulating and tracking markets. One new technology to consider is using a Q-code system, which when scanned would immediately pull up information about the drug, interactions it could have, dosing, ect. all in one place. This is just one such example of the modernization that could be considered during the review process for these regulations.

  12. captcha sniper
    November 29, 2011 at 12:41 am

    Thanks for the awesome info! Just what I was looking for.

  13. Retin
    December 1, 2011 at 2:32 pm

    Brilliant work. Hope now the human error element is completely eliminated from the system.

  14. Maloja
    December 12, 2011 at 8:53 am

    Its a briliant idea when professionals can use bar code scanning equipment to verify that the right drug. maloja

  15. Henry
    December 16, 2011 at 8:09 pm

    Take the time to make a difference for all food allergy families — those now struggling with LTFA and those to come.

  16. wjhat
    January 3, 2012 at 8:15 am

    good approch

  17. Neulabs
    March 15, 2012 at 4:34 pm

    This is a great opportunity by USDA to people to meet directly with the highest levels of top international trade leadership in the US and Globally.

  18. M Umer Bhatti
    May 1, 2012 at 2:53 pm

    Thanks a lot for the article post.Really thank you! Awesome.

  19. Angela
    May 11, 2012 at 7:35 pm

    Very interesting post !
    thx you I will share it

  20. Sniperspy
    July 11, 2012 at 8:17 pm

    Well done the FDA for recognizing this is an area that needs to be studied. I can’t say i really expected that from the FDA because it has made some dubious decisions since it inception.

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  24. xinpingzhang
    October 1, 2012 at 12:20 pm

    It’s the frist time i visit your blog which is very valuable for transparancy in drug regulation.

  25. Albania Real Estate
    October 5, 2012 at 12:08 am

    I have a small question regarding the bar code issue. I run a small business, I want to know how bar code will help my business

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