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GS1 Healthcare Newsletter
No. 24 – Spring / Summer – 2012 - www.gs1.org/healthcare/news_events
Johnson & Johnson roll out of GS1
Standards making progress
Mike Rose, Vice President of Supply Chain Visibility, Johnson
& Johnson, shared the business case behind the company’s
decision to adopt GS1 Standards for identiﬁcation and product
marking across their product range. The GS1 labelling project
is underway with already 100,000 GTINs implemented and by
the end 2012, all Medical Devices and Diagnostics products
will be identiﬁed by GS1 Standards. J&J is currently sending
data through the Global Data Synchronisation Network
(GDSN) to 54 retailers worldwide and has begun sending data
to the U.S. Department of Defense.
To conclude the Sydney
Conference, Sam Cawthorn,
Young Australian of the Year
in 2009, inspired the audience
and embarked on a journey encouraging them to be
resilient, overcome fears, and achieve goals and dreams
that might seem unachievable.
Read his Bounce Theory
To download the presentations from the Sydney Conference
visit our GS1 Healthcare website
GOVERNMENT & REGULATORY
USA: FDA reviews 2004
bar code rule
Last October the FDA announced a review of the “Bar Code
Final Rule,” published in 2004, which requires manufacturers
to put a linear barcode with the National Drug Code of the
product on most unit of use packages.
While medical errors in hospitals are still a concern, in
recent years FDA has become concerned by the invasion of
counterfeit drugs in the legitimate US distribution channel.
However, ﬁnding the leaks would require implementing
“track & trace systems”, which cannot be done with linear
barcodes. Yet, serialising products using GS1 DataMatrix bar
codes would allow “track & trace”. In addition, serialisation
not only reduces the chance of “bad product” reaching
patients, it also reduces the time and costs in complying
with a recall.
“For the past three years, many pharmaceutical manufacturers
have implemented GS1 DataMatrix in response to the California
Pedigree and FDA SNI guidance,” said Mark J. Goldberger
M.D., M.P.H., divisional Vice President, Regulatory Policy &
Intelligence, Abbott Laboratories. “Globally, GS1 DataMatrix
is the preferred data carrier for encoding variable data on
the unit of sale due to the small size of the data carrier”
(Packaging serialization update, www.contractpharma.com).
GS1 US and GS1 Healthcare provided comments to the US
FDA in its retrospective review of bar code technologies for
drugs and biological products. The information submitted
will help FDA to reassess the costs and beneﬁts of the rule
and to identify any relevant changes in technology that
have occurred since it went into eﬀect. The FDA will use
the information received to assess whether the Bar Code
Final Rule is achieving its intended beneﬁts as eﬀectively as
possible or should be modiﬁed.