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Longer lasting Belts, New Split Spools -- no regrind:Layout 1 8/26/2009 4: 37 AM Page 1
types of required reports—transaction his-
tory, transaction information, and trans-
action statements—known in the industry
by the abbreviation TH/TI/TS, or by the
shorthand “T3.”
Although the FDA will
not require companies to
shift from paper to electron-
ic T3 records until 2017,
many drug firms are mak-
ing the switch now to be
ready for the huge volumes
of data that will need to
be processed. Big health-
care distribution specialists
like Dublin, Ohio-based
“Paper is great … but there are not
enough filing cabinets in the world to store
this much data,” Bishop said. “And the law
requires that you keep the data for six years
and [be able to] produce it on 24-hour
notice … it’s a little mind-blowing.”
The current industry standard for han-
dling digital records is through advance
shipping notices (ASNs) transmitted
via electronic data interchange (EDI).
However, many smaller companies contin-
ue to use paper packing slips. That practice
will evolve in coming years toward the
EPCIS (electronic product code informa-
tion services) data standard as shippers
prepare for the full implementation of
DSCSA regulations, tracking every saleable
unit of prescription drugs by a unique seri-
al number.
BIG PAYOFF
Investing in the adoption of a global data
standard for pharmaceutical logistics could
be money well spent, according to the
McKinsey study. Establishing a single track
and trace technology for medical products
could cut counterfeiting in half, yielding
$15 billion to $30 billion in sales by 2016
that would otherwise be lost to counterfeits, the study showed.
The DSCSA regulations also benefit
pharmaceutical product distributors and
(not full product ownership as drug
manufacturers, wholesale drug dis-
tributors, re-packagers, and phar-
macies do), many have nonetheless
developed state-of-the-art tracking
and tracing capabilities.
“From a 3PL standpoint, we don’t
purchase or take ownership, but we
are in possession of the shipment; it
is stored in our facility and tracked
in our WMS (warehouse manage-
ment system),” said Tim Bishop,
healthcare compliance manager for
UPS Inc., the Atlanta-based trans-
portation and logistics giant. “So
the details of that particular drug are
known to us: where it came from,
where it went, when we shipped it,
[and] how much we sent.”
By working with a 3PL, pharma-
ceutical shippers can take advantage
of that tracking data and work in
concert with their carrier to stay in
compliance with the new regula-
tions. Some of the largest provid-
ers are already preparing for those
partnerships.
Contract logistics
firm Exel and its sister company DHL
Supply Chain, both
of which have worked
in the healthcare supply chain for many
years, have developed
serialization systems
to help life science
and healthcare (LSH)
companies manage the cost of
complying with the new regulations. UPS has contracted with an
unidentified technology provider
to transact DSCSA-mandated shipping data, a service Bishop said will
be invaluable to small to mid-sized
businesses. UPS is also creating a
digital repository to store the three
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