Pharmaceutical Commerce - June 2018 - 10
OV E RV I E W
supply chain for product movement. It is now recognized by
some manufacturers that aggregation can be better carried
out in the warehouse, as orders are put together for shipment,
than at the end of a packaging line, says Matt Deep, VP of
technology at DMLogic, an "edge computing" vendor for
traceability. Such edge systems manage serial data being
collected (for example) by handheld scanners at the receiving
dock, then track where in the warehouse those packages or
cases have been positioned, and finally which serial numbers
are going out with customer orders.
TraceLink, presumably recognizing this next step
in traceability, acquired Roc-IT Solutions, another edge
computing vendor, in the past year. Other players in the field,
including TrackTraceRx, Antares Vision and Systech also
provide this functionality.
"Most large pharma companies have full-fledged
warehouse management systems, but those systems typically
haven't been tailored to the needs of pharma traceability,"
says Deep, "and that's where we come in."
3PL connectivity is an issue in Europe where, nominally,
logistics providers are not part of the overall FMD reporting
framework-but there are exceptions, and now some
European 3PLs are scrambling to get ready. In the US, DSCSA
brought 3PLs under FDA oversight for the first time, and the
complication here is that FDA requests details on the statelevel licensure of the 3PL-but only a few states have set up
a licensing program for them. "Another complication is that
a 3PL operating in one state without a licensing program
might be required to obtain a license for shipping to another
state that does have such a program," notes Bob Glasgow,
a principal at D2 Consulting, which provides services on
pharma commercialization and licensing programs for
manufacturers, pharmacies and others in the supply chain.
This was recognized by FDA Administrator Gottlieb in his
February presentation: "We plan to release new regulations
that, when final, will apply to all state and federal licenses
issued to wholesale distributors and 3PLs. We're working to
publish these regulations later this year."
Wholesalers, at least in the US, have a nearer-term worry
than pharmacies and other downstream supply-chain
participants: in November 2019, DSCSA requires them to
be able to verify product returns at their warehouses before
re-entering them into commercial distribution.
HDA surveys have found that 94% of returns can be
re-introduced; that returns are a multi-billion-dollar value to
10 \ Visit our website at www.PharmaceuticalCommerce.com \ 06.2018
Fig. 3. Mettler Toledo PCE's newly redesigned T2620 system can
run at up to 400 cartons/min. Credit: MT.
healthcare, and that processing them is a multi-million-dollar
burden for each of the major wholesalers. The November
2019 deadline is part of what spurred HDA to take the lead in
developing the Origin master-data repository, and this year,
to push ahead with the so-called Verification Router Service
(VRS), which is intended to be a many-to-one source of which
manufacturers are responsible for which product identities
(since, much of the time, wholesalers get returns from products
that they themselves did not deliver to a pharmacy, and need to
locate the product's origin).
HDA hired ValueCentric to build and operate Origin;
the company has long experience in managing supply chain
data. Bill Henderson, EVP, says that signups for Origin by
manufacturers had slowed down after the FDA regulatory
delay last year, but are picking up now. ValueCentric currently
has business with some manufacturers to track specialty