A Wholesaler’s Perspective
AmerisourceBergen’s journey to implementing DSCSA requirements —
partnering with manufacturers and creating data exchange standards.
By Meg La Torre-Snyder, Editor
Signed into law on November 27, 2013, the Drug Supply Chain Security Act (DSCSA) doesn’t just affect U.S. pharmaceutical manufacturers. It also will have an
impact on wholesale distributors and third-party
logistics providers. In particular, it will require the
establishment of licensure standards and annual
reporting of information to the FDA. By November
2019, distributors will be required to have
implemented traceability at their operations.
In the first phase of the DSCSA, wholesale
distributors were tasked to trade only with authorized
partners; to send and receive transaction information,
transaction history, and transaction statements; to
quarantine and investigate suspect drugs; to notify
the FDA and other stakeholders of any illegitimate
drugs; and to meet the FDA licensing requirement.
AmerisourceBergen Corp. (ABC), one of the big
three pharmaceutical wholesale distributors, has
helped to shape the implementation of the DSCSA in
the pharmaceutical supply chain.
According to ABC’s Heather Zenk, Vice President
of Secure Supply Chain Operations, the company
started by identifying which system changes and
enhancements would be needed, which involved
changes to business processes, and whether there
were requirements that affected both.
She said that the company had a lot of the
processes already in place.
“What we’ve put in place is that we are receiving
our transactional information inbound from all of
our manufacturing trading partners. We receive
that, store it, and then we generate all of our
transactional information statement and history
to our pharmacy trading customers,” said Zenk.
“All we needed to do was change terminology to
align with the DSCSA requirements
and retrain a few associates on
appropriate handling of quarantined
“The accepting of the transactional
data in a standardized format was a
larger opportunity for us. That was
probably our most difficult [regulation]
to adhere to. That is solely due to the
modern manufacturers we conduct
At present, the company conducts
business with every U.S.-approved
pharmaceutical manufacturer in the
“If you break it all down, we
probably work with about 500
manufacturers,” said Zenk.
10 MARCH 2017 | PHARMACEUTICAL PROCESSING
AmerisourceBergen associates pick, pack, and ship medication.