26 JULY 2016 | PHARMACEUTICAL PROCESSING
Steps & Challenges
Despite a government-mandated, multi-year timeline for
implementation, many industry experts are left questioning
how to achieve and sustain unit-level traceability.
By Meg La Torre-Snyder, Editor
The Drug Supply Chain Security Act (DSCSA) was signed into law in November of 2013— enacted with the ultimate goal
of better visibility across the U.S.
pharmaceutical supply chain. Despite
a government-mandated, multi-year
timeline for implementation, many
industry experts are left questioning
how to achieve and sustain unit-level
Don Eberts, Senior Manager for
Clarkston Consulting, participated
in an exclusive interview with
Pharmaceutical Processing on the
DSCSA implementation steps and
its inherent challenges. His edited
responses are below.
In your opinion, what is one of the biggest
misunderstandings surrounding the
implementation of the DSCSA?
Eberts: Regarding unit level serialization, the
law is clear. Aggregation is implied but not
mandated by the law, which states that compliance
efforts “…may include the use of aggregation
and inference as necessary.” The omission of an
unambiguous requirement for aggregation in the
DSCSA has led some firms into asserting that
aggregation need not be implemented before the
November 27, 2023 deadline for full electronic
tracking and traceability. This legalistic position
may be theoretically correct, but it is practically
meaningless, given the recent announcements
by the Big 3 drug wholesalers, all of which are
demanding aggregation as a condition of doing
business, starting as early as 2018-2019. For
serialization to be logistically feasible, aggregation
will be needed for trading partner sales.
Along a similar line, what are companies’
biggest concerns in implementing DSCSA
regulations, specifically serialization?
Eberts: The manufacturers’ initial concerns were
centered on the effort to manage serialization
equipment and software implementations.
Most firms have made substantial progress
in this respect. The next area of concern is
how to transform serialization from a one-time implementation project into an ongoing
business responsibility. Once implemented on the
packaging unit, the exchange of data between
trading partners at the serial number level is