As serialization becomes an ever more important part of the pharmaceutical industry and the FDA's track & trace deadlines loom in the distance, we sat down
with Kelly Ng, the Healthcare Division's Product Manager at
Epson, to talk about the state of track and trace/serialization
technology, whether the industry is ready for the new requirements and how companies can make sure that they will make
the upcoming deadlines.
The government seems to keep pushing back the
deadlines, why is this?
Many of these delays can be attributed to the recently signed Drug Quality and Security Act (DQSA)
preempting California’s e-pedigree law in favor of
setting forth overarching federal track and trace
regulations. Covered in scope under the DQSA’s
Drug Supply Chain Security Act, these regulations
revolve around the content of pharmaceutical product labels and capturing of pedigree information.
The prevailing driver is to improve supply chain security and product integrity to curtail counterfeiting
and improve patient safety. It is likely that delays
were incurred on the regulation side of things as
lawmakers sidestepped the state-by-state “
patchwork” approach in favor of a national system.
While implementation deadlines have been set,
the FDA is in the midst of establishing standards
for the industry to follow regarding the exchange of
transaction data. The FDA has been seeking feedback on cur-
rent processes used by the industry with the hopes of finalizing
guidelines by November 2014. From a technical standpoint,
DQSA implementation falls on evaluation. Pharmaceutical man-
ufacturers, wholesalers or repackagers should assess whether
their current coding, labeling or packaging technologies can
meet serialization requirements under the DQSA.
What are the current deadlines?
The new regulations on label content are to be in place by
the end of 2014. The first implementation deadline under DQSA
goes into effect January 1, 2015. By this time, manufacturers
must be able to provide transaction information reflecting lot-
level pedigree information, transaction history and a transac-
tion statement. This includes the ability to provide information
for subsequent transactions every time ownership of product
is transferred. The final deadline for DQSA does not occur until
2023, but by November 2017, all of this information must be
available electronically. Also, product identifiers must be attached or imprinted on labels at the product and case level.
How far along is the industry in meeting these requirements?
Most existing technologies can adapt to meet these requirements, digital and flexo printing have evolved to be quite flexible, though some solutions are faster than others. Depending
on where a company falls in the supply chain, there are staggered implementation benchmarks. For example, while pharmaceutical manufacturers are required to place unique product
identifiers on drug packages by November 2017, repackagers
have until November 2018 to fulfill this requirement. Given the
diverse allocation of prescription drugs throughout the supply
chain, this will require a flexible approach to packaging, labeling and shipping product.
The more significant time sink here will be the effort that
goes into revamping software management systems and redesigning label formats. With serialization, it becomes more
difficult since each label will need to carry a unique product
identifier. With the obligation to incorporate additional transaction information as products travel to different trading partners, label variability and complexity will also play a larger role.
Between batch information, location and package contents, the
information on labels will change constantly and frequently.
High volume producers and distributors will largely feel this
requirement. Smaller companies that regularly deal in low volume, high mix product applications may be familiar with the
flexibility required here, but may face challenges in the sheer
volume of changes required under serialization implementation.
What questions should be asked before implementing a track
and trace/serialization system?
Companies should establish how they are defined within
the FDA’s breakdown of implementation, to develop an accu-
rate timeline for serialization planning, testing, and execution.
However, given the requirements for all supply chain parties
to reflect exchange of product on required transactional documents, providers should hold into account all aspects of serialization. For example, while wholesale distributors may have divergent deadlines, it may be beneficial to align implementation
with their primary upstream partners.
Focusing more specifically on the labeling aspect, valuable
■ By Nikita Ernst, Associate Editor
Is the industry ready?
The State Of Track &
they are defined
within the FDA’s
to develop an