California Comments on FDA Initiatives
In March, FDA asked for industry
comments on numerical identifier
standards and technology drug identification. The agency sought input on
how to develop a “standardized
numerical identifier to be applied to a
prescription drug at the point of manufacturing and repackaging (in which
case the numerical identifier shall be
linked to the numerical identifier
applied at the point of manufacturing)
at the package or pallet level, sufficient to facilitate the identification, validation, authentication, and tracking
and tracing of the prescription drug.”
FDA is also developing standards
addressing “radio-frequency identification, nanotechnology, encryption
technologies, and other track and
trace or authentication technologies.”
With less than a week before FDA’s
deadline of May 19, a few pharmaceutical companies and technology
providers had provided comments to
FDA. (See www.regulations.gov.) The
California State Board of Pharmacy
(BoP) had also weighed in.
California seeks what FDA wants: “a
drug supply chain in which security is
enhanced by a universal electronic pedigree requirement with full-system track
and trace, and mass serialization at the
unit level with standardized unique
numerical identifiers,” writes William
Powers, president, California State
Board of Pharmacy.
California endorses what FDA had in
2004 (but seems to have since tiptoed
away from): RFID. “RFID is a vastly
superior technology for all of the purposes served by an electronic pedi-gree/track and trace system, and should
be the industry standard for data carriers,” writes Powers. “2-D bar codes
have utility as a temporary or interim
solution, and as a back-up technology
on packaging in the event of a (rare)
RFID tag failure. However, in the long
term, 2-D bar codes should not be a primary technology, and should be used
solely as a secondary or back-up technology to the primary RFID tag(s).”
FDA is investigating a number of
aspects of track and trace programs:
feasibility, costs, timeline, interoperability, information technology, and
data storage.
dards and available item-level serialization options in the market today. Now 2-
D serialized codes are available at the
case and item level; high-frequency,
ultra-high-frequency (UHF), and UHF
near-field options are available at the
case and item level with proven read
rates in the field.
Industry infrastructure and experts
are on hand to help define and implement down to the sellable unit-level
package. Look for potential partners
with expertise in serialization implementation. Partners should be able to help
you determine the pros and cons of 2-D
and RFID options and what a technology road map can look like for case, item,
or pallet serialization.
Some larger drug makers we’ve talked
with need several years to enable full
compliance, including retrofitting potentially dozens of packaging lines, adding
serialization to hundreds of SKUs and
millions of sellable units, and updating
and integrating ERP systems (in some
cases, installing an ERP system). Producers know they must accelerate, even
as the California law is delayed.
Once drug makers completely realize
the size of the task ahead, they regret
not starting sooner. They don’t see a
delay as a reason to slow down. They
see it as a way to more effectively organize and implement a cohesive
Look for potential
partners with expertise
in serialization
implementation.
approach with time to collaborate with
trading partners. Challenges that must
be addressed up front with proven
products and tested expertise include:
Technical infrastructure. From
light to full integration of e-pedigree
and serialization data into their enterprise business systems (such as SAP),
manufacturers can evolve to and
beyond compliance. Drug makers can
realize ROI in inventory management,
track-and-trace programs, and forward
and reverse logistics.
Line capabilities. Infrastructure
architects must take note of other concerns. Consider the impact on packag-
ing lines to serialize and validate products, capture data, and distribute both
to electronic pedigree software and the
enterprise without significant loss of
line efficiencies. Evaluate benefits and
trade-offs between in-line serializations
versus receiving certified preserialized
products.
Alternative solutions. Firms must
identify, test, and implement alternate
serialization methods to meet specific
packaging configurations and biologics.
Training. With regard to the work
force, it is necessary to scale up and
train personnel and provide resources
for full-blown integration within the
operation.
Keep working on infrastructure and
launching pilots, and gain as much
expertise from suppliers and other
drug producers or wholesalers that
may be farther down the path. The
industry is preparing to scale up.
Expertise, capacity, and other
resources are becoming strained. ■
Nosco offers preserialized 2-D bar codes
and RFID-enabled printed packaging with
data certification produced under CGMP/
QSR-based processes.
