pliance standards are not met by what is essentially an arbitrarily
selected deadline date.
The alternative strategy emphasizes early adoption of
comprehensive serialization solutions. Many responsible
CPO firms have made significant investments to achieve serialization in advance of FDA deadlines. Positioned between
manufacturer and dispenser, the CPO and third party logistics
providers work with large clients. They also work with many
mid-size and small clients that have little to no leverage in
their dealings with national wholesalers. Smaller manufacturers and brand owners are concerned that orders may be delayed or rejected by wholesalers if their shipments are not fully
serialized by the deadline.
The transition to full serialization will be challenging and
wholesalers willing to work through the transition with larger
partners may not extend the same consideration to smaller players. Therefore, responsible contract packagers and third party
logistics providers that are serialization-ready are able to offer
serialization options to all clients that enable them to continue
operations post-deadline and minimize the possibility of disruption further along the supply chain due to potential DSCSA compliance issues.
A SIGNIFICANT COMMITMENT
Upgrading packaging and labeling equipment to conform to
DSCSA regulations is an important priority affecting many departments within contract packaging operations and third party
logistics providers including warehousing and distribution, reverse logistics, transportation management, information technology, quality assurance and regulatory affairs.
Item serialization requires specialized hardware and software
to serialize drug products with the Unique Product Identifier
(UPI) compliant with the GS1 Global Standard. The UPI contains
vital tracking information including serial number, lot number,
expiration date and other pertinent data.
In most cases, new printers, scanners, cameras, desktop
devices and other hardware must be installed on each line
and throughout the facility to read, store, print and process
the UPI and additional data requirements for DSC-
Line management software must be operational to
manage serial number allocation and aggregation on
each packaging line. To coordinate individual lines, additional technology is layered onto the system enabling
communication between software programs and Warehouse Management System (WMS).
The fundamental objective for item-level traceability
is achieved through a cloud-based repository to generate serial numbers and gain access to data for supply
chain partners to establish full chain of possession.
Although this comprehensive solution is not required by the November 27, 2017 deadline, contract
packagers and third party logistics firms that committed
early to complete serialization programs can offer more
options to clients requiring DSCSA compliance assistance. Many contract packagers and manufacturers are
choosing to wait to implement change or their serialization timetable may be delayed due to lack of outside resources.
Each situation may be slightly different. The prepared third party
logistics provider and contract packager is in a strong position to
bridge the gap for most clients to keep their businesses running
smoothly leading up to and beyond the upcoming deadline regardless of their compliance status.
DSCSA compliance has fostered an entire industry dedicated
to developing strategy, hardware and software for companies
operating within the pharmaceutical supply chain. Multiple
solutions are offered by different companies that each promote their own products and services. The crowded marketplace contrasts with the objective of the DSCSA to increase
transparency in the marketplace to authenticate the passage of
prescription medications from manufacturer to final dispenser
and in the reverse logistics channel.
Contract packagers and third party logistics providers occupy
an important place at the nexus of the supply chain between
manufacturers and patients. Early implementation of DSCSA requirements prior to FDA deadlines benefits responsible 3PL and
CPO firms and their small and mid-size clients including manufacturers and contract manufacturers.
Many manufacturers are delaying implementation until the
FDA provides further clarification about the law. However, FDA
public statements are always related to the phraseology of the
law itself with little or no interpretation or guidance. This same
situation is the reason responsible third party logistics providers
and contract packagers offer clients several levels of serialization
assistance. With correctly serialized products, all parties along the
supply chain must accept and process inbound shipments.
Uncertainty is the enemy of pharmaceutical logistics. Proper
planning with reputable contract manufacturers, packagers and
third party logistics providers increases confidence for manufacturers navigating through the transition to DSCSA compliance. CP
LARRY HOTZ is marketing manager at WDPrx – Woodfield Pharmaceutical, LLC.
Labeling on a production line at WDPrx – Woodfield Pharmaceutical, LLC in Houston, TX.