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The Drug Quality and Security Act creates national standards for serialization of drug products to protect against counterfeiting.
With the Jan. 1, 2015, California e-pedigree deadline less than 14 months away and federal traceability legislation likely to take effect, pharmaceutical manufacturers are focused on writing specifications, conducting pilot tests, and implementing full-scale serialization solutions on one or more packaging lines.
The California deadline is likely moot. The US House of Representatives passed the Drug Quality and Security Act (H.R. 3204) on Sept. 28, 2013, and sent it to the US Senate on Sept. 30, 2013 (1). The Senate passed it on Nov. 18, 2013. (See PharmTech's blog "Senate Finalizes Drug Compounding, Tracking Legislation.") The bill, which was not amended by the Senate and has widespread support from industry, now awaits President Obama’s signature.
Title I of H.R. 3204 clarifies FDA’s authority over compounding of human drugs and requires the agency to collaborate with state authorities to ensure the safety of compounded drugs. Title II of the bill would create a uniform national standard for drug supply-chain security to protect against counterfeit drugs. This standard would involve establishing a framework for supply-chain security and provide a 10-year transition to a unit-level tracking system (2).
If signed by the President, as expected, H.R. 3204 “will preempt the current California regulations,” says John DiPalo, COO of Acsis, a provider of turnkey serialization solutions and software, in an interview with Pharmaceutical Technology. “Companies that were developing a strategy just for California will now need to incorporate all operations across the entire supply chain. For example, if a company was looking to initially outfit a West-coast distribution center…to serve California, that will no longer be an option. In addition, it appears that the phased approach is no longer available and 100% of product moving through the supply chain will need to be serialized,” he explains.
Broader than the California regulations, H.R. 3204 “…affects all of the stakeholders in the process, including manufacturers, distributors and retailers,” notes DiPalo. Manufacturers would be required (by Jan. 1, 2015) to capture and provide transaction history, transaction information including a lot number, and a transaction statement. Four years after enactment, manufacturers would be required to affix a product identifier (e.g., two-dimensional barcode) to a package and homogeneous case. Manufacturers would also be required to have a serialized numeric identifier (SNI), lot, and expiration date. The regulation also spells out requirements for distributors, dispensers, and repackagers regarding information they must have to accept a product and information they must provide to the subsequent owner.
Even as federal regulations were being hammered out in Washington DC, work has been continuing on serialization implementations. One company with a serialization pilot in progress, Daiichi Sankyo, is installing a turnkey solution from Acsis on a line at its packaging plant in Pennsylvania. The Acsis Serialization Management Suite includes line management, site management, and serial aggregation management software and is integrated with vision inspection from Cognex, printing equipment from Domino, material handling technology from Omega Design, and labeling technology from Weiler Labeling Systems. In addition to managing all aspects of implementation and support, Acsis prebuilt integration with Daiichi Sankyo’s SAP Auto-ID Infrastructure and Object Event Repository so product data can be shared and tracked in real-time throughout the supply chain.
The Acsis software:
Acsis also works with Kodak to deliver integrated, end-to-end solutions that securely, cost-effectively, and reliably authenticate, track, and trace product. The collaborative effort, announced on Sept. 4, 2013, integrates Acsis Serialization Management software with the Kodak Traceless System and its viewers and Smartphone apps to create dual serialization marking and coding on the packaging line via a visible code for aggregation and distribution processes and an invisible covert code for investigation and enforcement. “[Acsis software]…has the level of granularity needed for item-level serialization that addresses both the packaging line requirements and tracking throughout the entire distribution chain,” says Randy Young, global director, Kodak Brand Protection Solutions (3).
The solution integrates to enterprise systems and can be implemented with minimum downtime, and without a major retooling of manufacturing or packaging processes. If needed, Acsis can provide its turnkey Serialization in a Box system, which integrates its Enterprise Serialization track-and-trace software with smart vision cameras and handheld barcode readers.
Whatever serialization solution is chosen, DiPalo advises allowing extra time for implementation. “Everything takes a little longer than you think, and you need to allocate adequate time and resources for validation,” he explains. He also recommends dedicating resources to the project instead of adding serialization responsibilities to existing duties. “Serialization affects many different areas of an operation, and it is a big job to keep track of all the moving parts. You are introducing new technology into the packaging world as well as additional information-technology requirements that typically the team members haven’t had to deal with in the past,” he notes.
Despite the rigors of implementation, serialization can achieve true supply-chain visibility and offer benefits beyond regulatory compliance. “There is some immediate payback in the areas of returns management and recall management that can provide some immediate, tangible benefits,” concludes DiPalo.
—Hallie Forcinio is Pharmaceutical Technology's packaging editor, firstname.lastname@example.org.