The FDA is currently exploring a track and trace system for prescription drugs through the supply chain. At a recent FDA track-and-trace workshop in February 2011, the FDA and supply chain partners met to identify the types of systems and standards that will ensure proper identification and authentication of prescription drugs, and improve efficiency and effectiveness of drug recalls to protect public health.
The FDA Amendments Act (FDAAA) passed in 2007 requires the FDA to establish standards on authentication and data management. The FDAAA doesn’t require manufactureres to serialize packages or to track and trace them; it requires the FDA to develop standards that manufacturers can use.
However, the state of California does requires manufacturers to serialize packages starting in 2015 and also requires them to pass an electronic pedigree. The Standardized Numerical Indicator (SNI) is a unique alphanumberic code placed on the unit-level packages. The SNIs are then put into a pedigree, an electronic drug transaction record that traces drug possession from the manufacturer all the way to the actual pharmacy or distribution point. This system provides the ability to go back through the supply chain to verify the chain of custody and chain of ownership. Both generic and brand drug manufacturers must pedigree 50% of their products by 2015, and the remaining 50% by 2016. Wholesalers and re-packagers must accept and pass pedigrees by July 2016, while pharmacies and pharmacy warehouses must accept pedigrees by July 2017.
A complete serialization program would provide a history of a given product’s chain of custody from the manufacturer to the point of dispensing. What is involved in a serialization program? Factors such as being able to capture the status of an SNI, how to store and exchange information among supply chain partners, how to authenticate the SNI and history, and how to safeguard corporate and patient data.
Pharmaceutical manufacturers are investing in ways to uniquely serialize each unit and to register the parent-child relationships of units into larger containers, cases or cartons and even up to pallets. The information required in a serialization program is strongly dependant on the many different national laws and standards. The pharmaceutical industry has already started to mass serialize drugs and there are already standards and concepts being implemented in Europe and the world today.
The FDA will likely initiate a pilot that would include several of the largest manufacturers, distributors, and transportation systems. California’s implementation dates for an e_Predigree presents a possible challenge, since California law is written to accept FDA regulations but may take effect before the FDA has finalized the rulings. Growth of globalization creates another set of challenges in the supply-chain management of the pharmaceutical industry, since the standards the FDA might develop could conflict with those packaging security systems already in place in other countries.