Things to Think About When Implementing a Serialization Project
Serialization and track-and-trace concerns began with the Prescription Drug Marketing Act of 1987. Since then regulations have changed, been rewritten and reevaluated.
2017 is fast approaching. That’s when the California ePedigree laws go into enforcement. That’s when all pharmaceutical manufacturers and pharmacy warehouses will be required to have programs in place to enable the tracking of drugs throughout their supply chain. California ePedigree Law (SB 1307 (Ridley-Thomas, Chapter 713, Statutes of 2008) mandates the following deadlines:
- 50 percent of a manufacturer’s products by 2015;
- The remaining 50 percent of the manufacturer’s products by 2016;
- Wholesalers and repackagers must accept and forward products with the e-pedigree by July 1, 2016; and
- Pharmacy and pharmacy warehouses must accept and pass epedigrees by July 1, 2017.
There are exceptions, for example radioactive drugs, but for the vast majority of the USA drug supply, serialization is fast becoming reality as the answer to the problem of theft and counterfeiting. Industry studies in the State of California, the state that is leading this movement, that 3.4 billion prescriptions were dispensed in the US in 2006. And one percent of this supply is counterfeit, which would mean that close to 34 million of these US prescriptions were filled with counterfeit medicine. In California, with roughly nine percent of the US prescription drug market, this would indicate that three million prescriptions were filled and dispensed with counterfeit medicine in 2006.
To comply with the new ePedigree law, manufacturers will have to invest in the systems, equipment and processes to ensure that their drugs are serialized at each level of packaging. It will be a significant investment regardless of size.
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