How to Fight Pharmaceutical Counterfeiting
Due to globalization and production outsourcing, the supply chain of pharmaceutical products includes many different steps between the producer and the end-consumer. In most cases, pharmaceutical companies opt for a combined strategy, depending on the individual counterfeiting risk, budget and technical abilities. Several layers of security can be created by combining tamperevident, serialization and authentication technologies to form a multi-layer approach for the best possible patient protection.
Recently, international organizations such as the World Health Organization (WHO) have worked alongside governments and producers, largely through their International Medical Products Anti-Counterfeiting Taskforce (IMPACT), to help curb this damaging practice. Future initiatives to combat counterfeiters will also rely heavily on manufacturers. International guidelines and regulations have been developed, but regional and local regulations still vary considerably and in parts they are contradictive.
EU serialization is due to be introduced in 2014, followed by the longawaited Food and Drug Administration (FDA)/California serialization standard, expected to be launched in 2015. The main goal of these regulations is to harmonize the coding of pharmaceutical products on an international level.
International Guidance and Legislation
The FDA’s final guidance for the standardized numerical identification of prescription drug packages recommends the introduction of a serialized National Drug Code (sNDC) at package level. This code is composed of two distinct codes: the National Drug Code (NDC) contains labeler, product and packaging code. The unique serial number is composed of a maximum of twenty characters. The implementation of California’s ePedigree for full traceability is now due to take place on a staggered basis from January 2015 to July 2017. Most of the guidance and regulations concentrate mainly on serialization to make pharmaceuticals traceable throughout the supply chain.