State Of Serialization: Where FDA & The Pharma Industry Currently Stand

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Serialization in the pharmaceutical sector is a direct response to the problems of counterfeit, stolen, and gray-market drugs. There’s been a huge incentive for counterfeiters to duplicate high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the black market for counterfeit drugs is about $75 billion annually. A bigger issue for consumers, however, is that falsely labeled medicines can have a direct impact on life and health. And for pharmaceutical manufacturers, the reputation of their brand and even company name can be severely tarnished. When we think of counterfeiting, typically we just think about falsely labeling drugs, but there is also a big problem with theft of drugs and hijacking — both breaking into warehouses and the hijacking of trucks. According to the World Health Organization (WHO), these factors are costing the global pharmaceutical industry about $40 billion a year.
To combat theses various issues, the FDA announced the Drug Supply Chain Security Act (DSCSA) in 2013. Essentially, the DSCSA requires the industry to institute electronic, interoperable systems that enable them to identify and trace prescription drugs distributed into the United States. To properly implement and be effective, this requires a series of activities, involving not just pharmaceutical manufacturers but also distributors, shipping companies, and the entire supply chain. This is not a one-time event, but an ongoing process that will be established over the next 10 years.
Initially, the critical point was November 27 of this year, as the DSCSA required pharmaceutical manufacturers to begin marking their salable units and homogeneous cases of prescription drugs with a serial identification code or product identifier by that date. Now, this is deadline has been extended one year, as several recent studies revealed that a significant percentage of the pharma industry is still not ready for the requirements, especially virtual and small to midsize companies.
Simply put, the industry didn’t properly anticipate how difficult this….
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Six Myths About Serialization

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