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What Now?

With the recent FDA announcement regarding a one-year delay in enforcement of the compliance policy for ‘Product Identified Requirements Under the Drug Supply Chain Security Act’ (DSCSA), many are left asking what this actually means for the wider pharmaceutical industry or their company’s initiatives. While the FDA communication specifically indicates a delay in enforcement, it is clear there is no delay of the law itself – a telling signal to the industry that this serialisation challenge is real.

Within the industry, much speculation and scepticism exists regarding what will happen in November 2017. Given the history of deadlines coming and going in California for most of a decade, followed by a national mandate passed by the US Congress (albeit watered down), many in the industry were left dubious that the government could realistically enforce the deadline. Furthermore, regulations and administration in Europe, Brazil and China have been walked back, morphed or changed over the past 12-18 months, adding to the industry’s doubts.

Over the past three to six months, the drumbeat of industry representatives appealing to the FDA for delayed enforcement has steadily increased. Despite best efforts, the industry as a whole is not prepared, and will not be so, for November of this year. While many leading pharma companies have actively progressed their serialisation initiatives, a large portion dragged their heels in a wait-and-see approach to enforcement. Equipment suppliers, third-party electronic product code information services providers, consultants and contract manufacturing organisations have raised concerns over the anticipated skyrocketing demand on resources as we approach the deadline. Since the beginning of 2017, those concerns have been fully realised. The industry simply does not have the collective resources to enable every pharma company to comply. Fortunately, the FDA listened to their concerns and acted accordingly. The industry has been given a reprieve – some breathing room – to get through the collective implementation. In the scope of work required for serialisation implementation, an additional 12 months is not a lot of time. It would be a very poor decision for any company to delay their current activity with the thought that the goal line has moved significantly.

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Justin Schroeder is Senior Executive Director of Global Marketing and Design at PCI Pharma Services. He is responsible for global marketing, creative package design and new account development, with a focus on the development and commercialisation of new products. Justin has over 20 years of experience in outsourced pharma services in various roles, including engineering, project management, marketing and development. He holds a Bachelor of Science from the School of Packaging at Michigan State University, US, and an MBA in marketing from Northern Illinois University, US. Justin is a certified Packaging Professional from the Institute of Packaging Professionals, US, and is the Vice Chairman of the US Healthcare Compliance Packaging Council. 
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Justin Schroeder
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