Requirements and Challenges of Aggregation in the United States

The production of counterfeit and fraudulent products is an extremely lucrative business, especially where medication is concerned. The black market for prescription medication has become a global threat and continues to flood hospitals and pharmacies throughout the world, putting put many patients’ lives at risk.

For more than a decade, counterfeiters have built strong networks and taken advantage of a pharmaceutical industry in dire need of regulations and protection. To fight back, most governments across the globe are taking the necessary steps to implement serious regulations and new legislations that will protect their countries, the different actors of the pharmaceutical supply chain, and first and foremost, the patients.

LEGISLATION

In the United States, the Drug Supply Chain Security Act (DSCSA) will make item-level serialization mandatory beginning in November 2018. Thanks to this new legislation, more and more companies are starting to see the value and potential return on investment of serialization and compliance.

Although aggregation is only expected to become mandatory and fully applied in 2023, according to the U.S. FDA (Food and Drug Administration), it is more realistic to say that most manufacturers, along with the top pharmaceutical companies, will either be ready by 2018/2019 at most, or have already implemented an interoperable Track&Trace system along with their serialization. This global transparency will prevent counterfeit and fraudulent products from entering the improved healthcare supply chain, therefore ensuring the safety of patients worldwide and creating trust in the pharmaceutical industry.

CHALLENGES

While aggregation is the key to patient safety and therefore a secure pharma industry, this process comes with new challenges. Aggregation adds steps to the packaging process, potentially reducing the current productivity rate, and it obviously comes with a cost. It is therefore essential to integrate a solution that is adapted and tailored-made, as much as possible, to your needs and production processes to minimize these impacts.

SOLUTION

OPTEL offers low-cost solutions that help manufacturers and CMOs seamlessly integrate serialization and aggregation that will follow the legislation, while providing tailor-made and efficient business solutions.

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