United States DSCSA Aggregation requirements and implementation

Legislation

In the United States, the Drug Supply Chain Security Act (DSCSA) made item-level serialization mandatory in November 2018. Thanks to this 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 be ready well before the deadline, or have already implemented an interoperable track-and-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.

What is aggregation?

Aggregation is the association of uniquely serialized items to higher packaging levels, which also have a unique serial number. The serialized items inside a container are known as the “children,” and the serialized container containing these packs is called the “parent.” In a bundle of bottles or cartons, each unit has its own serial number, but the bundle itself has a top label including a unique serial number. In this case, the bottles or cartons are the children, and the bundle itself is the parent.

In short, aggregation is the process of creating a hierarchical relationship between unique identifiers assigned to packaging containers.

The Benefits

The aggregation process is meant to facilitate and benefit everyone involved in the supply chain, from the production of medications, all the way to the end consumer. First, the new requirements make it extremely easy to rework packages, meaning that all necessary and important information about the medications will be accessible when scanning the parent. This saves an enormous amount of time, as it will no longer be necessary to open each container to scan each individual child. Since all the data is easily accessible, tracking products throughout the supply chain becomes much easier, and the entire distribution system becomes more efficient, secure and trustworthy.

Two choices to implement aggregation

A Two-Phase Process:

Choosing this option entails the implementation of serialization only as a first step. This is quicker and costs less in the short-term, allowing manufacturers and other stakeholders to comply with the statutory serialization requirements. enforced by the FDA. However, as with any short-term fix, there are a few drawbacks to think about. First, investments will drastically increase if serialization and aggregation are implemented in two phases rather than one. Lines will have to be stopped twice to allow for the integration and validation of each phase, and while each new technology, knowledge and procedures are mastered. And secondly, this decision could lead to the loss of contracts since many healthcare manufacturers and distributors already require aggregation from their suppliers.

 

One-Time Implementation:

Should you choose to implement aggregation right away, it will take a little longer and the process will be more complex, but overall, it presents numerous advantages that will benefit your whole company. For example, you will only need to stop production once instead of twice; proceed with one change instead of two; and train employees only once. Therefore, in the long run, it’s more cost-effective. In addition, aggregation leads to improved inventory management, rework, and even recall management. In time, new processes will be learned and adjusted to fit the needs of each company and the knowledge and level of training of the employees will be sufficiently high to have fully functional lines implemented seamlessly into the workflow, while meeting the needs of the pharma industry, clients and suppliers alike.

OPTEL full-stack aggregation solutions

OPTEL’s full-stack serialization, aggregation and track-and-trace technologies can help your business comply with all current and future regulations while guiding you through each crucial step toward a more intelligent supply chain.

When you choose OPTEL as your aggregation partner, this is what you get:

  • Scalable solutions toward a more intelligent supply chain
  • Easily accessible and actionable granular data
  • Complete supply chain visibility and transparency
  • Lowest false-reject rate
  • Added value at every step of your supply chain, increasing operational efficiency
  • Data optimization of multiple manufacturing and distribution sites
  • Analytics reporting

 

OPTEL’s aggregation technologies and expertise help you:

  • Manage reconciliation and avoid downstream supply chain issues (bad codes, missing cartons, wrong cartons)
  • Increase operational efficiencies and identify shortfalls in your packaging system
  • More efficiently and effectively manage targeted recalls

Learn more about the requirements of Aggregation by reading our white paper:

Requirements and Challenges of Aggregation in the United States

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