DSCSA Aggregation 2023 Compliance and Implementation

Learn about the requirements

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.

DSCSA AGGREGATION TIMELINE

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.

Implementation in the Pharma Industry

Some of the biggest pharma companies already fully implemented aggregation at the same time as serialization, since they knew it would be worth the effort, i.e., improved inventory, rework, and recall process management, among others.

Manufacturers who had only implemented serialization in order to quickly comply with the statutory serialization requirements now need to carefully plan the implementation of aggregation in their facilities. Although the process may be one you are not looking forward to, it is important to keep in mind that aggregation presents numerous long-term benefits.

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.

FAQ

What does DSCSA stand for?

DSCSA stands for Drug Supply Chain Security Act.

What is the purpose of the DSCSA?

The DSCSA outlines requirements for manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers (trading partners). The DSCSA is intended to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

The requirements, the development of standards and the system for product tracing have been in place since 2015 and are to be continued until 2023.

What are the DSCSA requirements and timeline? 

  • January 1st, 2015
    • Lot Traceability: All pharmaceutical manufacturers are required to print lot numbers on packaging for all prescription drugs.
    • For: Manufacturers, Repackagers, Distributors, Dispensers
  • November 27, 2018
    • Serialization: All pharmaceutical manufacturers and repackagers are required to include unique serial numbers and expiration dates on prescription drug packaging.
    • For: Manufacturers, Repackagers
  • November 27, 2019
    • Serial Verification: All pharmaceutical wholesale distributors must verify the product identifier upon receipt of a returned product that the wholesale distributor intends to further distribute.
    • For: Distributors
  • November 27, 2020
    • Serial VerificationAll pharmaceutical dispensers are required to authenticate and verify all the medicines they buy before selling them to consumers.
    • For: Dispensers
  • November 27, 2023
    • Interoperability: The entire supply chain must be DSCSA compliant. Complete unit-level traceability, including aggregation, will be mandatory.
    • For: Manufacturers, Repackagers, Distributors, Dispensers

Which products are covered and not covered in the DSCSA? 

  • Covered: Prescription drugs in finished dosage form for administration to a patient without further manufacturing (such as capsules, tablets, lyophilized products before reconstitution, etc.)
  • NOT covered: Blood or blood components intended for transfusion (such as radioactive drugs or biologics, imaging drugs, certain IV products, medical gas, homeopathic drugs, lawfully compounded drugs, etc.)

What are the exemptions in the DSCSA? 

Intracompany distributions – Distribution among hospitals under common control – Public health emergencies – Dispensed pursuant to a prescription – Product sample distribution – Blood and blood components for transfusion – Minimal quantities by a licensed pharmacy to a licensed practitioner – Certain activities by charitable organizations – Distributions pursuant to a merger or sale – Certain combination products – Certain medical kits – Certain IV products – Medical gas distribution – Approved animal drugs

What are the advantages of DSCSA compliance?

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.

What are the penalties of not complying with DSCSA regulations?

Not complying with the DSCSA can lead to fines, suspension or revocation of license, and even civil penalties or imprisonment.

HOW GALDERMA PLANS ON GOING BEYOND COMPLIANCE

Discover how Galderma gained higher productivity and plans on going beyond compliance, after successfully implementing aggregation and serialisation.

Read the case study

How OPTEL full-stack aggregation solutions can help

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