DSCSA Serialization Requirements: A Complete Guide to Pharmaceutical Serialization Compliance

The Drug Supply Chain Security Act (DSCSA) requires drug manufacturers and repackagers to implement serialization. Serialization assigns a unique identifier to each drug package. This system helps track prescription drugs, prevent counterfeit products, and improve supply chain security. The 2023 revision of the DSCSA introduces new requirements for compliance. This guide explains DSCSA serialization requirements, pharmaceutical serialization regulations, and steps to achieve compliance.

What is the DSCSA?
The DSCSA is a U.S. law passed in 2013. It aims to secure the pharmaceutical supply chain and prevent counterfeit drugs from reaching patients. The law applies to manufacturers, repackagers, distributors, and dispensers. The 2023 update adds stricter rules for traceability and data sharing.

Key DSCSA Serialization Requirements for 2023:

1. Product Serialization:
   • Serialization means assigning a unique identifier to each drug package.
   • The identifier includes a 2D barcode called a Data Matrix. This barcode contains product details like the National Drug Code (NDC), serial number, lot number, and expiration date.
2. Data Exchange:
   • Companies in the supply chain must share compliance documentation. This includes transaction history, transaction information, and transaction statements.
   • Serialization data must be stored for at least six years. This ensures traceability if issues arise.
3. Verification Systems:
   • Companies must verify the accuracy of serialization data. This involves checking the unique identifier and other product details.
   • Systems must identify and handle suspect products. Suspect products may be counterfeit, stolen, or otherwise compromised.

Pharmaceutical Serialization Regulations and Compliance:
Pharmaceutical serialization regulations require companies to implement systems for tracking and tracing drug products. Compliance involves:

• Understanding Serialization Requirements: Each drug package must have a unique identifier and 2D barcode.
• Upgrading Hardware and Software: Ensure labeling hardware supports 2D barcodes and software can process serialization data.
• Data Management: Store and share serialization data with supply chain partners.

Steps to Achieve Pharmaceutical Serialization Compliance:

1. Assess Current Systems:
   • Check if your labeling hardware supports serialization. This includes printers and scanners for 2D barcodes.
   • Ensure your software can process serialization data. This includes capturing, storing, and sharing the data.
2. Choose a Serialization Solution:
   • Select a system compatible with your supply chain partners. This ensures smooth data exchange.
   • Ensure the solution can handle your production speed and packaging types. For example, some systems work better with high-speed production lines.
3. Implement and Test:
   • Install the serialization hardware and software. This may involve retrofitting existing equipment.
   • Test the system to ensure accurate data capture and sharing. This includes verifying barcode readability and data accuracy.

HICOF Serialization Solutions:
HICOF provides hardware and software for pharmaceutical serialization. Their solutions include:

• HECTOR: A retrofit system for upgrading existing production lines. It includes a camera and printer for applying 2D barcodes.
• Cloud-Based Software: Enables easy data sharing across the supply chain. The software stores serialization data in the cloud for quick access.
• Custom Interfaces: Allows users to create interfaces for specific needs. This ensures the system works with existing production line software.

HICOF’s systems work with various production speeds and packaging types. They offer a single solution for serialization, reducing complexity for manufacturers.

Conclusion:
The 2023 DSCSA revision requires drug manufacturers to adopt serialization systems. Companies must assess their current setup, choose a compatible solution, and implement it effectively. HICOF offers tools to simplify this process and ensure compliance.

Call-to-Action:
Learn more about HICOF’s serialization solutions. Contact us for a detailed consultation on meeting DSCSA requirements.