DSCSA outlines the identification and tracking of prescription drugs across the entire supply chain. These regulations apply to manufacturers, repackagers, third-party logistics (3PL) providers, wholesale distributors, and dispensers.
Expert 3PL support is essential for companies to comply with serialization of pharmaceutical products requirements. It helps them deliver products to patients efficiently.
Learn how ICS supports companies to meet strict serialization requirements:

DSCSA 3PL support



What is pharmaceutical serialization?

The DQSA requires pharmaceutical supply chain trading partners to implement interoperable systems and processes for pharma serialization. This involves the exchange and maintenance of transaction information for each change in ownership of a prescription pharmaceutical covered by the DSCSA. When the enhanced requirements from the DSCSA take full effect, this serialization in pharma must be exchanged in a secure, interoperable, electronic manner and must include the package-level serial number information.
Package-level serial number information starts by assigning a unique serial number to each unit of a prescription drug as part of pharmaceutical product serialization. Each unit is then aggregated into a unique serialized case, building the relationship for all children within a homogenous case. The combination of package identifier and serial number allows tracing of the product’s origin, batch number, and expiry date.

Key challenges of pharmaceutical product serialization
The benefits of serialization
Dealing with drug serialization challenges is complex. Drug companies operating globally must navigate varied regulations. Even so, the benefits for the industry are clear:
- Greater supply chain security
- Optimized patient safety
- Continuous regulatory compliance across borders
Logistics partners can help drug companies handle pharmaceutical serialization challenges. This allows them to meet the regulatory requirements and generate value beyond compliance.
Why ICS?
ICS offers specialized pharma serialization for small and emerging manufacturer launching their first drug all the way to larger manufacturers with a wide portfolio of products. We partner with manufacturers along their commercialization journey and support various products across all storage conditions The can include cell and gene therapies, branded or generic drugs, and biosimilars.
Customers choose us for these key reasons:
Commitment to excellence
Expert account management model
Integrated commercialization solutions
Partnership-driven approach
Proven, innovative solutions
Proven performance
Want to find out more about how to choose the right 3PL partner for your serialization and logistics needs? Take a look at our blogs.
Pharma serialization: FAQs
What does it mean to serialize a product?
Drug serialization gives a unique serial number to each prescription product unit and packaging level. Each prescription product package identifier and serial number provides details on its origin, batch number, and expiration date. This unique identifier can be used to track each unit through the supply chain, even when they are packaged in larger bundles and cases. This is done to minimize the risk of counterfeit drugs entering the supply chain.
What is the difference between serialization and track and trace?
Serialization involves assigning a unique identifier to each pharmaceutical product unit and package level. Track and trace is what enables trading partners to exchange transaction information at the package level when a change of ownership occurs.