3PL pharma serialization services

Counterfeit and substandard drugs threaten public health worldwide. Many countries, including the U.S., have pharma serialization regulations. The U.S. Drug Quality and Security Act (DQSA) and the associated Drug Supply Chain Security Act (DSCSA), for example, were signed in 2013 to prevent counterfeit drugs.

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

DSCSA 3PL support

DSCSA 3PL support
The DQSA and the DSCSA brought regulatory mandates affecting drug companies. Pharmaceutical product serialization poses challenges for the industry regarding scalability, technology, and operations. Manufacturers must work with an experienced 3PL partner to support serialization efforts now and in the future.
DSCSA 3PL support
What is pharmaceutical serialization?

What is pharmaceutical serialization?

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.

What is pharmaceutical serialization?

Key challenges of pharmaceutical product serialization

Serialization in pharma presents challenges for companies seeking to follow regulations: 
Cost
Investment is needed for infrastructure and systems to support new pharmaceutical serialization requirements efficiently. 
Labelling requirements
Companies must redesign labels for all packaging levels to include the new 2D barcodes. This process may take time. 
Production efficiency implications 
Pharmaceutical serialization impacts many packaging processes. Labeling and scanning units, aggregating to cases and pallets may slow the production line, reducing output. 
Data management issues
Companies need data systems to manage serial numbers and aggregation efficiently and pass this data to their supply chain trading partners.
Team training
Team members across the supply chain must upskill for the new serialization complexity. They also need to manage additional pharma serialization data effectively.

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

We pursue it relentlessly and follow the highest quality standards. We always strive to improve to provide the best service.

Expert account management model

We act as a single point of access to strategic program design, better 3PL, and performance analytics for your supply chain.

Integrated commercialization solutions

Through us, you have access to solutions from across Cencora. They provide support for each step of the product and patient journey.

Partnership-driven approach

We manage client relationships with a partnership philosophy. We provide flexibility and a solutions-focused mindset. These ensure excellence throughout your product’s journey.

Proven, innovative solutions

We start with a consultative approach. We tailor your logistics strategy to your business goals and patients’ needs.

Proven performance

Our logistics expertise and patient-centric culture provide superior supply chain performance.

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Insight

White paper: Navigating new U.S. serialization requirements for pharmaceutical logistics success


ICS Connect
April 2023



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. 

Can your 3PL partner grow with you? 

Read on to learn the five questions you need to ask potential 3PL partners to see if they can scale their serialization and logistics support as you grow. 

Making a case for Title Model

Find out how ICS can change the way your supply chain and pharma serialization processes operate for the better, through our Title Model. 

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Looking for third-party logistics solutions that help you follow pharmaceutical serialization requirements? Contact us to learn more.
Learn more about pharma serialization


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.