United States

United States' Track and Trace Regulations Overview

The full complement of US requirements phases in between 2015 and 2023, with challenges for all supply chain companies at different points along the way.

With the 2015 Drug Supply Chain Security Act (DSCSA) lot-level traceability deadline behind us, pharmaceutical companies have turned their attention to full drug serialization. DSCSA requires that manufacturers mark packages with a product identifier, serial number, lot number, and expiration date by November 2017. Given everything that needs to happen by then, from altering highly regulated packaging and distribution processes to addressing enterprise-wide IT, pharma companies should be well on their way to readiness. At the same time, wholesale distributors and other supply chain companies will perform end-to-end serialization testing with their manufacturing partners in advance of the deadline to allow time for any necessary adjustments.

Product Tracing, Verification and Serialization Highlights

Product Tracing – By January 2015 pharmaceutical companies and wholesale distributors needed to achieve lot-based traceability, which involves sharing a Transaction History with every partner to whom you sell product. For many companies, establishing the necessary infrastructure for communication with partners at the level you need for regulatory compliance was the biggest challenge. In addition, the law does not prescribe standard formats for data exchange, so companies need to be equipped to receive transaction data in many configurations. 

By July 2015, dispensers needed to be able to receive and archive T3 information, and be prepared to produce it in the event of an inquiry.

When serialization comes into play, product tracking will still be required but the nature of the requirement changes. Track and trace and serialization requirements will finally converge in 2023. 

Verification –In the event of a suspect product inquiry, supply chain companies must be able to produce the relevant transaction documentation within twenty-four hours (dispensers have forty-eight). The challenge is in being able to locate and access the necessary records in this tight turnaround time. Businesses need a storage and retrieval mechanism that supports these queries. 

Serialization – During lot level preparation, the industry discovered that completing one transaction between two parties was challenging. When serialization with its end-to-end tracing takes effect, businesses will need to manage many transactions, involving billions of items, with tens to hundreds of partners, including outsourcing ones. So there is the supply chain communication challenge but there is also a data volume challenge as businesses generate, process, and store an unprecedented amount of data and transactions. In the US the smallest saleable unit and the sealed homogenous case need to be serialized. By law, aggregation is not required but there is speculation that it will be required at some future point.

Manufacturers must serialize by November 2017. The rest of the supply chain has more time before they need to make full use of the serial numbers, but there will be circumstances prior to that in which they need to interact with the serial number, like for product returns and suspect product investigations. 

How TraceLink Can Help

TraceLink is the World's Largest Track and Trace Network for connecting the life sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace.  We have worked with more than 500 customers, from all segments of the supply chain, on their compliance strategies. That deep, collective experience informs our approach in every conversation. 

The TraceLink Life Sciences Cloud, where we have more than 247,000 supply chain members, has commissioned more than 150 million serial numbers in 2016 alone and processed 184 million Transaction Histories overall.  The network enables you to interoperate with all of the businesses on it, seamlessly exchanging data and collaborating on key business processes. We accept any data type and translate into a canonical format, neutralizing one of the key challenges of DSCSA. We also have mechanisms in place to manage exception handling, which is quickly proving to be a significant challenge in the compliance landscape. And as your serialization production, events, and archiving needs grow, our Life Sciences Cloud scales with you, eliminating the need to worry about storage and computer processing capacity.  

The TraceLink platform meets your US compliance needs. If you operate internationally, it can help you manage your regulatory requirements in all of your markets, allowing you to focus on one global track and trace solution.  



US at a Glance

Government agency FDA 
Regulatory scope Tracing; verification; serialization
Product scope Most pharmaceuticals
Participants Manufacturers, wholesalers, repackagers, dispensers
Next deadline 11/2017 - 1st serialization deadline for manufacturers;
11/2018 - 1st deadline for repackagers;
11/2019 - 1st serialization deadline for distributors
Serial # format GS1 standard