First introduced in 2013 under The Drug Supply Chain Security Act (DSCSA), serialization aims to enable more effective traceability of drug products.
With the rise in counterfeit medications and the detrimental impact they can have on patient’s health well-documented, the U.S. Food and Drug Administration (FDA) has announced it will establish an enhanced version of the serialization system currently in place.
The new requirements outline that prescription drug products must be serialized with a unique product identifier (UPI) and all trading partners in the supply chain must verify the prescription drugs they receive and maintain records of this. Additionally, manufacturers, wholesale distributors, and dispensers must alert the FDA and their trading partners within 24 hours if they discover that a product they have received or distributed is suspect or illegitimate.
Supply chain complexities
Title II of the FDA’s Drug Quality and Security Act (DQSA), launching on 27 November 2023, aims to securely trace products at the package level, use unique product identifiers (UPIs) to verify products at the package level and enable prompt response to suspect and illegitimate products.
Pharma supply chains are complex. There are a number of hurdles companies are faced with in how drugs are developed, manufactured and delivered to patients.
There are also a number of external factors affecting supply chains, such as environmental, political and geopolitical that have prompted industry conversations about supply chain resilience.
Though the FDA’s new serialization requirements aim to prevent counterfeit drugs from entering the market and enhance patient safety, they have a significant impact on the pharma and biotech supply chain.
With manufacturers preparing to meet new serialization requirements later this year, modification of their production lines may be needed to integrate new equipment and processes. This can disrupt production schedules and require additional investment. These costs may include equipment upgrades, software development and training for employees.
The new regulations will also mean manufacturers have to handle vast amounts of data generated from serialization. Therefore they will require secure data management systems and infrastructure to ensure accuracy, security, and accessibility. These data management systems are also important in terms of the quality control tracking of UPIs.
In the case where there are any errors or discrepancies in UPIs and the database housing them, there may be product recalls, which can tarnish a brand’s reputation and result in financial losses.
The impact on stakeholders
It is not just manufacturers that will be affected by the new serialization requirements but also third-party logistics (3PL) providers, wholesalers and dispensers.
For 3PLs, the new requirements require them to verify the authenticity of received serialized products, including checking the UPI and transaction history of every product, which is a significant operational challenge.
Furthermore, they must comply with regulatory requirements for handling, storing, transporting, and ensuring that their process and controls maintain the integrity of the UPI. This all requires additional processes and systems to be put in place, which can be complex and may require additional staff training.
For wholesalers and dispensers responsible for verifying the authenticity of the products they receive, becoming DSCSA compliant may require these teams to bring in staff to undertake infrastructure upgrades and maintain the integrity of UPIs. The main benefit of this is that it can increase patient safety as it reduces the risk of errors and discrepancies and improves the identification and tracking of products.
It is patients, however, that are the main beneficiaries of the serialization system as enhanced traceability through the supply chain helps to ensure that patients receive legitimate pharmaceutical products, while building trust between healthcare providers and patients.
While there are multiple technologies on the market for serialization compliance, it is vital that companies consider the specific needs of a company and product, as well as the regulatory requirements of the market.
3PLs can support manufacturers effectively as trading partners as long they invest in new software, hardware, and methodologies for serialization.
ICS is one 3PL provider that offers pharmaceutical manufacturers customized healthcare logistics solutions to increase supply chain security. The company’s system architecture has been compliant with DSCSA in advance of the requirements.
ICS offers secure and interoperable data records; managing all data required for 3PL DSCSA obligations, tracking and transmitting data at the package level, and its system is integrated with the majority of data serialization providers used by its clients and their customers.
To meet these various needs, ICS offers logistics solutions to streamline logistics processes and improve speed to market – offering both traditional 3PL distribution and title model distribution.
The path ahead
With the enhanced serialization system to be launched later this year, the FDA aims to combat the rise in counterfeit, stolen and contaminated prescription drugs from entering the domestic market.
Manufacturers that implement the right supply chain solution can boost supply chain efficiency, maximize return on investments and enhance patient care.
To find out how to meet the latest US serialization requirements download the whitepaper below.