US FDA bid to strengthen drug supply chain

A secure interoperable track and trace solution

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The new system will make it possible to accurately identify the items in the supply chain and detect fake products easily.

27 November 2023 is the US Food and Drug Administration’s (FDA) deadline for compliance with the Drug Supply Chain Security Act (DSCSA), which aims to protect products and patients. The act aims to enhance the ability to help and protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful as well as to improve the detection and removal of potentially dangerous drugs from the drug supply chain.

All the pharmaceutical stakeholders, both manufacturers and trading partners (re-packagers, distributors, wholesalers, and dispensers), will be required to have a secure interoperable track and trace solution in place to build a complete interoperable electronic system for tracking and identifying prescription drugs on sale in the US.

The hierarchical aggregation will make it possible to accurately identify the items in the supply chain and to detect any counterfeited product more easily. The aggregation will also provide a higher level of security and visibility of products in the drug supply chain, facilitating the exchange of data with trading partners.

Among others, DSCSA’s goals are to implement interoperable, electronic tracing of products at the package level by 2023 that will enable secure tracing of a product at the package level; use product identifiers to verify products at the package level; enable prompt response to suspect and illegitimate products when found; and improve the efficiency of recalls.

The current situation – an overview

Serialization has been made mandatory by the FDA since 2017 and requires all players in the drug supply chain to adhere to the traceability requirements, serialize products, and verify the serial numbers. To verify the products at the package level within the entire supply chain, it is necessary to assign and authenticate the serial numbers on individual units and on their containers, starting from the manufacturers up to re-packagers, distributors, and dispensers. 

Manufacturers were required to serialize and verify products at the secondary packaging level (SKU). Both individual units and shippers contained serialization data without any parent relationship between them. When the manufacturer, wholesalers, or packager ships the products, it is required to transmit to trading partners the 3T documentation which includes the transaction history (TH), the transaction information (TI), and the transaction statement (TS). All the information included in the documentation does not provide the list of shipped serial numbers. 

The absence of hierarchical information between shippers and individual units is often the cause of long time for the operators to manage the simple warehouse re-working operations such as: shipments, partial shipments, re-packaging, and sampling.  

Since the code printed on the shipper label does not provide any information about the serial numbers of the individual units stored inside, for the trading partners that receive goods from the manufacturers, it is often hard to detect the position of every single individual unit because the products are packaged in a bigger shipper unit that is not linked with products inside it. 

The current situation involves many manual operations with consistent risks of human errors, and this is the main reason why the current situation will be changed in November 2023 with the introduction of modifications to enhance the current management of the supply chain. 

2023: enhanced drug distribution security

With the new requirements, wholesalers and dispensers are required to implement interoperable and electronic tracing of products at the package level, exchanging data (product tracing information, TI and TS) between themselves.  Additionally, if the distributors would like to resell a returned product, the manufacturer should be able to receive electronically a query to which respond promptly. 

This can happen using systems that are fully capable to trace and verify the distributed products across the pharmaceutical distribution supply chain.

What it is going to change

In detail, from 27 November 2023, the transaction information (TI) provided by the manufacturers will need to include the PI (product identifier) data at the package level, which will additionally contain the serial number and expiry date of each product. 

For manufacturers, this means that to continue to sell products in the supply chain, it will be necessary to implement an aggregation system, capable of associating the serial numbers of each product (cartons) with their upper packaging level (cases and pallets).  

Benefits of a traceability system

This will allow trading partners to easily communicate the serialization information to their final customer: the implementation of aggregation between containers and contents in fact will facilitate the operator procedure, which will be able with a single operation (e.g pallet’s label scanning) to access the list of all the serial numbers associated to cases and to the consequently associated unit-level serial numbers.

In another example of the many benefits that this system brings along, the re-packagers will not need to spend time reworking or scanning the saleable unit but will consider (scan) only the parent which will include the information of all the serial numbers inside it, saving time and reducing human error.

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