November 27th, 2023, it is the FDA’s deadline for compliance with the Drug Supply Chain Security Act (DSCSA). The Drug Supply Chain Security Act (DSCSA), aims to protect the product and the patient by meanings of the following:
- Enhance the ability to help and protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful
- Improve 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. Aggregation will also provide a higher level of security and visibility of products into the drug supply chain, facilitating the exchange of data with trading partners.
The current situation – an overview
Serialization is mandatory by the FDA since 2017 and requires all players in the drug supply chain to adhere to the traceability requirements, serializing products and verifying the serial numbers. To verify the products at 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 cause of long times for the operators to manage the simple warehouse re-working operations such as: shipments, partial shipments, re-packaging, 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 each single individual unit because the products are packaged in a bigger shipper unit that is not linked with the products inside it.
The whole 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 established by DSCSA, 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 November 27, 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 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 to associate the serial numbers of each product (cartons) with their upper packaging level (cases and pallets).
Benefits of implementing a traceability system that meets the requirements
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.
To make another example of the many benefits that this system brings along, the re-packagers will not need to spend time in reworking or scanning the saleable unit but will consider (scan) only the parent which will include the information of all the serials numbers inside it, saving time and reducing human error.
How to be prepared for US DSCSA
The physical aggregation relationship between “parent” shippers, and the secondary packages “or children” stored inside them, and it is typically set in an electronic system during the product packaging and distribution activities.
To build such an interoperable system capable to serialize, aggregate, and transmit electronical documentation, manufacturers must be prepared to exchange data with different organizations, each with its own system and data formats.
The minimum requirements to be ready can be summarized as follows:
- Setup of a complete all-in-one solution that assigns serial numbers to each product from individual units (cartons, bottles, vials, etc.) to upper levels (shippers/ pallets) and linked them together in a hierarchical relationship
- Setup a software able to implement a reliable process and product transaction history
- Be able to handle various export file formats such as CSV, XML that complies with GS1 standards (e.g. EPCIS 1.2).
- Be able to handle various data exchange protocols such as SFTP
- Setup an interoperable tracing system software able to exchange 3T documentation
Be ready in time
November 2023 may seem far away, but to arrive on time, it is now the moment to start considering this list below and be compliant asap with the regulation.
Recently in fact, as reported by Regulatory Focus, FDA Official said that DSCSA 2023 Interoperability deadline will not change and that they will not extend the November deadline for interoperability.
A flexible yet robust serialization & aggregation software is the key point of an intelligent supply chain solution.
The skills and experience of SEA Vision in cutting-edge track&trace software architecture enable manufacturers to be ready in time for the final DSCSA deadline of 27th, November 2023.
