The US FDA Drug Supply Chain Security Act (DSCSA) is progressing towards establishing requirements for manufacturers and trading partners to have full interoperable electronic track and trace systems in place by November 2023.
The goal is to improve traceability of drugs by creating a consistent and efficient process for verifying and protecting the legitimacy of drug products at the unit level, as they move throughout the U.S. pharmaceutical supply chain.
Preparing for 2023 DSCSA deadline
Serialization has been made mandatory by the FDA which requires all players in the secure drug supply chain to adhere to the traceability requirements. Which means that Manufacturers, re-packagers, distributors, and dispensers must generate, authenticate, and verify the serial numbers for all products in the supply chain.
The Standardized Numeric Identifiers (SNI) for the serial numbers must be generated as per the FDA directive
SNIs consist of the 20-character NDC (National Drug Code) and serial number.
Apart from SNIs, batch/lot number, Global Trade Item Number (GTIN), and expiration date are also required.
The smallest saleable unit needs to be packaged with a 2D Barcode Matrix with human-readable text.
Aggregation is the process of building a relationship between unique identifiers assigned to packaging containers. Shipping cases also require an SNI with a Serial Shipping Container Code (SSCC).
Aggregation requires to reflect the hierarchy of packaging a serialized product into a carton which goes into a case and ultimately into a pallet. This is a significant lift and leads to throughput delays and inaccuracies if not performed correctly.
VRS (Verification Router Service)
To prevent counterfeiting of saleable returns, wholesalers need to ensure that saleable returns are verified before being introduced to the supply chain again and has an interoperable system that provides interoperable data exchange. This is achieved by initiating a verification request by the wholesaler to the manufacturer to verify the returned products and the manufacturer must provide a response within 24 hours. The verification router service enables real time exchange of this information between the parties.
This includes the Product Information, the following four items are part of the Product Information
NDC: [insert product’s NDC]
SERIAL: [insert product’s serial number]
LOT: [insert product’s lot number]
EXP: [insert product’s expiration date]
The DSCSA will continue to use The Electronic Product Code Information Services (EPCIS) standard for exchanges.
So, to summarize, the transactional information including the Product Information should contain.
The name of the product
Dosage and strength of the product
NDC (National Drug Code)
Date of transaction
Date of Shipment
Date of Expiry
- Number of containers
Complete outline of all the transactions the product has gone through in its journey right from the manufacturer to the dispenser which summarizes the product's entire supply chain journey and has the required transaction information.
These statements identify if the seller:
Is registered & authorized
Has received the product from a registered and authorized party
Did not purposefully change the transaction history
Did not purposefully ship any ineligible, counterfeit, or suspicious product
Has acknowledged the transaction statement and information from the previous seller in the supply chain.
US DSCSA Standards for Trading Partners & Interoperable Exchange of Information
Starting November 27, 2023, electronic-based approaches will be generally required to be used among all trading partners to meet the enhanced drug distribution security requirements of the US DSCSA act. Trading partners will be required to use secure, interoperable, electronic approaches for all the following activities:
- To exchange transaction information that includes package level product identifiers for each package included in transactions and transaction statements
- To verify products at the package level
- To respond with the transaction information and transaction statement for a product in the event of a recall or for investigations.
- To facilitate the gathering of transaction information for a product going back to the manufacturer in the event of a recall or for investigations
- To accept saleable returns under appropriate conditions
FDA believes that interoperability, for purposes of the initial standards for the exchange of tracing information encompasses the ability to exchange transaction history, transaction information, and transaction statements accurately, efficiently, and consistently among trading partners. Also, it will help the subsequent purchaser’s system, process, or practice to successfully capture and maintain the transaction history, transaction information, and transaction statements, regardless of whether they are provided in a paper or electronic format.
However, in the last update published by FDA in July 2022, the standards have been updated to include that from November 27, 2023, onward paper-based tracing of medicines will no longer be permitted and the verification of product at the package level will be required, unless a "waiver, exception, or exemption" applies. This differs from the standards published before where the wholesale distributors, dispensers, and re-packagers were allowed to use either paper-based or electronic-based methods to provide transaction history, transaction information, and transaction statements to subsequent purchasing trading partners as long as the selected method allows the information to be exchanged in a manner that complies with the requirements of the US DSCSA act.
It has also been recommended for trading partners to use the Electronic Product Code Information Services (EPCIS) standard to provide and maintain the data associated with transaction information and transaction statements. As EPCIS is a global GS1 standard that allows trading partners to capture and share information about products as they are transacted through the supply chain. Use of EPCIS can support and enable electronic and interoperable interfaces used by trading partners to help ensure compliance with the DSCSA requirements and is compatible with a range of different technological approaches. An updated implementation guideline to apply the lightweight messaging standard DSCSA verification has also been published earlier this month.
FDA has published another update related to the guidance for trading partners to reflect the agency's current thinking on the status of certain entities such as private label distributors, salvagers, and returns processors and reverse logistics providers. This guidance also covers some specific drug distribution scenarios, including distribution for emergency medical use, office use, non-human research purposes, and research in humans under an investigational new drug application.
How can CosmoTrace Help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations and recent standards for various markets and can help you with implementing the serialization project to meet the November 2023 DSCSA deadline.
Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity.
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, partners and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions.
Please use the references below to follow the updates at the source.
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription (fda.gov)
Identifying Trading Partners Under the Drug Supply Chain Security Act | FDA