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.
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 recent 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.
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.
Disclaimer
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.
Identifying Trading Partners Under the Drug Supply Chain Security Act | FDA
