The Drug Supply Chain Security Act (DSCSA), enacted in 2013, is a transformative law aimed at enhancing the traceability and security of prescription drugs in the United States. One of its core mandates is the creation and maintenance of comprehensive transaction records throughout the pharmaceutical supply chain. These transaction records, often called T3 data (Transaction Information, Transaction History, and Transaction Statement), are critical for tracing the movement of prescription drugs from the manufacturer to the end patient. As companies prepare for the final phase of DSCSA implementation, understanding the role of transaction records and how to maintain compliance is essential.
Transaction records are central to DSCSA compliance because they provide an auditable trail that enhances supply chain transparency and accountability. By documenting each transaction, from the sale or transfer of ownership of drugs to their receipt by authorized parties, these records help verify the legitimacy of products and their secure movement through each point in the supply chain. In addition to identifying a product’s origin and chain of custody, T3 records help prevent counterfeiting and provide rapid response capability if a product recall or investigation is required.
T3 Data under DSCSA is comprised of three main components:
- Transaction Information (TI): This includes details about the drug, such as the proprietary or established name, strength and dosage form, National Drug Code (NDC), and container size, as well as the lot number, transaction date, and shipment information.
- Transaction History (TH): This is an electronic or paper record that includes details of all prior transactions for the product.
- Transaction Statement (TS): This is a declaration by the seller confirming that they are authorized, that the product was handled in compliance with DSCSA, and that there is no reason to believe the product is suspect or counterfeit.
These records form a comprehensive digital trail for each product unit, making it easier for supply chain partners to authenticate the legitimacy of drugs and pinpoint problems in the event of quality issues, shortages, or potential counterfeiting.
Under DSCSA, all parties in the supply chain, from manufacturers to wholesalers and dispensers, share responsibilities for maintaining and sharing transaction records. Each entity must establish systems and processes to capture T3 data for each transaction and ensure that these records are stored securely and shared as needed with downstream partners.
Manufacturers, for instance, must capture and provide transaction records with each transfer of ownership. Wholesalers must verify and store T3 information as they receive, hold, and distribute products. Dispensers (such as pharmacies) are responsible for maintaining records on the products they receive and must be prepared to authenticate or quarantine a product if a quality issue arises.
Historically, transaction records were maintained in paper form, which posed significant challenges in terms of accuracy, efficiency, and retrieval. As DSCSA mandates full electronic interoperability, companies are turning to digital solutions and blockchain technology to enhance security and streamline the recording and sharing of T3 data. Electronic transaction records offer advantages, such as real-time data access and faster reporting, which are critical for recall situations or audits. Blockchain adds an extra layer of security, with its immutable records offering an ideal format for secure and transparent data-sharing across a distributed network.
For many companies, implementing an interoperable digital system for DSCSA compliance requires an overhaul of existing records systems and integration with upstream and downstream partners. Companies are finding solutions in cloud-based platforms, blockchain systems, and electronic data interchange (EDI) systems to facilitate T3 data exchanges and meet compliance requirements. Many solutions also integrate with tracking and monitoring tools, allowing companies to monitor product movement and instantly retrieve T3 data as needed.
Challenges in Managing DSCSA Transaction Records
While the DSCSA promotes a safer and more transparent supply chain, maintaining and managing transaction records is not without challenges. Companies must ensure data accuracy and integrity at every transfer, preventing data inconsistencies that could complicate traceability. The integration of electronic systems can also be resource-intensive, requiring training, technical support, and collaboration across multiple stakeholders in the supply chain.
Another concern is the interoperability of digital solutions across different entities, as some may adopt different software solutions or standards for data exchange. Ensuring that T3 data is readable and usable across systems requires careful planning and sometimes additional support from third-party integration partners.
For pharmaceutical companies navigating the complexities of DSCSA compliance, partnering with a quality and compliance expert like EMMA International can simplify the process. EMMA International offers support for companies in establishing compliant transaction record systems and integrating digital solutions to streamline T3 data collection and sharing. By helping companies adopt secure data management practices, implement digital systems, and prepare for audits, EMMA International enables companies to maintain DSCSA compliance effectively. Are you ready to learn more? Call us at 248-987-4497 or email info@emmainternational.com today!
FDA (July 2024) Drug Supply Chain Security Act (DSCSA) retrieved from: https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
