At-a-glance updates to the DSCSA: Enhancing the Security of the Drug Supply Chain
DeSpir provides high-quality, safe transportation to ensure the efficacy of medical products for our customers, and most importantly the patients.
We have created a short summary for those that want a quick update. For the full document click here.
The Drug Supply Chain Security Act (DSCSA), a significant piece of legislation aimed at ensuring the integrity and safety of the pharmaceutical supply chain in the United States, has recently undergone substantial updates. Enacted in 2013, the DSCSA established a framework for tracing prescription medications as they move through the supply chain to enhance the Food and Drug Administration’s (FDA) ability to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
Key points and updates include the following:
– Enhanced Drug Distribution Security (EDDS): This requires an electronic, interoperable system for tracking prescription drugs at the package level, mandating robust product tracing systems.
– Serialization: This process assigns a unique product identifier to each package and case of drugs, ensuring they can be uniquely identified and tracked throughout the supply chain.
– Electronic Interoperability by November 2023: Aims to replace paper-based systems with secure and efficient digital systems, enhancing traceability accuracy and speed while reducing errors and fraud.
– Enhanced Verification Requirements: This regulation mandates the verification of product identifiers before returning drugs to the supply chain and calls for prompt investigation of suspected illegitimate products.
– Authorized Trading Partners and Licensing Standards: This policy emphasizes dealing only with properly licensed trading partners to ensure high accountability and transparency in the supply chain.
– Pilot Projects and Industry Collaboration: The FDA collaborates with industry stakeholders on pilot projects to identify best practices and challenges and refine strategies and technologies for DSCSA compliance.
– Advanced Tracking Technologies by Transportation Companies: Road transportation companies are using GPS and RFID systems to monitor drug shipments in real time, ensuring transparency and traceability.
– Electronic Data Interchange (EDI) Systems: Transportation companies are adopting EDI systems to facilitate seamless communication and data exchange, ensuring accurate and accessible transaction information.
– Enhanced Security Measures: These include tamper-evident seals, secure protocols, and rigorous checks and training for drivers to prevent theft, tampering, and other risks during drug transportation.
– Compliance Training and Certification: Comprehensive training for transportation staff on DSCSA regulations and best practices, with many companies seeking industry certifications to demonstrate compliance and excellence.
In conclusion, the updates to the DSCSA represent a significant step forward in safeguarding the U.S. drug supply chain. By enhancing serialization, improving electronic interoperability, tightening verification requirements, and ensuring that all trading partners are authorized and properly licensed, these updates aim to create a more secure and efficient system for tracking prescription drugs. DeSpir plays a crucial role in this process: comprehensive driver training, a carrier vetting program to ensure all vehicles meet the highest standards, implementing advanced tracking technologies, adopting electronic data interchange systems, enhancing security measures, and fostering collaboration with supply chain partners.
In road transportation, it’s crucial to know who is handling your goods and ensure that they are trained and operating from a quality management system that meets security and GxP requirements for transporting your products. As the pharmaceutical industry adapts to these changes, the ultimate goal remains clear: protecting patients and consumers from the risks associated with compromised medications.