Horseheads, New York – August 26, 2024
XGen Pharmaceuticals DJB, Inc. (XGen), a leading manufacturer in the generics pharmaceutical industry, is proud to announce that it has achieved full compliance with the Drug Supply Chain Security Act (DSCSA) well ahead of the November 27, 2024 deadline established by the FDA. This significant milestone underscores XGen’s commitment to ensuring the highest standards of safety and security in the pharmaceutical supply chain.
The DSCSA, enacted by Congress in 2013, is designed to protect consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs by enhancing the security and traceability of prescription medications as they move through the supply chain. Compliance with the DSCSA is critical for maintaining the integrity of the pharmaceutical distribution system and safeguarding public health.
XGen has been compliant with all components of DSCSA prior to the original deadline of November 23, 2023. During the one-year stabilization period granted to the industry by the FDA, XGen has further strengthened and optimized our systems for universal compatibility to include:
- Product Identification: XGen has implemented systems to ensure that all prescription drug packages are properly labeled with a product identifier. This identifier is in the form of a standardized numerical identifier (SNI), which includes the National Drug Code (NDC), serial number, lot number, and expiration date.
- Product Tracing: XGen has established procedures to track and trace the full transaction history of prescription drugs as they move through the supply chain. This includes the secure exchange of transaction information (TI), transaction history (TH), and transaction statements (TS) with authorized trading partners.
- Product Verification: XGen has adopted robust verification processes and established an integrated VRS node with NABP’s Pulse VRS platform to confirm the legitimacy of products within its supply chain. This includes the ability to verify the product identifier on suspect products within 24 hours of a request from the FDA or other trading partners.
- Detection and Response: XGen has implemented advanced systems and procedures to detect, investigate, and respond to suspect and illegitimate products. This includes procedures for quarantine, investigation, and reporting to the FDA and trading partners, ensuring that any potential threats to the supply chain are swiftly addressed.
- Interoperable Electronic Systems: In line with DSCSA requirements, XGen has developed and deployed interoperable electronic systems to facilitate the secure and seamless exchange of Electronic Product Code Information Services (EPCIS) data with authorized trading partners. This ensures the integrity and transparency of the pharmaceutical supply chain.
- Authorized Trading Partners: XGen ensures that it only conducts business with trading partners who are registered and authorized under federal and state laws through rigorous verification procedures. This further protects the supply chain from infiltration by unauthorized or illegitimate entities.
“We are proud to have achieved full DSCSA compliance well ahead of the deadline, demonstrating our unwavering commitment to the safety and security of the pharmaceutical supply chain,” said Ed Vanderbeck, President of XGen. “This achievement reflects our dedication to protecting patients and ensuring that they receive the highest quality medications. We will continue to invest in the systems and processes necessary to maintain the highest standards of supply chain integrity.”
About XGen Pharmaceuticals, DJB, Inc.
XGen Pharmaceuticals, DJB, Inc. is a leading manufacturer of generic pharmaceutical products, dedicated to ensuring the highest standards of safety, quality, and customer satisfaction. With a strong commitment to innovation and regulatory compliance, XGen serves distributors, pharmacies, and hospital systems across the United States pharmaceutical supply chain.
For more information about XGen and its DSCSA compliance, please visit https://xgenpharmadjb.com/dscsa/.