DSCSA Compliance & Requirements
Pharmaceutical companies operating in the United States are subject to compliance with the Drug Supply Chain Security Act (DSCSA). This legislation was enacted to enhance drug safety and improve traceability throughout the pharmaceutical supply chain. Understanding and adhering to DSCSA requirements is crucial for pharmaceutical companies to ensure regulatory compliance and maintain consumer trust.
The DSCSA sets forth a series of guidelines that pharmaceutical companies must follow. These guidelines include implementing systems for product tracing, verifying authorized trading partners, detecting and responding to suspect products, maintaining transaction records, and providing product identifiers on packaging.
One of the key aspects of DSCSA compliance is product tracing. Pharmaceutical companies are required to have systems in place that allow them to trace the ownership history of each drug package as it moves through the supply chain.
Maintaining comprehensive transaction records is also essential under DSCSA regulations. Pharmaceutical companies must keep accurate records of each transaction involving their products, including information about the parties involved, dates, quantities shipped or received, lot numbers, and expiration dates. These records enable efficient tracking in case of recalls or investigations into suspicious activities.
Furthermore, pharmaceutical companies are required to provide unique product identifiers on packaging that allow for easy identification and verification at each point along the supply chain. These identifiers typically include a National Drug Code (NDC), serial number, lot number, and expiration date. By complying with DSCSA requirements and guidelines, pharmaceutical companies can contribute to the overall safety and integrity of the drug supply chain. It is important for these companies to stay updated on any changes or updates to the legislation, as non-compliance can result in penalties and damage to their reputation.
ePedigree – Ensuring Compliance with DSCSA
ePedigreeRX is our cloud-based ERP platform designed specifically for pharmaceutical companies to optimize their operations while ensuring full compliance with DSCSA guidelines.
Furthermore, ePedigreeRX offers its own internal Electronic Product Code Information Services (EPCIS) database. This database allows for efficient tracking and monitoring of product information, including serialization, batch numbers, expiration dates, and more. With this comprehensive data management system in place, pharmaceutical companies can streamline their processes and enhance overall efficiency.
ePedigreeRX also offers customization options to meet the specific needs of each organization. Companies can tailor the platform to align with their unique workflows and requirements. This flexibility ensures that ePedigreeRX becomes an integral part of their operations, providing maximum value and efficiency.
ePedigreeRX is a versatile cloud-based ERP platform that goes beyond traditional solutions by offering dynamic features tailored to benefit pharmaceutical companies. Its’ compliance with DSCSA regulations and internal EPCIS database ensure optimized operations while maintaining full traceability and security throughout the supply chain.