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
ePedigree is our cloud-based ERP platform designed specifically for pharmaceutical companies to
optimize their operations while ensuring full compliance with DSCSA guidelines.
Furthermore, ePedigree 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.
ePedigree 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 ePedigree becomes an integral part of their operations, providing maximum value and efficiency.
ePedigree 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.
