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What is dscsa?

Drug Supply Chain Security Act
(DSCSA)

The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013. Title 2 of the DQSA, the Drug Supply Chain Security Act (DSCSA) delineates steps to “achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.”

The DSCSA is a law that the Food and Drug Administration (FDA) enforces to improve the security of prescription drugs in safeguarding patients from exposure to counterfeit, stolen, contaminated or harmful drugs. Some DSCSA compliance requirements are already in play. The extended stabilization deadline is the second part of DSCSA, which addresses the Track and Trace serialization law, providing direction on how to track and trace transaction histories as prescription drugs move from pharmaceutical manufacturing sites to pharmacies. The deadline for manufacturers is May 27, 2025, and the deadline for wholesale distributors is August 27, 2025. Third-party logistics providers (3PLs) will align with the deadlines of their partner organizations.

Requirements for Manufacturers, Distributors, 3PLs​, Micro Distributors and Governments

Product Identification​

Identify products using unique, human and machine-readable barcodes on drug packages. These must include GTIN, and a 2D Data Matrix

Product Verification​

Validate the authenticity of suspect products with the trading partner by reconciling physical product against the Electronic Packing List or EPCIS File.

Electronic
Identification of ATPs

Authorized trading partners (ATPs) must be electronically identifiable, and products can only be purchased from ATPs with valid licenses, EPCIS data, or, if applicable, a filed Waiver, Exception, and Exemption (WEE) collected from the vendor.

Interoperability
& Product Tracing

The pharmaceutical supply chain must be interoperable to store and exchange serialized EPCIS data, enabling secure tracing of product ownership transfers.

Enhanced Drug Distribution Security ​

Verify the inclusion of a Serial Shipping Container Code (SSCC) and EPCIS data upon receipt, and notify suppliers of any discrepancies.

DSCSA Standard
Operating Procedures

DSCSA Standard Operating Procedures must be established to document the process to identify suspect drugs.

Licensure

Licensure verification is required for all supply chain companies, maintaining DSCSA compliance between all trading partners.

Data Storage​

Electronic Data Retention is required, ensuring the data is complete, accurate, and stored for 6 years.

Use of FDA Form 3911​

Use the FDA 3911 form to report suspect products at once

Drug Supply Chain Security Act Law and Policies ​

Visit the FDA Website

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 DSCSA-ready operations for your workflow.

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Frequently Asked Questions

What makes RxERP's serialized ERP different from other solutions?

RxERP is the only fully serialized ERP built by pharma for pharma, with serialization embedded directly into the core ERP system rather than functioning as a separate add-on. This integrated approach eliminates the data inconsistencies and coordination challenges that occur when using separate ERP and serialization systems, ensuring that all supply chain partners work with accurate, real-time data throughout the pharmaceutical product lifecycle.

Embedded serialization is essential for meeting DSCSA requirements because it enables unit-level tracking of pharmaceutical drugs throughout the entire supply chain. By assigning unique identifiers to each product and integrating this data directly within the ERP system, RxERP automatically captures and maintains the traceability information, transaction histories, and EPCIS data required by DSCSA regulations, making compliance seamless and reducing the risk of regulatory violations.
Yes, serialization is a powerful anti-counterfeiting tool. By assigning unique serial numbers to each pharmaceutical product, RxERP enables you to verify the authenticity of every item in your inventory. This capability allows you to quickly identify and quarantine suspect or illegitimate products before they reach patients, protecting both your organization and public health from the dangers of counterfeit medications.
When a product recall occurs, serialization allows you to pinpoint exactly which items are affected based on their unique identifiers, lot numbers, and other tracking data. Instead of conducting broad recalls that impact large portions of inventory, you can precisely identify and segregate only the compromised products. This targeted approach minimizes disruption to your business operations, reduces financial losses, and most importantly, protects patient safety more effectively.
A serialized ERP provides granular visibility into every pharmaceutical product in your inventory, enabling more sophisticated inventory management. You can track individual units from receipt through distribution, identify slow-moving products that may be approaching expiration, optimize stock levels based on actual usage patterns, and monitor cost data at the serial number level. This comprehensive product intelligence helps reduce waste, improve cash flow, and ensure you always have the right products available when needed.