In the pharmaceutical industry, safety, transparency, and accountability are of upmost importance. Consequently, the DSCSA is a key regulation focused on ensuring integrity across the pharmaceutical supply chain.
Passed in 2013, the DSCSA established extensive regulations aimed at protecting consumers from counterfeit, contaminated, or unsafe drugs by enhancing the traceability of prescription medications throughout the supply chain.
In 2024, the DSCSA compliance deadline took full effect, which meant pharmaceutical companies, wholesalers, dispensers, and third-party logistics providers were under pressure to ensure that their systems, partners, and processes met regulatory requirements.
This blog explores the key elements of DSCSA, the challenges of compliance, and how the right technology partners — such as Slingshot Pharma — can help organizations remain fully compliant and competitive.
What Is the DSCSA?
The Drug Supply Chain Security Act establishes a federal requirement for an interoperable electronic system to ensure end-to-end traceability of prescription drugs. Administered by the FDA, the DSCSA is part of the broader Drug Quality and Security Act (DQSA) and applies to:
● Manufacturers
● Re-packagers
● Wholesale distributors
● Dispensers (e.g., pharmacies)
● Third-party logistics (3PL) providers
The goal of the Act is to provide end-to-end visibility into the drug distribution chain, helping to identify and remove suspect or illegitimate products quickly and efficiently.
Core Requirements of the DSCSA
1. Product Serialization
Every prescription drug must be packaged carrying a unique product identifier, including:
● National Drug Code (NDC)
● Serial Number
● Lot Number
● Expiration Date
It lets stakeholders authenticate the drug product at every stage of the supply chain.
2. Transaction Data
Supply chain partners must exchange three types of data every time ownership of a product changes:
● Transaction Information (TI): What the product is
● Transaction History (TH): Where it has been
● Transaction Statement (TS): A confirmation that the product was handled in compliance with DSCSA
3. Verification
All parties must be able to verify serialized products and respond to verification requests within 24 hours. This includes:
● Investigating suspect products
● Quarantining illegitimate products
● Alerting the FDA and partners about verified counterfeit or illegitimate products
4. Authorized Trading Partners (ATP)
Entities may only engage in transactions with authorized trading partners, each of whom must be registered with the FDA and compliant with DSCSA requirements.
Challenges in Achieving DSCSA Compliance
While the DSCSA provides a framework for improving drug safety, compliance has proven to be challenging for many organizations. Here’s why:
🔹 Complex Supply Chains
The pharmaceutical industry involves numerous players — from manufacturers (inhouse and contracted) to pharmacies — making interoperability between systems and stakeholders a tall order.
🔹 Technology Gaps
Many organizations still rely on outdated or manual processes that are not equipped to handle serialized data or secure data exchange. This is a compliance risk for reasons beyond DSCSA.
🔹 Data Integrity
Ensuring accurate, real-time data tracking at each transaction point is crucial — but requires tightly integrated systems with strong validation and audit trails.
🔹 Training and Culture
Compliance isn’t just about systems — it’s also about people. Employees need ongoing training to understand their roles in managing and verifying supply chain data. SOP’s (Standard Operating Procedures) and training records must be kept up to date for all employees that play a part in the process.
Best Practices for DSCSA Compliance
To meet DSCSA requirements efficiently and with minimal disruption, pharmaceutical companies should adopt the following best practices:
● Implement a validated, DSCSA-compliant ERP or inventory management system that supports serialization, traceability, and secure data exchange.
● Integrate with EPCIS (Electronic Product Code Information Services) standards for interoperable communication between supply chain partners. These services can be provided by companies such as Tracelink.
● Conduct partner due diligence to ensure all trading partners are authorized and compliant.
● Establish SOPs (Standard Operating Procedures)for handling suspect and illegitimate products.
● Maintain audit-ready documentation and system logs that demonstrate data integrity and regulatory adherence.
How Slingshot Pharma Ensures DSCSA Compliance
Slingshot Pharma is purpose-built to support the complex regulatory needs of the pharmaceutical industry — including full compliance with the Drug Supply Chain Security Act(DSCSA).
Here’s how:
✅ Serialized Inventory Tracking: Slingshot Pharma enables full product serialization down to the unit level, with support for NDC, lot, expiration, and serial numbers.
✅ Automated Transaction Data Exchange: The platform generates, stores, and transmits TI, TH, and TS records in compliance with DSCSA requirements.
✅ Interoperability: Supports integration with EPCIS and major trading partners for seamless electronic data exchange.
✅ Verification & Alerts: Built-in tools for problematic product verification, quarantine workflows, and automated notifications.
✅ ATP Management: Validates and tracks trading partner authorization status to ensure DSCSA-aligned transactions.
✅ 21 CFR Part11-Ready: Electronic records and signatures are stored securely with audit trails and user authentication — meeting the highest standards of data integrity.
Slingshot Pharma is not just a software solution — it’s a compliance partner that helps pharmaceutical companies confidently navigate DSCSA and other FDA requirements.
📦 Ready for DSCSA? Slingshot Pharma Is.
As DSCSA enforcement ramps up, the need for secure, traceable, and compliant systems becomes more urgent than ever. Slingshot Pharma delivers the tools and functionality required to meet DSCSA standards — from serialization to verification — ensuring that your supply chain is secure, compliant, and future-ready.
Let Slingshot Pharma help you stay one step ahead of regulation — and protect the patients who depend on you.
.png)