How Pharma Pedigree Tracking Ensures Compliance with DSCSA Regulations

In the pharma industry, ensuring the safety and authenticity of drugs is extremely important. The U.S. Food and Drug Administration (FDA) has established strict guidelines to prevent counterfeit or contaminated drugs from entering the supply chain. One such regulation is the Drug Supply Chain Security Act (DSCSA), which mandates the strict tracking and tracing of pharmaceutical products.

Pharma pedigree tracking plays a critical role in ensuring compliance with DSCSA regulations, ensuring patient safety, and maintaining supply chain integrity. Software solutions like Slingshot Pharma provide innovative solutions that help businesses navigate these regulations effectively and efficiently.

Understanding DSCSA Regulations

The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 by the FDA to enhance and protect the drug supply chain process. The Act’s primary goal is to prevent counterfeit, stolen, or contaminated drugs from infiltrating the supply chain process and protecting those drugs from reaching the patient.

The DSCSA outlined a 10-year roadmap for full compliance, including requirements for serialization, tracing, verification, and reporting.

Key DSCSA Compliance Requirements

1. Product Serialization: Manufacturers must assign a unique product identifier to each package and case of prescription drugs.
2. Traceability: The law requires an electronic, integrated system for tracking the movement of pharmaceuticals through the supply chain.
3. Verification: Supply chain stakeholders, including wholesalers and retailers, must verify serialized products before further distribution.
4. Authorized Trading Partners: Only authorized manufacturers, wholesalers, distributors, and retailers can engage in transactions.
5. Product Quarantine and Investigation: All companies that make up a drug’s supply chain must quarantine and investigate suspect or fraudulent products and report findings to the FDA.

Compliance with DSCSA regulations requires a comprehensive tracking system that ensures visibility and accountability at every stage of the supply chain. This is where pharma pedigree tracking becomes important.

What is Pharma Pedigree Tracking?

Pharma pedigree tracking is a system that records the movement of pharmaceutical products from the manufacturer to the point where it reaches the hands of the patient. Tracking provides a documented history of a drug’s journey, ensuring transparency and security in the supply chain.

Components of Pharma Pedigree Tracking

●       Serialization Data: A unique identifier assigned to each product.

●       Electronic Records: Digital documentation of product transactions.

●       Authentication Mechanisms: Verification of products at each stage of distribution.

●       Cloud-Based Solutions: Technologies that enhance security and traceability.

An effective pharma pedigree tracking system helps businesses comply with DSCSA requirements by providing a reliable method to trace drugs back to their source, thereby preventing fraudulent medications from infiltrating the market.

How Slingshot Pharma Ensures DSCSA Compliance

Slingshot Pharma is a leading software provider of supply chain solutions that streamline compliance with DSCSA regulations. By leveraging advanced technologies and innovative tracking mechanisms, Slingshot Pharma helps pharmaceutical companies meet regulatory requirements efficiently.

1. Advanced Serialization Solutions

Slingshot Pharma ensures that every product is serialized with a Unique Product Identifier (UPI), which includes:

●       National Drug Code (NDC): Identifies the manufacturer and product type.

●       Serial Number: A unique identifier foreach package.

●       Lot Number: Tracks production batches.

●       Expiration Date: Ensures product validity.

With the help of Electronic Product Code Information Services (EPCIS) and with the receipt of the product, Slingshot Pharma sends the EPCIS query to the EPCIS provider.

If the received product is not valid, Slingshot Pharma marks the inventory as “DSCSA non-compliant”.

2. Verification Process

Verification is acritical component of DSCSA compliance. Slingshot Pharma employs a verification process that allow supply chain participants to:

●       Instantly track serialized products.

●       Identify and quarantine suspect products.

●       Prevent unauthorized drug transactions.

These systems enhance the security and efficiency throughout the supply chain process, ensuring compliance at every distribution stage.

3. Cloud-Based Data Management

To maintain compliance, pharmaceutical companies need a reliable solution for storing and managing a large amount of data. Slingshot Pharma offers cloud-based data management solutions that:

●       Securely stores all compliant pharma-related transactional data.

●       Provide access to compliance-related reports.

●       Simplify regulatory audits by organizing all necessary documentation in one place.

By utilizing cloud-based technology, Slingshot Pharma eliminates the need for manual record-keeping, reducing errors and ensuring seamless compliance.

4. Integration with Authorized Trading Partners & DSCSA Providers

DSCSA requires that only authorized entities handle Pharma products. Slingshot Pharma provides seamless integration capabilities with authorized manufacturers, distributors, and DSCSA providers, ensuring that all transactions comply with regulatory guidelines.

5. Configurable Monitoring and Reporting

Slingshot Pharma helps businesses stay ahead of compliance requirements with configurable monitoring tools that:

●       Alert users about potential compliance risks.

●       Access to monitoring tools that can display any possible suspicious system access.

●       Generate detailed compliance-related reports for regulatory submissions.

This proactive approach minimizes the risk of non-compliance and enhances supply chain security.

Conclusion

Pedigree tracking is essential for maintaining the integrity of the pharmaceutical supply chain and ensuring compliance with DSCSA regulations. With increasing concerns over fraudulent drugs and supply chain deficiencies, companies must implement resilient and reliable tracking and verification systems.

Slingshot Pharma provides state-of-the-art solutions, including serialization, automated verification, and cloud-based data management, to help pharmaceutical businesses navigate DSCSA requirements seamlessly.

By leveraging Slingshot Pharma’s innovative technologies, companies can enhance patient safety, prevent counterfeit drugs, and maintain regulatory compliance with ease. As DSCSA enforcement deadlines approach, investing in reliable pedigree tracking solutions is no longer optional—it is a requirement for the future of pharmaceutical supply chain management.