DSCSA Solution

Ensuring compliance ease of use security accuracy reliability efficiency trust safety at every step of the supply chain.

InfiniTrak offers a comprehensive suite of compliance solutions designed to streamline processes, enhance patient safety, and ensure full DSCSA compliance. Our user-friendly platform is tailored to the needs of pharmacies, hospitals, and healthcare institutions, providing real-time tracking, reporting, and analytics capabilities.

Stay Compliant with the Drug Supply Chain Security Act (DSCSA)

The DSCSA, enacted by the FDA in 2013, is transforming how pharmacies track and trace prescription drugs. By 2024, all drug information will be electronically exchanged at the individual package level, ensuring full visibility across the supply chain. This complex law has reshaped pharmacy operations, requiring businesses to adapt to evolving compliance standards. At InfiniTrak, we specialize in helping pharmacies navigate these regulatory changes with practical, structured solutions that keep you ahead of the curve.

Download Our Free DSCSA Pocket Guide

Industries We Help Comply with DSCSA Compliance

Healthcare

Regulators classify healthcare institutions as both distributors and dispensers. Compliance requires a gap analysis of operations, legal, and IT to ensure full adherence to DSCSA requirements. InfiniTrak provides tailored solutions to help healthcare organizations achieve seamless DSCSA interoperability while maintaining operational efficiency.

Healthcare

Regulators classify healthcare institutions as both distributors and dispensers. Compliance requires a gap analysis of operations, legal, and IT to ensure full adherence to DSCSA requirements. InfiniTrak provides tailored solutions to help healthcare organizations achieve seamless DSCSA interoperability while maintaining operational efficiency.
Get Started Today

Pharmacies

With the FDA now enforcing DSCSA electronic data transmission, pharmacies must ensure compliance with evolving regulations. InfiniTrak simplifies this process with track & trace software that enables seamless data exchange and integration with existing supply chain systems. By using InfiniTrak, pharmacies can easily generate required reports, stay audit-ready, and maintain compliance without disrupting daily operations.

Pharmacies

With the FDA now enforcing DSCSA electronic data transmission, pharmacies must ensure compliance with evolving regulations. InfiniTrak simplifies this process with track & trace software that enables seamless data exchange and integration with existing supply chain systems. By using InfiniTrak, pharmacies can easily generate required reports, stay audit-ready, and maintain compliance without disrupting daily operations.
Get Started Today

Wholesalers

DSCSA interoperability brings new challenges for dispensers as they navigate stricter compliance requirements. InfiniTrak ensures dispensers remain compliant with EPCIS capability and regulatory tracking. As the last line of defense in the supply chain, dispensers play a critical role in protecting patients from counterfeit and illegitimate drugs, and InfiniTrak provides the tools needed to uphold that responsibility with confidence.

Wholesalers

DSCSA interoperability brings new challenges for dispensers as they navigate stricter compliance requirements. InfiniTrak ensures dispensers remain compliant with EPCIS capability and regulatory tracking. As the last line of defense in the supply chain, dispensers play a critical role in protecting patients from counterfeit and illegitimate drugs, and InfiniTrak provides the tools needed to uphold that responsibility with confidence.
Get Started Today

Key Features & Benefits

  • Seamless Trading Partner Connectivity – Easily integrate and manage relationships.
  • Regulatory Compliance Confidence – Stay ahead of DSCSA mandates.
  • Operational Efficiency – Automate compliance workflows and reduce costs.
  • FDA-Compliant Reporting – Effortlessly generate and transmit Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS).
  • Robust Security & Accessibility – Hosted on Microsoft Azure for maximum reliability.

Effortless Compliance, Seamless Integration

InfiniTrak simplifies compliance with an intuitive, web-based interface that integrates with your standard operating procedures (SOPs). Our solution provides:

  • Real-time transaction management with advanced reporting and search tools.
  • Automated workflows for trading partner verification and suspect product management.
  • Secure document storage for SOPs, compliance records, and audit trails.
  • Cloud-based accessibility with 24/7 availability and security.

We’ve helped thousands of pharmacies achieve and maintain DSCSA compliance.

Adding Value Beyond Compliance

The InfiniTrak team knows the importance of choosing the right track & trace solution. Our unique approach to product development allows us to serve the independent market and address key compliance challenges.

InfiniTrak continuously enhances automation for pharmacy processes, improving productivity and patient safety based on customer needs. Here are just a few of our added features beyond industry-leading compliance.

Features & Fuctionality

Compliance Management & Oversight

InfiniTrak’s Account Management & Interoperable System provides seamless compliance oversight across your pharmacy network. Administrators can manage users, control access, and track compliance tasks efficiently—all from a single sign-on.

Mobile App

Stay DSCSA compliant on the go with InfiniTrak’s mobile app for Android and iOS. The app mirrors the platform’s full functionality, including mobile scanning for added convenience.

Expiry & Recall Management

Optimize inventory with custom expiry alerts, helping you remove soon-to-expire products and maximize refunds. Recall Management automates tracking of recalled products, instantly pinpointing their location within your supply chain to ensure patient safety.

Product Verification & Scanning

Authenticate pharmaceuticals and prevent counterfeit risks with InfiniTrak’s integrated scanning system. Our HID scanner integration enables instant verification, eliminating manual entry errors and reducing operational costs while enhancing patient safety.

Suspect & Illegitimate Product Identification

Detect, quarantine, and report non-compliant or suspicious products. InfiniTrak’s monitoring tools help prevent the circulation of illegitimate pharmaceuticals, ensuring supply chain security.

Compliance Data & Analytics

Gain real-time insights with InfiniTrak’s Data Analytics & Retention tools. Our reporting system allows you to visualize inventory, track compliance tasks, and securely store and retrieve transaction records—all in one place.

Transaction History & Information Review

Manage and verify supply chain data efficiently. InfiniTrak’s system keeps a detailed record of transactions, ensuring transparency and traceability.

Authorized Trading Partner Verification

Validate and manage partner compliance with InfiniTrak’s Trading Partner Verification tools. Ensure all supply chain partners meet regulatory standards for secure transactions.

Unit Level Serialization

Enable precise tracking at the lot and item level with InfiniTrak’s serialization tools. This ensures product authenticity and compliance with DSCSA requirements.

Stay Ahead of Compliance

AcariaHealth values compliance. We chose InfiniTrak because the software is user-friendly and enables our company to streamline DSCSA compliance across our nationwide network of pharmacies. They provide a true partnership, and their software has exceeded our expectations.

FAQ

The Drug Supply Chain Security Act (DSCSA) is an ambitious overhaul of federal drug safety regulations that will eventually move the pharmaceutical industry toward unit level serialization of drugs. DSCSA was created in response to growing vulnerability in the pharmaceutical supply chain, and addresses threats to public health, such as inefficient means to respond to a drug recall. The FDA began officially enforcing these requirements on March 1, 2016. Many new requirements have been added throughout the years that present gaps in coverage with far too many dispensers.

Any company involved in the sale or purchase of prescription drugs. Commonly known as trading partners, these include manufacturers, repackagers, dispensers, wholesale distributors, and third-party logistic providers.

While wholesalers may store your data, if you have more than one, your information is not centrally located. The wholesalers do not provide a compliance solution for the other parts of the law, such as verification of trading partners, suspect product verification, and quarantine requirements. Also, if you want to change wholesalers, you may have difficulty getting the data transferred to you in a form you can use. Click here to review the Wholesaler Portal Myth for more details.

InfiniTrak is the leader in DSCSA compliance for independent, retail chain, and healthcare system pharmacies. InfiniTrak is a cost-effective and complete solution for all your DSCSA compliance requirements, centralizing and automating all the business requirements and processes required by the law. In addition, InfiniTrak has built in automated processes and best practices as the industry moves into interoperability.

Yes, go to our contact us page and schedule a demo today!

Yes! Click here and you can get started today. 

In one word – development. Even before the law was enacted, InfiniTrak spent two years to develop the most intuitive platform that would keep pharmacists in front of patients rather than behind computers. We are focused on dispensers whether large pharmacy chains, independent, healthcare systems like hospitals, and long-term care facilities. We are known for our user-friendly platform that requires little to no training. Solutions like our Suspect Product Wizard™ have become such great time savers that many dispensers have switched to InfiniTrak for our unique automated processes alone.

InfiniTrak is the only solution built from the ground up for pharmacies which is why it is the compliance solution of choice to save both time and money. Over recent years the innovative approach has been expanded to new functionality over and above what is regulated by the DSCSA.

The fastest growing segment of InfiniTrak’s customer base has been within the Hospital and Healthcare arena. The past two years, many hospital groups have discovered their internal system or outsourced vendor does not cover all aspects of DSCSA. This has opened an opportunity for InfiniTrak to capitalize a significant market share. The fact that our implementation team has expediated the transition process with our No-Touch Implementation only makes the decision to utilize InfiniTrak’s customizable solutions much easier to use. Want to ensure your hospital is compliant? Schedule a Gap Analysis.

Ready to Simplify Compliance?

Whether you're getting started, need a demo, or have questions—InfiniTrak is here to help. Join thousands of pharmacies and healthcare organizations streamlining DSCSA compliance with our intuitive solutions.

American Associate Pharmacies (AAP)

Sign up below to receive your exclusive partner affiliation code, registration link, and a personalized quote. Once submitted, you’ll have everything you need to start becoming DSCSA compliant right away.