Frequently Asked Questions

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.

For the most streamlined DSCSA compliance, 2D barcode scanning is far superior to manual check-in methods. It allows users quick check-in that are error-free. InfiniTrak’s intuitive solution led the industry with their ground-breaking scanning capabilities in 2015. Schedule a demo to see how quick a DSCSA compliant product check-in can be!

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.

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 wholesale space. The past two years, many hospital groups have discovered their internal system are outsourced and their current 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 Wholesale Operation is compliant? Schedule a Gap Analysis.

Yes! While there has been an exemption on DSCSA enforcement for dispensers through 11/27/2025 and a deadline of 11/27/2026 for small dispensers, this only applies to the serialization component of the law. All other phases of the law are still enforceable not only by regulators but also PBMs and insurance companies. Don’t just take our word for it see what NABP has to say below.

Getting compliant is easy with our No-Touch Implementation. Just click here to Get Started.

CSTS is InfiniTrak’s Controlled Substance Tracking System. It provides regulators with advanced detection regarding pharmacies that are ordering excessive amounts of opioids. A statewide Controlled Substances Tracking System (CSTS):

• Supports full implementation of the DSCSA and makes pharmacies in every state DSCSA compliant, and
• Establishes a central database and interoperable system that can detect anomalies in the prescription ordering, identify unusual dispenser supply loading patterns beyond a single pharmacy, and support state regulatory and law enforcement efforts to secure the drug supply chain

CSTS not only provides regulators advance detection of pharmacies that are ordering excessive amounts of opioids, but it also can identify a wholesaler that is shipping excessive opioids into the state. To accomplish this InfiniTrak worked with state regulators to design a portal where data can be analyzed in the application through a dashboard or customized reports.

The PDMP, ARCOS and other law enforcement efforts each have their own merits; however, no existing program gives regulators a holistic view of controlled substances across each segment of the supply chain, and across state lines. The growing opioid crisis and our ability to provide a holistic view was the driving force behind InfiniTrak’s CSTS to serve an unmet need.