DSCSA - Frequently Asked Questions
The Drug Supply Chain Security Act (DSCSA) is a law implemented by the FDA to secure the drug supply chain and improve patient safety. It outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. The system is designed to facilitate the exchange of information at the individual package level, showing each stop a drug has been at in the supply chain. This is a complex law that continues to bring significant change to the way most pharmacies track and trace their products.
The U.S. Pharmaceutical Drug Supply Chain is in the process of moving to a fully interoperable system with full electronic data exchange. This is changing the landscape for all stakeholders, Manufacturers, Suppliers, and Dispensers. The FDA has announced that it will not enforce this law until November 27, 2024. This enforcement delay is referred to as “Stabilization” period. During this time, all stakeholders are expected to move forward with their plans to implement a DSCSA solution.
Dispensers will need to have a system that provides full DSCSA compliance. This includes the ability to conduct product tracing when requested by other stakeholders within the drug supply chain. Dispensers will also be required to validate that they have received all pharmaceutical drug products that have been ordered and have procedures in place to quarantine products that require additional investigation.
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.
1. Transaction Management:
- Receive and store transaction data for a minimum of six years.
- Be sure the pharmacy can quickly retrieve the data if requested.
- Only except prescription drugs if they are accompanied by complete and accurate product tracing documentation.
2. License Verification:
- The pharmacy should engage in business only with licensed or registered suppliers.
3. Suspect Product Process:
- The pharmacy must have a method to identify, quarantine, investigate, and if necessary, report suspect and/or illegitimate product.
4. Product Identifier:
- Physically inspect the product to ensure it has a product identifier, also known as a 2D barcode.
5. Policies & Procedures:
Make sure the pharmacy understands the importance of DSCSA and their part in protecting the US Pharmaceutical Supply Chain and more importantly, the patients.
Have a policy detailing how the pharmacy will meet the requirements of the DSCSA and ensure the staff is fully trained in the process.
6. Interoperability: Also known as Enhanced Drug Distribution Security (EDDS)
- All transaction data traveling between entities in the supply chain must be exchanged in an electronic format.
- Transaction information must include the unique product identifier down to the lowest saleable unit for every prescription drug product that is covered under DSCSA
- Saleable returns must be accompanied by transaction information and transaction statement.
7. Product Verification & Product Tracing:
- The pharmacy is required to have a system in place to verify suspect product in which a message is sent to the manufacturer to verify the lot and serial number on the product in question is legit.
- With EDDS, transaction history will no longer be part of the required transaction data therefore the pharmacy must have a method to trace the product from the pharmacy all the way back to the manufacturer.
- The pharmacy may be required to perform product tracing at the request of an auditor or other industry regulator and must do so within 24 hours.
The biggest impact on the pharmacy is the day-to-day handling of prescription drugs, primarily the receiving process. Pharmacies need to determine the best procedures for receiving products while minimizing the impact on business workflow, all while maintaining DSCSA compliance. This means:
- Checking every product for a unique product identifier
- Checking that transaction data is provided for every product received & confirming the data matches the product – NDC, description, GTIN, lot, expiration, & serial number
- Inspecting product to identify any suspect product and promptly quarantine the product for further investigation.
As the stabilization period ends, the industry has realized that not all stakeholders are fully DSCSA compliant and will be by November 27, 2024. HDMA, NABP, and others stressed the need to allow the dispensers to have additional time to comply with DSCSA regulations. The FDA has granted a two-year extension to small dispensers.
They define small dispensers as any pharmacy dispenser with 25 or fewer full-time pharmacists and pharmacy technicians by November 27, 2024. The important thing to note about this extension is that it only delays enforcement of the EDDS phase of DSCSA. This means all the other requirements are in effect and enforceable. For example:
- Pharmacies are still required to receive transaction data for every prescription drug product, store that data for six years, and be able to retrieve it. However, the transaction data does not have to be electronic until November 27, 2026.
- The transaction data must have lot level information, but it is not required to have serialized data for every product.
- Pharmacies must be able to identify and investigate suspect products, but they are not required to perform a product verification or product tracing.
- The pharmacy may be asked by an industry regulator, or even a potential supplier, to provide a policy and procedures manual, as well as be able to show progress towards full compliance with EDDS.
DSCSA can be achieved without the expense of a solution provider, but in the end, it will cost the pharmacy more in expenses. The pharmacy will need to consider the following questions:
- Who will oversee DSCSA compliance?
- How will the pharmacy electronically receive the transaction data and most importantly, interpret the transaction data to allow the staff to reconcile the data and the products.
- What electronic system will be used to store the data and how will it be quickly retrieved?
- Who will be responsible for manually completing a product tracing or product verification, including contacting the manufacturer and each stakeholder who had possession of the product.
If the pharmacy chooses to use a wholesaler portal to retrieve & store the transaction data, do they have access to a portal for every supplier they purchase from? Who will be responsible for logging into each of these portals and searching for the data every time a purchase arrives or needs to be received?
Once the pharmacy answers these basic questions, look at the cost before moving onto other requirements. Can the pharmacy employee staff whose only job is DSCSA compliance?
The FDA and industry regulators are looking for progress. The one-year stabilization period and the two-year small dispenser extension are not excuses to stop moving towards compliance. They are simply a way to keep the industry moving towards compliance without hindering the flow of prescription products, which would cause patients to go without lifesaving medication. The Boards of Pharmacy, PBMs, DEA, and other regulatory bodies are still looking for the dispensers to have a plan in place and to be taking steps to put that plan into action. Furthermore, prior to the stabilization period, the industry saw a mass stampede in August of dispensers looking for DSCSA compliance and expecting it to be as simple as flipping a switch. They found out that is not the case. Implementing a DSCSA solution takes time – time to establish connections with all the pharmacy’s suppliers, time to train staff, and time to create procedures. Connecting with the suppliers alone is time consuming with some suppliers having a 30-60 day wait list before they can begin working on the connection which then can take up to 7 days to complete.