The Drug Supply Chain Security Act (DSCSA), effective November 27, 2024, introduces strict regulations to safeguard patients from counterfeit, tainted, or stolen pharmaceuticals. As mandated by the U.S. Congress, all stakeholders in the drug supply chain—from pharmaceutical producers to dispensers like pharmacies—must electronically track and trace prescription medications.
This means that for every medication purchased, sold, or exchanged, pharmacies must retain detailed records including a transaction history, transaction information, and a transaction statement. Additionally, pharmacies are required to verify the authenticity of drug products and ensure their validity before dispensing them.
Beyond tracking, pharmacies need processes in place to review product tracing data and respond to audits from the FDA or other authorities. Compliance with the DSCSA involves significant operational changes that many pharmacies may find challenging.
The Challenges Pharmacies Face with DSCSA
Pharmacies face several hurdles in complying with DSCSA regulations, primarily related to the massive amounts of data they must now manage and store. Handling and maintaining transaction histories and product identifiers for each medication is no small task. Pharmacies will need to implement new software and processes to manage this data efficiently and ensure compliance.
Monitoring and verifying the authenticity of drugs to prevent counterfeit or stolen products from entering the supply chain is another challenge. Pharmacies also rely on their wholesale distributors to provide accurate product tracing data. Establishing and maintaining strong relationships with these distributors is critical to ensuring that DSCSA data is available and accurate.
The scale of these responsibilities underscores the importance of pharmacies having a reliable and efficient purchasing solution. Without proper systems in place, pharmacies could face penalties, product quarantines, or even loss of inventory—complicating their operations and threatening patient safety.
How SureCost Helps Pharmacies Comply with DSCSA
SureCost is the Smarter Purchasing Solution™ that not only enhances purchasing transparency and improves profitability for pharmacies, but it also simplifies the complex process of complying with DSCSA regulations. SureCost’s DSCSA Compliance Packs ensure that pharmacies are meeting their regulatory requirements without adding to their workload.
Through a single interface, pharmacies can receive EPCIS data, report on DSCSA data, and store all transaction records for the required six years. Key features of the Compliance Packs include tracking product identifiers for store-to-store transfers, capturing and verifying T2 data at receiving, quarantining items, and ensuring vendor accountability.
By providing a consistent and reliable process for handling DSCSA data, SureCost helps pharmacies maintain compliance and avoid the costly risks associated with regulatory non-compliance. Pharmacies can instantly scan and capture DSCSA-mandated data, ensuring that it matches the EPCIS shipping data from vendors. If discrepancies arise, SureCost flags them immediately, giving pharmacies the ability to resolve issues before an audit ever occurs.
Ensuring Accountability and Reducing Compliance Risks
Accountability is crucial in meeting DSCSA regulations, and SureCost helps pharmacies stay ahead of compliance audits by providing a comprehensive view of all transaction data. By matching physical inventory with vendor-supplied EPCIS data, SureCost enables pharmacies to hold products in quarantine when there are compliance concerns or missing data.
Additionally, SureCost’s transfer management feature ensures that DSCSA data is accounted for when inventory is moved between multiple locations. Even though the DSCSA doesn’t explicitly require tracking of store-to-store transfers, SureCost’s solution provides an extra layer of security by making sure all movements are traceable and compliant. This proactive approach reduces the risk of non-compliance and protects pharmacies from hefty fines and penalties.
Convenience for Pharmacies Managing DSCSA Compliance
One of the most valuable aspects of SureCost’s DSCSA Compliance Packs is the convenience it offers. Pharmacies can manage purchasing, inventory, and compliance through a unified platform, streamlining operations and making the compliance process easier.
The mobile app scanning feature simplifies the capture of DSCSA data during receiving, ensuring that every transaction is recorded accurately. In case of an audit, pharmacies will have complete electronic records of all DSCSA-related data.
Furthermore, SureCost’s system allows for quick and easy reconciliation with trading partners, minimizing the risk of discrepancies between physical inventory and electronic data.
In short, SureCost offers pharmacies a seamless, all-in-one solution to meet the rigorous demands of DSCSA compliance while improving operational efficiency so pharmacies focus on what matters most: delivering high-quality care to their patients.
With the DSCSA deadline fast approaching, pharmacies need to act quickly to implement the right tools and processes. SureCost is here to ensure that your pharmacy is prepared and compliant, helping you navigate the complexities of the DSCSA with ease. Book a complimentary DSCSA consultation today.
