MedTrax Inc Highlights Urgent DSCSA Compliance Needs Ahead of FDA Enforcement

With November’s DSCSA enforcement looming, MedTrax Inc outlines compliance challenges facing pharmacies and introduces industry-specific technological solutions.

United States, 1st Jul 2025 – It was a day like any other for a mid-sized pharmacy when a notification from the FDA arrived, an official penalty for non-compliance with the Drug Supply Chain Security Act (DSCSA). The fine, though financially significant, was the least of their concerns. What followed was the suspension of their license to operate, creating chaos for both staff and customers. With the looming deadlines of DSCSA legislation, many pharmacies found themselves unprepared to meet the extensive compliance requirements.

The Drug Supply Chain Security Act (DSCSA) is a critical law aimed at protecting Americans from unsafe, counterfeit, or misbranded medications by establishing a transparent, secure, and traceable drug supply chain. While the law’s intent is straightforward, the full enforcement of the DSCSA is set to take effect this November, leaving many pharmacies scrambling to meet the legal obligations.

Decoding the DSCSA: Background and Obligations

Enacted in 2013, the DSCSA requires manufacturers, wholesalers, and dispensers to securely transmit and maintain electronic pedigrees (proof of origin) for all drugs in the supply chain. The goal is to ensure that all medications are traceable, from manufacturer to patient. However, the specifics of the law’s implementation have created significant challenges for many pharmacies, particularly with the upcoming deadlines for full enforcement.

Pharmacies must maintain an unalterable, tamper-proof record of medication history, but many remain unaware of the complexities and potential penalties for non-compliance. As enforcement ramps up, the risks of failing to meet these standards are significant, including hefty fines, loss of licensure, and even criminal charges.

Complexity Overload: Key Challenges in Pharmacy Compliance

While large pharmacy chains may have the resources to tackle DSCSA compliance, many smaller and mid-sized pharmacies struggle with the logistics, technology, and financial investment required to meet these regulations. For some, the issue isn’t a lack of understanding of the law itself but the overwhelming complexity involved in integrating compliance systems into daily operations.

The penalties for non-compliance are severe: fines, loss of licensure, and even criminal charges. In recent years, several companies in the pharmaceutical supply chain have faced legal action for failing to meet DSCSA standards. These cases have raised alarms, underscoring the importance of timely and thorough compliance.

Closing the Gap: Technology as a Compliance Solution

To assist pharmacies with these challenges, several technology providers offer solutions designed to streamline the compliance process. One such solution is MedTrax, a software platform designed to simplify DSCSA compliance for pharmacies. MedTrax’s system helps pharmacies track and store drug pedigree data electronically, ensuring that all records are securely transmitted and stored in accordance with the law.

Key features of DSCSA compliance platforms like MedTrax include:

• Two-Factor Authentication: Enhances login security by requiring verification beyond just a password.
   
• 24/7 Data Access: Allows pharmacies to retrieve compliance data at any time, supporting uninterrupted operations.
   
• Real-Time Medication Tracking: Utilizes EPCIS (Electronic Product Code Information Services) data standards to trace the journey of each drug from manufacturer to delivery.
   
• Automated Recall Alerts: Integrated with the National Recall Alert Center, the system notifies pharmacies of any recalled medications within their inventory.

Customized for the Industry: Why Specificity Matters

While many general compliance tools are available, industry-specific solutions like MedTrax provide a more tailored approach, designed to integrate seamlessly into pharmacies’ existing workflows. These systems aim to reduce the burden of compliance by automating data entry, tracking medication movement, and offering real-time alerts for recalls.

What sets these specialized solutions apart is their focus on understanding the operational needs of pharmacies. By integrating DSCSA compliance features into existing pharmacy management systems, these platforms reduce the complexity and potential for errors, allowing pharmacies to focus more on patient care rather than regulatory compliance.

Regulatory Reality Check: The Urgency of Compliance

As the FDA’s enforcement of DSCSA regulations begins to intensify, pharmacies need to act quickly to ensure they meet all requirements. The penalties for non-compliance are not just financial; they can lead to the suspension of operations, reputational damage, and even criminal charges. Pharmacies that are not yet compliant with the law face a looming deadline to integrate solutions that ensure they meet the law’s requirements.

The good news is that solutions like MedTrax and other industry-specific compliance platforms can help pharmacies stay on top of DSCSA requirements, providing the tools needed to protect patients and ensure secure, efficient operations.

Momentum and Mandate: Industry Voices on DSCSA

“As I mentioned at the outset, the agency (FDA) is encouraged by the industry’s continued progress towards full implementation of DSCSA requirements, advance of the expiration of the Connected Trading Partners exemption,” Sangeeta Chatterjee stated at the PDG-FDA Townhall.

About MedTrax Inc

MedTrax offers DSCSA (Drug Supply Chain Security Act) compliance software. The DSCSA was passed in 2013 to protect Americans from counterfeit, misbranded, adulterated, or otherwise unsafe medications. MedTrax ensures pharmacies meet requirements such as secure, interoperable data transmission, verification of trading partners, and FDA reporting. With decades of experience in pharmacy support services, MedTrax delivers reliable, integrated compliance solutions tailored to industry needs.
Phone: 909-328-4140
Business Phone: 855-863-3872
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