DSCSA Compliance Software: What Hospitals Need to Know About the New Track and Trace Requirements

Hospital pharmacies are under pressure as extensions on prescription drug tracking and verification requirements end in 2025. These requirements, set forth by the Drug Supply Chain Security Act (DSCSA), hold drug manufacturers, distributors, and hospital pharmacies accountable for prescription drug visibility and security from manufacturer to patient.

The Food and Drug Administration (FDA) implemented updated DSCSA requirements in October 2024, focusing on improving electronic systems to track medications as they move throughout the supply chain.

While DSCSA requirements contribute to increased patient safety, they also create a more reliable healthcare supply chain. Enforcing strict regulations on tracking and tracing drugs can help prevent shortages of critical supplies, such as IV fluids and insulin. 

As the days count down, hospitals are currently tasked with meeting the enhanced DSCSA track and trace requirements. Part of that means adopting an electronic system that allows interoperable, secure data exchange between all trading partners, including manufacturers, distributors, and third-party logistics providers.  

Here are the most important things for hospitals to know about these enhanced requirements.

DSCSA serialization and “track and trace” requirements

First, let’s define the DSCSA requirements and how they affect our current healthcare system. In short, the goal of these requirements is two-fold: to identify (or track) prescription drugs as they move throughout healthcare facilities; and to keep counterfeit, expired, recalled, or otherwise harmful drugs out of the supply chain.

To remain compliant, serialization information must be included on each drug label. This information includes the National Drug Code (NDC), serial number, lot number, and expiration date.  

Another core mandate is transaction records, or T3 data. There are three components that make up T3 data: 

1. Transaction Information (TI) – Includes specific details like medication name, strength, lot number, and shipment information 
2. Transaction History (TH) – A record or documentation that shows details of all prior transactions of that specific medication 
3. Transaction Statement (TS) – A declaration that confirms medication was authorized, underwent DSCSA compliance, and that the seller believes the product is safe for use 

Healthcare systems and pharmacies must prepare to implement highly scalable and interoperable solutions to comply with these mandates. These electronic solutions must be able to capture and store a significant amount of information, including serialized data, for audit purposes. For example, should a medication be flagged as counterfeit, all trading partners are notified and must respond accordingly within 24 hours.

DSCSA-compliant software will be critical for patient care 

Ensuring the safety of prescription drugs contributes to better patient outcomes. When healthcare systems are compliant with DSCSA serialization and tracking requirements, patients are more protected from harm caused by counterfeit medications as well as drugs that have been recalled or deemed unsafe for use. This added layer of protection can help foster an environment of trust and confidence between patients and providers. 

Having the most up-to-date software systems to capture prescription drug traceability is a critical piece of the compliance puzzle that will set hospitals up for long-term success. Hospital systems have a critical decision to make when it comes to selecting software because not all options are created equal. DSCSA-compliant software systems must be interoperable, able to receive and store T3 data for a minimum of six years, and serve as a reliable tool within the hospital ecosystem.

Hospitals will benefit from upgrading to electronic systems that do more than just the bare minimum. To get ahead, they’ll need software that supports consistent interoperability and enhanced insights into medication status and supply across state lines, and even globally. 
 
In addition to software, utilizing RFID-tagged medications can alleviate some of the pressure that pharmacists face as they navigate enhanced regulations. With advanced RFID technology and software systems combined, pharmacists get:

• An added layer of safety and security, as RFID tags are more difficult to tamper with or counterfeit than a barcode, which helps to prevent drug diversion 
• Staff spending less time manually scanning barcodes and inputting information
• Visibility into medication location as they move through the pharmacy system
• The ability to capture all drug data in a centralized system, which is ideal for audits, usage trends, and reporting 

The DSCSA timeline for compliance is quickly approaching

As the final implementation deadlines grow near, healthcare systems and pharmaceutical supply chain partners that were formerly exempt from full DSCSA compliance are preparing to meet these standards. Trading partners are subject to different timelines based on their role within the supply chain:

• Manufacturers (e.g., Pfizer, Johnson & Johnson, Eli Lilly and Company, Fresenius Kabi) and Repackagers: May 27, 2025 
• Wholesale distributors (e.g., Cardinal Health, Cencora, McKesson): August 27, 2025 
• Dispensers (pharmacies) with 26 or more full-time employees: November 27, 2025 

With 2025 deadlines closing in, the time to update and upgrade hospital pharmacy systems is now. After these respective dates, non-compliance could result in fines, license suspension, and even criminal charges.

Learn more about how Intelliguard’s Mira Ecosystem can help hospitals go above and beyond meeting DSCSA compliance by delivering unprecedented inventory control through cloud-enabled software.