Counterfeiting, product recalls, and supply chain disruptions are on the rise, meaning regulatory compliance is a non-negotiable for pharmaceutical companies. At the heart of that compliance sits one critical component: labeling. And when it comes to regulations like the U.S. Drug Supply Chain Security Act (DSCSA), the quality and accuracy of your labeling and artwork management processes could mean the difference between smooth operations and costly non-compliance.
What Is the DSCSA?
The Drug Supply Chain Security Act (DSCSA) is a U.S. federal law introduced in 2013 that aims to protect consumers from counterfeit, contaminated, or otherwise unsafe drugs. Its ultimate goal? To create an electronic, interoperable system that can trace prescription drugs throughout the entire supply chain.
Here’s what DSCSA requires in a nutshell:
- Every package and case of prescription drugs must carry a unique identifier
- Companies must be able to track and trace every unit across the supply chain at the unit-level
- Businesses need to verify the product’s legitimacy before it’s sold or returned
- Information about products must be shared digitally between supply chain partners
This regulation affects every player in the pharma supply chain—manufacturers, repackagers, distributors, and dispensers. And while much of the attention has focused on serialization and data exchange, one essential component is often overlooked: the role of labeling and artwork management in achieving DSCSA compliance.
Why Labeling Matters Under DSCSA
A label isn’t just a regulatory box to tick, it’s the vehicle for the serialized data that DSCSA requires and a critical touchpoint for verifying authenticity and ensuring supply chain continuity.
If your labels are:
- Inconsistent across products or facilities
- Incorrect due to manual entry
- Not linked to an audit trail
- Unable to adapt quickly to new regulations
…then you’re putting your business at serious risk.
What’s more, if you're still managing labeling processes manually or across disconnected systems, the chances of non-compliance skyrocket. Errors in serialization, mislabeling, or delays in label changes can lead to serious consequences, from major delays in getting products to market to recalls and fines, and not to mention the serious risk to consumers.
Why 2025 Is the Turning Point
With the DSCSA enforcement deadline now in full effect, 2025 is the year organizations will either succeed or stumble depending on their labeling and artwork process. And that’s not just about DSCSA. It’s about the future of supply chain compliance. The growing complexity of global regulations, such as the EU MDR, UKCA marking, and ESG reporting, means pharma companies must adopt a future-proof labeling strategy. Relying on manual methods or fragmented platforms simply doesn't cut it anymore.
The Solution: Digitization
Digitizing your labeling and artwork management process is a game-changer for compliance. A centralized, cloud-based platform like Kallik’s Veraciti™ empowers organizations to create and manage labeling and artwork with complete consistency and accuracy across the globe. By replacing manual processes with AI and automation tools, businesses can significantly reduce the risk of errors while increasing efficiency and, therefore, speed-to-market. Plus, every action and change is tracked in a full audit trail, giving companies the traceability they need to meet strict pharmaceutical regulations with confidence. With Veraciti, labeling is no longer a stressful, monotonous task, but a powerful tool for driving transparency, accountability, and operational efficiency across the entire supply chain.
Understanding the Future of Supply Chains: Download the New Guide
If your organization is struggling with compliance, our experts are ready to help. Our new guide, “A Supply Chain Director’s Guide to Labeling in 2025,” explores how to future-proof your supply chain with AI, automation, blockchain, and other technologies that go far beyond DSCSA.
Download the guide today to learn how you can:
- Eliminate compliance risks with smarter labeling
- Improve traceability across multi-region supply chains
- Reduce costs, errors, and time-to-market
Don’t let outdated labeling processes hold you back from DSCSA compliance. The future of pharmaceutical supply chains depends on transparency, accuracy, and agility, and it all starts with your labels. Want to know more about digitizing your labeling process? Speak to one of our experts on +44 (0) 1827 318100, email enquiries@kallik.com or click here to book a demo.