New U.S. rules for comparator sourcing and what trial sponsors need to know

The journey to full implementation of the U.S. Drug Supply Chain Security Act (DSCSA) has taken over 10 years, with shifting deadlines and a huge operational effort across the healthcare supply chain. Now, with the final phase of DSCSA enforceable, sponsors and procurement teams face a new reality: mandatory traceability, serialization and sourcing integrity across the entire supply chain.

For international trial sponsors managing clinical trials across the U.S. and other regions, these requirements add complexity — and failing to comply risks more than regulatory penalties. Trials could be delayed, supply chains disrupted, and ultimately, patients could be left waiting for critical therapies.

“Many companies underestimate just how much goes into being DSCSA compliant,” says Christen McGowan, Director, Global Comparator Sourcing at Cencora. “It’s not a box to tick — it’s a rigorous standard that touches every point in the supply chain.”

A game-changer for international sourcing

DSCSA compliance is now a non-negotiable for any company moving clinical trial comparators into the U.S. Every product must be traceable from manufacturer to dispenser, with strict rules around authorized trading partners and serialized packaging. For global sponsors, this means ensuring that sourcing partners in their home markets meet U.S. standards — or risk products being held at the border.

And the impact isn’t limited to the U.S. As DSCSA-inspired regulations emerge worldwide, global trial sponsors will need partners that understand these complexities and can help them stay ahead. 

The risks of non-compliance

Working with non-compliant brokers or wholesalers can expose sponsors to significant risks:

• Regulatory delays that slow down trials and inflate costs
• Compromised product integrity, including exposure to counterfeit or substandard drugs
• Gaps in traceability that undermine patient safety and trial outcomes

“The temptation to save money by using third-party brokers is understandable,” says Christen. “But the cost of failure far outweighs the savings. When a comparator is worth hundreds of thousands per dose, you can’t take chances on integrity.”

A partner to simplify compliance

At Cencora, DSCSA compliance isn’t an afterthought — it’s built into every step of our comparator sourcing process. As one of the industry leaders helping to shape and operationalize DSCSA requirements, we’ve been at the forefront of readiness and implementation from day one. 

As an authorized distributor with global reach, we help sponsors:

• Reduce risk, by sourcing directly from verified, compliant manufacturers.
• Improve efficiency, with integrated sourcing, storage, transport, and documentation.
• Enhance reliability, through serialization, traceability and secure supply chains.

This means sponsors can source comparators with confidence — knowing their products are authentic, secure and fully compliant.

Looking ahead: The global ripple effect

While DSCSA is a U.S. regulation, its influence is already being felt globally. As more countries move towards harmonized standards, sponsors will need partners that can manage multiple regulatory frameworks with ease.

“Clinical trials are increasingly global,” Christen notes. “Working with a partner like Cencora means you’re prepared not just for today’s requirements, but for the standards that are coming next.”