On April 16, 2025, the U.S. Department of Commerce announced a new Section 232 national security investigation focused on the imports of pharmaceuticals and pharmaceutical ingredients, including active pharmaceutical ingredients (APIs), finished drug products, medical countermeasures, and key starting materials.

What’s a Section 232 investigation?

For those unfamiliar, Section 232 of the Trade Expansion Act of 1962 allows the U.S. government to investigate whether certain imports pose a national security risk. If they do, the president can impose tariffs, quotas, or other restrictions. While we’ve seen this used for steel, aluminum, and autos, this is a rare move in the pharmaceutical space—and it’s one to watch closely.

Why It Matters

This investigation could lead to significant trade restrictions on imported pharma inputs. Importing APIs, excipients, or even finished dosage forms could impact cost, availability, and your broader supply chain strategy.

The Department of Commerce is specifically looking for information on:

• U.S. demand for pharma ingredients (now and in the future)
• The capacity of U.S. manufacturers to meet that demand
• How much we rely on foreign suppliers, and where those suppliers are concentrated
• Foreign subsidies and trade practices that distort pricing
• The feasibility of increasing U.S. production
• Whether new tariffs or trade measures are needed to protect the sector

How to Comment

If you have a stake in the pharmaceutical supply chain—this is your opportunity to weigh in. You can submit comments directly through Regulations.gov – Docket BIS-2025-0022. The deadline is May 7, 2025.

They’re accepting comments, data, case studies, or other input. If submitting anything confidential, ensure it’s marked and accompanied by a public version.

What You Can Do Now

• Review your supply chain and assess exposure
• Gather data to support a comment if appropriate
• Monitor for further developments—this could move quickly
• Consult with your broker, legal team, or compliance advisor

Marken stays committed to supporting clients in navigating the regulatory and trade landscape of the global clinical supply chain. For more information or if you have any questions, contact our team at TradeCompliance@marken.com.