On April 2, the White House invoked Section 232 of the Trade Expansion Act, a law built for steel and aluminum, and applied it to medicine. Patented pharmaceuticals and their active ingredients now face a tariff of up to 100%. Generic drugs are excluded, at least for now.
The rollout happened in two waves. The 17 large manufacturers named in the proclamation's Annex III started paying on July 31. Every other importer of record starts paying on September 29, and on September 23, the Commerce Department published the guidance that determines how much.
Countries and trade blocs, including the EU, UK, Japan and India, identified as eligible for a 0% rate on specialty pharmaceutical products.
The carve-outs matter as much as the headline number
Commerce's September 23 notice defines which products count as specialty for the zero rate: drugs where every approved indication is designated orphan, nuclear medicines, plasma-derived therapies, fertility drugs, cell and gene therapies, antibody-drug conjugates, certain medical countermeasures and animal-health products. It also names the eligible jurisdictions, including the EU, UK, Japan, South Korea, India and Switzerland.
Devices are next in line, not exempt
The proclamation's own fact sheet flags medical consumables, medical equipment and devices, and robotics as sectors under active Section 232 investigation. A separate proclamation covering devices is possible in 2026 or 2027. Nothing about today's pharma-only scope should be read as permanent, and device manufacturers reviewing their own HTSUS exposure now would not be reviewing it too early.
Landed-cost models built before April 2 are wrong for any company with patented, non-onshored, non-specialty products crossing into the US. The gap between the 0% and 100% branches in this tree is the difference between a viable US launch and a withdrawn one.
What to watch
Watch which companies secure onshoring or MFN pricing commitments before their tariff exposure locks in, and watch whether the medical device investigation produces its own proclamation. Companies with combination products that mix a device and a drug should not assume today's pharma exemptions travel with them automatically.
Trade policy has become a market-access variable in its own right, not a backdrop to it. A regulatory-clear, reimbursement-ready product can still fail commercially if nobody modeled the tariff line. That planning now belongs in the same conversation as classification and evidence strategy, not after it.