A new U.S. Federal Register notice outlined how manufacturers can apply for company-specific “onshoring agreements” to reduce Section 232 pharmaceutical tariff burdens, but key eligibility questions remain unresolved as a June 12 submission deadline approaches. The Department of Commerce did not provide further exemption guidance, leaving firms uncertain about which products and supply-chain inputs fall under the highest tariff rates. The guidance implies that input materials for patented pharmaceuticals may still be tariffed, adding documentation and operational complexity for companies preparing applications under time pressure. The uncertainty also raises concerns about handling sensitive sourcing information. For biotech manufacturers and developers, the policy signal is less about immediate tariff relief and more about planning risk—where procurement, packaging, and regulatory filings must be coordinated before the window closes.