The Trump administration has released detailed guidance regarding specialty pharmaceutical tariff exemptions for products including orphan treatments, nuclear medicines, cell and gene therapies, and antibody-drug conjugates (ADCs). Effective September 29, 2026, these rules allow specific drug classes to enter the United States duty-free, bypassing broad 100% Section 232 tariffs on patented pharmaceutical products and ingredients. Developed by the Department of Commerce in consultation with the FDA and USDA, the guidance clarifies that eligibility for a 0% tariff rate is contingent upon meeting strict clinical and jurisdictional criteria.
Under the new framework, orphan therapies are only exempt if all of their approved indications carry the “orphan” designation. The exemptions also cover nuclear medicines, plasma-derived therapies, fertility drugs, and medical countermeasures. The cell and gene therapy category includes cellular immunotherapy, autologous or allogeneic cellular products, and stem cell products. Notably, the Commerce Department added antibody-drug conjugates to the exempt list, providing a significant benefit to manufacturers such as Daiichi Sankyo and AstraZeneca, whose HER2-targeted breast cancer treatment, Enhertu, is the world’s top-selling ADC.
Jurisdictional Requirements and Compliance
To qualify for these specialty pharmaceutical tariff exemptions, products must originate from one of 19 distinct jurisdictions, which include the European Union, India, Japan, South Korea, Switzerland, and the United Kingdom. Products from China are notably excluded from this list, although the Commerce Department stated the list may be subject to future revisions. Manufacturers sourcing from outside these 19 jurisdictions may only request separate exemptions by demonstrating an urgent U.S. public health need, supported by data on the disease treated, patient population size, and a lack of alternative therapies.
The implementation of Section 232 tariffs follows the expiration of a grace period for all drugmakers that have not signed “most favored nation” (MFN) drug pricing deals. Seventeen large pharmaceutical companies previously secured exemptions until early 2029 by signing MFN accords, and nine mid-sized foreign firms reached similar agreements last month. For all other importers, the tariffs are now active, necessitating careful assessment of on-shoring plans, pricing commitments, and supply chain variables to manage exposure as the administration continues its review of the pharmaceutical sector, including generic medications.
