# 2026-19498: Tariff Waivers Unlock Rare Disease Drugs and Gene Therapies 2026-19498, Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals and Associated Pharmaceutical Ingredients and Technical Corrections to the Harmonized Tariff Schedule of the United States for Duties Imposed Under Proclamation 11020, is a Federal Register notice from Commerce Department, Industry and Security Bureau published 2026-09-23, effective 2026-09-23; PRIA reads it as touching household money (as of 2026-09-30). - Canonical: https://policyrisk.com/federal-register/2026-19498 - As of: 2026-09-30 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2026-19498 - Title: Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals and Associated Pharmaceutical Ingredients and Technical Corrections to the Harmonized Tariff Schedule of the United States for Duties Imposed Under Proclamation 11020 - Type: Notice - Agencies: Commerce Department; Industry and Security Bureau - Citation: 91 FR 60360 - Published: 2026-09-23 - Effective: 2026-09-23 - Comments close: not stated - Significant: no - Touches household money: yes - Regulation identifier numbers: 0694-XC15 - Last updated: 2026-09-30 ## In one line Tariff Waivers Unlock Rare Disease Drugs and Gene Therapies ## Summary Starting September 23, 2026, certain specialty medicines and their ingredients can enter the U.S. without extra tariffs if they come from approved countries or meet urgent health needs. This includes rare disease drugs, gene therapies, and medical countermeasures. The Department of Commerce also fixed some technical errors in the tariff rules and set up a way for the public to ask for urgent health need approvals. ## Abstract This notice defines the pharmaceutical products and lists the jurisdictions that are eligible to receive an ad valorem tariff rate of zero pursuant to Presidential Proclamation 11020 of April 2, 2026, "Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States," (Proclamation 11020). These pharmaceutical products include drugs and associated ingredients where all approved indications are designated as orphan; nuclear medicines; plasma derived therapies; fertility drugs; cell therapy product; gene therapy product; antibody drug conjugates; medical countermeasures related to chemical, biological, radiological, and nuclear threats; and animal health. Proclamation 11020 states that such products and associated ingredients receive the Section 232 zero tariff rate if they are products of a jurisdiction that has a current or forthcoming trade and security framework agreement or if they meet an urgent U.S. health need. This notice also includes procedures for the public to submit information for the Department of Commerce's (Commerce) approval to determine if imports of the pharmaceutical products and associated ingredients meet an urgent U.S. health need. This notice also issues five technical corrections to Annex I and one technical correction to Annex IV of the Proclamation. ## Effects PRIA read - Zero tariffs for certain specialty medicines: benefit, high. If you import or rely on certain specialty medicines, those products can qualify for a zero ad valorem tariff under Proclamation 11020 if they are in the listed categories and come from an eligible jurisdiction or meet an urgent U.S. health need. The eligible product categories named include orphan… - Which countries qualify for zero tariffs: benefit, medium. Products described in the rule are eligible for the zero tariff if they are products of one of the listed jurisdictions: Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, European Union, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, Republic of Korea, Switzerland and L… - How to request urgent-health-need tariff approval: benefit, medium. Companies can request Commerce approval for a zero tariff on a single patented specialty product if the import meets an urgent U.S. health need by emailing BIS at [email protected]; submissions are accepted on an ongoing basis starting September 23, 2026. Each application must include organization… - Zero duty for clinical-trial and R&D imports: benefit, medium. A new HTSUS heading 9903.04.70 provides an ad valorem tariff rate of zero for pharmaceutical products and associated ingredients that are solely for clinical trials, research and development, or other non-commercial uses. This change is effective for goods entered on or after 12:01 a.m. eastern tim… - Generic definition now includes unpatented animal products: benefit, medium. The rule amends the definition of 'generic pharmaceutical articles' (subdivision (c)(iii) for heading 9903.04.67) to specifically include 'unpatented animal health products.' Earlier in the notice the agency states Section 232 pharmaceutical tariffs do not apply to generic pharmaceutical products,… - Confidentiality protections for submissions: benefit, low. Commerce will protect confidential, trade secret, and proprietary information submitted in requests for urgent-health-need approvals to the fullest extent allowed by law, citing the Trade Secrets Act (18 U.S.C. 1905) and FOIA Exemptions 3 and/or 4. Commerce will limit dissemination of confidential… ## Related documents - [2026-20058](https://policyrisk.com/federal-register/2026-20058): Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request;…, 2026-09-30 - [2026-19927](https://policyrisk.com/federal-register/2026-19927): URAL Airlines JSC, Utrenniy Lane 1-g, Yekaterinburg, Russia 620025; Order Renewing Temporary Denial of Export Privileges, 2026-09-29 - [2026-19537](https://policyrisk.com/federal-register/2026-19537): Measures To Restrict Stockpiling of Polysilicon and Polysilicon Derivatives Under Proclamation 11052, 2026-09-24 - [2026-19019](https://policyrisk.com/federal-register/2026-19019): UTair Aviation JSC, Khanty-Mansiysk Airport, Tyumen Region, Russia 628012; Order Renewing Temporary Denial of Export Privileges, 2026-09-17 - [2026-19021](https://policyrisk.com/federal-register/2026-19021): Azur Air, Office 29, Vzletnaya St. 57, Krasnoyarsk, Russia 660020; Order Renewing Temporary Denial of Export Privileges, 2026-09-17 - [2026-19020](https://policyrisk.com/federal-register/2026-19020): PJSC Aeroflot, 1 Arbat St., 119019, Moscow, Russia; Order Renewing Temporary Denial of Export Privileges, 2026-09-17 ## Sources - [2026-19498 on federalregister.gov](https://www.federalregister.gov/documents/2026/09/23/2026-19498/guidance-and-procedures-for-implementing-tariff-adjustments-for-specialty-pharmaceuticals-and) - [2026-19498 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-09-23/pdf/2026-19498.pdf) ## Related - [Previous: 2026-19488, Notice of OFAC Sanctions Action](https://policyrisk.com/federal-register/2026-19488) - [Next: 2026-19489, Notice of Informal Presentation of Views](https://policyrisk.com/federal-register/2026-19489) - [All Federal Register documents](https://policyrisk.com/federal-register) Source: PRIA, https://policyrisk.com/federal-register/2026-19498 (as of 2026-09-30).