The U.S. Department of Commerce has released a formal notice detailing specific exemptions from Section 232 tariffs on patented pharmaceuticals, technical updates to the Harmonized Tariff Schedule (HTS), and the process for filing exclusion requests based on urgent health needs.
The technical corrections take effect September 29, while exemption submissions open September 23.
Qualifying Categories and Reciprocal Partner Countries
Under the initial presidential proclamation, imported pharmaceuticals may qualify for a zero-percent tariff rate across several defined categories, including:
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Orphan drugs and associated ingredients (where all approved indications hold orphan designation)
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Plasma-derived therapies
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Cell and gene therapy products
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Antibody-drug conjugates
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Nuclear medicines and fertility drugs
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Medical countermeasures for chemical, biological, radiological, and nuclear threats
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Animal health products
Zero-rate treatment applies automatically to qualified imports originating from trade partners with reciprocal tariff agreements with the United States. Eligible jurisdictions include:
Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union member states, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, South Korea, Switzerland and Liechtenstein, Taiwan, Thailand, the United Kingdom, and Vietnam.
Filing for Urgent Health Need Exemptions
Importers sourcing qualifying products from non-reciprocal countries can still request tariff relief if the goods address an urgent health need.
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Where to Submit: Email requests to the Bureau of Industry and Security (BIS) at [email protected].
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Required Details: Importer identification, complete product specifications, and supporting rationale demonstrating why the import satisfies an urgent public health requirement.
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Review Process: Commerce evaluates petitions on a case-by-case, company-specific basis and provides written determinations. Approved adjustments will be coordinated directly with U.S. Customs and Border Protection (CBP) for entry summary processing. CBP reserves the right to request supporting documentation upon entry.
HTS Technical Corrections and Definitions
The Commerce notice also establishes key structural revisions to Chapter 99 of the HTS:
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New Subheading 9903.04.70: Established for imports intended solely for non-commercial applications, including clinical trials and research & development.
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Refined Definition of “Pharmaceutical Articles”: Clarified to cover strictly finished pharmaceutical products, active pharmaceutical ingredients (APIs), and key starting materials (KSMs) used to produce those APIs.
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Expanded Definition of “Generic Pharmaceutical Articles”: Amended to include unpatented animal health products.
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Subheading 9903.04.69 Clarification: Notes that this provision captures imported items classified under tariff lines covered by the measure that do not meet the finished drug, API, or KSM definitions.
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Annex Adjustments: Resolves duplicate classifications between tariff schedules and aligns with July 1 statistical reporting updates. Subheadings 2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00, and 3004.49.00 have been officially removed from the zero-tariff Annex IV list.
Importers and customs brokers should audit current pharmaceutical supply chains, verify country-of-origin eligibility against the reciprocal partner list, and prepare exemption dossiers where necessary ahead of entry filings.
