Commerce/BIS guidance implementing Section 232 pharmaceutical tariff adjustments: zero-rate eligibility for specialty pharmaceuticals and HTSUS technical corrections (91 FR 60360)
The Bureau of Industry and Security (BIS) issued implementation guidance for Presidential Proclamation 11020 (April 2, 2026 Section 232 pharmaceutical proclamation imposing a 100% ad valorem tariff on certain patented pharmaceuticals and associated ingredients, effective September 29, 2026 for all companies other than those listed in Annex III) (91 FR 60360): (1) it defines the specialty pharmaceutical categories eligible for a 0% ad valorem rate under clause 3(d) — orphan drugs, nuclear medicines, plasma derived therapies, fertility drugs, cell therapy products, gene therapy products, antibody drug conjugates, CBRN medical countermeasures, and animal health products; (2) it lists 19 eligible jurisdictions (EU, UK, Japan, Korea, Switzerland and Liechtenstein, Taiwan, India, Indonesia, Vietnam, Thailand, Malaysia, etc.), subject to change in future notices; (3) it sets out an individual, fact-specific approval process for imports meeting an urgent U.S. health need (pharma232@bis.doc.gov, 10-digit HTSUS classification required, rolling submissions, limited to patented products under Annex I codes); and (4) it makes HTSUS technical corrections: new heading 9903.04.70 (pharmaceutical articles and associated ingredients solely for clinical trials, R&D, or other non-commercial applications, at applicable subheading duty + 0%), U.S. note 40 subdivision (a) range revised to 9903.04.60-9903.04.70, subdivision (c) list replaced with 149 HTSUS codes (incorporating the July 1, 2026 HTSUS changes), clarified definitions of pharmaceutical articles/generic pharmaceutical articles (the latter now covering unpatented animal health products), and Annex IV updated with 521 codes while removing 5 codes overlapping Annex I. Effective for entries for consumption, or withdrawal from warehouse for consumption, on or after 12:01 a.m. ET September 29, 2026.
Scope
HTSUS chapter 99 subchapter III: new heading 9903.04.70 (0%); definition/text corrections to 9903.04.67 and 9903.04.69; 149 codes in U.S. note 40 subdivision (c); Proclamation 11020 Annex IV updated with 521 codes (overlapping codes removed: 2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00, 3004.49.00) (670)
Old → new values
| Item | Old value | New value |
|---|---|---|
| New heading 9903.04.70 for pharmaceutical articles and associated ingredients solely for clinical trials, R&D, or other non-commercial applications | No dedicated heading (captured under 9903.04.69 and related provisions) | The duty provided in the applicable subheading + 0% |
| U.S. note 40 subdivision (a) heading range | 9903.04.60-9903.04.69 | 9903.04.60-9903.04.70 |
| Definition of "generic pharmaceutical articles" (U.S. note 40 (c)(iii), heading 9903.04.67) | APIs or components in drug/biosimilar products approved under a qualifying application | Expanded to include "unpatented animal health products" |
| Overlap cleanup between Proclamation 11020 Annex IV and Annex I | Annex IV contained codes overlapping Annex I | Removed 5 overlapping codes: 2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00, 3004.49.00 |