TariffsAPI
August 3, 2026

The 100% pharmaceutical tariff now applies to every company: the fact your HTS code can't tell you

Since September 29, 2026, the Section 232 duty on patented pharmaceuticals and their ingredients reaches every company, not just the 17 named in Annex III. The rate is 100%, 15% or 0% depending on origin, but only if the product is patented. Generics owe nothing under this action, and no HTS code says which one you import. Here is how to tell which side you are on, and why any single number for a covered line is an assumption you should check.

Checked against Proclamation 11020, its Annex I and the Commerce notice on the UK rate on September 14, 2026, and against Commerce’s technical corrections of September 23, 2026 on October 19, 2026. If a notice has changed since, the notice wins.

Since September 29, 2026, the Section 232 duty on patented pharmaceuticals applies to every company, not only the 17 named in Annex III.

The rate most people quote is 100%. For a lot of importers the right number is 15%, 0%, or no Section 232 duty at all. Which one is yours depends partly on country of origin, which your entry already carries, and partly on whether the product is patented, which it does not.

This guide covers what changed, how the rate is calculated, how to work out which side of the patent line you are on, and what to check in any duty figure you are given for these lines.

What changed on September 29

Proclamation 11020, signed April 2, 2026, puts a Section 232 duty on patented pharmaceuticals and their ingredients. Clause (4) sets two start dates for goods “entered for consumption, or withdrawn from warehouse for consumption”:

  • July 31, 2026 for the 17 companies listed in Annex III.
  • September 29, 2026 for other companies.

The test is the entry date, not the ship date. Anything entered on or after September 29 is inside the action, whenever it shipped.

The covered products are listed at ten digits in U.S. note 40(c) to chapter 99, across HTS chapters 29 and 30. A sibling code under the same eight digits can be outside it, so check the ten-digit numbers you actually file.

The rate depends on origin

Note 40 gives each origin group its own heading:

Origin Chapter 99 Rate How it is calculated
Everyone not listed below 9903.04.60 100% Total, including your Column 1 duty
EU member states, Japan, South Korea, Switzerland, Liechtenstein 9903.04.62 15% Total, including your Column 1 duty
United Kingdom 9903.04.63 +0% Added on top of Column 1

The UK rate was +10% in the proclamation. Commerce reduced it to +0%, effective July 31, 2026, in a notice published August 4 (FR Doc. 2026-15799), so UK goods have never owed the 10%.

Total, not on top

For 9903.04.60 and 9903.04.62, notes 40(d) and 40(f) say the Column 1 duty plus the additional duty equals the heading rate. Where Column 1 is already higher, no additional duty is due. Clause (7) of the proclamation states the same rule and excludes the UK by name.

Take 2918.99.30.00, a covered line with a Column 1 General rate of 6.5%:

Origin Section 232 part Total
Germany (9903.04.62) 8.5% 15%
A default origin (9903.04.60) 93.5% 100%

Germany is 15%, not 21.5%. If your landed-cost model adds 15% on top of the base, it over-quotes every dutiable EU and Japanese line by its Column 1 rate.

A free trade agreement does not take you out of it. Note 40(b) says these duties are collected in addition to any special rate you would otherwise claim.

The fact your HTS code can’t tell you

Clause (5) of the proclamation is one sentence: “Generic pharmaceuticals and their associated ingredients shall not be subject to tariffs pursuant to section 232 at this time.”

Note 40(c) draws the line, and neither side of it is a fact about classification:

  • Patented means subject to a valid, unexpired U.S. patent and listed in the FDA’s Orange Book or Purple Book, plus the ingredients for such articles.
  • Generic means FDA-approved, not subject to a valid, unexpired U.S. patent, and off exclusivity, and approved under one of four pathways: an ANDA (505(j)), a 505(b)(2) application deemed therapeutically equivalent to a listed drug, a 351(k) biosimilar application, or an authorized generic application. From September 29, 2026, an unpatented animal health product is generic too.

Straight after the fourth pathway the note adds “provided that the products are imported by a generic or biosimilar manufacturer.” It does not say whether that condition covers only authorized generics or all four. If you are not a generic or biosimilar manufacturer, ask your broker before you rely on the generic heading.

Two shipments under the same ten-digit code, from the same country, on the same day, can owe 100% and no Section 232 duty at all.

None of this happens by itself. CBP’s guidance (CSMS #69395344, updated by CSMS #70054007) requires every importer of a covered code to report one of the 9903.04.60 to .70 headings. A generic is entered under 9903.04.67, and the evidence for that heading is yours to keep.

The same line decides a second duty. The Section 301 forced-labor action, in U.S. note 52(f)(8), does not apply to “patented pharmaceutical articles provided for in headings 9903.04.60–9903.04.66.” A generic or a non-pharmaceutical article is outside that exemption, so check whether the forced-labor duty reaches your code on its own terms. Generic means no Section 232 duty, not necessarily no duty.

Which side are you on

Work through it in this order. The headings are mutually exclusive, and note 40(a) makes 9903.04.60 the default “unless another of these headings applies.”

  1. Is it a pharmaceutical article at all? Only finished pharmaceutical products and their active ingredients (with the key starting materials for those ingredients) are. Inactive ingredients and excipients are not, whatever their code. Anything that is not goes under 9903.04.69. No Section 232 duty.
  2. Is it solely for clinical trials, research and development, or other non-commercial use? Then 9903.04.70, a heading added from September 29, 2026. No Section 232 duty.
  3. Is it generic, as defined above? Then 9903.04.67. No Section 232 duty.
  4. Is it neither patented nor generic? Then 9903.04.69 as well, under the second branch of note 40(i). No Section 232 duty.
  5. Does your company or product meet a condition that changes the rate? Three headings apply to patented articles when it does. They are in the table below.
  6. None of the above, and the product is patented? Then the origin table applies: 100%, 15%, or +0% for the UK.
Heading Rate Condition
9903.04.64 +20% Imported for a company with an onshoring plan approved by Commerce. The proclamation raises it to 100% on April 2, 2030. The heading prints the rate as +20% on top of Column 1; clause (7) of the proclamation reads as if 20% were the total. The two readings differ only on lines with a Column 1 duty. CBP said on July 30 that, per Commerce, no company was yet eligible.
9903.04.65 +0% An approved onshoring plan and a Most-Favored-Nation pricing agreement with HHS. The schedule deletes it on January 20, 2029.
9903.04.66 +0% Orphan-designated drugs, nuclear medicines, plasma-derived therapies, fertility treatments, cell and gene therapies, antibody drug conjugates, certain medical countermeasures, animal health products and other specialty products Commerce identifies, from a jurisdiction with a trade and security framework or meeting an urgent U.S. health need. Commerce named the eligible jurisdictions in its notice of September 23, 2026 (FR Doc. 2026-19498) and may change the list by a later notice, so check the current one. The product still has to be in one of the categories.

Each of these turns on a Commerce plan, agreement or notice about your company or product. Separately, the proclamation ratified 13 company-specific agreements in its Annex II, which set their own terms.

Some products fit neither definition: one with a valid patent but no Orange Book or Purple Book listing, or one off patent but still under exclusivity. Until September 29 the text left them in a gap. Commerce’s corrections closed it: from that date note 40(i) sends a pharmaceutical article that is neither patented nor generic to 9903.04.69, with no Section 232 duty. Whether your product is one of them is still a question of fact, and one for your customs broker.

Any single number for these lines is an assumption

A duty lookup, ours included, works from what an HTS code, a country of origin and a date can tell it. Patent status is none of those. It is a fact about the product, held by the importer, and no tariff code can carry it. So for a covered line there is not one answer but at least two:

Line Origin If patented If generic
3004.90.92.76 India 100% total, under 9903.04.60 No Section 232 duty, under 9903.04.67
2918.99.30.00 Germany 15% total, under 9903.04.62: 8.5% on a 6.5% base No Section 232 duty, under 9903.04.67

Both columns are correct. They describe different products under the same code. Any tool that gives you one number for a covered line, whether a calculator, a broker’s spreadsheet or an API, has picked a column for you. Find out which one.

What our API returns for these lines

Our API does not pick a column. For a covered line entered on or after September 29, a lookup returns both branches in rate_conditional: the patented branch under your origin’s heading, and the generic branch under 9903.04.67. Each branch names its heading, its Section 232 rate and any other duty that applies on that branch only, such as a forced-labor duty that is relieved for a patented article and owed on a generic one. No single total is stated: total_resolved_ad_valorem_rate is null and total_declined_reason is scope_attribute, and the response carries a SCOPE_ATTRIBUTE_REQUIRED warning. The one exception is a line where both branches owe the same duties on a plain percentage column 1 rate, for example a United Kingdom line on which no Section 232 or forced-labor duty applies either way: there the total is stated, served is "patented" and both branches stay in rate_conditional. Duties that apply either way stay in additional_measures. Which branch is yours is the one fact you supply.

When you get a duty figure for a covered pharmaceutical line, check:

  1. Which side of the patent line it assumed. If it does not say, do not assume either one.
  2. Whether your product is on that side. Only you, or your regulatory team, can answer that, and it is your evidence at entry.
  3. Whether it asked at ten digits. Coverage is listed line by line. An answer for an eight-digit subheading like 3004.90.92, which holds both covered and uncovered lines, cannot be right for all of them.
  4. Which date it used. A covered line before September 29 and the same line after are different answers for most companies.
  5. Which company conditions it ignored. Annex III, an Annex II agreement or an approved onshoring plan change the rate, and none of them is visible in a code.
  6. What else it stacked. Generic means no Section 232 duty, but the forced-labor duty and any other duty on the line still has to be checked on its own terms.

What to do now

  1. List your covered lines at ten digits. Match the codes you file against note 40(c), not the chapter or the subheading.
  2. Split each covered line by patent status. Patent and Orange Book or Purple Book facts sit with regulatory affairs, not logistics. Keep the evidence; you are the one declaring the heading.
  3. Check your supplier and your own company. Is either named in Annex III, party to an Annex II agreement, or holding an approved onshoring plan?
  4. Test your arithmetic on one dutiable EU or Japanese line. If it produces base plus 15%, it is wrong.
  5. Check every entry made since September 29. Each covered line needed one of the 9903.04.60 to .70 headings, and the heading you reported has to match the evidence you hold.
  6. Watch the Federal Register. The UK rate has already moved once, the specialty-product jurisdictions can change by notice, and the onshoring and pricing-agreement lanes depend on Commerce decisions about named companies.

Common questions

When did the Section 232 pharmaceutical tariff start? For goods entered on or after September 29, 2026, for all companies other than the 17 listed in Annex III of Proclamation 11020. Those 17 have been subject since July 31, 2026.

What is the Section 232 tariff rate on pharmaceuticals? For patented products, 100% under heading 9903.04.60 by default and 15% for products of the EU, Japan, South Korea, Switzerland and Liechtenstein under 9903.04.62, both as totals including the Column 1 duty, and +0% for the United Kingdom under 9903.04.63.

Are generic drugs subject to the Section 232 pharmaceutical tariff? No. Clause (5) of Proclamation 11020 excludes generic pharmaceuticals and their ingredients “at this time,” and heading 9903.04.67 carries no additional duty. Generic has a specific meaning in note 40(c), tied to patent status, exclusivity and the FDA approval pathway.

Can I tell from the HTS code whether my product owes the duty? Only whether its code is covered. Whether it owes 100%, 15% or nothing also depends on whether the product is patented or generic, which no HTS code records.

Is the 15% rate added to the normal duty? No. For the EU, Japan, South Korea, Switzerland and Liechtenstein, 15% is the total including the Column 1 duty. A line with a 6.5% base pays 8.5% under Section 232.

Sources

Proclamation 11020 of April 2, 2026, published April 9, 2026, 91 FR 18183 (FR Doc. 2026-06956): clauses (3) through (8) for rates, dates, generics and the total-rate rule; Annex I for U.S. note 40 and headings 9903.04.60 through 9903.04.69; Bureau of Industry and Security, technical corrections to the HTSUS for Proclamation 11020, published September 23, 2026, 91 FR 60360 (FR Doc. 2026-19498), effective September 29, 2026, for heading 9903.04.70, the amended note 40(c)(i), (c)(iii) and (i), and the jurisdictions eligible under heading 9903.04.66; Annexes II and III for the agreements and the July 31 companies. The Federal Register prints the annexes as images; the White House published them as text. Bureau of Industry and Security, Notice of Reduction of Tariffs on Patented Pharmaceuticals and Pharmaceutical Ingredients for Products of the United Kingdom, published August 4, 2026, 91 FR 49406 (FR Doc. 2026-15799). CBP CSMS #69395344, July 30, 2026, for the reporting requirement and the onshoring eligibility note. USTR’s Section 301 forced-labor final action (FR Doc. 2026-15181), Annex I part B, for note 52(f)(8). Column 1 rates from the USITC Harmonized Tariff Schedule.

We report duties on codes you already have. We do not classify products, and we do not decide whether your product is patented.

Related: how tariff stacking works, our Section 232 reference, and the data changelog.