Section 232 Pharmaceutical Tariffs: Patented, Generic and the 9903.04 Headings

What are the Section 232 pharmaceutical tariffs?

They are duties imposed by Proclamation 11020 of April 2, 2026 on patented pharmaceuticals and their active ingredients: 100 percent by default (Column 1 duty plus Section 232 combined), 15 percent for Japan, the EU, South Korea, Switzerland and Liechtenstein, 0 percent added for the UK, 20 percent for approved onshoring plans and 0 percent for listed specialty products. They apply from July 31, 2026 for companies listed in Annex III and from September 29, 2026 for all others.

Do generic drugs pay the Section 232 pharmaceutical tariff?

No. The proclamation states that generic pharmaceuticals and their ingredients, biosimilars included, "shall not be subject to tariffs pursuant to section 232 at this time." Importers of covered lines still report heading 9903.04.67, which adds no duty.

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TL;DR

The Section 232 pharmaceutical tariffs cover 149 ten-digit HTS lines in Chapters 29 and 30, listed in U.S. note 40(c) to Chapter 99. Every entry on one of those lines reports exactly one heading from 9903.04.60 to 9903.04.70, and the heading, not the HTS code, decides whether the duty is 100 percent, 15 percent or nothing. For a pharmaceutical importer bringing in 60 SKUs from four origins, that is one patent check, one origin check and one company check per line. GingerControl's Tariff Calculator shows the base rate and each Section 232 and 301 line for an HTS code, value and entry date.

Verified against Proclamation 11020, the Commerce notices of August 4 and September 23, 2026, CBP CSMS 70054007 and the USITC HTS (Revision 21) on October 15, 2026. Commerce can still change rates, companies and jurisdictions by notice; recheck before you file.

What did Proclamation 11020 impose on pharmaceuticals?

Proclamation 11020 was signed April 2, 2026 and published April 9, 2026 at 91 FR 18183 ^[1]. It rests on a Commerce finding under 19 U.S.C. 1862 that imports of pharmaceuticals and their ingredients threaten to impair national security. The proclamation records the import dependence behind that finding: according to the FDA, as of 2025 "approximately 53 percent of patented pharmaceutical products distributed domestically are produced outside the country," and the proclamation adds that "only 15 percent of patented APIs by volume" are produced domestically for the U.S. market.

The duty reaches three things, defined in U.S. note 40(c) as amended effective September 29, 2026 ^[3][5]:

• Pharmaceutical articles: finished pharmaceutical products, their active pharmaceutical ingredients and the key starting materials for those ingredients, when classified in one of the listed Chapter 29 or 30 provisions. Inactive ingredients and excipients are not pharmaceutical articles.
• Patented pharmaceutical articles: pharmaceutical articles "subject to a valid, unexpired U.S. patent" and listed in the FDA Orange Book or Purple Book, plus their ingredients.
• Generic pharmaceutical articles: FDA-approved articles that are off patent and off exclusivity, approved under an ANDA, a therapeutically equivalent 505(b)(2) application, a 351(k) biosimilar application or an authorized generic application, plus unpatented animal health products.

The rate is set as a combined rate. Clause 7 of the proclamation says the Section 232 duty plus the Column 1 duty equals the listed rate, and where the Column 1 rate is already higher, only the Column 1 rate applies. The UK tier is the exception: it is written as an additional duty on top of the Column 1 rate. If more than one rate could apply, clause 8 says "the lowest applicable rate shall apply."

The classification question comes first. Whether an article falls in one of the 149 listed lines depends on its HTS subheading, and the pharmaceutical HTS classification guide covers how APIs and finished dosage forms are classified before any Chapter 99 heading is chosen.

Which 9903.04 heading applies, and at what rate?

U.S. note 40(a) makes the headings "mutually exclusive, such that an imported article will be subject to no more than one of these headings," and pharmaceutical articles fall to 9903.04.60 unless another heading applies ^[5]. CBP's guidance says that from July 31, 2026 all importers of the covered Chapter 29 and 30 lines "are required to report an applicable Chapter 99 HTSUS classification," regardless of company ^[7].

Bottom line: For a compliance team holding a list of Chapter 29 and 30 SKUs, the work is choosing one heading from 9903.04.60 to 9903.04.70 per line, and eight of the eleven add no Section 232 duty. The duty depends on three facts the HTS code does not carry: patent status, origin and the company behind the product.

CBP's July 30, 2026 guidance noted that no company with a qualifying onshoring plan was yet eligible for 9903.04.64 ^[7]. Commerce set the onshoring application procedure at 91 FR 26989 on May 13, 2026, with applications requested by June 12, 2026 ^[2]. Check the current CBP guidance before filing under 9903.04.64 or 9903.04.65; under U.S. note 40(h), eligibility rests on the Secretary of Commerce notifying CBP of each agreement.

For the specialty heading 9903.04.66, the eligible jurisdictions Commerce listed on September 23, 2026 are Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, the Republic of Korea, Switzerland and Liechtenstein, Taiwan, Thailand, the United Kingdom and Vietnam ^[3]. A product from elsewhere qualifies only through a company-specific Commerce approval for an urgent U.S. health need, requested by email to BIS with one product per application.

How does the combined rate work on a real entry?

The combined rate changes the arithmetic depending on the Column 1 rate. Take a $200,000 entry of a patented active ingredient classified in 2933.59.53, a listed line with a Column 1 general rate of 6.5 percent, and a $200,000 entry of a patented finished medicine in 3004.90.92, where the Column 1 rate is Free ^[5].

Bottom line: For an importer of patented APIs with a positive Column 1 rate, the default tier costs the same 100 percent as a duty-free finished product; the Column 1 duty is absorbed, not added. Only the UK tier stacks on top of Column 1. Merchandise processing fees and any other Chapter 99 layers are outside this table.

A free trade agreement claim does not change this: U.S. note 40(b) says the duties in headings 9903.04.60 to 9903.04.68 "shall be collected in addition to any special rate of duty otherwise applicable" under the agreements and programs in general note 3(c)(i) ^[5]. The way these layers sit on top of each other generally is explained in the guide to how tariff stacking works.

What happened on July 31 and September 29, 2026?

Clause 4 of the proclamation set two start dates, both at 12:01 a.m. eastern time, for goods entered for consumption or withdrawn from warehouse ^[1]:

1. July 31, 2026: the duties began for products of the companies listed in Annex III. On the same date, CBP required every importer of a covered line to report a 9903.04 heading. Products of all other companies entered under 9903.04.61 with no Section 232 duty through September 28, 2026 ^[7]. Also on July 31, the UK rate under 9903.04.63 dropped from 10 percent to 0 percent, after Commerce found that the U.S.-UK pharmaceutical pricing arrangement's requirements were being met (91 FR 49406, published August 4, 2026) ^[4].
2. September 29, 2026: the duties began for all other companies, and 9903.04.61 stopped applying. Commerce's September 23, 2026 notice also took effect that day: it added 9903.04.70 for clinical trial and research use, clarified that "pharmaceutical articles" covers only finished products, their APIs and key starting materials, not inactive ingredients or excipients, added unpatented animal health products to the generic definition, and removed five codes (2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00 and 3004.49.00) from the proclamation's Annex IV, where they overlapped with Annex I ^[3].

Annex III names the companies; it is printed as an image in the Federal Register, so confirm a company against the proclamation itself or with CBP's Trade Remedy Branch. Since September 29, the company split matters only for the reduced-rate headings, because every company's patented products are now in scope.

Every other Section 232 product is in the Section 232 tariff rates by product reference; this page covers the pharmaceutical row in depth.

Are generic pharmaceuticals subject to Section 232 tariffs?

No, not at this time. The proclamation says so twice. Paragraph 11 records the decision "not to adjust imports of generic pharmaceuticals and their associated ingredients, including biosimilar products," including purchases for the Strategic API Reserve. Clause 5 directs that generics "shall not be subject to tariffs pursuant to section 232 at this time" ^[1]. Commerce's September 23 notice repeats it: "Section 232 Pharmaceutical Tariffs do not apply to generic pharmaceutical products and associated ingredients" ^[3].

Three qualifications matter for a generics importer:

• The heading is still required. A generic on a covered line reports 9903.04.67. Omitting it misses CBP's reporting requirement even though no duty results.
• "Generic" is a defined term. It turns on the FDA approval pathway and on being off patent and off exclusivity, as set out in note 40(c)(iii). An authorized generic qualifies only when imported by a generic or biosimilar manufacturer.
• The position has a review date. Clause 5 requires the Secretary of Commerce to report to the President within one year of April 2, 2026 on any circumstances that might call for action on generics. That is a review, not an announced tariff.

An article that is a pharmaceutical article but neither patented nor generic, for example an unpatented product not approved through a generic pathway, falls to 9903.04.69, which also adds no duty.

How do pharmaceutical tariffs interact with the Section 301 forced labor duty?

The Section 301 forced labor duties in headings 9903.05.20 to 9903.05.84 apply to goods entered on or after July 24, 2026 (91 FR 47318) ^[8]. Three exemptions in U.S. note 52 reach pharmaceutical lines, and they work differently:

Bottom line: For an importer of patented products, note 52(f)(8) settles the forced labor question through the 9903.04 heading. For generics, research material and non-pharmaceutical chemicals on the same lines, the answer depends on which list the HTS line sits on and, for 52(e), on how the article is used.

The 52(f)(8) exemption was added by Annex I, Part B of the USTR notice, effective for goods entered on or after 12:01 a.m. eastern time on July 31, 2026 ^[8]. The detailed map of the 9903.05 country and exemption headings is in the 9903.05 headings by country reference. Note 52(f)(8) concerns the forced labor action only; it says nothing about other Section 301 actions.

Quotable insight: Of the 149 ten-digit lines listed in U.S. note 40(c), 101 sit in provisions on note 52(b)'s unconditional exemption list and 48 sit in provisions on note 52(e)'s list, which applies only to articles for use in pharmaceutical applications (comparison of HTS Revision 21 text, October 15, 2026). For those 48 lines, the forced labor duty can turn on the same fact that decides 9903.04.69: whether the chemical is used in medicine at all.

A worked case from the text: a generic API in 2933.59.53, a product of India, for use in making a finished drug, reports 9903.04.67 and 9903.05.89 and pays the 6.5 percent Column 1 rate. The same chemical imported for a non-pharmaceutical use is not a "pharmaceutical article," so it reports 9903.04.69, cannot use 9903.05.89, and on the face of the notes carries India's forced labor heading 9903.05.44 at an added 10 percent, for 16.5 percent in total. Confirm the end-use facts and the heading choice with your licensed broker before filing.

What should an importer check on every pharmaceutical line?

For one product, the USITC HTS search and CBP's attachment to CSMS 70054007 are enough. Across a catalog, run the same checks line by line:

1. Classify the article. Confirm the 10-digit subheading and whether it is one of the 149 lines in note 40(c).
2. Decide what the article is. Finished product, API or key starting material, or an excipient or non-pharmaceutical article that goes to 9903.04.69.
3. Check patent and approval status. Orange Book or Purple Book listing and an unexpired U.S. patent point to the patented headings; an ANDA, biosimilar or other qualifying approval points to 9903.04.67.
4. Check origin and company. Origin decides 9903.04.62 and 9903.04.63; Commerce's notifications to CBP decide 9903.04.64, 9903.04.65 and urgent-need approvals under 9903.04.66.
5. Check use. Clinical trial and research shipments go to 9903.04.70; the 52(e) forced labor exemption needs a pharmaceutical use.
6. Date the entry. The July 31 and September 29, 2026 start dates and the UK change all turn on the time of entry or withdrawal from warehouse.
7. Plan for drawback and FTZ. Clause 10 makes drawback available on these duties, and clause 13 requires covered goods admitted to a foreign trade zone after the effective date to take privileged foreign status ^[1]. The manufacturing drawback guide covers how Section 232 duty drawback claims are built.

Entries filed under 9903.04.60 where a lower heading applied, or Section 232 duty paid on exported product, can leave money on the table. GingerControl identifies and documents the opportunity; your licensed broker or counsel files.

Putting the 9903.04 decision into your entry review

The pharmaceutical tariffs turn on facts outside the HTS code. GingerControl's Tariff Calculator takes an HTS code, value and entry date and compares U.S. import duty by country, with the base rate, each Section 232 and 301 line, MPF and HMF; it prices the layers in effect on the entry date you enter, and GingerControl updates the rates whenever the official rates change. The patent, company and use facts behind the heading choice stay with the importer and its licensed broker.

For manufacturers with large product lines, GingerControl builds GingerOS, the AI trade compliance platform that runs on your process: it checks every SKU against a new rule, such as a Section 232 notice, and lists the ones it hits.

References

1. Federal Register, Proclamation 11020 of April 2, 2026, "Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States"
   Data cited: 100%, 20%, 15% and UK rates; specialty 0% rate; effective dates for Annex III and other companies; generics not subject; combined-rate rule; lowest-rate rule; drawback; U.S.-origin exclusion; FTZ status; FDA import-reliance figures
   Source: 91 FR 18183, FR Doc. 2026-06956
   Published: April 9, 2026
2. Federal Register, Bureau of Industry and Security, "Procedures To Apply for Company-Specific Onshoring Agreements To Obtain Tariff Adjustments for Pharmaceuticals and Pharmaceutical Ingredients Under Proclamation 11020"
   Data cited: onshoring agreement application procedure; applications requested by June 12, 2026
   Source: 91 FR 26989, FR Doc. 2026-09489
   Published: May 13, 2026
3. Federal Register, Bureau of Industry and Security, "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"
   Data cited: specialty product definitions; 19 eligible jurisdictions; urgent health need procedure; heading 9903.04.70; amended definitions of pharmaceutical and generic articles; Annex IV removals; generics statement
   Source: 91 FR 60360, FR Doc. 2026-19498
   Published: September 23, 2026
4. Federal Register, Bureau of Industry and Security, "Notice of Reduction of Tariffs on Patented Pharmaceuticals and Pharmaceutical Ingredients for Products of the United Kingdom Implemented by Presidential Proclamation 11020"
   Data cited: heading 9903.04.63 changed from +10% to +0% from July 31, 2026
   Source: 91 FR 49406, FR Doc. 2026-15799
   Published: August 4, 2026
5. U.S. International Trade Commission, Harmonized Tariff Schedule of the United States, Revision 21 (2026), Chapter 99 U.S. notes 40 and 52, headings 9903.04.60 to 9903.04.70 and 9903.05.44 to 9903.05.90, subheadings 2933.59.53 and 3004.90.92
   Data cited: heading texts and rates; note 40(a) to 40(i); the 149 lines in note 40(c); note 52(b), 52(e) and 52(f) lists; Column 1 rates of 6.5% and Free
   Source: USITC HTS
   Accessed: October 15, 2026
6. U.S. Customs and Border Protection, CSMS # 70054007, "UPDATED GUIDANCE: Section 232 Duties on Imports of Pharmaceutical Articles and Ingredients"
   Data cited: rate and status of each heading 9903.04.60 to 9903.04.70; 9903.04.61 no longer in effect; 9903.04.65 expiry; trade agreement, drawback and FTZ treatment
   Source: CSMS # 70054007
   Published: September 28, 2026
7. U.S. Customs and Border Protection, CSMS # 69395344, "GUIDANCE: Section 232 Duties on Imports of Patented Pharmaceutical Articles and Ingredients"
   Data cited: reporting requirement for all importers from July 31, 2026; 9903.04.61 for other companies through September 28, 2026; no company then eligible for 9903.04.64
   Source: CSMS # 69395344
   Published: July 30, 2026
8. Federal Register, Office of the United States Trade Representative, "Notice of Actions in Section 301 Investigations of Acts, Policies, and Practices of Various Economies Related to the Failure of Each Economy To Impose and Effectively Enforce a Prohibition on the Importation of Goods Produced With Forced Labor"
   Data cited: forced labor headings 9903.05.20 to 9903.05.84; Annex I, Part B adding note 52(f)(8) for patented pharmaceutical articles from July 31, 2026
   Source: 91 FR 47318, FR Doc. 2026-15181
   Published: July 28, 2026