HTS Code 300431: Containing insulin — 2026 US Tariff Rates
Data sourced from USITC 2026 Harmonized Tariff Schedule · Last verified May 31, 2026
Quick Answer
HTS 300431 = Containing insulin
Duty rate: Free · Unit: 30-digit · Column 1: Free
About This HTS Subheading
This 6-digit Harmonized Tariff Schedule subheading (300431) covers containing insulin. The table below lists all 8-digit and 10-digit statistical suffixes under this subheading, including General, Special (Free Trade Agreement), and Column 2 duty rates. Data is sourced from the official USITC 2026 Harmonized Tariff Schedule Revision 9. Always verify final classifications and duty rates with US Customs and Border Protection (CBP) before importing.
Complete Classification Table
All 8-digit and 10-digit tariff codes under HTS subheading 300431. Use this table to find the correct statistical suffix and applicable duty rate for your product.
| HTS Code | Full Description | General Rate | Special Rate | Column 2 Rate |
|---|---|---|---|---|
3004.31.00.00 |
Containing insulin | Free | — | 25% |
Duty Estimator
Enter your product value to estimate the import duty. This is an estimate only — actual duties are assessed by CBP at the port of entry.
Quick Answer: HTS 300431 Duty Rates
HTS subheading 300431 (containing insulin) contains 1 sub-classification.
1 suffix carry duty-free General rates.
Suffix 3004.31.00.00: General rate Free.
Always verify with CBP — Section 301, Section 232, and ADD/CVD may apply.
What Importers Need to Know About HTS Chapter 30
This subheading falls under an HTS chapter covering pharmaceutical products including medicines, vaccines, blood fractions, diagnostic reagents, and sterile medical supplies. Importers of these products should be aware of the following trade compliance considerations:
Pharmaceutical imports are regulated by FDA CDER/CBER. NDA/ANDA approval, facility registration, and GMP compliance required. DEA controlled substance registration for scheduled drugs.
For the specific subheading HTS 300431, we recommend you:
- Verify the correct 10-digit statistical suffix — even within a 6-digit subheading, duty rates can differ significantly between suffixes
- Check FTA eligibility — if your product qualifies for preferential treatment under USMCA, KORUS, or another FTA, you may reduce or eliminate duties by providing the required origin certification
- Monitor for trade remedy changes — Section 301, Section 232, and anti-dumping duties are updated periodically. A rate that was correct last quarter may have changed
- Consult CBP resources — for binding classification rulings, CBP's National Commodity Specialist Division provides written determinations
Frequently Asked Questions About HTS 300431
What is the import duty rate for products under HTS 300431?
Duty rates for HTS 300431 vary by the specific 8- or 10-digit statistical suffix and the country of origin. Suffix 3004.31.00.00 has a General rate of Free. Always verify the exact duty rate with US Customs and Border Protection before importing, as rates may change and additional trade remedies (Section 301, Section 232, anti-dumping) may apply depending on the country of origin.
Can I get duty-free treatment for goods classified under HTS 300431?
Yes — 1 statistical suffixes under HTS 300431 carry a General rate of Free. Additionally, many products qualify for duty-free treatment under Free Trade Agreements (USMCA, KORUS, and others) even if the General rate is not Free. Check the Special rate column for your specific country of origin. To claim FTA preferences, you must provide the required origin certification documentation.
How do I know if I am using the correct HTS classification?
The correct HTS classification depends on the specific product's composition, function, and in some cases its country of origin. For binding certainty, you can request a written ruling from CBP's National Commodity Specialist Division. Misclassification can result in retroactive duties, penalties under 19 USC §1592, and interest on underpaid amounts. For products classified under heading 300431, the key classification factors include the General Rules of Interpretation (GRI), Section Notes, and Chapter Notes. When in doubt, consult a licensed customs broker.
HTS Chapter 30 Classification Guide: Pharmaceutical Products
Chapter 30 covers pharmaceutical products including medicines, vaccines, blood fractions, diagnostic reagents, and sterile medical supplies. The critical classification distinction is between bulk pharmaceutical intermediates (Chapter 29), medicaments in measured doses (3004), and medicaments not put up for retail (3003). FDA CDER/CBER regulation is mandatory for all pharmaceutical imports.
Common Misclassification Errors
- Classifying bulk pharmaceutical chemicals under Chapter 30 instead of Chapter 29 — only put-up medicines and finished pharmaceutical preparations belong in Chapter 30
- Confusing heading 3003 (not put up for retail sale) with 3004 (put up in measured doses or retail packaging) — this is the most common classification error in pharmaceuticals
- Failing to register with FDA and obtain NDA/ANDA approval before importing pharmaceutical products
Duty Calculation Tips for HTS 300431
Most pharmaceutical products qualify for duty-free treatment under the WTO Pharmaceutical Agreement. FDA registration, NDA/ANDA approval, and GMP compliance are mandatory. Import Alert 66-40 (unapproved new drugs) is one of the most frequently triggered FDA import alerts. DEA registration required for controlled substance imports. Section 301 generally does not apply to pharmaceutical products.
Chapter 30 Frequently Asked Questions
What is the difference between heading 3003 and 3004?
Heading 3003 covers medicaments not put up for retail sale (bulk, institutional packaging). Heading 3004 covers medicaments put up in measured doses or retail packaging (tablets, capsules, vials with specific dosing). The distinction is based on the product's presentation, not its active ingredient. Misclassifying between these headings is a common error.
Are pharmaceutical imports duty-free?
Most pharmaceutical products qualify for duty-free treatment under the WTO Pharmaceutical Agreement. This includes many active ingredients, finished medicaments, vaccines, and diagnostic reagents. Check the Special rate column for your specific product. Some pharmaceutical packaging materials may not qualify for duty-free treatment.
What FDA requirements apply to pharmaceutical imports?
All pharmaceutical imports require FDA establishment registration and drug listing. Prescription drugs need NDA or ANDA approval. OTC drugs must comply with OTC monograph requirements. Importers must file FDA prior notice before the shipment arrives. GMP compliance of the foreign manufacturer is verified by FDA inspection.
What is Import Alert 66-40?
Import Alert 66-40 is FDA's automatic detention policy for unapproved new drugs. Products appearing to be unapproved new drugs are detained without physical examination. The importer must demonstrate that the product has valid NDA/ANDA approval or is otherwise compliant. This is one of the most frequently triggered import alerts at US ports.
Do controlled substance pharmaceuticals require DEA registration?
Yes. Importers of controlled substance pharmaceuticals (Schedule II-V) must register with DEA, obtain import permits, and comply with strict record-keeping and storage requirements. Schedule I substances cannot be imported for commercial purposes. The DEA registration is separate from FDA requirements and must be obtained before importation.
This HTS classification data is programmatically parsed from the official 2026 US International Trade Commission (USITC) Harmonized Tariff Schedule Revision 9. The PoliteDraft data engine aggregates 8-digit and 10-digit statistical suffixes under their 6-digit subheading parents to create comprehensive, data-rich reference pages. Our editorial team reviews data parsing accuracy against the official USITC source files. This database is provided for informational and preliminary research purposes only. PoliteDraft is not a licensed customs broker or legal advisor.
Related HTS Codes in This Section
Trade & Compliance Insights for Chapter 30
Expert analysis on tariff policy, trade remedies, and compliance strategies relevant to HTS 300431.
View all insights →Browse All HTS Codes in This Section
See the complete list of HTS subheadings under the same section as 300431.
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