📦 TariffPeek
HomeSearchAbout
AboutPrivacyTermsContact

Related Resources

ShippingCalculatorsSalaries

© 2026 TariffPeek. Data from UN Comtrade & WCO. Not legal advice.

Home / Section VI / HS 3004.31

HS 3004.31

Subheading

Medicaments; containing insulin, for therapeutic or prophylactic uses, packaged for retail sale

HS Code 3004.31 classifies "Medicaments, containing insulin, for therapeutic or prophylactic uses, packaged for retail sale" under Section VI (Products of Chemical or Allied Industries). This subheading-level code is used internationally for customs classification, tariff determination, and trade statistics.

Classification Details

HS Code3004.31
DescriptionMedicaments; containing insulin, for therapeutic or prophylactic uses, packaged for retail sale
LevelSubheading (6-digit)
SectionVI — Products of Chemical or Allied Industries
Chapter30

🇺🇸 US Import Duty

Average Duty Rate0%
Duty Range0-6%
NotesPharmaceuticals: most are duty-free under WTO agreement
Free Trade AgreementsWTO Pharma Agreement: 0%

Rates are approximate and based on MFN (Most Favored Nation) tariffs. Actual rates may vary by specific product classification. Always verify with USITC for official rates.

Classification Guide

When classifying goods under HS 3004.31, ensure the product matches the specific description. This 6-digit subheading is the international standard. Most countries add 2-4 additional digits for national tariff lines. Check your destination country's tariff schedule for the full code.

Trade Context

Section VI covers chemical and pharmaceutical products — a high-value trade sector.

Regulatory Note

Pharmaceutical imports often require regulatory approval (FDA, EMA). Chemical safety data sheets (SDS) are mandatory for most products.

🇺🇸 US Import Document Checklist

Documents required when importing products under HS 3004.31 into the United States.

Required for All Imports

☑Commercial InvoiceCBP
Detailed invoice from the seller showing product description, quantity, unit price, total value, and terms of sale (Incoterms).
☑Packing ListCBP
Itemized list of contents in each package, including weights, dimensions, and marks/numbers matching the shipping containers.
☑Bill of Lading (B/L) or Airway BillCarrier
Transport document issued by the carrier confirming receipt of goods for shipment. Acts as a contract of carriage and receipt.
☑CBP Entry Summary (Form 7501)CBP
The formal customs declaration filed with US Customs and Border Protection for all commercial imports.
☑Importer Security Filing (ISF/10+2)CBP
Must be filed at least 24 hours before ocean cargo is loaded. Required for all ocean shipments to the US.
☑Customs BondCBP
A financial guarantee ensuring payment of duties, taxes, and fees. Required for commercial shipments over $2,500.

Product-Specific Requirements

⚠️FDA Drug RegistrationRequired

Drug establishments must be registered with FDA. Foreign manufacturers need a US Agent.

Agency: FDA

⚠️FDA Drug ListingRequired

All commercially marketed drugs must be listed with the FDA.

Agency: FDA

📋DEA Import PermitMay be required

Required for controlled substances (Schedule I-V). Apply at least 4 weeks before import.

Agency: DEA

📋Certificate of Pharmaceutical Product (CPP)May be required

WHO-format certificate confirming the product is authorized in the country of origin.

Agency: FDA

FTA Certificate of Origin (for preferential rates)

🤝USMCA Certificate of Origin — self-certification by importer, exporter, or producer. No prescribed format.
🤝Korea-US FTA Certificate of Origin — can be issued by importer, exporter, or producer.

This checklist is for general guidance only. Actual requirements may vary based on specific product, country of origin, and current regulations. Always consult with a licensed customs broker or the relevant agency for official requirements.

Related HS Codes

30.01Glands and other organs (extracts, secretions thereof) for o3001.20Glands and other organs; extracts of glands or other organs 3001.90Glands and other organs; heparin and its salts; other human 30.02Human blood; animal blood for therapeutic, prophylactic or d3002.12Blood, human or animal, antisera, other blood fractions and 3002.13Blood, human or animal, antisera, other blood fractions and 3002.14Blood, human or animal, antisera, other blood fractions and 3002.15Blood, human or animal, antisera, other blood fractions and

Related Data Resources

ShipCalcWize - Shipping cost calculator →CalcPeek - Unit converters →

Frequently Asked Questions

What is HS Code 3004.31?
HS Code 3004.31 classifies "Medicaments, containing insulin, for therapeutic or prophylactic uses, packaged for retail sale" under Section VI (Products of Chemical or Allied Industries). This subheading-level code is used internationally for customs classification, tariff determination, and trade statistics.
What products fall under HS 3004.31?
HS Code 3004.31 covers: Medicaments, containing insulin, for therapeutic or prophylactic uses, packaged for retail sale. This is a specific product classification used for customs declarations worldwide.
How do I use HS Code 3004.31 for customs?
When classifying goods under HS 3004.31, ensure the product matches the specific description. This 6-digit subheading is the international standard. Most countries add 2-4 additional digits for national tariff lines. Check your destination country's tariff schedule for the full code.
What are the trade regulations for Products of Chemical or Allied Industries?
Pharmaceutical imports often require regulatory approval (FDA, EMA). Chemical safety data sheets (SDS) are mandatory for most products.
Is HS 3004.31 the same in every country?
The first 6 digits of HS codes are standardized worldwide by the World Customs Organization (WCO). However, most countries add additional digits (8-10 total) for their national tariff schedules. Always verify the full code with your destination country's customs authority.
What is the US import duty for HS 3004.31?
The average US import duty for products under HS 3004.31 is approximately 0% (range: 0-6%). WTO Pharma Agreement: 0% Note: actual rates depend on the specific product classification and country of origin. Verify with USITC for official rates.
Can I get a lower tariff rate under a Free Trade Agreement?
WTO Pharma Agreement: 0%. The US has FTAs with 20 countries including Canada, Mexico (USMCA), South Korea (KORUS), Australia, and others. To qualify for preferential rates, goods must meet rules of origin requirements and have proper documentation (e.g., Certificate of Origin).

Data verified March 2026 · Source: UN Comtrade & USITC

Was this data helpful?

Need Import/Export Assistance?

Find licensed customs brokers and freight forwarding services for this HS code. Compare trade compliance solutions, cargo insurance quotes, and international shipping rates to optimize your supply chain costs.