HTS Code 300251: Cell therapy products — 2026 US Tariff Rates
Quick Answer
HTS 300251 = Cell therapy products
Duty rate: Free · Unit: 30-digit · Column 1: Free
Complete Classification Table
All 8-digit and 10-digit tariff codes under HTS subheading 300251. 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 |
|---|---|---|---|---|
3002.51.00.00 |
Cell therapy products | Free | — | Free |
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
Importing Under HTS 300251: What Importers Ask
Does this chemical product require TSCA certification?
Chemical products under this HTS chapter are subject to EPA TSCA (Toxic Substances Control Act) requirements. Verify your substance is listed on the TSCA Inventory. New chemicals require PMN (Pre-Manufacture Notice) submission to EPA at least 90 days before import.
How are pharmaceutical intermediates classified differently from finished drugs?
Pharmaceutical intermediates generally fall under Chapter 29 (organic chemicals), while finished dosage-form drugs fall under Chapter 30. The distinction affects both duty rates and FDA regulatory requirements — finished drugs face higher scrutiny under CDER/CBER.
What safety data sheet (SDS) requirements apply to chemical imports?
OSHA HazCom Standard requires SDS for hazardous chemical imports. CBP may hold shipments without proper SDS documentation. Ensure your foreign supplier provides GHS-compliant SDS in English. Certain chemicals also require EPA or DEA import certification.
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.
Quick Answer: HTS 300251 Duty Rates
HTS subheading 300251 (cell therapy products) contains 1 sub-classification.
1 suffix carry duty-free General rates.
Suffix 3002.51.00.00: 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 300251, 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
Duty Calculation Tips for HTS 300251
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.
At a Glance
- All 1 sub-classifications under HTS 300251 are duty-free under the General rate — no tariff applies regardless of country of origin.
- This code falls under a chapter covering pharmaceutical products including medicines, vaccines, blood fractions, diagnostic reagents, and sterile medical supplies.
Official Sources
PoliteDraft recommends verifying duty rates directly with official government sources before filing import documentation.
Independent editors organize official USITC HTS data and explain how to check the exact suffix, unit, origin, and trade remedies. This site is a research reference, not a customs broker, attorney, or classification opinion.
Related HTS Codes in This Section
Related Chapters
HTS Chapter 30 is frequently cross-referenced with the following chapters in supply chain and trade compliance workflows.
Trade & Compliance Insights for Chapter 30
Expert analysis on tariff policy, trade remedies, and compliance strategies relevant to HTS 300251.
View all insights →Browse All HTS Codes in This Section
See the complete list of HTS subheadings under the same section as 300251.
View Section Overview →<strong>Editorial note:</strong> The first listed General rate for HTS 300251 (Cell therapy products) is duty-free in this revision. Check every statistical suffix and the Special column for country-specific treatment before filing.