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HSChapter 30
U.S. imports of mixed immunological products, not in measured doses (not for retail sale) (HS 300214) totaled $285.4M in April 2026, traded with 32 countries.
Importers of Mixed Immunological Products, Not in Measured Doses (Not for Retail Sale) paid $15K in duties in April 2026 — an effective duty rate of 7.0% on $221K in dutiable value, based on actual customs collections rather than the published tariff schedule. Mixed Immunological Products, Not in Measured Doses (Not for Retail Sale) imports of $285.4M in April 2026 ran 54% below the year-to-date monthly average of $614.1M.
Last updated: April 2026 dataBulk mixed immunological preparations — including those based on monoclonal antibodies — that have not yet been packaged into measured doses fall here, distinguishing them from retail-ready formulations. FDA's Center for Biologics Evaluation and Research (CBER) governs admissibility, and importers must ensure the foreign establishment holds the appropriate biologics license or operates under an FDA import authorization. Ireland and South Korea are the leading US suppliers under this heading, reflecting the concentration of large-scale biologics contract manufacturing in those markets. The US schedule separates monoclonal-antibody-containing products (3002140010) from other mixed immunological preparations (3002140090), a distinction that can affect both classification and FDA review pathways.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
The key split is whether the mixed immunological product contains monoclonal antibodies (3002140010) versus other immunological mixtures (3002140090). Both require FDA CBER oversight, but monoclonal-antibody products may trigger additional biologics license application (BLA) review and distinct labeling requirements. Importers should confirm classification with a licensed customs broker before entry.
Importers generally need an FDA establishment registration for the foreign manufacturer, a valid biologics license or import authorization, a commercial invoice specifying the product's composition and intended use, and compliance with FDA's prior notice and entry filing requirements. Because admissibility rules are complex, consulting a licensed customs broker and regulatory counsel is strongly advised.
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Monthly import values over time
| Country | Imports | Exports | Balance |
|---|---|---|---|
| IRELAND | $52.7M | $203.4M | +$150.8M |
| SWITZERLAND | $84.7M | $54.5M | -$30.2M |
| ITALY | $683K | $120.6M | +$119.9M |
| GERMANY | $18.0M | $78.5M | +$60.5M |
| NETHERLANDS | $20.4M | $72.0M | +$51.6M |
HS10 import codes under this HS6 parent. Source: U.S. Harmonized Tariff Schedule.
| Code | Description | Import Value | Effective Tariff % | Duty Collected |
|---|---|---|---|---|
| 3002140010 | IMMUN PROD W MONOCLONAL ANTIBODIES, NOT FOR RETAIL | $185.5M | 0.00% | -- |
| 3002140090 | IMMUNOLOGICAL PRODUCTS, MIXED, NOT FOR RETAIL SALE | $100.0M | 10.00% | $15K |
IMMUN PROD W MONOCLONAL ANTIBODIES, NOT FOR RETAIL
IMMUNOLOGICAL PRODUCTS, MIXED, NOT FOR RETAIL SALE
HS10 export codes under this HS6 parent. Source: U.S. Schedule B export classification.
| Code | Description | Export Value |
|---|---|---|
| 3002140000 | IMMUNOLOGICAL PRODUCTS,MIXED, N FOR RETAIL SALE | $651.9M |
IMMUNOLOGICAL PRODUCTS,MIXED, N FOR RETAIL SALE
142.1K kg
MEDICAMENTS NESOI, MEASURED DOSES, RETAIL PK NESOI
HS 300490
IMMUNOLOGICAL PRODUCTS, IN MEASURED DOESE/RTL SALE
HS 300215
VACCINES FOR HUMAN MEDICINE
HS 300241
HORMONES ETC. (NO ANTIBIOTICS CONTAINED) DOSAGE FM
HS 300439
ANTISERA AND OTHER BLOOD FRACTIONS
HS 300212
MEDICAMENTS CONT CORTEX HORMONES ETC DOSES
HS 300432
| State | Imports | Exports | Balance |
|---|---|---|---|
| Puerto Rico | $9.8M | $204.2M | +$194.4M |
| California | $77.2M | $104.5M | +$27.2M |
| Massachusetts | $7.9M | $112.6M | +$104.7M |
| Port | Imports | Exports | Balance |
|---|---|---|---|
| NEWARK, NJ | $11.8M | $214.5M | +$202.7M |
| JFK INTERNATIONAL AIRPORT, NY | $70.6M | $61.7M | -$9.0M |
| CHICAGO, IL | $68.2M | $58.8M | -$9.5M |