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HSChapter 30
Classified under tariff line 3003310000, these are bulk or intermediate insulin preparations not yet put up in measured doses or retail packaging — a critical distinction from their dosage-form counterparts under heading 3004. Denmark dominates US supply, reflecting the global manufacturing footprint of major insulin producers headquartered there, with Mexico as a secondary source. All pharmaceutical imports in this heading require FDA review and must originate from facilities registered with the agency; importers should confirm Current Good Manufacturing Practice (cGMP) compliance before shipment.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
Heading 300331 covers insulin-containing medicaments that are NOT put up in measured doses or packaged for retail sale — typically bulk pharmaceutical intermediates or hospital-supply formats. Heading 300431 covers the same active ingredient but in finished dosage form (e.g., vials, cartridges, pens) intended for end-use administration.
Importers must ensure the foreign manufacturing facility is registered with FDA under the Drug Establishment Registration program, that the product has an applicable drug master file or IND/NDA reference, and that the shipment is accompanied by a commercial invoice identifying the active ingredient, concentration, and intended use. FDA may detain shipments for examination if the facility lacks a satisfactory inspection history.
| Country | Imports | Exports | Balance |
|---|---|---|---|
| DENMARK | -- | $1.8M | +$1.8M |
| BAHAMAS | -- | $14K | +$14K |
| FRANCE | -- | -- | -- |
| ST KITTS AND NEVIS | -- | -- | -- |
| MEXICO | -- | -- | -- |
Monthly import values over time
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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
IMMUNOLOGICAL PRODUCTS, MIXED, NOT IN MSRED DOSES
HS 300214
| State | Imports | Exports | Balance |
|---|---|---|---|
| North Carolina | -- | $1.8M | +$1.8M |
| Georgia | -- | $14K | +$14K |
| Florida | -- | -- | -- |
| Port | Imports | Exports | Balance |
|---|---|---|---|
| DURHAM, NC | -- | $1.5M | +$1.5M |
| CHICAGO, IL | -- | $308K | +$308K |
| WEST PALM BEACH, FL | -- | $14K | +$14K |