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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.
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Monthly import values over time
| Country | Imports | Exports | Balance |
|---|---|---|---|
| DENMARK | -- | $1.8M | +$1.8M |
| BAHAMAS | -- | $14K | +$14K |
| MEXICO | -- | -- | -- |
| ST KITTS AND NEVIS | -- | -- | -- |
| FRANCE | -- | -- | -- |