3004.31.00.00/Humalog Insulin KwikPen/Germany

Humalog Insulin KwikPen from Germany

Humalog is a rapid-acting insulin lispro injection used for managing blood sugar levels in diabetes patients. It is put up in pre-filled KwikPen devices containing measured doses of 3mL (100 units/mL) for retail sale. Classified under HTS 3004.31.00.00 as a medicament containing insulin, a hormone of heading 2937, in measured doses for therapeutic use.

Duty Rate — Germany → United States

15%

Rate breakdown

9903.04.6215%Pharmaceuticals: patented pharma from JP/EU/KR/CH/LI — 15% floor rate

9903.05.860%Universal product exemption (U.S. note 52(b))

9903.05.900%Articles already subject to Section 232 (steel/aluminum/copper + derivatives, autos + parts, wood, medium/heavy vehicles + parts, semiconductors, patented pharma) — U.S. note 52(f)

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Import Tips

• Verify insulin concentration and formulation match declared specs; FDA requires exact NDC codes on commercial invoice

• Include certificates of pharmaceutical product (CPP) and free sale certificates from country of origin for FDA import clearance

• Avoid misclassification as unmixed insulin (3004.90); ensure packaging shows measured doses for retail to qualify under 3004.31