3004.31.00.00/Lantus SoloStar Insulin Pen/Germany

Lantus SoloStar Insulin Pen from Germany

Lantus SoloStar is a long-acting insulin glargine injection for basal glycemic control in type 1 and type 2 diabetes. Each pre-filled pen delivers 3mL of 100 units/mL insulin in measured doses for patient self-administration. Falls under HTS 3004.31.00.00 as a mixed insulin product put up for retail 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

• Temperature-controlled shipping mandatory (2-8°C); include validated cold chain documentation to prevent FDA rejection

• Declare exact batch numbers and expiry dates; insulin imports require prior FDA Drug Establishment Registration