Standard International Trade Classification
U.S. imports of Insulin Medicaments, Dosage Form or Retail Packings (SITC 54223) totaled $66.8M in August 2026, imported from 7 countries.
Importers of Insulin Medicaments, Dosage Form or Retail Packings paid $110K in duties in August 2026, an average duty rate of 0.16% — duty actually collected as a share of the imports that cleared customs, not the published tariff schedule. Insulin Medicaments, Dosage Form or Retail Packings imports of $66.8M in August 2026 ran 130% above the year-to-date monthly average of $29.0M.
Last updated: August 2026 dataFinished insulin products — vials, cartridges, prefilled pens, and other measured-dose or retail-packaged forms — are among the most commercially significant pharmaceutical imports for the US healthcare system. FDA regulates these products as drugs (and increasingly as biologics), requiring foreign manufacturers to hold valid approvals or licenses and comply with cGMP; all shipments are subject to FDA admissibility review at entry. The dosage-form presentation distinguishes these patient-ready products from bulk insulin intermediates and triggers different supply-chain, cold-chain, and regulatory handling requirements. Importers should be aware that insulin biosimilars and interchangeable biologics have distinct regulatory pathways that affect admissibility.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
253 import shipments a month
Finished insulin products require continuous refrigeration (typically 2–8°C) throughout transit, and importers should maintain temperature excursion logs, shipper qualification records, and carrier temperature monitoring data. While CBP does not mandate a specific cold-chain document set, FDA may request temperature records during admissibility review, and product exposed to out-of-range temperatures may be considered adulterated and refused entry.
No — insulin biosimilars and interchangeable biologics must receive their own FDA approval or licensure under the applicable biologics pathway before they can be legally imported and marketed in the US. A product approved in another country does not automatically qualify for US entry; the foreign manufacturer must have an FDA-approved application covering the specific product and presentation.
Basic heading 57 of 465 in section 5
Basic heading 54223 · $66.8M of $27.5B
Trade Directory
List your company and tag the 6-digit products you trade, so the companies trading them can find you. Be the first supplier listed.
Imports · August 2026
origin
Germany and Malaysia together supply 98% of it. France pays 15.0% duty; Germany 0.0%.
customs district
Census does not publish district detail for this classification system.
destination
Census does not publish state detail for this classification system.
entry
Census does not publish port detail for this classification system.
ImportsExports
Imports
$66.8MYoY · free account
Exports
$18.5MYoY · free account
12-mo low · imports
Low · free accountOver the twelve months to August 2026, the U.S. imported $278.5M of Insulin Medicaments, Dosage Form or Retail Packings and exported $224.2M.
Through August 2026. Source: U.S. Census Bureau.