Standard International Trade Classification
U.S. exports of Medicaments NES, Not in Dosage or Retail Form (SITC 54291) totaled $98.5M in August 2026.
Importers of Medicaments NES, Not in Dosage or Retail Form paid $173K in duties in August 2026, an average duty rate of 0.25% — duty actually collected as a share of the imports that cleared customs, not the published tariff schedule.
Last updated: August 2026 dataBulk pharmaceutical preparations that are not yet packaged for end-use sale occupy a distinct commercial niche: they move through the supply chain as active pharmaceutical ingredient (API) intermediates or compounding inputs rather than finished consumer products. SITC 54291 captures these not-elsewhere-specified medicaments in non-dosage, non-retail form, distinguishing them from finished-pack equivalents in 54292 and 54293. FDA's drug import program still applies to bulk drug substances, and importers must ensure the foreign manufacturer holds appropriate registration. Because this category spans a wide range of chemical entities, precise product identification in entry documentation is critical to avoid misclassification. Consult a licensed customs broker or regulatory counsel to confirm admissibility requirements for specific bulk pharmaceutical inputs.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
204 import shipments a month
Bulk drug substances still require FDA prior notice and are subject to admissibility review, but they are evaluated as APIs rather than finished drug products. The foreign facility must be registered with FDA, and the substance must comply with applicable pharmacopeial or specification standards. Finished-dosage requirements such as labeling and packaging rules do not apply at this stage.
The key distinction is intended pharmaceutical use: if the substance is destined for further formulation into a drug product, it is classified as a medicament rather than a general chemical. Supporting documentation—such as a certificate of analysis, intended-use declaration, and FDA facility registration number—helps establish the correct classification and smooths port-of-entry review.
Basic heading 58 of 465 in section 5
Basic heading 54291 · $98.5M of $26.2B
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Exports · August 2026
destination
Netherlands and Ireland together take 56% of it.
customs district
Census does not publish district detail for this classification system.
origin
Census does not publish state detail for this classification system.
entry
Census does not publish port detail for this classification system.
ImportsExports
Imports
$62.7MYoY · free account
Exports
$98.5MYoY · free account
12-mo low · imports
Low · free accountOver the twelve months to August 2026, the U.S. imported $848.4M of Medicaments NES, Not in Dosage or Retail Form and exported $1.2B.
Through August 2026. Source: U.S. Census Bureau.