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SITCSection 5
U.S. imports of medicaments nes, not in dosage or retail form (SITC 54291) totaled $96.8M in April 2026, traded with 34 countries.
Importers of Medicaments NES, Not in Dosage or Retail Form paid $62K in duties in April 2026 — an effective duty rate of 9.9% on $624K in dutiable value, based on actual customs collections rather than the published tariff schedule. Medicaments NES, Not in Dosage or Retail Form imports of $96.8M in April 2026 ran 22% above the year-to-date monthly average of $79.4M.
Last updated: April 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.
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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.
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| Country | Imports | Exports | Balance |
|---|---|---|---|
| PORTUGAL | $64.1M | $108K | -$64.0M |
| IRELAND | $2.5M | $33.6M | +$31.1M |
| NETHERLANDS | -- | $25.3M | +$25.3M |
| INDIA | $2.3M | $13.7M | +$11.4M |
| BELGIUM | $507K | $10.7M | +$10.2M |
Monthly import values over time