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SITCSection 5
U.S. imports of antibiotics (not elsewhere specified), bulk pharmaceutical grade (SITC 54139) totaled $96.8M in April 2026, traded with 24 countries.
Importers of Antibiotics (Not Elsewhere Specified), Bulk Pharmaceutical Grade paid $12K in duties in April 2026 — an effective duty rate of 20% on $59K in dutiable value, based on actual customs collections rather than the published tariff schedule. Antibiotics (Not Elsewhere Specified), Bulk Pharmaceutical Grade imports of $96.8M in April 2026 ran 91% above the year-to-date monthly average of $50.6M.
Last updated: April 2026 dataBulk antibiotic substances not elsewhere specified and not formulated as finished medicaments occupy a critical upstream position in pharmaceutical supply chains, serving as active pharmaceutical ingredients (APIs) for downstream drug manufacturing. FDA oversight applies at entry, and importers must ensure the exporting facility is registered and compliant with current Good Manufacturing Practice (cGMP) standards. Because many bulk antibiotic APIs originate from a concentrated set of foreign manufacturers, supply-chain resilience and facility qualification are persistent concerns for US pharmaceutical buyers.
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FDA reviews these shipments under its drug import authority; the foreign manufacturing facility must be registered with FDA and subject to cGMP inspection. Shipments may be detained or refused if the facility is on an import alert or lacks adequate documentation of identity and purity.
The distinction turns on whether the substance is in a measured dose or retail packaging intended for therapeutic use. Bulk powders, granules, or solutions sold by weight to pharmaceutical manufacturers — without dosage form or retail labeling — fall here, while tablets, capsules, and vials ready for patient use are classified as medicaments.
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Monthly import values over time