North American Industry Classification System
U.S. exports of Biological Products (Except Diagnostic) (NAICS 325414) totaled $4.5B in August 2026.
Importers of Biological Products (Except Diagnostic) paid $1.9M in duties in August 2026, an average duty rate of 0.08% — duty actually collected as a share of the imports that cleared customs, not the published tariff schedule.
Last updated: August 2026 dataNon-diagnostic biological products — including vaccines, blood-derived products, therapeutic proteins, monoclonal antibodies, and gene therapy products — are regulated by FDA's Center for Biologics Evaluation and Research (CBER) or Center for Drug Evaluation and Research (CDER) depending on product type, and require a Biologics License Application (BLA) for US marketing authorization. These products are among the most complex to import, combining stringent cold-chain requirements, lot-release testing, and facility licensure obligations that apply to both domestic and foreign manufacturers. Supply chains for biologics are highly specialized, and any deviation in storage or handling during transit can render a shipment inadmissible. Trade professionals should coordinate closely with FDA-licensed importers and qualified persons responsible for lot release.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
5.4K import shipments a month
For many biological products, FDA requires lot-by-lot release testing — either by FDA itself or by the manufacturer under an approved protocol — before the product can be distributed in the US. The BLA holder or licensed importer is responsible for ensuring that each lot meets release specifications and that required documentation accompanies the shipment. Failure to comply can result in detention or refusal of the entire lot.
Biologics are highly sensitive to temperature excursions, and documented cold-chain failures during transit can render a shipment inadmissible or require quarantine pending investigation. Importers must maintain continuous temperature monitoring records from the point of manufacture through port of entry, and FDA may request these records during admissibility review. Robust cold-chain qualification of carriers and freight forwarders is a critical risk-management step.
National industry 1 of 4 in naics industry 32541
National industry 325414 · $4.5B of $8.9B
Exports · August 2026
destination
customs district
Census does not publish district detail for this classification system.
origin
Census publishes state breakdowns for NAICS to the 4-digit level only. See NAICS 3254 for those.
entry
Census does not publish port detail for this classification system.
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.
ImportsExports
Imports
$2.5BYoY · free account
Exports
$4.5BYoY · free account
12-mo low · imports
Low · free accountOver the twelve months to August 2026, the U.S. imported $30.5B of Biological Products (Except Diagnostic) and exported $57.7B.
Through August 2026. Source: U.S. Census Bureau.