Country guide: United States
Cleanroom contractor in the USA: rules for buyers
In the United States the Food and Drug Administration (FDA) enforces good manufacturing practice at the owner's drug plant, not at the contractor. FDA has been a PIC/S participating authority since January 2011, and Chinese-origin goods face separate US duties.
By ZY Cleanroom · Updated · Sources at the end of the page
Which rules apply to your plant
Section 211.42(c)(10) of 21 CFR sets design features for aseptic processing areas: smooth, hard, easily cleanable floors, walls and ceilings, temperature and humidity controls, an air supply filtered through HEPA filters under positive pressure, an environmental monitoring system, a cleaning and disinfecting system, and a system for maintaining the equipment that controls aseptic conditions (eCFR, 21 CFR 211.42).
FDA's guidance Sterile Drug Products Produced by Aseptic Processing, Current Good Manufacturing Practice, is dated October 2004 (FDA, guidance page). Ask the owner's quality team which guidance, FDA or EU Annex 1, it applies.
| Facility | Rule |
|---|---|
| Drug plant | 21 CFR Part 211, section 211.42 |
| Aseptic processing area | 211.42(c)(10): HEPA air, positive pressure, monitoring |
| Aseptic guidance | FDA, October 2004 |
Who builds cleanrooms here
Drug makers with aseptic or sterile operations are the regulated buyers of cleanrooms. State building codes, state pharmacy rules and contractor licensing differ by state, and this page does not cover them.
What a foreign supplier must arrange
On 20 February 2026 the Supreme Court held in Learning Resources v. Trump that the International Emergency Economic Powers Act (IEEPA) does not authorise tariffs (Supreme Court, No. 24-1287). That ruling covers IEEPA tariffs only.
The Trade Representative still runs the China Section 301 tariff actions, Lists 1 to 4, with an exclusion process (USTR). A separate Section 301 action on forced-labor import bans adds a 12.5 percent duty on products of China from 24 July 2026, on top of the older duties. It does not apply to goods already subject to Section 232 tariffs (USTR; Alston & Bird).
Separately, the Presidential Proclamation of 2 April 2026, effective 6 April 2026, applies Section 232 duties on steel and aluminium derivatives to the full customs value. Its Annex I-A, at 50 percent, lists steel structures under 7308 and coated flat-rolled steel under 7210. Its Annex I-B, at 25 percent, lists prefabricated buildings of steel under 9406.20.00 (White House, annexes). A proclamation of 1 June 2026 left both rates in place (Thompson Hine). Check the current tariff schedule line by line with a licensed customs broker.
What to send for a first scope
Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State the state, whether the plant is new or existing, and whether the rooms are aseptic. Give the HTS lines the owner's customs broker proposes for panels and doors.
Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. CE-marked and FM-approved panels can be supplied for projects that require them, and other certification can be arranged per project.
Who does the site work
Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.
Questions
Common questions
Does FDA approve cleanroom contractors?
No. FDA's rules apply to the drug plant. The owner chooses and manages the contractor.
Did the Supreme Court end all tariffs on Chinese goods?
No. On 20 February 2026 it held that IEEPA does not authorise tariffs. Section 301 and Section 232 duties are separate (Supreme Court; USTR).
Which Section 232 annex lists steel structures?
Annex I-A at 50 percent lists heading 7308 structures. Prefabricated steel buildings, 9406.20.00, are in Annex I-B at 25 percent (White House, April 2026).
Is the US a PIC/S member?
Yes. PIC/S lists FDA with accession to the scheme in January 2011 (PIC/S, checked 1 November 2026).
Related guides
- Building a cleanroom inside an existing building
- How to Import a Cleanroom from China
- Writing a cleanroom URS: contents and testable wording
- How to choose a cleanroom contractor: questions and evidence
- Turnkey cleanroom contractor
- Room list builder
Sources
- eCFR via Cornell LII, 21 CFR 211.42 (checked 1 November 2026)
- FDA, Sterile Drug Products Produced by Aseptic Processing, October 2004 (checked 1 November 2026)
- Supreme Court, Learning Resources, Inc. v. Trump, No. 24-1287, decided 20 February 2026
- USTR, China Section 301 tariff actions and exclusion process (checked 1 November 2026)
- White House, Proclamation of 2 April 2026, Strengthening Actions Taken to Adjust Imports of Aluminum, Steel, and Copper
- White House, Annexes I-A, I-B, II, III and IV to the April 2026 proclamation
- Thompson Hine, President Trump modifies Section 232 tariffs on aluminum, copper and steel imports (June 2026)
- USTR, Takes Action in Forced Labor Section 301 Investigations (23 July 2026)
- Alston & Bird, USTR finalizes and imposes 10 to 12.5 percent Section 301 forced labor duties (July 2026)
- Global Trade Alert, Forced-labour Section 301 tariffs on 60 economies take effect on 24 July (July 2026)
- PIC/S, list of participating authorities (checked 1 November 2026)
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
Email: [email protected]
WhatsApp: +44 7962 561184