Clinical trial supplies now have a zero rate under the US pharma 232: what goes on file to prove it?

Orla Fitzgerald ieTrade Compliance Lead · A pharmaceutical logistics operation, Cork

Sanity check, and I will lay out what I have read before I ask, because this is the kind of line where the missing detail turns out to be the one that mattered.

CBP put out updated Section 232 pharmaceutical guidance on 28 September in CSMS 70054007. Alongside it, the Commerce technical corrections from the 23 September notice created a new heading, 9903.04.70, which took effect on 29 September. It gives zero additional duty to pharmaceutical articles and their ingredients where the only use is a clinical trial, research and development, or some other non-commercial purpose. For anything patented and of EU origin, the comparison is 9903.04.62 at a combined 15%, so on investigational product going from Ireland to a US trial site that is not a rounding difference.

What I have checked: the CSMS text and two summaries of the Commerce notice. What I have not found in any of them is a word on evidence. No certification, no statement on the invoice, nothing about what the importer of record should hold if CBP asks why a given carton was declared under the zero heading.

What I am assuming, and would like someone to tell me I am wrong about: that the burden sits with whoever claims it, and that "only for a trial" will be read narrowly. That leaves me with two cases I cannot settle. The first is comparator drug, which is a marketed product bought in and relabelled for blinding. Its use is a trial, but the article itself is commercial. The second is excess trial stock that ends up on a different path after the study closes.

For temperature controlled consignments, a query at the border is not a paperwork problem for long, so I would rather build the file now than at the hold. My instinct is the protocol reference, the sponsor's confirmation of trial use, and the depot's destruction or return records. Is that what others are keeping, has anyone seen CBP say anything more specific since the 29th, or am I overthinking a heading that will mostly be waved through?

Asked 6 Oct 2026

4 replies

Le Thu Havn3d ago

I do not know pharmaceuticals, so this is from the documentation side only. The word in the heading that worries me is "solely". A file usually proves a purpose at the moment of shipment, but your second case is about what happens after the study closes. So I would ask it the other way round: if excess stock later leaves the trial, who records that, and who tells the importer of record?

In my work, an end use claim is believed when each lot number on the invoice can be found again in a record made at the time, not in a letter written when the question arrives. Your protocol reference and sponsor confirmation look right to me, but keyed by lot.

The CSMS gives a Trade Remedy mailbox for questions. Has anyone written to it yet?

Park Soo-jinkr2d ago

This is fine until the audit asks where one lot went. A border query tests purpose at entry. An audit tests disposition, and that is where files run out.

Your three documents are right, and keyed by lot, as suggested above, they would hold up. The gap is who holds them. The sponsor's confirmation comes from the party that benefits, so the depot's return and destruction records carry the weight, and those sit with the depot, not the importer of record. Make the depot contract require a report on any lot leaving the trial.

On comparator, I have not seen CBP say how it reads "solely". Do not assume.

Aya Morimotojp1d ago

Sorry, maybe I read this wrongly, but I would not discount the sponsor's confirmation only because the sponsor benefits.

In my own market, export control, the end use undertaking is also signed by the party who benefits. It still carries weight, because of what is written in it: the user promises to ask before any change of use or transfer, not to explain afterwards. That is our practice and also what our regulator asks for.

The depot records prove where a lot went. The undertaking makes the excess stock case a broken promise somebody had to report, which is a much better position at audit. So I would ask the sponsor for a confirmation with that clause, keyed by lot, and keep the depot clause too.

On comparator I do not know how CBP reads it. The text is silent, and I will not guess.

Bev Tranca22h ago

Comparator: don't guess. Ruling request before the first carton. Bring the protocol, the relabelling spec, the commercial invoice.

4 replies

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