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Short answer
CBP Form 3461, “Entry/Immediate Delivery,” is the entry document U.S. Customs and Border Protection (CBP) names in 19 CFR 142.3(a)(1) as the first item required to release imported merchandise. It does not travel alone: the same regulation lists proof of entitlement to make entry, a commercial invoice, a packing list where appropriate, and any other documents that CBP or another agency requires. This page is general regulatory information for lab and clinic staff, not customs-broker or legal advice.
Definition and scope
CBP’s own bulletin CSMS 15-000946 (16 December 2015) describes the form this way: “The CBP Form 3461: Entry/Immediate Delivery is the paper entry document that accompanies Non-ABI (full paper) entries.” In other words, the printed form is the paper vehicle for the entry data. Under 19 CFR 142.3(a)(1) the requirement is written as “CBP Form 3461 (appropriately modified), or its electronic equivalent,” prepared in accordance with 19 CFR 141.61(a)(1).
The form sits at the start of the import chain. The later entry summary is a separate document, covered in the guide to CBP Form 7501. Who is allowed to make entry is covered in the guides to importer of record and customs bonds; this page stays on the release documents.
What must accompany Form 3461 (19 CFR 142.3(a))
The regulation lists what is needed to obtain release. For a laboratory or clinic that is importing instruments, consumables or devices, the list works as a pre-arrival checklist.
| Item in 19 CFR 142.3(a) | What the regulation says |
|---|---|
| Entry | CBP Form 3461 (appropriately modified) or its electronic equivalent. For merchandise from a contiguous country, Form 7533 in duplicate may be used instead. |
| Proof of entitlement | Evidence that the filer is entitled to make entry, under 19 CFR 141.11. |
| Commercial invoice | A commercial invoice, or a pro forma or other listed document where 19 CFR 141.83(d) excuses the invoice. |
| Packing list | A packing list, “where appropriate.” |
| Other documents | Any other documents that CBP, or other federal, state or local agencies, require for the goods. |
The last row matters for labs and clinics. Regulated goods can bring in requirements from other agencies, which is why the guides to importing medical devices into the US and FDA Form 2877 sit beside this one. The regulation itself does not say which agency documents any particular product needs.
Documents may be paper or electronic where appropriate (19 CFR 142.3(d)).
Who must be named on the entry documents
Under 19 CFR 142.3(a)(6), when goods are imported after being sold or consigned to a person in the United States, that person’s name, street address and identification number (as provided in 19 CFR 24.5) must appear on the entry documents, which the regulation lists as CBP Form 3461, “3461 ALT” and Form 7501, or their electronic equivalents. If there is no known buyer at the time of immediate delivery, entry or release, the name, street address and identification number of the U.S. premises to which the goods will be delivered must be shown instead. For a university lab receiving a shipment, the practical consequence is that the consignee details on the paperwork should be consistent across all three documents.
When Form 3461 is not required
19 CFR 142.3(b) sets out an exception. When the entry summary is filed at the time of entry under 19 CFR 142.12(a)(1) or 142.13, Form 3461 (or 7533) is not required. In that case Form 7501 or Form 3311 can serve as both the entry and the entry summary, accompanied by the documents in 142.3(a)(2) through (a)(5) and the provisions of 19 CFR 142.16(b). So the answer to “do I need a 3461” depends on the filing route used, not on the type of goods.
Paper form versus electronic filing
CSMS 15-000946 explains that the older paper form was “not compatible with ACE Cargo Release data elements” and that non-ABI entries were to be submitted on the new ACE version of the form. The bulletin allows a “user generated document on plain paper with cargo release data organized in the same way” only in one situation: “when a 3461 is required by CBP for cargo examinations or for filer downtime data requests, if the entry was filed in ACE.” The regulation’s phrase “electronic equivalent” is what lets most filers submit the data electronically rather than on paper.
Checks before a lab shipment arrives
- Confirm who will be named as importer of record and that proof of entitlement to make entry exists (19 CFR 141.11).
- Have the commercial invoice and, where appropriate, the packing list ready.
- Identify any other agency documents for the goods, as 19 CFR 142.3(a)(5) anticipates.
- Make sure the consignee name, street address and identification number match across the entry documents, or list the U.S. delivery premises if no buyer is known.
- If a customs power of attorney is being used, see the guide to CBP Form 5291.
Common misunderstandings
“Form 3461 is the same as Form 7501.”
They are different documents. 19 CFR 142.3 lists them separately, and 142.3(b) shows the single case in which Form 7501 can do the work of both entry and entry summary.
“Every import needs a 3461.”
Not when the entry summary is filed at entry under 19 CFR 142.12(a)(1) or 142.13 (see above).
“The form alone releases the goods.”
The regulation requires the form together with the other listed documents.
FAQ
What is immediate delivery on Form 3461?
It is the second half of the form’s official title, “Entry/Immediate Delivery.” The regulation requires the form among the documents for releasing merchandise, and 19 CFR 142.3(a)(6) refers to the time of “immediate delivery, entry or release” when it describes identifying the buyer or delivery premises.
When can a plain-paper document be used instead of the printed form?
Only in a narrow case. For an entry filed in ACE, when CBP requires a 3461 for a cargo examination or a filer downtime data request, CSMS 15-000946 allows either the ACE-version form or a user-generated plain-paper document with the cargo release data organized in the same way. For non-ABI entries more broadly, the bulletin says to move to the new ACE-version paper form; it does not offer plain paper as a general substitute.
Which documents go with the form?
Proof of entitlement to make entry, a commercial invoice (or an allowed substitute), a packing list where appropriate, and any documents other agencies require, per 19 CFR 142.3(a).
Sources
- 19 CFR 142.3, Documents required: https://www.law.cornell.edu/cfr/text/19/142.3 (Cornell Legal Information Institute text of the Code of Federal Regulations), checked 1 November 2026.
- CBP Cargo Systems Messaging Service bulletin CSMS 15-000946, 16 December 2015: https://content.govdelivery.com/accounts/USDHSCBP/bulletins/12b5c5b, checked 1 November 2026.
