FSMA 204 for distributors and warehouses: shipping and receiving records

A distributor or warehouse that holds foods on the Food Traceability List is covered by the FDA Food Traceability Rule, and its main job is keeping a receiving record and a shipping record for every lot. Each record has eight data points. A company that only drives the food from place to place, with no other role, is a transporter and is not covered. This guide explains the difference, lists what to capture at the dock, and shows where distributors most often trip up.

Does FSMA 204 apply to distributors and warehouses?

Yes, if you handle foods on the list. FDA’s rule page says the rule applies to persons who manufacture, process, pack or hold foods on the Food Traceability List. Holding food in a warehouse or cold store counts as holding, and the definitions in 21 CFR 1.1310 name warehouses and cold storage.

Check the list first. Our guide to which foods are on the Food Traceability List goes category by category. Then check the exemptions in 21 CFR 1.1305. Our exemptions guide covers the ones that matter to small companies.

Carriers are treated differently. The rule has its own definitions. 21 CFR 1.1310 defines a transporter as a person who has possession, custody or control of food for the sole purpose of transporting it. 21 CFR 1.1305 says the subpart does not apply to transporters of food.

The word “sole” matters. If your company buys the food, stores it in your building, or sells it on, it is doing more than transporting. Whether a particular arrangement counts is a question for a food safety or legal professional, not a blog post.

What must you record when food arrives?

Receiving is defined as an event in which food is received by someone other than a consumer. Under 21 CFR 1.1345(a), for each traceability lot you receive, keep:

1. The traceability lot code
2. The quantity and unit of measure
3. The product description
4. The location description for the immediate previous source (other than a transporter)
5. The location description for where the food was received
6. The date received
7. The location description for the traceability lot code source, or the source reference
8. The reference document type and number

Notice item 4. The “previous source” is the business that shipped to you, not the trucking company. Your driver’s name or carrier is not what the rule asks for there.

What must you record when food leaves?

Shipping is defined as an event in which food is arranged for transport. 21 CFR 1.1340(a) lists these data points for each lot you ship:

1. The traceability lot code
2. The quantity and unit of measure
3. The product description
4. The location description for the immediate subsequent recipient (other than a transporter)
5. The location description for the location the food was shipped from
6. The date shipped
7. The location description for the traceability lot code source, or the source reference
8. The reference document type and number

There is one more duty. Under paragraph (b) of the same section, you must give the next recipient the information in items 1 through 7, in electronic, paper or other written form. A packing slip or advance ship notice that carries those seven items can do the job.

Do you assign new lot codes as a distributor?

Usually not, unless you do first land-based receiving of fishing-vessel food or a transformation. Under 21 CFR 1.1320, lot codes are assigned at initial packing of a raw agricultural commodity, at first land-based receiving of food from a fishing vessel, or at transformation, so in other activities such as shipping the code should pass through you unchanged. Our guide to assigning traceability lot codes explains who does that and when.

The exception is transformation. 21 CFR 1.1310 defines it as an event that involves manufacturing or processing a food or changing a food, and the definition gives commingling, repacking and relabeling as examples of changing a food. For each new lot produced through transformation, 21 CFR 1.1350 requires its own records, including the input lot codes, the new lot code and the date the transformation was completed. A distributor that breaks pallets into repacked cases, or combines lots, should read that section with a professional.

Also look at 21 CFR 1.1345(b). When food arrives from a person the rule does not apply to, and it has no lot code, the receiver must assign one. Check the exact conditions in the text.

Where do distributors go wrong?

These are common gaps, listed here as illustrative examples, not statistics:

• Lot codes dropped at the dock. The code is on the case label, but the receiving clerk logs only the PO number.
• Unit mismatches. The supplier ships in cases, you sell by the pallet, and nobody can tie the two quantities together.
• Split loads. One inbound lot goes to six customers, and the outbound records point to the wrong lot.
• Paper that never leaves the clipboard. A bill of lading with the data on it cannot be sorted.
• Location descriptions that vary. The same warehouse is spelled three ways across three systems.

Can you produce the records in 24 hours, and by when?

21 CFR 1.1455 says records must be available to FDA within 24 hours of a request, or within a reasonable time FDA has agreed to. For records required under sections 1.1325 through 1.1350, requested during an outbreak or recall, the information must be given in an electronic sortable spreadsheet. The rule gives some small farms and small businesses another option, so see our guide on the 24-hour sortable spreadsheet.

On the compliance date, FDA’s rule page says the original compliance date was January 20, 2026. FDA proposed to extend the compliance date by 30 months to July 20, 2028, and Congress, in a 2026 appropriations act, directed FDA not to enforce the rule before that same date. The page says FDA intends to comply with that directive. Retailers may ask for the data sooner, so see why retailers want traceability data before 2028 and our compliance date explainer.

Where Lotcrumb fits

Lotcrumb is being built to read the invoices, bills of lading and case labels a distributor already handles, capture the key data elements, and assemble the sortable spreadsheet on request. It is not built yet. Join the waitlist.

This is general information about a federal rule, not legal advice. Check the current text of 21 CFR Part 1, Subpart S, and talk to a qualified food safety or legal professional about your situation.