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Answer trace requests while holding owner stock

3PL add-on For: Compliance manager, Warehouse staff Checked on 18.0.0.2.0, 18.0.1.0.0

When you hold owners' stock, every trace request has a scope: your own records, or the records you hold for one owner. The search, the results and the response zip cover that scope only, so one owner's documents never reach a requester who asked about another owner's units or about yours. This page covers only what the scope changes; logging, searching, responding and sending are the core steps of Answer trace requests.

Background: a request about an owner's stock concerns the owner's records, the response is prepared in the owner's name with its approval recorded, and one owner's transaction information stays out of another's response (FD&C Act § 582, requests for information; see Compliance background). This is how the modules read the law; it has not been reviewed by counsel. See the disclaimer.

Answer a trace request about an owner's records​

Use this when the FDA, a state or a trading partner asks about units or documents you hold or shipped for an owner, or when the owner itself asks. The response is prepared on the owner's behalf and records the owner's approval.

Your procedure decides how you obtain the owner's approval of a response and who at the owner may give it; the software requires the approver, the approval's reference and its date before it builds the response.

Who: Rx Tracking User or Manager

Requires: Rx Tracking (DSCSA): 3PL and title model, with 3PL switched on.

Before you start:

  1. Go to Inventory ‣ Rx Tracking ‣ Trace Requests and open the request, or select New and fill in Requested By, Requester, Their Reference and the question as in EXC-06.

  2. In Owner Concerned, choose the owner company, for example Northwind Generics LLC. Choose the company, not one of its contacts.

    Result: a blue banner says "This request concerns the records we hold for the owner concerned: the search and the response cover that owner's records only, and the response is prepared on the owner's behalf. Record the owner's approval before responding.", and the Owner's Approval group appears.

  3. Fill in the Query group, for example Lots BPDPZ2508K, then select Search.

    Result: the request is In Progress. The Documents tab lists only documents issued in the owner's name or received for it (DSCSA/NWG/OUT/2026/00001, DSCSA/NWG/IN/2026/00001); the Packages tab only the owner's units (12 for Northwind's lot BPDPZ2508K: 10 In Stock, 1 Shipped, 1 Returned). When units of other scopes match the query, the chatter has an internal note, for example "Left out by this request's owner scope (Northwind Generics LLC): 36 unit(s) matching the query, of our own stock (24); Summit Specialty Pharma Inc. (12). The response doesn't cover them; log a request for their owner if they were asked about."

  4. In the Owner's Approval group, fill in:

    • Approved By (Owner): name and role, for example Dana Reyes, QA Director
    • Approval Reference: for example NWG-TR-APPROVAL-0433
    • Approval Date: the date of the approval (today or earlier)

    Screenshot of a trace request with the blue banner and the Owner's Approval group filled in. Owner Concerned is outlined.

  5. Save, then select Respond and Ok in the confirmation "Build the response zip from these results? The request is then closed and can't be changed.".

    Result: the request is Responded and Download Response appears. The chatter says "Response DSCSA-TR-YYYY-NNNNN-response.zip built by … : 2 document(s), 12 package(s). SHA-256 …".

  6. Select Download Response.

    Result: the browser downloads DSCSA-TR-YYYY-NNNNN-response.zip. Its request.txt has two lines under the company line: "Prepared by Demo Rx Distribution LLC as third-party logistics provider on behalf of Northwind Generics LLC" and "Owner's approval: Dana Reyes, QA Director, reference NWG-TR-APPROVAL-0433, on YYYY-MM-DD".

Result: the response holds the owner's records only, and the owner's approval is frozen with it. Records: the request in the Responded state with the approval, the response zip (on the Response tab with its SHA-256, and in the chatter), and the tracked changes in the chatter. Send the zip as in Respond to a trace request with the response zip, and send it. What the zip contains: What an owner-scoped trace response contains.

Due On is still the core's 24-hour internal target from Received On; the software has no per-owner response time. An archived owner (a former client, for example Cedar Ridge Pharmaceuticals Inc.) can still be the Owner Concerned, so its records can be asked for after the relationship ends.

If it doesn't work

Known issue

Known issue (PF-A08-06): Owner Concerned offers every company, customers and suppliers included, not only owners. Choosing one that isn't an owner is refused when you save; choose the owner company named by the request.

Find the requests about owners' records​

In Inventory ‣ Rx Tracking ‣ Trace Requests, open the search options: the filters Our Own Records and Owners' Records, and the Group By option Owner Concerned, split the list by scope. To show the Owner Concerned column, open the optional columns menu at the right end of the list header and select it.

Answer a trace request about our own records while we hold owners' stock​

A request about your own stock or sales is answered with your records only, even when owners' units of the same product or lot are in the warehouse. The search tells you when it left out units that belong to an owner, so you can log a separate request for that owner.

Who: Rx Tracking User or Manager

Requires: Rx Tracking (DSCSA): 3PL and title model, with 3PL switched on.

Before you start:

  1. Go to Inventory ‣ Rx Tracking ‣ Trace Requests and open the request, for example DSCSA/TR/2026/00002 (a state inspector's question about Prototamol lot BPPTM2509A).

  2. Leave Owner Concerned empty: the field shows "Our own records".

  3. Fill in the Query group and select Search (EXC-07).

    Result: the request is In Progress with your documents and units only: for lot BPPTM2509A, your inbound document DSCSA/IN/2026/00001 (the unit you bought from Summit Specialty Pharma Inc. in place) and your unit 600000023001. Summit's two units of the same lot are left out, and the chatter has an internal note.

  4. Read the note in the chatter:

    Left out by this request's owner scope (our own records): 2 unit(s) matching the query, of Summit Specialty Pharma Inc. (2). The response
    doesn't cover them; log a request for their owner if they were asked about.

    Screenshot of the trace request chatter with the internal note about 2 units of Summit Specialty Pharma left out of the scope.

  5. If the requester asked about those units too, log a separate request with Owner Concerned = that owner and answer it with the owner's approval (3PL-TRC-01).

  6. Respond and send the zip as in EXC-08.

Result: the response covers your records only. Records: the request, Responded, with its response zip. The zip never contains an owner's documents; its packages.csv has an empty owner column, and a unit you bought from an owner in place shows only your movement (title_in) and your inbound document, whose stored file carries the owner's side of the sale. Details: What an owner-scoped trace response contains.

Variants:

  • A query naming the serial of a unit held for an owner finds nothing in your scope: the request shows "Not found: serial SERIAL" and the note names the owner (for example "… of Northwind Generics LLC (1)").
  • Before the company's first owner profile, trace requests work exactly as without 3PL: no Owner Concerned, no note.

If it doesn't work