Left out by definition. No serial, no transaction record.
Why does compounded medicine have no chain of custody?
Because the federal traceability law excludes it by definition, and every rule written since still assumes the pharmacy knows where each lot went.
A record with one author is a claim. A record with three is evidence. Until Custody, a pharmacy published a record about a unit and hoped the patient kept it.
Nobody wrote down who received the unit, whether it was in date when it was drawn, or where it went if it never arrived. Four public sources describe the same gap from four sides.
Drug Supply Chain Security ActFD&C Act §581(13)
… a drug compounded in compliance with section 503A or 503B.
| Source | What it says | What it assumes |
|---|---|---|
| Drug Supply Chain Security Act, 21 U.S.C. 360eee(13) | The definition of a traceable product excludes a drug compounded in compliance with section 503A or 503B. | Manufactured drugs travel with a serialized package and a transaction record. Compounded drugs travel with neither. |
| NABP, 29 July 2026 | Names the absence of supply-chain traceability tools for compounded products as a gap it will build standards around. | Boards of pharmacy will ask for the record that the tools would keep. |
| 22 Texas Administrative Code 291.133 and USP <797> | A pharmacy compounding sterile preparations keeps a written procedure for preparation recall; the chapter adds complaints and adverse-event reporting. | The pharmacy can say who received a lot. |
| ASHP Guidelines on Outsourcing Sterile Compounding Services | A hospital that buys from an outsourcing facility qualifies the vendor and keeps the records that show it. | The receiving side carries part of the burden. |
NABPJuly 29, 2026
… the absence of supply-chain traceability tools for compounded products, and the difficulty of verifying the bulk substances from which compounded medications are made …
Seven events. Each written by the hand that acted.
What does one record hold?
Seven events, each written by the hand that acted, each carrying the hash of the line before it.
Custody is not a second document. The Seal (the serialized QR on each unit's label) stays the record and the Passport (the proof issued for each dispensed order) stays the proof. What changes is who may write to the record and who it reaches.
The vocabulary is fixed and published, so a wholesaler, a board or a rival can read a Veritura record without a glossary.
| Event | Written by | What the line carries |
|---|---|---|
| Released | The pharmacy | The lot cleared and reviewed by a named person, the Passports issued, the Seals printed. The release slip in the box carries one shipment code. |
| Shipped | The pharmacy | The box, its code, the units inside it and the clinic it was sent to. |
| Received | The clinic | Received by code, or typed in from the packing slip, with accept or hold and the reasons. |
| Administered | The clinic | Unit, lot, date and the clinic's own reference. Never a patient's name. |
| Returned | The clinic | The unit and the date it went back. |
| Recalled | The pharmacy | The lot, declared once, reaching every clinic that holds it. |
| Reported | The clinic | An adverse-event report drafted from the unit's own record. |
Every line stores the hash of the one before it. Edit or remove a line in the middle and the chain no longer verifies, on the statement and on the public page. The statement says plainly what that check covers.
Bench to chair, five moments. One scan each.
How does a unit move from the bench to the chair?
Five moments, one scan each, and nothing new to type at the bench.
- Release
Nothing changes at the bench. The lot clears, a named person reviews it, the Passports issue and the Seals print. The release slip already in the box now carries a shipment code: one code per box, one Seal per unit.
- The door
The clinic scans the slip and every unit in the box lands on its desk with the pharmacy's paperwork behind it.
A box with no Seal is typed in from the packing slip and marked no record on file; if the clinic enters the pharmacy's email, the request for the record goes to that pharmacy, at most once a day.
Either way the desk shows accept or hold, with the reasons, before the box goes in the fridge.
- Administration
The clinic scans the unit at the chair. The line is written: unit, lot, date and the clinic's own reference. The patient's page shows the chain, and the clinic's administration log fills itself as the work happens.
- Recall
The pharmacy declares a recall once. Every clinic holding the lot sees the recalled units named on its desk and is emailed, and every patient who saved a unit from the lot is emailed.
The pharmacy sees which clinics have opened the notice and which have not.
- Report
An adverse-event report is drafted from the unit's own record, with product, lot, pharmacy and dates in place. The clinic states what it saw and sends it.
The report is a line on the unit's record, so the pharmacy can see that one exists. Patient identity stays with the clinic.
Where its units went. Four numbers it could not count before.
What does the pharmacy learn that it could not before?
Where its units went. Every other figure a pharmacy holds is about what it made; these four are about where it went.
| Number | What it counts | Why it matters |
|---|---|---|
| Unaccounted | Units shipped and not yet received or returned, by lot and by clinic. | The number a recall procedure assumes the pharmacy can state. |
| Off path | A Seal read at a clinic it was not shipped to, administered a second time, administered before any receipt was recorded, or read after it was returned. | A fact about scans, stated as such, and told to the pharmacy first. |
| Expiring on a clinic shelf | Units received and not administered, inside fourteen days of their use-by date. | The pharmacy can warn the clinic before an inspector finds the unit. |
| Recall notices not yet opened | Clinics holding a recalled lot that have not opened the notice on their desk. | Who still needs a phone call. |
The same view issues a numbered custody statement for each lot: released through administered, unaccounted stated, the chain verified, readable at a public address with no account.
It is the document a board asks for under a recall procedure, and one a buyer's contract can name. The full event record exports as CSV for the pharmacy's own systems.
A desk for every unit on hand. It costs the clinic nothing.
What does a clinic get, and what does it cost?
A desk for every unit on hand, and it costs the clinic nothing.
A clinic, medical spa or telehealth practice opens On hand: every unit in the fridge by lot, with the pharmacy's paperwork behind it. Today shows four stacks: arrived and awaiting a decision, expiring within fourteen days, recalled and not yet read, and waiting on paperwork.
The desk takes every shipment, sealed or not, so a pharmacy that does not seal its boxes shows up as the thinner record on its own customer's screen.
- The door decision states its reasons
- Whether the pharmacy's lot is cleared and a person there reviewed it, whether the use-by date is clear, whether a recall is recorded, and whether the pharmacy is on Veritura, which is never presented as supplier qualification.
- Administration is one scan per unit
- Against the clinic's own reference. No patient name, chart or prescription enters Veritura.
- An adverse-event report is drafted
- From the unit's record for the clinic to complete and send.
Two more lines for the patient. Received, and administered.
What does the patient see?
Two more lines on the page the patient already opens from the label.
The same code the patient scans now carries the middle hand: received by the clinic, with the date, and administered, with the date. The clinic's name and nothing more. No score, no posture word, and nothing about the patient.
A patient who wants recall notices can save the unit from its page with only an email address, which is kept until they delete it. That is the one piece of patient information Custody ever holds, and the patient chooses to give it.
No line in it is Veritura's. Each names the hand that wrote it.
Why can a record kept on Veritura be relied on?
Because no line in it is Veritura's. Each line names the hand that wrote it, and the lines are chained.
Anyone can open a lot's statement without an account. No record on file is a legitimate state, and the market learns to read it.
Because the event vocabulary and the export are published, a buyer can write the record into a supply agreement in one sentence:
For each lot delivered, the supplier provides a certificate of analysis and a custody record the buyer can open without an account, stating units released, received and unaccounted.
Where Custody stops.
Where does Custody stop?
- Custody says who held a unit and what the paperwork established. It never says a preparation is safe, effective or approved, and it is not a certificate of analysis.
- Off path is a fact about where and when a Seal was read. Custody never uses the words diverted, counterfeit or stolen. The pharmacy draws the conclusion.
- No patient identity is stored. An administration carries the clinic's own reference, so which unit went to which patient holds only as far as the clinic's own records go.
- Nothing that shipped before is retired. Custody sits over the Passport, the Seal, the order channels and the recall notice.
The public record this note stands on.
- DSCSA
- Federal Food, Drug, and Cosmetic Act section 581(13), 21 U.S.C. 360eee(13), definition of product
- NABP
- Press release of 29 July 2026 on supply-chain traceability and bulk substance verification for compounded medicine
- Texas
- 22 Texas Administrative Code 291.133, pharmacies compounding sterile preparations
- USP
- General Chapter <797>, quality assurance, recalls, complaints and adverse-event reporting
- ASHP
- Guidelines on Outsourcing Sterile Compounding Services
See Custody on a sample lot.
The workspace view, from the release slip to the public statement, on a seeded sample workspace where every firm and lot is fictional.