The short version
- A vessel program is judged on seven document sets, not on how tidy the locker looks.
- Form 223 registration details must be held at the principal office and be readily retrievable.
- On the requisition route, copy 2 of the triplicate record of sale must be retained aboard the vessel.
- Both annual reports must exist and be producible, even though neither is mailed to DEA.
- Records under part 1304 must be kept and available for inspection and copying for at least two years.
A locker can be immaculate and a program can still fail. What is examined is the paper trail that proves the stock was acquired lawfully, held under someone accountable, dispensed traceably, and disposed of through a permitted route.
This is a document checklist, not a legal opinion on inspection procedure. It is built from the record duties 21 CFR 1301.25 and 21 CFR part 1304 actually impose[1][2]. For a full program review see Consulting.
The seven document sets, in order
| # | Document set | What it has to show | How it usually fails |
|---|---|---|---|
| 1 | Proof of registration structure | DEA Form 223 details, held at the principal office and readily retrievable | The certificate is at a shore office nobody aboard can reach during the visit |
| 2 | Acquisition records | Record of sale for each purchase. On the requisition route, copy 2 of the triplicate, retained aboard | Copy 2 was never retained aboard, or was filed ashore with the others |
| 3 | The written requisitions | Vessel stationery, official number, country of registry, owner or operator, port, signature and date | A requisition missing the official number or the country of registry |
| 4 | Dispensing log | Who received what, when, and under whose responsibility | Gaps across a crew change, or entries that cannot be tied to a person |
| 5 | The two annual reports | Officer report dated to registration expiry, master report per calendar year | One report produced instead of two, or the master report filed nowhere |
| 6 | Disposal documentation | The route used under part 1317 and the record of what left the chest | Expired stock destroyed aboard, with no lawful route behind it |
| 7 | Storage and access control | Physical security of the stock and who holds access | Access shared informally, so no single person is accountable |
Where each document is supposed to live
Location is a compliance fact, not an administrative preference, and two of the seven are location-specific in the regulation itself.
The master annual report has a conditional address: filed with the medical officer if one is employed, otherwise retained by the master[1]. That distinction is set out in the two annual reports.
How long everything has to be kept
Section 1304.04(a) requires every inventory and record kept under part 1304 to be kept by the registrant and available for inspection and copying by authorised employees of the Administration for at least two years from the date of the record[2].
Two years is a floor, not a target. Programs that purge on the anniversary lose the ability to explain a discrepancy that surfaces later.
Preparing without rehearsing
The useful preparation is not a drill. It is a dry read of the seven sets by someone who did not create them, asking one question of each: can an outsider follow this without being told what it means?
- Read acquisition to dispensing to disposal as one chain for a single drug across a single year. If the chain breaks, it breaks in the same place for every drug.
- Confirm copy 2 is physically aboard if you are on the requisition route[1]. Read the guide to the two routes in medical officer or master requisition.
- Confirm both annual reports exist, on their correct clocks, before anyone asks for them.
- Confirm every disposal has a lawful route behind it under part 1317[3]. See disposal from a ship chest.
The wider medical audit, covering the chest, records, cargo kits and facilities alongside controlled drugs, is set out in vessel medical compliance audit.
Common questions
What documents does a vessel controlled substances program need?
Seven sets: registration structure, acquisition records, the written requisitions, the dispensing log, the two annual reports, disposal documentation, and storage and access control. The duties come from 21 CFR 1301.25 and 21 CFR part 1304[1][2]. See Controlled Substances.
Where must the DEA registration details be kept?
21 CFR 1301.25(b) requires the Form 223 details to be maintained at the principal office of the owner or operator and be readily retrievable[1]. Read the rule in 21 CFR 1301.25 explained.
Which record has to be physically on the ship?
On the master requisition route, copy 2 of the triplicate record of sale is retained aboard the vessel[1]. It is the single most commonly missing document in a vessel program. Our recordkeeping guide sets out the full triplicate flow.
How long must records be retained?
Section 1304.04(a) requires records kept under part 1304 to be maintained and available for inspection and copying for at least two years from the date of the record[2]. Ask us to review your retention.
Do we have to produce the annual reports even though we never file them?
Yes. Neither the officer report nor the master report is submitted on a schedule, but both are delivered to the Administration upon request[1]. A report never prepared cannot be produced. See the two annual reports.
What is the most common failure?
A missing document rather than a missing drug, and most often copy 2 of the record of sale[1]. The second most common is one annual report where the regulation requires two. Our Consulting service checks both.
Does this replace a full medical compliance audit?
No. This checklist covers the controlled substances document chain only. The wider audit also examines the chest and inventory, treatment records, hazardous cargo kits and facilities, and is described in vessel medical compliance audit.
