The short version
- Eight record types make up a compliant vessel program, and they do not all live in the same place.
- Copy 2 of the record of sale must be retained ABOARD the vessel. It is the document most often missing.
- Copy 3 goes to the nearest DEA Division Office within 15 days after the end of the month of sale.
- DEA registrant records are generally kept at least two years and must be available for inspection.
- Readily retrievable means produced without delay. If you have to call a ship at sea, it is not.
A fleet manager can hold every purchase record in a shore office, filed perfectly, and still fail an inspection. The regulation does not only ask whether the record exists. It asks where it is.
This page sets out the eight record types a vessel controlled substances program produces, where each one must sit, and how long to keep it. For the service that runs this, see Controlled Substances. For the two routes that generate these records in the first place, see medical officer or master requisition.
What records a vessel program must hold
The vessel-specific records come from 21 CFR 1301.25, and the general registrant obligations from 21 CFR part 1304[1][2]. Together they produce this set.
| Record | What it contains | Where it must be held | Authority |
|---|---|---|---|
| Registration record | DEA Form 223 details for the medical officer | Principal office, readily retrievable | 21 CFR 1301.25(b) |
| Written requisition | Vessel stationery, official number, country of registry, owner or operator, port, date, signature | With the vendor, copy retained | 21 CFR 1301.25(d) |
| Record of sale, copy 2 | The vessel’s copy of each purchase | Retained ABOARD the vessel | 21 CFR 1301.25(d) |
| Record of sale, copy 3 | Vendor submission to DEA | Nearest DEA Division Office, within 15 days after month end | 21 CFR 1301.25(d) |
| Medical officer annual report | Detailed accounting per vessel plus a fleet summary | Filed to the registration expiry date | 21 CFR 1301.25(e) |
| Master annual report | Accounting for substances obtained by requisition | Filed per calendar year | 21 CFR 1301.25(h) |
| Disposal records | Documented destruction or transfer of expired stock | With the program records | 21 CFR part 1317 |
| Inventories and dispensing logs | General registrant records and reports | Registered location, readily retrievable | 21 CFR part 1304 |
Where the records live: aboard or ashore
Two locations matter and they are not interchangeable.
Aboard the vesselCopy 2 of every record of sale. Paragraph (d) states it is furnished to the officer of the vessel and retained aboard[1]. A shore-office copy does not satisfy this.
At the principal officeThe medical officer’s DEA Form 223 details, kept readily retrievable per paragraph (b)[1], alongside the inventories and dispensing records that part 1304 requires of any registrant[2].
The failure we find most oftenA well-run program with complete shore records and no copy 2 aboard. The purchase was lawful, the paperwork exists, and the vessel still cannot produce the document an inspector asks for first.
How long must records be kept?
DEA registrant records are generally required to be retained for at least two years and to be available for inspection[2][3]. Treat two years as the floor.
Two practical reasons to keep longer. A fleet record set that reaches back only two years cannot demonstrate a pattern of compliance across registration cycles. And because the medical officer report is dated to registration expiry rather than the calendar, a two-year window can cut a reporting cycle in half.
The two annual reports, and the 15-day clock
Three deadlines govern a vessel program and none of them share a date.
- Copy 3 to DEA: within 15 days after the end of the month in which the sale was made[1].
- Medical officer annual report: dated to the expiry of the registration, giving a detailed accounting for each vessel and a summary for all vessels under supervision[1].
- Master annual report: filed against the calendar year, so it never aligns with the officer report[1].
Build the calendar oncePut all three on one compliance calendar with the registration expiry date as an anchor. Programs that track only the calendar year miss the officer report window, which is the error we correct most often in a consulting review.
The readily retrievable test
Paragraph (b) requires the Form 223 details to be readily retrievable[1]. The phrase is doing real work.
A useful internal test: could the person who answers the phone produce this document within the length of that call, without contacting a vessel at sea? If not, the record is stored, not retrievable, and an unannounced inspection will find that out.
Building a record set that survives an inspection
Five steps, in the order we run them.
- Fix the aboard copy first. Audit every vessel for copy 2 of each record of sale. This is the fastest gap to close and the one most likely to be open.
- Anchor the calendar to registration expiry, then add the calendar-year master report and the 15-day monthly clock around it.
- Separate disposal from restock. Disposal under part 1317 produces its own record[4] and should reconcile against the chest inspection record. See MedChest.
- Test retrievability, do not assume it. Ask for three documents at random and time the response.
- Re-check after any ownership change. A new owner or operator can invalidate the registration structure the records were built under.
Common questions
What controlled substance records must a vessel keep?
At minimum: the medical officer registration details, any written requisitions, copy 2 of every record of sale retained aboard, both annual reports, and disposal records. 21 CFR 1301.25 sets the vessel-specific items and 21 CFR part 1304 governs registrant records and reports generally. See Controlled Substances.
How long must DEA records be kept?
DEA registrant records are generally required to be retained for at least two years and to be available for inspection, under 21 CFR part 1304. Vessel operators should treat that as a floor, not a target, because a fleet record set that only reaches back two years cannot demonstrate a pattern. Ask us to review your retention practice.
Which record has to physically stay on the vessel?
Copy 2 of the record of sale. 21 CFR 1301.25(d) states it is furnished to the officer of the vessel and retained aboard. It is the single most commonly missing document we find. Our route comparison covers when the requisition process applies.
What does readily retrievable actually mean?
It means a record can be produced for inspection without delay or reconstruction. 21 CFR 1301.25(b) applies the phrase to the Form 223 details kept at the principal office. In practice, if finding a document requires calling a vessel at sea, it is not readily retrievable.
Do the two annual reports use the same dates?
No, and this is a frequent error. The medical officer report under paragraph (e) is dated to the expiry of the registration. The master report under paragraph (h) runs per calendar year[1]. Read the paragraph-by-paragraph walkthrough.
How should expired stock be recorded?
Disposal is governed by 21 CFR part 1317 and must be documented, not simply discarded. Pair the disposal record with the chest inspection record so the two agree. See MedChest and our flag-state comparison.
