The short version
- 21 CFR 1301.25 creates two separate annual reports, not one.
- The medical officer report under paragraph (e) is dated to the day the DEA registration expires.
- The master report under paragraph (h) runs on the calendar year, so the two clocks rarely align.
- Neither report is filed with DEA on a schedule. Both are held and produced on request.
- The master report goes to the medical officer if one is employed, and stays with the master if not.
A vessel program can hold every drug lawfully and still fail an inspection on paperwork. The two annual reports are the most commonly confused part of 21 CFR 1301.25, because operators assume there is one report and that it gets mailed somewhere[1].
Neither assumption is right. There are two, they run on different clocks, and the regulation does not require either to be submitted on a schedule. For the rule read paragraph by paragraph, see 21 CFR 1301.25 explained.
Two reports, two different clocks
The distinction that catches well-run programs is temporal. One report is anchored to an administrative date that belongs to a person, the other to the calendar.
| Medical officer report, para (e) | Master report, para (h) | |
|---|---|---|
| Who prepares it | The DEA-registered medical officer | The Master of the vessel |
| The clock | The date the DEA registration expires | Each calendar year |
| Scope | Detail for each vessel, plus a summary for all vessels supervised | Detail for that one vessel |
| What it accounts for | Controlled substances purchased, dispensed or disposed of | Controlled substances purchased, dispensed or disposed of |
| Normal destination | Kept with the other required records | Filed with the medical officer, if one is employed |
| When DEA sees it | On request | On request |
Why the clocks matterA DEA registration expires on a date set when it was granted. Unless that date happens to be 31 December, the officer report and the master report cover different twelve-month windows. Two windows means two reconciliations, and a figure that balances in one will not automatically balance in the other.
The medical officer report under paragraph (e)
Paragraph (e) requires the medical officer, in addition to every duty imposed on registrants generally, to prepare an annual report as of the date on which the registration expires[1].
Two things in that sentence are routinely missed.
- It is not one accounting, it is two. The report must give in detail an accounting for each vessel, aircraft or other entity, and a summary accounting for all of them under that officer’s supervision[1]. A single fleet-level total does not satisfy it.
- It covers three verbs, not one. Controlled substances purchased, dispensed or disposed of during the year. Programs that track acquisition and dispensing but treat disposal as a separate exercise produce an incomplete report. Disposal is covered in our disposal guide.
The officer then maintains the report with the other records required under the Act and, upon request, delivers a copy to the Administration[1]. Read that as: it lives in your records, and DEA reads it when DEA asks.
The master report under paragraph (h)
Paragraph (h) requires the Master of a vessel to prepare a report for each calendar year giving in detail an accounting for all controlled substances purchased, dispensed or disposed of during the year[1].
Same three verbs, different clock, single vessel. Where it differs sharply from the officer report is the destination.
Where each report actually goes
The master report has two possible destinations and the regulation picks between them based on one fact: whether the owner or operator employs a medical officer[1].
| Your compliance route | What the master does with the report | How DEA sees it |
|---|---|---|
| Owner or operator employs a medical officer | Master files the calendar-year report with the medical officer | Medical officer keeps it with the required records and produces it on request |
| No medical officer, master requisition route | Master keeps the report with the other records required under the Act | Master delivers a copy to DEA on request |
Neither report is mailed to DEA on a scheduleNothing in paragraph (e) or (h) requires periodic submission. Both are prepared, retained with the required records, and delivered to the Administration upon request[1]. Operators who believe they are late filing are usually not late. Operators who never prepared the report at all have a real problem, because there is nothing to produce when the request comes.
Which route you are on is decided by the employment test in paragraph (b). That test disqualifies more programs than any other line in the rule, and it is set out in medical officer or master requisition.
Building both reports from one record set
Both reports account for the same three verbs, so they should be generated from one underlying ledger rather than assembled separately at year end.
- Acquisition. Every purchase, tied to its record of sale. On the requisition route, copy 2 of the triplicate stays aboard[1], which makes the vessel the primary source for its own acquisitions.
- Dispensing. Every administration, dated and attributable. Paragraph (e) permits dispensing without the officer present, provided the person who dispensed is responsible to the officer to justify their actions[1].
- Disposal. Every removal from stock, with the route used under 21 CFR part 1317[2].
General registrant records under 21 CFR part 1304 must be kept at least two years and be available for inspection and copying[3]. Build to that retention, not to the reporting year. Our recordkeeping guide sets out the full record set.
The four ways operators get this wrong
- Producing one report instead of two. A fleet summary is not the officer report, and the officer report is not the master report.
- Aligning both to the calendar year. Convenient, and wrong for paragraph (e) unless the registration genuinely expires on 31 December.
- Omitting disposal. All three verbs belong in both reports.
- Filing the master report nowhere. If a medical officer is employed, the master files it with the officer. It does not simply sit in the ship’s office.
An inspector reads for the document, not the intention. What else gets examined is set out in the inspection document checklist and the broader compliance audit guide.
Common questions
How many annual reports does a vessel controlled substances program owe?
Two. 21 CFR 1301.25 paragraph (e) requires an annual report from the medical officer dated to the expiry of the DEA registration, and paragraph (h) requires the Master to prepare a report for each calendar year[1]. They are separate documents on separate clocks. See Controlled Substances.
Do we mail the annual reports to DEA?
No. Neither paragraph requires periodic submission. Both reports are prepared, maintained with the other records required under the Act, and a copy is delivered to the Administration upon request[1]. Read the rule in 21 CFR 1301.25 explained.
Is the medical officer report due on 31 December?
Only if the DEA registration happens to expire then. Paragraph (e) dates the report to the day the registration expires, not to the calendar[1]. The master report under paragraph (h) is the one that runs per calendar year. Ask us to map your dates.
Who does the master file the calendar-year report with?
With the medical officer employed by the owner or operator of the vessel, if there is one. If there is not, the master maintains the report with the other required records and delivers a copy to DEA on request[1]. Which route applies is decided by the employment test covered in medical officer or master requisition.
What has to be in the medical officer report?
A detailed accounting for each vessel, aircraft or other entity, plus a summary accounting for all of them under that officer supervision, covering controlled substances purchased, dispensed or disposed of during the year[1]. Per-vessel detail and a fleet summary, not one or the other. See recordkeeping.
How long do we keep the reports?
Records required under 21 CFR part 1304 must be kept by the registrant and available for inspection and copying for at least two years[3]. Build retention to that standard rather than to the reporting year. Our MedChest service holds the record set as part of the program.
Does disposal belong in the annual reports?
Yes. Both paragraph (e) and paragraph (h) account for controlled substances purchased, dispensed or disposed of during the year[1]. Disposal must run through 21 CFR part 1317[2], which is covered in disposing of expired controlled substances from a ship chest.
