The short version
- 21 CFR 1301.25 does not distinguish by schedule when permitting controlled substances aboard.
- The employment and registration test, the requisition route and the two annual reports are the same for every schedule.
- What does change is recordkeeping: Schedule II records must be kept separately from all other records.
- Schedules III, IV and V may be kept separately or readily retrievable from ordinary business records.
- That rule reaches a vessel medical officer through 21 CFR 1304.04(g), which applies paragraph (f) to practitioners.
Operators plan vessel medicine chests as if the schedule of a drug changes the compliance regime around it. For the most part it does not. One rule genuinely changes, it is a filing rule, and it is the one most programs have never applied.
This page separates the two. For the schedules themselves, DEA publishes the current listing[4]. For how the chest gets built, see how to stock a ship medicine chest.
The vessel exception is schedule-blind
So the structural questions are the same whichever schedule you carry: is there a state-licensed physician employed by the owner or operator and DEA-registered, or are you on the master requisition route. That test is set out in medical officer or master requisition.
The one rule that does change by schedule
Section 1304.04(f) splits recordkeeping by schedule, and the split is sharp[2].
| Schedule | Typical maritime relevance | How records must be kept |
|---|---|---|
| Schedule II | Morphine, fentanyl and similar high-potency analgesics carried for severe pain at sea | Records and inventories must be maintained separately from all other records of the registrant |
| Schedules III, IV and V | Moderate analgesics, sedatives and antitussive preparations | Records may be kept separately or in a form where the information is readily retrievable from ordinary business records |
Read the Schedule II row carefully. Separately from all other records is not “clearly labelled within the file”. It is a separate record set. A program that keeps one combined controlled substances ledger has not met it.
Why that rule reaches a vessel medical officer
Paragraph (f) lists manufacturers, distributors, importers, exporters and narcotic treatment programs, which is why programs assume it does not apply to them.
Retention does not move with the schedule either: at least two years, available for inspection and copying[2]. How the whole ledger fits together is set out in recordkeeping aboard a vessel.
Four things that do not change by schedule
| The belief | The position |
|---|---|
| The vessel exception only covers lower schedules | False. 21 CFR 1301.25 does not distinguish by schedule when it permits controlled substances to be held aboard |
| Schedule changes whether you need a medical officer | False. The employment and registration test in paragraph (b) is the same regardless of schedule |
| Only Schedule II appears in the annual reports | False. Both annual reports account for controlled substances generally, purchased, dispensed or disposed of |
| Lower schedules can be destroyed aboard | False. Part 1317 governs disposal for all schedules, and the non-retrievable standard does not soften by schedule |
The disposal row is the costly one. Part 1317 governs disposal for every schedule and the non-retrievable standard does not relax for a Schedule IV sedative[3]. See disposal from a ship chest.
What this means for how you file
- Split the ledger at Schedule II. One record set for Schedule II, a second for III to V. This is the single change most vessel programs need to make.
- Keep the reporting unified. Both annual reports account for controlled substances across schedules, so the split ledger must roll up cleanly[1]. See the two annual reports.
- Do not let the schedule drive the security decision. Access control is judged on the program, not on a drug class.
- Check what you actually carry. Chest contents follow your flag state and voyage profile, and the schedule follows from the drug. Compare frameworks in medicine chest requirements by flag state.
Common questions
Does 21 CFR 1301.25 treat schedules differently?
No. 21 CFR 1301.25 permits controlled substances aboard qualifying vessels without carving the permission by schedule[1]. The employment test, the requisition route and both annual reports apply the same way. See 21 CFR 1301.25 explained.
What does change by schedule?
Recordkeeping. Section 1304.04(f) requires inventories and records of Schedule I and II substances to be maintained separately from all other records, while Schedules III, IV and V may be separate or readily retrievable from ordinary business records[2]. See recordkeeping.
Does the Schedule II separation rule apply to a vessel medical officer?
Yes. Section 1304.04(g) applies the paragraph (f) manner of keeping records to each registered individual practitioner and institutional practitioner[2]. A DEA-registered vessel medical officer falls inside that. Ask us to check your ledger.
Can lower-schedule drugs be destroyed aboard?
No. Part 1317 governs disposal for all schedules and the non-retrievable destruction standard does not soften by schedule[3]. Expired stock comes ashore. See disposal from a ship chest.
Which schedule is a given drug in?
DEA publishes the current controlled substance schedules and they are amended over time[4]. Verify against the current listing rather than a supplier catalogue. Our MedChest service checks contents against both the schedule listing and your flag requirements.
Do both annual reports cover every schedule?
Yes. Paragraphs (e) and (h) account for controlled substances purchased, dispensed or disposed of during the year without limiting by schedule[1]. A split ledger still has to roll up into one accounting. See the two annual reports.
How long are the records kept?
At least two years from the date of the record, available for inspection and copying by DEA, under 21 CFR 1304.04(a)[2]. The retention period does not vary by schedule. See Controlled Substances.
