The short version
- Flag is decision one. It selects the binding instrument, and every later decision inherits from it.
- Write the chest standard before buying the chest. For a US-flagged vessel no federal contents list exists, so your documented method is the standard.
- Decide early whether you carry controlled substances. A yes creates a second program with its own registrations, records and two annual reports.
- Radio medical advice is a free state obligation under MLC 2006 and 92/29/EEC. The US has ratified neither, so a US vessel writes its own escalation route.
- US fishing rules set no chest inspection interval. Adopt the annual one anyway, because an absent interval means no dated evidence.
Most vessel medical programs start with a purchase order. Somebody buys a chest, the chest arrives, and eighteen months later an inspector asks which standard it was built to and nobody can answer. The buying decision is the fourth or fifth decision, not the first.
Six decisions come before it, and every one of them constrains the next. Get the order right and the program builds itself. Get it wrong and you pay twice.
Decision one: which instrument actually binds this hull
Flag decides everything downstream, and it is the decision operators skip because it feels administrative. It is not. Two vessels doing identical work under different flags carry different obligations, different chest standards and different inspection intervals.
| Flag or operation | Binding instrument | Chest standard it implies |
|---|---|---|
| EU Member State flag | Directive 92/29/EEC[2] | Category A, B or C by voyage pattern, with the Annex II schedule |
| US documented fishing vessel in Subpart C | 46 CFR 28.210[1] | “A size suitable for the number of individuals on board”, undefined. You write the method |
| Flag that has ratified MLC 2006 | MLC Regulation 4.1 and Standard A4.1[7] | Chest, equipment and a medical guide, inspected at regular intervals |
| Open registry, for example Marshall Islands | The flag’s own marine notice, MN 7-042-1[8] | Follows the flag notice, which usually points to the WHO guide |
If the fleet spans several registries, do this once across all of them rather than vessel by vessel. The flag state comparison is the shortcut, and the 92/29/EEC breakdown covers the EU side in detail.
Decision two: the standard, written down before anything is bought
For an EU-flag vessel the standard is handed to you. For a US-flagged one it is not, and that is a decision rather than a gap. FDA addressed ship medicine chests in Compliance Policy Guide Sec. 460.500 and stated it has never suggested or recommended any particular procedure[3].
What “documented method” means in practice
One page, naming four inputs: persons carried, longest voyage, distance to definitive care, and the work performed. Then the reference you anchor quantities to, which for most operators is the WHO Quantification Addendum of 2010[5]. Signed and dated. That page is the standard you are judged against, and without it you are judged against whatever the inspector assumes.
The WHO guide is guidance, not law, and there is no fourth edition[4]. Naming it as your reference is defensible. Claiming it as your authority is not. The build itself is covered in how to stock a ship medicine chest, and for US fishing vessels specifically in the 46 CFR 28.210 rules.
Decision three: whether you are carrying controlled substances at all
This is a yes or no decision and it belongs early, because a yes creates an entire second program with its own registrations, records and reporting. 21 CFR 1301.25 is prescriptive in a way nothing else in a vessel chest is[6].
The medical officer test is conjunctive: state-licensed physician, employed by the owner or operator, DEA-registered. Employment is where programs fail, because a consulting physician is not employed. The alternative is the master requisition route[6], and the two are compared in medical officer or master requisition.
Say yes and four obligations follow that nothing else in the program touches: recordkeeping, how it changes by schedule, two annual reports on different clocks, and disposal ashore. Say no and the chest gets simpler by an order of magnitude.
Decision four: who answers at three in the morning
Every program needs a named escalation route, and this is the decision where operators most often buy something they may not need to buy.
| Capability | What the instruments say | What it means for you |
|---|---|---|
| Radio or satellite medical advice | MLC 2006 Standard A4.1(4)(d) requires ratifying states to ensure it is available free of charge[7]. 92/29/EEC requires Member States to designate centres giving free advice by radio[2] | Under a ratifying flag this is a state obligation. The United States has not ratified MLC 2006, so a US-flagged vessel has no treaty guarantee and must write its own route down |
| Doctor carried on board | Required at 100 or more workers on an international voyage over three days, in both instruments[2][7] | Almost no commercial fleet reaches it. Below the threshold the answer is shore-side physician oversight |
| Sick bay | 92/29/EEC: vessels over 500 gross tons carrying 15 or more crew on voyages exceeding three days[2] | A tonnage and crew test, not a judgement call. Check it once and record the answer |
The useful discipline here is to separate what a treaty already guarantees from what you are being sold. Write the escalation route on one page: who is called, on what number, in what order, and who decides to divert. That page is worth more at three in the morning than any subscription.
Decision five: how many people, certified in what
Competence requirements are set by the same instrument that set your chest standard, and they are headcount tests rather than judgement calls. A US fishing vessel in Subpart C steps at 2, 16 and 49 individuals on board, requiring 1 and 1, then 2 and 2, then 4 and 4 in first aid and CPR[1]. Under 92/29/EEC the captain and designated workers need special training updated at least every five years[2].
Two practical points. Certificates expire on their own schedule, not yours, so the roster needs a renewal column and an owner. And a person who holds both first aid and CPR counts in both columns under the US tiers, which changes the arithmetic on a small crew[1].
Decision six: the cycle that produces evidence
A program is not a document, it is a repeating cycle that leaves a dated trail. Directive 92/29/EEC requires an annual inspection by a competent person or authority, and MLC Guideline B4.1.1 points at intervals of at most twelve months[2][7].
Where a US operator should borrow
US fishing rules set no inspection interval for the chest at all. That sounds like relief and is actually exposure, because an absent interval means there is no dated evidence that anything was ever checked. Adopt the annual cycle even though nothing compels it. It is the cheapest defensible record you can generate[1].
What the cycle should produce each year: an expiry sweep and restock, a reconciliation of the controlled substance ledger, a certification roster check against current headcount, and a signed inspection record naming who did it. The full examination view is in what a vessel medical compliance audit checks, and the drug-side document list in the DEA inspection checklist.
Why the order is the whole point
Run these in sequence and each decision narrows the next. Run them out of order and the failure mode is predictable: a chest bought to no standard, a controlled substance file opened after the drugs are already aboard, and an escalation route that exists only in somebody’s phone.
| # | Decision | Owner | The evidence it must leave behind |
|---|---|---|---|
| 1 | Which instrument binds this hull | Operations or DPA | A one-line determination per vessel, naming flag and instrument[2] |
| 2 | The written chest standard | Physician or medical adviser | A signed, dated method page naming the four inputs and the quantity reference[5] |
| 3 | Controlled substances, yes or no | Owner or operator | If yes, the DEA registration or the requisition file, kept separately[6] |
| 4 | The escalation route | Master and shore contact | One page: who is called, on what number, in what order, who decides to divert |
| 5 | Certification against headcount | Crewing | A roster with a renewal column and a named owner[1] |
| 6 | The annual cycle | Whoever signs the inspection | A dated inspection record, an expiry sweep and a ledger reconciliation[2] |
Notice the right-hand column. Every decision resolves to a document, and the document is what survives a change of master, a change of manager or an inspection two years later. A program that lives in one experienced person’s head is not a program, it is a dependency.
The 80/20 sits in decisions one and two. Flag and written standard take an afternoon between them and they determine everything else. If you would rather hand the whole sequence to a physician, that is what maritime medical consulting is, and MedChest carries the chest side once the standard exists. The wider library sits on the blog, the full list on services, and the physicians on the about page.
Common questions
What is the first decision in setting up a vessel medical program?
The flag, not the chest. Flag decides which instrument binds you, and every later decision inherits from it. An EU flag pulls in Directive 92/29/EEC and its categories[2]; a US fishing vessel answers to 46 CFR 28.210 instead[1]. Buying a chest before settling the flag is the single most common sequencing error. Our consulting service starts here.
Do I have to pay for 24-hour medical advice by radio?
Under MLC 2006 Standard A4.1(4)(d), ratifying states must ensure free 24-hour radio or satellite medical advice, and Directive 92/29/EEC requires Member States to designate centres giving free advice by radio[7][2]. The United States has not ratified MLC 2006, so a US-flagged vessel gets no treaty guarantee and should write its own escalation route down. We help build that route.
What contents list should the chest be built to?
For a US-flagged vessel there is no federal list. FDA states in CPG Sec. 460.500 that it has never recommended any particular stocking procedure[3], so you document a method and anchor quantities to the WHO Quantification Addendum[5]. See how to stock a ship medicine chest.
How often should the chest be inspected?
Directive 92/29/EEC requires an annual inspection by a competent person or authority, and MLC 2006 Guideline B4.1.1 points to inspection at regular intervals of at most 12 months[2][7]. US fishing rules set no interval, which is exactly why you should adopt the annual one. See what an audit checks.
When does a vessel need a doctor on board?
Under 92/29/EEC, a crew of 100 or more workers on an international voyage of more than three days requires a doctor on board, and MLC 2006 Standard A4.1(4)(b) sets the same 100 persons and three-day international voyage test[2][7]. Almost no commercial fleet reaches 100 workers, so for practically every operator the real decision is who provides oversight from ashore and how they are reached. Consulting covers exactly that gap.
Where do controlled substances fit in the program?
In a separate file with its own owner. 21 CFR 1301.25 is the most prescriptive rule touching a US vessel chest and it fails independently of everything else[6]. Read 21 CFR 1301.25 explained and see the Controlled Substances service.
How long does a program take to stand up?
The six decisions can be made in a week. Sourcing, certification and the first documented inspection cycle take longer, and the annual review is what makes it durable. The mistake is treating it as a purchase rather than a cycle. Talk to a physician about your fleet or read the guidance library first.
