The short version
- Section 28.210(a) requires “a complete first aid manual and medicine chest of a size suitable for the number of individuals on board in a readily accessible location”. Nothing more.
- Subpart C applies on three triggers, not two. Beyond the Boundary Lines, more than 16 individuals, or a fish tender in the Aleutian trade.
- There is no US federal contents list. FDA said in CPG 460.500 that it has never recommended any particular stocking procedure, and has not withdrawn that.
- Certification tiers by headcount: more than 2 needs 1 and 1, more than 16 needs 2 and 2, more than 49 needs 4 and 4.
- Controlled substances are the exception. 21 CFR 1301.25 is prescriptive where 28.210 is silent.
46 CFR 28.210 is one paragraph long on the equipment side, and that paragraph is the entire federal specification for a commercial fishing vessel medicine chest. It tells you to carry one. It does not tell you what goes in it.
That gap is not an oversight and it is not a loophole. It is a deliberate federal position, stated by FDA in 1980 and never withdrawn[3]. Understanding it is the difference between a chest that survives a Coast Guard boarding and a shopping list copied from a vendor catalogue. For the build process itself, see how to stock a ship medicine chest.
Who Subpart C actually applies to, including the trigger most summaries drop
Section 28.200 sets applicability for the whole of Subpart C, and it is a three-way test where any single trigger is enough[2].
| Trigger under 46 CFR 28.200 | What it captures |
|---|---|
| (a) Operates beyond the Boundary Lines | The offshore fleet. Most operators know this one and assume it is the only one. |
| (b) Operates with more than 16 individuals on board | Crew size alone pulls a vessel in, regardless of where it works. |
| (c) Is a fish tender vessel engaged in the Aleutian trade | A named trade, captured by definition rather than by distance or headcount. |
A live SERP defect worth knowing aboutGoogle’s AI Overview for this query, captured 19 August 2026, describes the scope as vessels operating beyond the boundary lines or carrying more than 16 individuals. It omits the Aleutian trade tender entirely. Anyone scoping compliance from that summary would leave a whole class of vessel out. Read the section, not the summary[2].
Applicability is also where audits start. If you want to see how the rest of a program is examined once Subpart C bites, the vessel medical compliance audit walks the five areas an auditor opens.
What 28.210 requires, word for word
The equipment sentence in fullSection 28.210(a): each vessel must have on board “a complete first aid manual and medicine chest of a size suitable for the number of individuals on board in a readily accessible location”[1]. Three obligations, no contents list, no inspection interval, no expiry rule.
The training paragraphs are more specific than the equipment one. Certificates must come from the American National Red Cross first aid courses named in the section, the American Heart Association for CPR, or a Coast Guard approved equivalent, and the required headcount tiers with the number of individuals on board[1].
| Individuals on board | Certified in first aid | Certified in CPR |
|---|---|---|
| More than 2 | At least 1 | At least 1 |
| More than 16 | At least 2 | At least 2 |
| More than 49 | At least 4 | At least 4 |
One person holding both certificates counts in both columns[1]. Notice the asymmetry that runs through the whole section: the people are specified precisely and the chest is not specified at all.
The contents list does not exist, and that is the federal position
Operators regularly assume a missing list means the answer sits in another agency. It does not. FDA addressed ship medicine chests directly in Compliance Policy Guide Sec. 460.500, issued 1 October 1980 and still listed as Final[3].
What FDA actually saysFDA states it does not wish to place obstacles in the way of stocking ships’ chests and that it has never suggested or recommended any particular procedure. The only control the guide describes sits on the supply side: the pharmacist or supplying firm should exercise reasonable care that the drugs reach the chest and are not diverted[3].
So the United States has no federal contents list for prescription drugs in a ship’s medicine chest. The obligation in 28.210(a) is real and enforceable, and the standard against which it is measured is left to the operator to establish. That is uncomfortable, and it is also an opportunity, because a documented method beats a copied list every time.
Turning “a size suitable” into something an auditor can accept
Since the phrase is undefined, the defensible position is a written sizing method rather than a number. Four published references are in common use, and none of them is US law. Say so on the face of the document, then use them anyway.
| Reference | What it gives you | Legal status for a US fishing vessel |
|---|---|---|
| WHO International Medical Guide for Ships, 3rd ed | A contents framework and clinical guidance, joint ILO, IMO and WHO text[4] | Guidance, not law. It grants no authority to hold prescription or controlled drugs |
| WHO Quantification Addendum, 2010 | Recommended quantities, indications and dosing[5] | Guidance. The most usable quantity anchor in print |
| EU Directive 92/29/EEC, Categories A, B and C | Scaled chest categories tied to voyage distance[7] | EU law. Binds EU-flag vessels, not US-flag. Useful as a published sizing logic |
| 21 CFR 1301.25 | The controlled substance regime for vessels[6] | Binding US law, and the only part of the chest that is federally specified |
There is no fourth edition of the WHO guide. Anything advertised as one is a reseller listing[4]. If your vessel also answers to a foreign flag, the flag state comparison shows where those regimes diverge.
The one part of the chest Washington does specify
Everything above concerns the open question. Controlled substances are the closed one. 21 CFR 1301.25 governs how a vessel may hold them, and it is prescriptive where 28.210 is silent[6].
The medical officer test is three-part and conjunctive: state-licensed physician, employed by the owner or operator, and DEA-registered. A consultant is not employed, which is the trap most programs fall into. Where no officer is accessible, the master requisition route applies instead, with a record of sale in triplicate and copy 2 retained aboard[6]. The full comparison sits in medical officer or master requisition.
Two annual reports follow from holding the drugs, on different clocks, and they are the item most often missed at inspection. See the two DEA annual reports, the recordkeeping rules, what changes by schedule, and how expired stock leaves the vessel under controlled substance disposal.
Six steps that make 28.210 defensible
- Confirm which trigger catches you. Boundary Lines, more than 16 individuals, or Aleutian trade tender. Write down which one and why[2].
- Write the sizing method before the list. Persons carried, longest voyage, distance to definitive care, work performed. The method is what you defend, not the quantities.
- Anchor quantities to a published reference. The WHO Addendum is the usual choice, cited on the face of your chest document[5].
- Match the manual to the chest. Section 28.210(a) requires a complete first aid manual[1]. If it describes drugs you do not carry, fix one or the other.
- Separate the controlled substance file. That part is federally specified and inspected on its own terms[6]. Our DEA inspection checklist lists the documents.
- Set a review interval and keep the evidence. The section sets none, so yours becomes the standard you are held to. Annual is the norm across flag regimes.
Steps one, two and four cost nothing but an afternoon and they carry most of the risk. That is the 80/20 of this regulation. The rest is stocking, and MedChest exists for operators who would rather not run it in-house. If you want a second opinion before an inspection instead of a service, consulting is the lighter route, and the guidance library covers the adjacent rules.
Common questions
Does 46 CFR 28.210 list what goes in the medicine chest?
No. Section 28.210(a) requires “a complete first aid manual and medicine chest of a size suitable for the number of individuals on board in a readily accessible location” and stops there[1]. There is no federal contents list. FDA states in CPG Sec. 460.500 that it has never recommended any particular procedure for stocking a ship chest[3]. Our MedChest service builds the list the regulation leaves open.
Which fishing vessels does Subpart C apply to?
Three triggers, and any one is enough: operating beyond the Boundary Lines, operating with more than 16 individuals on board, or being a fish tender vessel engaged in the Aleutian trade[2]. The third is the one most summaries drop. If you are unsure which applies, ask a physician to review the operation.
How many crew need first aid and CPR certificates?
It tiers by the number of individuals on board. More than 2 requires at least 1 certified in first aid and 1 in CPR. More than 16 requires 2 and 2. More than 49 requires 4 and 4[1]. One dual-certified person can satisfy both columns. See the vessel medical compliance audit for how this gets checked.
What does a size suitable for the number of individuals mean?
The regulation does not define it, so the defensible reading is a documented method rather than a number. Size against persons carried, voyage length, distance from definitive care and the work being done. The WHO Quantification Addendum is the most widely used quantity reference[5]. See how to stock a ship medicine chest.
Can a fishing vessel carry controlled substances in that chest?
Only under 21 CFR 1301.25, which is the one part of a US chest that is federally specified[6]. It sets a three-part test on the medical officer and a master requisition route when no officer is accessible. Read 21 CFR 1301.25 explained and the medical officer or master requisition comparison.
Does the first aid manual have to be a specific publication?
Section 28.210(a) says “a complete first aid manual” without naming a title[1]. The practical test at a boarding is whether the manual on board matches the contents of the chest on board. A manual describing drugs you do not carry is worse than useless. Our consulting service pairs the two.
Do EU Category A, B and C chests apply to a US fishing vessel?
No. Categories A, B and C come from Council Directive 92/29/EEC, which binds vessels flying the flag of an EU Member State[7]. They are still useful as a sizing reference because they are published and defensible. Talk to us about building the chest.
