The iron entry
On this page11
What it covers
"Noninjectable animal and human drugs providing iron for therapeutic or prophylactic purposes, and containing a total amount of elemental iron, from any source, in a single package, equivalent to 250 mg or more elemental iron."
Noninjectable, which is the route
An oral or topical iron preparation. An injectable iron product is a different thing and is not described here.
From any source, which closes a loophole
It is the elemental iron that counts, whatever salt or complex delivers it. A formulation cannot get under the threshold by changing the form of the iron.
In a single package, which is the packaging trigger
The threshold is per package rather than per dose. Dispensing a larger quantity into one bottle can take a product over the line that a smaller quantity would not.
Which is a real decision at a dispensing counter
The same tablets, split across two bottles or put in one, sit on different sides of a federal packaging requirement. That is worth knowing before the bottle is chosen.
The concentration thresholds
At or above 0.025 percent on a weight to volume basis for liquids, and 0.05 percent weight to weight for nonliquids including powders, granules, tablets, capsules, wafers, gels, pastes and ointments.
Two exclusions
Animal feeds used as a vehicle for drug administration, and preparations in which iron is present solely as a colorant. Both are sensible and both are narrow.
Why iron and nothing else
Because iron poisoning in small children was a documented and repeated harm, and the rule followed the evidence. The list is a history of harms rather than a taxonomy.
Which is the useful way to read the whole list
It names what hurt children. A veterinary product that is not on it has not been declared safe; it has not been the subject of the same history.
And it argues for the voluntary position
If the list is a record of harms already done, waiting to be added to it is a poor packaging strategy for a clinic.