Approval covers the labeling

What the section says

A new animal drug shall, with respect to any particular use or intended use, be deemed unsafe unless there is in effect an approval of an application with respect to that use and the drug, its labeling, and such use conform to the approved application.

Three things have to conform

The drug, its labeling, and the use. Changing any one of them puts the product outside the approval, which is why label changes on an approved animal drug are not a marketing matter.

And it is use-specific

The deeming applies with respect to any particular use or intended use. So an approval for one species, one weight range or one indication does not carry across to another, and extending the claim extends past the approval.

There are three other routes besides a full approval

A conditional approval, an index listing for a use in a minor species, or an emergency use authorization. Each has the same conforming requirement attached, so none of them is a looser regime for labeling.

Which matters for a repackager

If you repackage an approved animal drug, the labeling has to stay the approved labeling. Your brand on the front is a departure from the approved application in exactly the way the pesticide rules also forbid.

So the approval holder is the gatekeeper

As with a registered pesticide, the lawful route runs through whoever holds the approval and what they will agree to in writing. That is a commercial conversation before it is a packaging one.

And the minor species provision is genuinely useful

The statute makes specific provision for minor uses and minor species, which is the route for products aimed at animals outside the major species. Worth knowing exists rather than assuming the only door is a full approval.

References