Tools and directories

The check, before anything is formulated

Updated October 2026

On this page9

One: what does it do, and what will you say it does?Two: which marking will the finished product carry?Three: is it CBD with a therapeutic claim?Four: does it need to be sterile?Five: are you repackaging somebody else’s registered or approved product?Then the ordinary packaging work And write the claim rules down for whoever answers customers Two of five are stops, and that is deliberate References

Five questions. Two of them can end the project, which is the point of asking them first.

One: what does it do, and what will you say it does?

Kill, repel or mitigate a pest? Treat or prevent a condition? Or clean and groom with no such claim? Those are three different regimes, and the third is the only one that is just a packaging project.

Two: which marking will the finished product carry?

An EPA registration number and establishment number, or an animal drug approval with conforming labeling, or neither. If neither, the product cannot carry a pest or disease claim and the claim is what changes.

Three: is it CBD with a therapeutic claim?

If so, the statute has already characterized it: a new animal drug with no approval in effect is deemed unsafe for that use. That is a question for real advice rather than for a careful label.

Four: does it need to be sterile?

Anything for the eye, anything going into a wound, anything described as sterile. Nothing on these shelves is sterile and no step you can take makes it so. That answer is a stop rather than a specification.

Five: are you repackaging somebody else’s registered or approved product?

Then you need their written permission and, for a pesticide, a registered establishment and a container meeting the refillable container standards. Nothing in our catalog meets the last of those.

Then the ordinary packaging work

Material and liner against the formula, a fitment that matches the dose, a graduated pipette if it is dosed by drop, and a safety data sheet behind the shipped container.

And write the claim rules down for whoever answers customers

Owners ask direct questions about their animals, and the answer given on the phone is a claim. That is the pressure point in this category and the label review never reaches it.

Two of five are stops, and that is deliberate

Most of the checks in this library add work. Two of these end the exercise, which is why they come before the formulation rather than after it, and why this page is the one to read first.

References

7 U.S.C. 136(u), the FIFRA definition of pesticide, which covers substances intended for preventing, destroying, repelling or mitigating any pest and then excludes any article that is a new animal drug within the meaning of the Federal Food, Drug, and Cosmetic Act, or that has been determined not to be one by regulation, or that is an animal feed bearing or containing a new animal drug. law.cornell.edu

21 U.S.C. 321(v), the definition of a new animal drug: any drug intended for use for animals other than man whose composition is not generally recognized among qualified experts as safe and effective for use under the conditions prescribed, recommended or suggested in its labeling, with a pre-1938 saving clause and provisions for minor species and minor uses. law.cornell.edu

21 U.S.C. 360b(a)(1), which deems a new animal drug unsafe with respect to any particular use unless there is in effect an approval, a conditional approval, an index listing for a minor species or an authorization, and "such drug, its labeling, and such use conform" to it. law.cornell.edu

40 CFR 156.10, the EPA pesticide labeling requirements, which require the product registration number preceded by "EPA Registration No." or "EPA Reg. No." and the producing establishment number preceded by "EPA Est.", along with an ingredient statement, hazard and precautionary statements, directions for use and a use classification. law.cornell.edu

29 CFR 1910.1200, Hazard Communication, which sets what a shipped container of a hazardous chemical carries and requires a safety data sheet. law.cornell.edu

Written from federal statute, not from a veterinary bench. Which regime a specific product falls under is a determination about that product, and state feed and drug programs run alongside the federal ones. Nothing here is a registration, an approval, or advice on a particular formulation.