What a dog medicine label proves, and what it only appears to prove

The line that shows approval

For full approval, look for "Approved by FDA under NADA #" or the version with "ANADA #", then a six-digit number. For conditional approval, the wording starts "Conditionally approved by FDA". It then says "pending a full demonstration of effectiveness" and gives the application number. This means the FDA expects the medicine to work, but the company is still gathering full proof.

That number can be checked for free in Animal Drugs @ FDA, a searchable online list of most approved and conditionally approved animal medicines.

A missing line on a tiny vial label is not proof on its own, because the full wording may sit on the carton or insert, and a printed line can be faked.

Three lines that do not show approval

• An NDC number. It shows only that the product sits on an FDA listing of marketed drugs, and drugs without approval carry these codes as well.
• A caution line about federal law restricting the drug to vets and to people acting on a vet's instruction. The FDA requires that line on prescription-type animal drugs, approved or not.
• "Made in an FDA-registered facility" or similar wording. The FDA says not to read it as proof that a drug is lawfully marketed.

What a compounded medicine's label carries

Compounding is a pharmacist or vet reworking ingredients into a custom medicine, such as a flavored liquid for an animal that refuses tablets. What comes out is not FDA-approved, even when an approved drug went in.

For medicines made from raw powder under its guidance, the FDA calls for a label naming the patient, the pharmacy and the prescribing vet, plus a use-by date. It also calls for wording saying the medicine is compounded, without FDA approval or an index listing. An index listing permits sale for certain small-market animals without full approval. Dogs cannot use that list.

A compounded medicine is not a generic. Generic animal drugs carry their own FDA approval and act in the body just as the brand does, while compounded drugs get no FDA check before they are sold.

The words for dogs on a listing

The purpose a seller gives a product is what makes it a drug. A supplement or research-chemical tag does not undo that.

A product on open sale without a prescription can still be an unapproved animal drug. The FDA's own example: no pain reliever of the NSAID type sold over the counter for dogs is approved.

Checking a label at home

1. Find the carton or the leaflet, not only the small container.
2. Look for the approval line and the number after it.
3. Search that number, or the ingredient, in Animal Drugs @ FDA.
4. Take the label, and any listing it came from, to the vet.