1. Metronidazole (Flagyl) for Giardia in a lamb
Metronidazole is prohibited for extralabel use in food animals
2. Gentamicin for respiratory disease in a steer
AMDUCA requires that other labeled drugs are either not available or are clinically ineffective; it would be hard to justify that none of the drugs labeled for respiratory disease were effective (ceftiofur, oxytetracycline, gamithromycin, tulathromycin, enrofloxacin, danofloxacin, tildipirosin, tilmicosin, etc.).
3. Clotrimazole topically for ringworm
There are not products labeled for ringworm, so the ratio nale for extralabel use of some kind is reasonable. However, there are no published data in cattle on which to base a withdrawal time for clotrimazole, and a with drawal time must be estalished or the animal must not enter the food supply.
4. Tilmicosin for seminal vesiculitis in a yearling bull
This seems like a potentially reasonable extralabel use and the reason for AMDUCA.
5 Ketoprofen for bovine respiratory disease
The labeled non-steroidal anti-inflammatory drug, flunixin, would have to be shown to be ineffective for extralabel use of ketoprofen to be legal.
6. Oxytetracycline feed additive at 10 mg/lb for Mycoplasma arthritis
Feed additives cannot be used in an extralabel manner, and this etiologic agent is not on the label.
7. Distilled water with baking soda and 50% detrose for fluid therapy in a neonate
Drugs that are not approved are not covered by AMDUCA. If your intent for a compound or combination of compounds is to diagnose, treat, mitigate, control, or prevent disease, then it is by definition a drug. Baking soda and distilled water are not approved as drugs. Is this a major food safety issue? Probably not. But it is technically illegal.
8. Intramammary aloe vera for treatment of mastitis
Unapproved drug being used as a drug is not legal.
9. Intramammary colloidal silver for treatment of mastitis
Unapproved drug being used as a drug is not legal, plus FDA sent a letter (1997) that specifically called out colloidal silver as illegal and unsafe.
10. Ceftiofur for treatment of metritis in a goat
Ceftiofur is approved for the treatment of respiratory disease in goats, and there is no drug approved for metritis in goats, so this is a reasonable extralabel use. The ban on extralabeluse of cephalosporins did not include minor species. Major species are cattle, swine, horses, dogs, cats, chickens, and turkeys, and everything else is a minor species.
11. Ceftiofur for treatment of calf septicemia
Cephalosporins may not be used in an extralabel dose or route of administration, but may be used for an extralabel indication. If the calf were dosed as labeled, this would potentially be a legal use.
12. Enrofloxacin for treatment of respiratory disease in a dairy cow
Dairy cows are not on the enrofloxacin label, and the extralabel use of fluoroquinolones is prohibited.
13. Tilmicosin for treatment of respiratory disease in a dairy cow
Dairy cows are not on the tilmicosin label, and a milk withdrawal time is likely to be prolonged with this drug – any extralabel use resulting in a violative residue would be by definition illegal. There are other drugs labeled for respiratory disease in dairy cows that are effective, so this use would likely also fall into that category.
14. Six growth promotant implants in a steer for heat detection
Heat detection is a production purpose, and AMDUCA only allows extralabel use for therapeutic purposes, when animal suffering will result if not treated.
15. Sulfachlorpyridazine for treatment of metritis in dairy cows
The only currently marketed sulfonamide approved in lactating dairy cows (which means any cow which has lactated at any time and includes dry cows) is sulfadimethoxine, which must be used as labeled.
16. Pediatric human-labeled trimthoprim-sulfa for E. coli in a neonatal calf
The hierarchy for extralabel use is to (1) use a drug labeled for the indication, (2) use a drug labeled for a food animal in an ex tralabel manner, and (3) use a drug labeled for companion ani mals or humans in an extralabel manner. There are probably foodanimal drugs that could be used extralabel for this indication.