Drugs and Drug Classes Prohibited from Extra Label Drug use
The FDA may prohibit the extra label use of approved animal or human drugs in animals if they determine that:
- An analytical method for residue detection needs to be established, however such method has not been established or cannot be established.
- The use of a drug or drug class in an extra label manner presents a risk to public health (i.e. the drug or drug class may be known to cause cancer, toxic reactions, or lead to antimicrobial resistance).
- Diethylstilbesterol (DES)
- Fluoroquinolone class antibiotics (i.e. enrofloxacin, etc.)
- Glycopeptide class antibiotics (i.e. vancomycin, etc.)
- Indexed drugs (see here)
- Medicated Feeds
– potential exception for minor species (refer to CPG Section 615.115 for more information)
- Nitroimidazoles (i.e. dimetridazole, ipronidazole, metronidazole, etc.)
- Nitrofurans (i.e. furazolidine, nitrofurazone, etc.)
- Adamantane & Neuraminidase Inhibitors - prohibited in poultry, including chickens, turkeys, and ducks
- Cephalosporins - except Cephapirin, in MAJOR food animal species (cattle, pigs, chickens, and turkeys)
– ELDU in Major food animal species is permissible only for therapeutic indications not listed on the label
– ELDU in minor food animal species is permitted
- Gentian Violet - use in food or feed of all food producing animals
- Phenylbutazone - prohibited in female dairy cattle greater than 20 months of age
- Sulfonamide class antibiotics - prohibited in adult lactating dairy cattle or dairy cattle greater than 20 months of age
– Use in milking sheep and goats is discouraged but not prohibited.
- Non-Medical Grade Dimethylsulfoxide (DMSO) – no use or on-site storage allowed
- Dipyrone – no use allowed
- Colloidal Silver – no use or storage allowed