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:

  1. An analytical method for residue detection needs to be established, however such method has not been established or cannot be established.
  2. 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).
  3. Drugs Not Allowed For Extra Label Use in Any Food-Producing Animal Species

    • Chloramphenicol
    • Clenbuterol
    • 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.)

     

    Drugs with Restricted ELDU in Food-Producing Animal Species

    • 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.

    Drugs with Restrictions for Grade "A" Dairy Operations


    Extra Label Drug Use Requirements

    Learn what it means to use Food Animal Drugs in an extra label manner
      21 CFR 530 Part 530

    View the pubished extra label prohibited drug list at the FDA's website
      Printable PDF

    Download a one-page printable PDF of Prohibited and Restricted Food Animal drugs

    Updated 05-16-2017