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Restricted and Prohibited Drugs in Food Animals

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Under provisions of the American Medicinal Drug Use Clarification Act (AMDUCA) and 21 CFR part 530, FDA can prohibit extra-label use of approved animal or human drugs or prohibit use of an entire class of drugs in selected animal species if FDA determines that: (I) an acceptable analytical method needs to be established and such a method has not or cannot be established; or (II) the extra-label use of the drug or drug class presents a public health risk. FDA can also limit the prohibition on extra-label use to specific species, indications, dosage forms, routes of administration, or a combination of these. In addition to the following lists, it should be noted that regulations related to the Pasteurized Milk Ordinance (PMO) prohibit the presence of dimethyl sulfoxide (DMSO) or colloidal silver on dairy farms.

(I) Drugs Prohibited from Extra-label Use in Any Food-Producing Species

• CHLORAMPHENICOL
• CLENBUTEROL
• CRYSTAL (GENTIAN) VIOLET
• DIETHYLSTILBESTEROL or DES
• DIPYRONE
• FLUOROQUINOLONE–CLASS ANTIBIOTICS
• GLYCOPEPTIDES – all agents, including VANCOMYCIN
• MEDICATED FEEDS
• NITROIMIDAZOLES – all agents, including DIMETRIDAZOLE, IPRONIDAZOLE, METRONIDAZOLE and others.
• NITROFURANS – all agents, including FURAZOLIDINE, NITROFURAZONE and others.

(II) Drugs with Extra-Label Use Restrictions in Food-Producing Animal Species

• ANTIVIRAL AGENTS (poultry) - including ADAMANTANE and neuraminidase inhibitors
• CEPHALOSPORIN-CLASS ANTIBIOTICS except CEPHAPIRIN (cattle, chickens, pigs and turkeys) ¹
• INDEXED DRUGS (some agents have exceptions for minor-use species)
• PHENYLBUTAZONE (all female dairy cattle 20 months or age or older)
• SULFONAMIDE-CLASS ANTIBIOTICS (lactating dairy cattle) ²

Further Information:

¹ The effective date for prohibition of extra-label use of cephalosporins was April 5, 2012. The restrictions imposed by FDA are different for major (cattle, chickens, swine and turkeys) vs. minor food-producing animal species. Veterinarians may still use or prescribe extra-label use of cephalosporins in major species as long as they follow the dose, frequency, duration, and route of administration that is on the label of approved products. In addition, veterinarians may use or prescribe cephalosporins for extralabel uses in minor species of food-producing animals. (View Press Announcement)

² Currently, the only sulfonamides approved for use in lactating dairy cattle are sulfadimethoxine, sulfabromomethazine and sulfaethoxypyridazine. These agents must be used according to label instructions (no extra-label use permitted) and use of sustained-release products is prohibited.

For additional information on extra-label drug use in food animals, including requirements for use, record-keeping requirements and labeling requirements, please visit the American Veterinary Medical Association (AVMA) website.