September 19, 2002
REMINDER -- EXTRA-LABEL USE OF FLUOROQUINOLONES PROHIBITED
FDA's Center for Veterinary Medicine (CVM) would like to remind veterinarians that extra-label use of fluoroquinolone antibiotics in food-producing animals is prohibited. CVM has received some information indicating that fluoroquinolone antibiotics such as enrofloxacin are being prescribed for use in food-producing animals including lactating dairy cattle for which they are not approved.
The prohibition against extra-label use of fluoroquinolones is based on a finding by CVM that the extra-label use of these antibiotics in food-producing animals presents a risk to the public health for the purposes of the Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994. These extra-label uses are capable of increasing the antibiotic resistance of the bacteria that can cause human illness and that are present in treated animals at the time of slaughter. Information about this prohibition was published in the May 22, 1997, Federal Register.
AMDUCA amended the Federal Food, Drug, and Cosmetic Act to allow licensed veterinarians to prescribe extra-label uses of approved animal drugs and human drugs in animals. Section 2(a)(4)(D) of the AMDUCA provides that the Agency may prohibit an extra-label drug use in animals if, after affording an opportunity for public comment, the Agency finds that such use presents a risk to the public health.
The following drugs (both animal and human), families of drugs, and substances are prohibited for extra-label uses in all food-producing animals:
Chloramphenicol;
Clenbuterol;
Diethylstilbestrol (DES);
Dimetridazole;
Ipronidazole;
Other nitroimidazoles;
Furazolidone, Nitrofurazone, other nitrofurans;
Sulfonamide drugs in lactating dairy cattle (except approved use of
sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine);
Fluoroquinolones; and
Glycopeptides.
Veterinarians who have questions about AMDUCA or the extra-label use of drugs may contact FDA/CVM Division of Compliance, 7519 Standish Place, HFV-230, Rockville, MD 20855, 301-827-1168.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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