FDA Order Prohibits Extralabel Use Of Fluoroquinolones And Glycopeptides

June 2, 1997

In the May 22, 1997 Federal Register, The Food and Drug Administration (FDA) issued an order prohibiting the extralabel use of fluoroquinolones and glycopeptides. The Agency issued this order because it believes that some extralabel uses of fluoroquinolones and glycopeptides in food-producing animals are capable of increasing the level of drug resistant zoonotic pathogens (pathogens that are infective to humans) in treated animals at the time of slaughter. In the order, FDA determined that some extralabel uses of fluoroquinolone and glycopeptide drugs in food-producing animals likely will cause an adverse event, which constitutes a finding under the Animal Medicinal Drug Use Clarification Act of 1994 (the AMDUCA) that extralabel use of these drugs in food animals presents a risk to the public health. Therefore, the Agency issued the order of prohibition.

On October 22, 1994, the President signed the AMDUCA into law. The AMDUCA amended the Federal Food, Drug, and Cosmetic Act to allow licensed veterinarians to prescribe extralabel 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 extralabel 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.

FDA intends to prohibit by order the extralabel use of fluoroquinolones and glycopeptides in food-producing animals because the Agency has determined that use of these drugs other than for the approved label indications in food-producing animals meets the criteria for prohibition in the AMDUCA. Under this order, fluoroquinolones and glycopeptides were added to the list of those drugs already prohibited for extralabel use. The revised list states that the following drugs, families of drugs, and substances are prohibited for extralabel animal and human drug uses in food-producing animals.

1. Chloramphenicol;
2. Clenbuterol;
3. Diethylstilbestrol (DES);
4. Dimetridazole;
5. Ipronidazole;
6. Other nitroimidazoles;
7. Furazolidone (except for approved topical use);
8. Nitrofurazone (except for approved topical use);
9. Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine);
10. Fluoroquinolones; and
11. Glycopeptides.

The order of prohibition is effective August 20, 1997. Written comments on this order are to be submitted by July 21, 1997, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., Room 1-23, Rockville, MD 20857. Comments should contain the Docket Number, 97N-0172.

Information on this prohibition is contained in the Federal Register which is available for review or downloading on CVM's Internet Home page Website. Paper copies are available from the Communications Staff, FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, telephone 301-594-1755.

Questions about this order may be directed to Richard L. Arkin, Center for Veterinary Medicine (HFV-238), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1737.