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U.S. Department of Health and Human Services

Animal & Veterinary

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Reminder – Doramectin not Permitted for Use in Dairy Cattle

June 21, 2004

FDA has become aware of recent incidents involving the misuse of Doramectin (Dectomax®) to treat dairy cattle. Doramectin is not approved for use in female dairy cattle 20 months of age or older. If a lactating cow is exposed to Doramectin, milk from the cow may have detectable residues of the drug for as long as 60 days. Any detectable level of Doramectin in milk is considered by FDA to be illegal.

Doramectin (NADA 141-095) is approved for topical use to treat and control various worms (roundworms, lungworms, and eyeworms), grubs, lice, horn flies, and mange mites. It is also approved to control infections and to protect from reinfection with Cooperia oncophora and Dictyocaulus viviparus for 21 days, Ostertagia ostertagi, C. punctata, and Oesophagostomum radiatum for 28 days, and Haemonchus placei for 35 days after treatment.

Under the Animal Medicinal Drug Use Clarification Act of 1994 amendments to the Federal Food, Drug, and Cosmetic Act, licensed veterinarians are permitted to prescribe extra-label uses of approved animal drugs and human drugs in animals under certain conditions specified in Title 21, Code of Federal Regulations, Part 530 . However, non-veterinarians are not permitted to use drugs in an extra-label manner.

As mentioned in the compliance policy guide entitled, “ Proper Drug Use and Residue Avoida nc e by Non-Veterinarians” , “Extra-label use of drugs by non-veterinarians in food-producing animals is a significant public health concern and a contributing factor in illegal residues in edible animal tissue. Such use of drugs is illegal under the Federal Food, Drug, and Cosmetic Act (the Act).”

Dr. Stephen F. Sundlof, Director of FDA’s Center for Veterinarian said “food animal producers should remember to read veterinary drug labels carefully and follow label directions to help avoid causing illegal residues in their products.”

 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855