April 5, 2006
ECP Not Approved for Use in Animals
FDA's Center for Veterinary Medicine (CVM) would like to remind food-animal producers and veterinarians that estradiol cypionate (ECP) is not approved for use in animals in part because the safety of its use has not been demonstrated, as required under the Federal Food, Drug, and Cosmetic Act.
ECP has been used as an estrogenic hormone for reproductive therapy in food animals. However, there are no FDA-approved new animal drugs containing this product. The Agency has received reports that ECP has been compounded for use in dairy cows and beef cattle by pharmacies and veterinarians. The use of ECP in food-producing animals is illegal, and manufacturing or compounding of ECP for such use is illegal. In addition, the extra-label provisions of the Federal Food, Drug, and Cosmetic Act do not permit this use.
The Animal Medicinal Drug Use Clarification Act (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. However, under AMDUCA extra-label use is limited to treatment modalities when the health of an animal is threatened or suffering or death may result from failure to treat. The extra-label use of ECP for reproductive purposes does not qualify under these provisions.
Questions about the prohibition against the manufacturing, compounding, or use of ECP may be addressed to Dr. Michael Talley, FDA/Center for Veterinary Medicine, Division of Compliance, 865-919-5407, Michael.Talley@fda.hhs.gov.
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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