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U.S. Department of Health and Human Services

Animal & Veterinary

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Cattle Reproductive Drug Estradiol Cypionate (ECP) Illegal, CVM Reminds Industry

FDA Veterinarian Newsletter November/December 2005 Volume XX, No VI

The Center for Veterinary Medicine (CVM) in April issued a reminder to veterinarians and compounding pharmacies that estradiol cypionate (ECP) is not approved for use in cattle.

The Center has received reports that some veterinarians are using ECP that was compounded from bulk products for reproductive purposes in dairy and beef cattle. FDA has never approved the drug for veterinary uses.

Before 2003, a commercially marketed, unapproved ECP product was available. The manufacturer removed the product from the market when CVM asked the company to submit data in accordance with the drug approval process or to stop marketing it.

Since then, some veterinarians and veterinary drug compounders have continued to make a product for use in cattle. CVM officials say that the overall use of ECP has fallen off significantly since the company stopped marketing it, but has not ended completely.

Food and Drug Administration investigators are checking with compounding firms to find the source of ECP used for compounding.

Under certain circumstances, veterinarians can use drugs to treat conditions not listed on the approved label. The Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994 provides the legal basis for extralabel drug use. Using ECP to increase reproductive performance or production is not a permitted extralabel use under AMDUCA, CVM said. The extralabel use of drugs as provided for under AMDUCA is limited to FDA approved animal and human drugs, when the health or life of an animal is threatened.

The reminder to veterinarians, pharmacies, and others was issued as a “CVM UPDATE,” which is available at http://www.fda.gov/cvm/CVM_Updates/ECPup.htm.