The Food and Drug Administration's Center for Veterinary Medicine has received reports that certain pharmacies and veterinarians have compounded estradiol cypionate for use in dairy cows and beef cattle.
In response to the reports, the FDA issued a statement reminding food animal producers and veterinarians that 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.
No FDA-approved new animal drug contains ECP, which has been used as an estrogenic hormone for reproductive therapy in food animals. The FDA reported that the use of ECP in food animals, along with the manufacturing or compounding of the product for such use, is illegal.
The Animal Medicinal Drug Use Clarification Act amended the Federal Food, Drug, and Cosmetic Act to allow licensed veterinarians to prescribe extralabel uses of approved animal drugs and human-use drugs in animals. Under AMDUCA, extralabel use is limited to the treatment of a disorder when the health of the animal is threatened, when the animal is suffering, or when death may result from failure to treat the animal. The extralabel use of ECP for reproductive purposes does not qualify under these provisions.
For more information, contact Dr. Michael Talley at the FDA-CVM's Division of Compliance by phone, (865) 919-5407, or e-mail, Michael.Talley@fda.hhs.gov. The department's statement may be found online at www.fda.gov/cvm/ECPup.htm.