Revised October 3, 2006
Revised - Consent Decree Filed in Compounding Case Against BET Pharm, LLC, Revised October 3, 2006
On September 25, 2006, Judge Forester (U.S. District Court for the Eastern District of Kentucky) entered a Consent Decree between the United States and BET Pharm, LLC, resolving a dispute over compounded drug products for use in horses. The U.S. Marshal for the Eastern District of Kentucky seized these compounded drug products on August 12, 2004. The Complaint alleged that these compounded drug products are adulterated because they are new animal drugs that have not been approved as required by the Federal Food, Drug, and Cosmetic Act. Additionally, the Complaint alleged that the compounded drug products are misbranded because they fail to bear adequate directions for use. The Consent Decree requires BET Pharm, LLC to pay costs and to destroy the seized compounded drug products.
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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