Last Update: August 07, 2003
Warning Letter to Veterinary Drug Firm
The FDA's New Orleans District Office Nashville Branch issued a Warning Letter on April 10, 2001, to Classic Care Products, Inc., d.b.a. The River City Co., Chattanooga, Tennessee, as the result of an inspection of the firm on March 20 and 22, 2001. The inspection found topical veterinary drug products being manufactured under inadequate conditions. Deviations from the CGMPs included no component testing; no master production records; failure to conduct stability studies on finished products and to assign expiration dates based on these studies; and no label control. The firm also was not registered and the veterinary drug products were not listed.
Unapproved Veterinary Drugs Promoted on the Internet
On June 28, 2001, the FDA's Minneapolis District Office issued a Warning Letter to Vets Plus, Inc., Knapp, Wisconsin. FDA conducted an inspection of the firm's veterinary drug and nutritional supplement manufacturing facility on March 7 and 13, 2001.
The inspection disclosed that the firm was manufacturing veterinary products that, based on the labels and well as product catalogs, contained therapeutic and structure-function claims causing the products to be unapproved new animal drugs. The firm's web sites contained numerous promotional statements and claims for four lines of products marketed by the firm that established that the firm clearly intended the product to be used as animal drugs. In addition, the firm failed to list any of the products with the Center for Veterinary Medicine, and the products were not manufactured in compliance with CGMP regulations.
Distributor of Prescription Veterinary Drugs Receives Warning
On August 27, 2001, the FDA's Philadelphia District Office issued a Warning Letter to the president of Equirace Health and Speed Products, Washington, Pennsylvania. The firm is an exclusive distributor of prescription veterinary and human drugs to horse owners. The FDA conducted an inspection of Equirace on December 5, 2000. The inspection and a review of information from the New Mexico Livestock Board disclosed that the firm was distributing prescription veterinary and human drugs to lay persons without a lawful order from a licensed veterinarian who has a valid veterinarian-client-patient relationship with customers.
The Warning Letter advised the owner that Equirace's distribution business violates several sections of the FD&C Act. For example, the firm's prescription veterinary drugs are misbranded because they are not dispensed by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian's professional practice. Although there was a licensed veterinarian at the firm, he did not have a valid veterinarian-client-patient relationship with any of Equirace's customers. The Warning Letter also noted that certain prescription veterinary and human drugs offered for sale by Equirace were adulterated because they were new animal drugs that were not approved by the FDA for use in horses.
Illegal Veterinary Drugs Exported
On March 5, 2001, the FDA's San Juan District Office found that a shipment of veterinary drugs from Santo Domingo to the U.S. Virgin Islands, consisting of drugs such as antibiotics, hormones and dietary supplements, contained numerous unapproved drugs for veterinary use. The drugs were placed on hold by the U.S. Customs at the Aguadilla airport. The shipment was exported under Custom's supervision.
FDA Assists Customs in Seizure of Illegal Vet Drugs
On July 10, 2001, the FDA's San Juan District Office, in conjunction with U.S. Customs, detained and seized a shipment of veterinary drugs not approved for sale in the U.S. that was imported from Santo Domingo. U.S. Customs agents notified San Juan District Office that the shipment was imported as "Hair Products," but actually contained veterinary drugs. FDA's inspection of the shipment revealed that the veterinary drugs were smuggled among a variety of soaps. The shipment, which was originally thought to consist of a few bottles, contained a total of 793 bottles/pouches of a variety of illegal veterinary drugs. The shipment was detained by FDA and seized by U.S. Customs agents. The value of the shipment was approximately $7,000.
Importer Attempts to Re-Enter Vet Drugs Previously Refused Entry
On May 2, 2001, the FDA's San Juan District Office, in conjunction with U.S. Customs Service seized a shipment of IVOMEC-F, a veterinary drug not approved for sale in the U.S. The shipment was from importer Hacienda Las Carolinas, Santo Domingo. The San Juan District Office was notified by U.S. Customs agents that a shipment that had been refused entry on February 10, 2001, and had been exported under Customs supervision was re- introduced through the same port on March 16, 2001, by the same importer. The value of the shipment was $3,500.00.
Seizure at Veterinary Pharmacy
On December 20, 2000, an FDA investigator accompanied the U.S. Marshals Service in a seizure of unapproved new animal drugs at Veterinary Pharmacy Corporation (d.b.a. Vet Rx Pharmacy), St. Peter, Minnesota. The firm is a compounding pharmacy for veterinary drugs. The firm has a history of serious violations of the FD&C Act, particularly the 1994 Animal Medicinal Drug Use Clarification Act (AMDUCA). The seized drugs, valued at approximately $50,000, were intended for administration to food-producing animals, and were unapproved new drugs in that they were compounded from the bulk active ingredients. Such compounding violates AMDUCA and the implementing regulations, 21 C.F.R. Part 530. The FDA conducted inspections at the firm on June 27 - 29, and July 6 - 7, 2000. These inspections disclosed the above violations.
Consent Decree of Condemnation and Permanent Injunction
U.S. v. Sulfadiozie Sodium and Veterinary Pharmacy Corp. d.b.a. Vet Rx Pharmacy (D. Minn.) On February 28, 2002, a U.S. District Judge signed a Consent Decree of Condemnation and Permanent Injunction against this veterinary pharmacy and two corporate officers, as well as the drugs seized in this action. The Decree orders the defendants to destroy the seized drugs and enjoins them from engaging in compounding activities that fail to conform to the AMDUCA regulations.