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U.S. Department of Health and Human Services

Animal & Veterinary

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CONSENT DECREE ENTERED IN ANIMAL DRUG COMPOUNDING CASE

FDA Veterinarian Newsletter March/April 1999 Volume XIV, No II

On December 24, 1998, the United States District Court for the Southern District of Iowa entered a Consent Decree of Condemnation filed by the United States and the Mortar & Pestle Veterinary Pharmacy, Inc., Des Moines, IA. Under the terms of the Consent Decree, products seized by the U.S. Marshals Service on September 14-15, 1998, and claimed by Mortar & Pestle were deemed adulterated and misbranded and ordered condemned and forfeited to the United States. The total value of the articles seized was estimated at $284,000; however, Mortar & Pestle only claimed approximately $60,000 worth of the seized articles. On November 12, 1998, the Court entered a Default Decree of Condemnation and Destruction with respect to the unclaimed articles, and those articles will be destroyed by the U.S. Marshals Service. Pursuant to the Consent Decree entered on December 24, 1998, the claimed articles may be released to Mortar & Pestle for reconditioning if they obtain written permission from the Food and Drug Administration (FDA) and comply with a number of conditions listed in the Consent Decree.

Also under the Consent Decree, Mortar & Pestle's President, Stan Henderson, and Owner, Meri C. Russell, agreed not to engage in the business of manufacturing, processing, packing, or labeling drugs unless and until they register as a drug establishment and adopt and implement procedures adequate to ensure that their operations fully comply in all respects with good manufacturing practice, the Federal Food, Drug, and Cosmetic Act (the Act), and FDA regulations. In addition, Mr. Henderson and Ms. Russell agreed that they would not re-enter the business of compounding drugs unless and until they adopt and implement procedures adequate to ensure that their operations fully comply in all respects with FDA guidance regarding the compounding of drugs, the Act, and FDA regulations.

The government initiated this seizure action because Mortar & Pestle was not compounding animal drugs in compliance with the law and FDA's guidance and, therefore, the drugs were adulterated, misbranded, and unapproved under the Act. In 1996, FDA published a Compliance Policy Guide (CPG) outlining the criteria and boundaries for the compounding of animal drugs. This CPG states that FDA recognizes that circumstances exist when it may be necessary for a veterinarian to compound, or direct a pharmacist to compound an article that will result in an unapproved new animal drug. The Agency will exercise its regulatory discretion and ordinarily will not take regulatory action against violations of the Act resulting from the compounding of an unapproved new animal drug if the criteria described in the CPG are met. However, Mortar & Pestle was not following the stipulations in the CPG.

FDA urges any pharmacy that wishes to compound animal drugs to become thoroughly familiar with the CPG 608.400, "Compounding of Drugs for Use in Animals." Copies of this CPG may be obtained by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755. Send one self-addressed adhesive label to assist in processing your request.