Wednesday, January 9, 2013

An Example from the Past(1998) Where FDA Took Enforcement Action and Seized Compounded Veterinary Drugs That Were in Violation of Law: Why Aren't We Seeing Any of These Actions Being Taken Today in the Veterinary World Where It is Appears Some Compounders Are Actually Manufacturing?


FDA Veterinarian Newsletter November/December 1998 Volume XIII, No VI
On September 14, 1998, the U.S. Marshals Service conducted a seizure of veterinary drugs at the Mortar & Pestle Veterinary Pharmacy, Inc., Des Moines, IA. The seizure included all bulk drugs and finished pharmaceuticals at this firm. The products seized are valued at approximately $284,800. The Food and Drug Administration (FDA) issued a Warning Letter to Mortar & Pestle on June 13, 1997, advising the firm that its products were not in compliance with the Federal Food, Drug, and Cosmetic Act (the Act). When the firm did not make any significant corrections, its drug products were seized under the Act as unapproved new animal drugs and adulterated and misbranded drugs.
In 1996, FDA published a Compliance Policy Guide (CPG) that outlines criteria and boundaries for the compounding of animal drugs. This CPG states that FDA recognizes 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 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. Among those criteria are:
  • There must be a prescription from a licensed veterinarian, and dispensing must be done within the confines of a valid veterinarian-client-patient relationship.
  • Advertising, or other solicitation, for specific drug products or classes is not acceptable.
  • Products should be produced under good compounding practices using current pharmaceutical and pharmacological standards.
  • Products should be labeled with an expiration date that is in line with the treatment period.
In taking this seizure action, FDA consulted frequently with the Iowa Board of Pharmacy. Federal and State authorities working together and independently developed information on violations of their respective laws by Mortar & Pestle Veterinary Pharmacy, Inc. The Iowa Board of Pharmacy has been advised that the firm will surrender its pharmacy license, and is currently waiting to finalize its disciplinary action.
FDA is concerned about what appears to be a proliferation of animal drug compounding operations, many of which are actually manufacturing large quantities of unapproved new animal drugs. The Agency urges any pharmacy that wishes to legally compound animal drugs within the context of a veterinarian-client-patient relationship to become thoroughly familiar with the CPG 608.400, "Compounding of Drugs for Use in Animals." Copies of this CPG may be obtained from FDA's Internet Home Page or by calling or writing the FDA Veterinarian.
Source found here

No comments: