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U.S. Department of Health and Human Services

Animal & Veterinary

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Ask CVM - July/August 2005

FDA Veterinarian Newsletter July/August 2005 Volume XX, No IV

Q. My veterinarian has prescribed a human prescription drug for my pet. I found that if I buy the drug from Mexico, I can get it a lot cheaper and without a prescription. I understand that Center for Veterinary Medicine (CVM) will permit individuals to bring limited amounts of drugs into the United States under a personal import policy. So, is it legal for me to buy this drug in this manner?

A. If the same drug you are buying from Mexico is available in the United States, then CVM cannot grant you permission to import it. Our regulations do not recognize cost or different marketing status (over-the-counter versus prescription) as a reason to allow imports of drugs into the United States. However, if the drug you are importing has a necessary attribute not found with the drug available in the United States, such as different dosage forms (e.g., liquid versus tablet) or different strengths/concentrations, then CVM may grant your veterinarian permission to import a small amount of the drug for use with your pet. Requests for drug importation can be made only by veterinarians and are considered on a case-by-case basis by CVM’s Division of Compliance. Requests can be addressed to the Food and Drug Administration, Center for Veterinary Medicine, Division of Compliance, 7519 Standish Place, HFV-230, Rockville, MD 20855

Q. Does the Food and Drug Administration (FDA) have jurisdiction over drugs for my aquarium fish?

Yes, and the procedures FDA uses to allow those drugs on the market will be changing. In the past, we made special exceptions to keep certain limited-use drugs available where needed, but now a new law will give us broader authority to make such drugs legally available.

The Minor Use & Minor Species Animal Health Act of 2004 (MUMS Act), among other purposes, was intended to improve FDA’s ability to encourage the development of products intended for use in aquarium fish.

The MUMS Act grew out of a concern of Congress and FDA about the lack of legally available drugs for use in minor species (including aquarium or ornamental fish, zoo animals, and many pets, such as guinea pigs or ferrets, as well as animals of agricultural importance such as sheep, goats, and catfish) or for minor use in major species. The primary reason for this lack of drug availability is the cost that potential drug sponsors face to put a drug through the FDA animal drug approval process. The potential market return typically is less than the cost of the approval. The market for aquarium fish products, in many cases, is simply too small to generate enough financial return to warrant the cost of approval.

FDA approval is currently the only basis for the legal marketing of animal drugs, and FDA has approved only one drug for use in aquarium fish. Therefore, all other aquarium drug products are actually being marketed without FDA approval. FDA could take legal action (if resources permitted) to remove all of these products from the market—leaving no means of treating aquarium fish.

Instead, the Agency has elected to use regulatory discretion to keep products intended for the treatment of aquarium fish available. For those products, FDA requires that they be produced under good manufacturing practices, registered, and listed with FDA. Also, FDA requires the manufacturer to follow drug labeling -requirements.

Meanwhile, FDA looked for a better system, which the MUMS Act will -offer.

The MUMS Act contains an entirely new basis for the legal marketing of animal drugs intended for use in minor species such as aquarium fish. This process will be considerably less expensive and time-consuming for sponsors than the approval process.

This new category will be called the Legally-Marketed Unapproved New Animal Drug Index, or “The Index.”

FDA is in the process of writing regulations to implement the indexing provisions of the MUMS Act. The proposed regulations are due to be published by February 2006, and the final regulations are due by August 2007. The option to request indexing of drugs for minor species will be available after the publication of the final regulations.

The new process will be restricted to products that pose no food safety, environmental, or user safety concerns. Most products for aquarium fish should readily meet these requirements.

Under the new process, panels of qualified experts from outside the Agency will assess the available evidence relating to target animal safety and effectiveness of selected drug products. If the panel finds that the evidence supports a conclusion that the benefits of a product outweigh its risks under specified conditions of use, the drug manufacturer will request that the FDA include the product in an -index of drugs legally available for use in minor species.

If the FDA agrees with the conclusions of the expert panel, it will grant the manufacturer’s request and index the product.

Not all such products will be over the counter. The panel may conclude that a product should be available, but restricted to prescription status.

You can find out more about MUMS-related issues at CVM’s website http://www.fda.gov/cvm/minortoc.htm.