Ask CVM - November/December 2005

FDA Veterinarian Newsletter November/December 2005 Volume XX, No VI

Are mail order pet medications the same as those I get directly from the veterinarian?

As Internet technology becomes increasingly used to market consumer products, FDA has noticed more FDA-regulated products promoted and sold on line. In most cases, these activities are as legitimate as any other business activity conducted in traditional ways, but we have encountered unscrupulous and fraudulent practices.

FDA is aware that some people or firms are selling prescription drugs without a legitimate prescription, misbranded products with unsubstantiated claims, or unapproved or illegal -products.

The FDA has prepared a webpage containing information about purchasing medicines and medical products on line. The URL for the website is: http://www.fda.gov/oc/buyonline/.

I need a drug to treat my pet that you can’t buy in the United States, but it is available overseas. How can I get permission to import that drug?

All requests to import medication for pets must come directly from the veterinarian treating the animal. The veterinarian must provide certain information to CVM so it can evaluate the request. CVM will send a document outlining the information needed to allow the importation to occur to any veterinarian inquiring about obtaining unapproved new animal drugs from non-U.S. sources. The veterinarian will be asked to provide information that identifies who he or she is, describe the disease or condition to be treated, the reasons why available products will not work, the legal status of the drug in a foreign country, and an exact specification of the product the veterinarian wants to import.

A letter of non-objection is prepared if the request is considered appropriate and reasonable. If the request is received via fax, a copy of the letter of non-objection is often faxed back. CVM also mails a hard copy of the letter of non-objection to the veterinarian.

The process can take three weeks or longer, depending on the volume of such requests that CVM received. The Center averages almost 50 letters a week

I found the same drug my veterinarian sells me, but for a much lower price in another country, and I can order it on-line. Do I need permission from FDA to import that drug?

Importing an animal drug that is available in the United States is illegal, and CVM cannot grant you permission to import it. CVM’s regulations do not recognize cost or different marketing status (over the counter versus prescription, for instance) as a reason to allow imports of drugs. However, if the drug you want to import has an attribute not found with the drug available in the United States, such as a different dosage form (liquid versus tablet) or different strength or concentration, CVM might grant your veterinarian permission to import that drug. Decisions are made on a case-by-case basis.

Do I contact CVM if I have a concern about my vet, such as his treating my dog with drugs not approved for dogs, or the fact that he makes me buy drugs from him because he won’t write a prescription the way my doctor will.

FDA does not regulate the practice of veterinary medicine. Writing prescriptions, etc., is considered the practice of medicine. Pet owners may contact the veterinary licensing board in their States to file a complaint about the practices of their veterinarians. This is a link to the listing of State veterinary licensing boards—http://www.aavsb.org/.

To address the specific concerns raised in this question, veterinarians have the legal right to prescribe a drug for a dog even if the drug is not labeled for use in dogs. A 1994 law, the Animal Medicinal Drug Use Clarification Act, gives veterinarians the right to use any legally obtained human or animal drug in an “off-label” manner in pets, under certain conditions. For instance, the veterinarian must have firsthand knowledge of the animal’s medical condition and must be available to handle any follow-up treatment or address any adverse reaction to the drug.

In addition CVM does not address issues about how animal drugs are sold to customers, beyond classifying the drugs as over-the-counter or prescription. Veterinarians are not prohibited from selling drugs to treat animals. At the same time, veterinarians are not required to sell drugs to animal owners. Some write prescriptions that the animal owner gets filled the same way a prescription for a human drug is filled.

Who in FDA should I notify if I think there is something wrong with my dog’s commercially made pet food?

You should contact the FDA Consumer Complaint Coordinator for your State. Information for FDA Consumer Complaint Coordinators is available on FDA’s website, www.fda.gov.

I’ve seen several food additive products that are supposed to make my dog feel better. Does CVM regulate these products?

Yes, CVM regulates them and companies that market pet food supplements should not be making any health claims about the products, i.e., claims that the product works to reduce or eliminate conditions suffered by a pet, or that the product does anything other than supply nutritional components. Under current law, dietary supplements for animals are not recognized as a class of products. Products for animals are either foods or drugs.

Under the Dietary Supplement and Health Education Act (DSHEA), some human food products are considered to be dietary supplements rather than food additives or drugs. However, FDA has determined that DSHEA was not intended and does not apply to animal feed, including pet food. Thus, products marketed as dietary supplements or “feed supplements” for animals still fall under the Federal Food, Drug, and Cosmetic Act (the Act) prior to DSHEA, i.e., they are considered “foods,” “food additives,” or “new animal drugs” depending on the intended use.

Under the Act, expressed or implied claims that establish the intended use of a product to cure, treat, prevent, or mitigate disease, or affect the structure/function of the body in a manner other than food (nutrition, aroma, or taste), indicated that the product is being offered as a “drug.” Unless the “drug” product has been shown to be safe and effective for its intended use via approval of a New Animal Drug Application (NADA), it could be subject to regulatory action as an adulterated drug. Certain substances have been marketed as nutritional supplements. However if there is no known nutritional requirement for the compound, it cannot legally be marketed as a nutritional supplement for animals.

I read in a magazine that I can contact CVM for free health care advice about my pet. Who do I talk to?

The Center continuously receives calls from individuals seeking free health care information about pets or financial assistance in providing -veterinary care for their pets. As a regulatory agency, CVM cannot offer pet health care advice or financial assistance.

The calls were prompted by a publication that said, erroneously, that CVM offered such assistance. We have contacted the publisher and asked it to stop publishing the incorrect information.

CVM has some fliers on pet care that can be found on its Home Page at: http://www.fda.gov/cvm/consumer.html.