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U.S. Department of Health and Human Services

Animal & Veterinary

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Ask CVM - July/August 2003

FDA Veterinarian Newsletter July/August 2003 Volume XVIII, No 4

The CVM Home Page receives quite a bit of mail. The questions and answers featured here are composites of multiple questions the Home Page has received on the same topic. If you would like to send a question to the CVM Home Page and select “contact CVM” or write us directly at CVMHomeP@cvm.fda.gov.

We are a manufacturer of human medical devices. We want to expand our business and develop medical devices for pets. Please let me know if there are any regulations for pet medical devices. If so, where can I find the detailed information?

While FDA does not require pre-approval of veterinary medical devices, we do ask that you submit a copy of all labeling and promotional materials for review. Please click here for additional information.

I purchased a bag of my regular dog food and it is spoiled. How do I file a complaint about this product?

You should contact the Complaint coordinator at the FDA District Office in your area. A listing of the complaint coordinators can be found at http://www.fda.gov/opacom/backgrounders/complain.html.

I am interested to know if the FDA has legislation/codes/guidelines determining how a veterinary medicine may be distributed? As such, what criteria do you use to decide if the product should be confined to veterinary surgeons or made available over the counter?

FDA has the responsibility for determining the marketing status (prescription, over-the-counter, or Veterinary Feed Directive) of animal drug products based on whether it is possible to prepare “adequate directions for use” under which a layperson can use the drugs safely and effectively. An animal drug which is not safe for animal use except under the professional supervision of a licensed veterinarian because of:

  1. its toxicity or other potential for harmful effects, or
  2. the method of its use, or
  3. the collateral measures necessary for its use

is an Rx drug if it is not possible to prepare “adequate directions for use” under which a layperson can use the drugs safely and effectively. Such products can be dispensed only by or upon the lawful written order of a licensed veterinarian. Products for which adequate directions for lay use can be written must be labeled for over-the-counter (OTC) use under existing law. Safe use includes safety to the animal, safety of food products derived from the animal, safety to the persons associated with the animal, and safety in terms of the drug’s impact on the environment.

Effective use of a drug product assumes that an accurate diagnosis can be made with a reasonable degree of certainty, that the drug can be properly administered, and that the course of the disease can be followed so that the success or lack of success of the product can be observed.

The same drug substances can be marketed in a number of different dosage forms, intended for use by different routes of administration, and in different species of animals. Thus, these drug products may be appropriately labeled Rx in some cases and OTC in others. Rx products must bear the legend: ”Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

I would like to know if the heartworm medications that I can buy from Internet pharmacies are FDA-approved and not imported.

Before dealing with internet pharmacies you should see the information on FDA’s Home Page (www.fda.gov/oc/buyonline/default.htm). We recommend that you only deal with a reputable pharmacy that can assure you that the products you are purchasing are approved for sale in the United States. We do not have jurisdiction over products produced overseas and you have no guarantees that these products have been made to the same standards as drugs produced (and approved) for sale in the U.S.

I would like to know what I have to do to import shampoo, conditioner, perfume, soap to use in dogs and cats. Does it need approval or can I just bring it? Does it need to be regulated or tested here?

The animal counterpart of a cosmetic is commonly referred to as a “grooming aid.” The Act defines a cosmetic as pertaining only to human use (201(i)). Therefore, products intended for cleansing or promoting attractiveness of animals are not subject to FDA control. However, if such products are intended for any therapeutic purpose or if they are intended to affect the structure or function of the animal, they are subject to regulation as new animal drugs under the FD&C Act.

Therefore, unless they are intended for any therapeutic purpose, i.e., for treatment of a disease, or intended to affect the structure or function of the animal, you do not need approval to bring these products into the U.S.