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U.S. Department of Health and Human Services

Animal & Veterinary

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Ask CVM - May/June 2003

FDA Veterinarian Newsletter May/June 2003 Volume XVIII, No 3

The CVM Home Page receives quite a bit of mail. Starting with this issue, the FDA Veterinarian will feature samples of the types of inquiries that come in to the Home Page and how CVM responds to them. The questions and answers featured here are composites of multiple questions we have received on the same topic. If you would like to send a question to the CVM Home Page,  select “contact CVM” or write us directly at CVMHomeP@cvm.fda.gov.

I reported an adverse drug reaction to CVM by submitting a “Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report” (Form FDA1932a). How can I get a copy of the form I sent in for my records?

You can obtain a copy of the report you submitted by filing a Freedom of Information (FOI) request. Instructions for filing an FOI request are on the Internet. Please be sure to include as much detail as possible in your request.

I am trying to find a list of FDA restricted drugs for food animals, where would I find it?

There is a list of drugs that are prohibited from use in food animals outside of the specified label uses. These drugs are:

  • Chloramphenicol
  • Clenbuterol
  • Diethylstilbestrol (DES)
  • Dimetridazole
  • Ipronidazole
  • Other nitroimidazoles
  • Furazolidone
  • Nitrofurazone
  • Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine)
  • Fluoroquinolones
  • Glycopeptides

Additionally, use of drugs other than as specified on the label is not allowed except under the order of a licensed veterinarian within a valid veterinarian-client-patient relationship. Extra-label use of drugs in treating food-producing animals for improving rate of weight gain, feed efficiency, or other production purposes, or for routine disease prevention is prohibited under the Animal Medicinal Drug Use Clarification Act. See FDA and the Veterinarian on our Home Page for more details click here.

How can I find out if a drug is approved for use in dogs?

A listing of drugs approved for animal use in the U.S. can be found in the Green Book on the Internet. You can search the Green Book by the name of the drug, approved species, indications, ingredients, dose forms, trade names, or sponsor name.

We are looking into marketing dietary supplements for animals in the U.S. What can we say on the label about such supplements in terms of any benefits, claims, etc.?

Please be advised that if your product is a drug i.e., “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles other than food intended to affect the structure or any function of the body of man or other animals,” it will need to be the subject of an approved new animal drug application before it can be sold. This also includes articles intended for use as a component of a drug.

Information on filing a new animal drug application can be found here. If your product is a feed you can find information at CVM's web site.

You can find information about labeling of pet food products. You may also find helpful information in “Interpreting Pet Food Labels—Special Use Foods”.

There is also an article about animal dietary supplements in the FDA Veterinarian.