Understanding Compounded Drugs

April Knudson, DVM, is an equine specialist with Merial Veterinary Services Here, she answers a question about compounded equine drugs.

Q. Some of my friends at the barn were talking about compounded drugs and whether or not they are safe to use. What are they? Should I ever use them?

A. The equine drug marketplace can be overwhelming. There are websites offering drugs for sale, products being sold at equine events around the country, and suggestions available from nearly everyone who has ever owned a horse. It's really important to sort through all of the information and consult with your veterinarian before giving anything to your horse.

First, let's clear up any confusion about what is meant by a "compounded drug." The American Association of Equine Practitioners (AAEP) defines a compounded drug as one that is created by manipulating an existing U.S. Food and Drug Administration (FDA)-approved drug. Examples include crushing a tablet to make a paste or gel, or adding a flavor to a drug to make it more palatable. For a drug to be legally compounded:

  • It must be compounded by a licensed veterinarian or pharmacist for a single horse to meet a specific need;
  • The horse owner must have a valid client-patient relationship with the prescribing veterinarian;
  • There must be no FDA-approved, commercially available drug that will appropriately treat the patient; and
  • The product must be made from an FDA-approved commercially available drug.

While the use of legally compounded drugs is recognized as an occasional necessity in equine health care, the AAEP cautions veterinarians to "limit the use of compounded drugs to unique needs in specific patients." Because of the time and financial investment required to bring a new equine drug to the marketplace, there are times when a legally compounded medication could be a veterinarian's only option. Conversely, some equine drugs are illegally compounded or manufactured. These drugs have not been through the stringent FDA approval process so they have not been demonstrated to be safe or effective for their intended use.

Before administering any drug to your horse, ensure that drug is FDA-approved or legally compounded. A drug's FDA approval status can be identified by looking for a New Animal Drug Application number, or, for generic animal drugs, an Abbreviated New Animal Drug Application number. The six-digit numbers and the statement "Approved by the FDA" are usually found on the drug's label. A list of approved drugs can also be found by searching the database at Animal Drugs @ FDA.

Remember, if you have any doubts, consult your veterinarian.

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