Reminder Regarding FDA's position on Compounding domperidone for Horses

EQUIDONE (domperidone) Gel - Pharmacy Professionals

Dear Pharmacy Professional:

The U.S. Food and Drug Administration (FDA) recently approved EQUIDONE (domperidone) Gel for the prevention of fescue toxicosis in pregnant mares. Fescue toxicosis is associated with reproductive problems in both the mare and her foal around the time of birth. A mare at-risk for fescue toxicosis is treated with EQUIDONE Gel once daily starting 10 to 15 days before her expected due date. She may continue to be treated up to 5 days after giving birth. Please see the approval announcement at http://www.fda.gov/AnimalVeterinary/NewsEvents/ CVMUpdates/ucm235719.htm.

EQUIDONE Gel, distributed by Dechra Veterinary Products, is available in the United States as an oral gel. The gel comes in disposable 25 cc syringes that can be used for multiple doses. The strength is 110 mg domperidone per cc of gel. EQUIDONE Gel is the only FDA-approved animal drug that contains domperidone as the active ingredient. Now that EQUIDONE Gel is approved and available for veterinary use in the United States, domperidone should not be imported from other countries or compounded from bulk.

Each FDA-approved animal drug goes through a rigorous evaluation process. Before the drug is approved, it is clinically tested for safety and effectiveness in the target animal species. FDA also thoroughly inspects and evaluates the adequacy of the manufacturing process to make sure the drug’s identity, strength, quality, and purity are preserved. FDA continues to monitor the drug’s quality and safety after it is approved. An animal drug that is compounded from bulk drug ingredients is not FDA-approved. The safety and effectiveness of the compounded drug, as well as the adequacy of the manufacturing process, have not been evaluated.

There may be instances where you may be asked to compound domperidone for specific patients that require the drug in strengths or forms that are not offered by EQUIDONE Gel. In these limited cases, domperidone can only be legally compounded if it is done by or on the order of a licensed veterinarian within the practice of veterinary medicine, and if FDA-approved EQUIDONE Gel is used as the starting material. Additional requirements and information on legal animal drug compounding are available in Title 21, Code of Federal Regulations, Section 530.13.

At FDA’s Center for Veterinary Medicine (CVM), we are committed to promoting and protecting animal health by ensuring safe and effective drugs are available for animals.

For more information, please contact the CVM Communications Staff at 240-402-7002 or AskCVM@fda.hhs.gov.

Sincerely,

FDA’s Center for Veterinary Medicine

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Page Last Updated: 04/20/2015 

quoted from here: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm235691.htm