AAEP Issues Guidelines for Compounded Drugs
Updated: Wednesday, February 23, 2005 12:20 PM
Posted: Wednesday, February 23, 2005 12:20 PM
The American Association of Equine Practitioners, in an effort to educate members, has issued guidelines for the responsible use of compounded medications by veterinarians.
The AAEP tackled the subject at its annual convention last December. Veterinarians were told it's critical to make sure a generic drug is licensed and has been approved by the Federal Drug Administration.
Compounded medications generally are drugs combined to create a desired effect. Because they aren't licensed, they aren't subject to typical quality control standards. Use of compounded medications is illegal under strict interpretation of the Federal Food and Drug Cosmetic Act because compounded substances result in unapproved drugs, the AAEP said in its guidelines.
"While drug compounding serves a very legitimate and important purpose in animal health, manufacturers must abide by federal regulations in order to create a high-quality, safe product and encourage a fair marketplace for animal health products," the AAEP said in a release.
The guidelines list three types of drugs: FDA pioneer drugs, which have been tested for safety and efficacy under mandated standards; generic drugs, which are the equivalent to brand name drugs in dosage form and have labels that signify FDA approval; and compounded drugs.
"Preparation, sale, distribution, and use of unapproved new animal drugs is in violation of the (federal act)," the AEEP said in the guidelines. "The preparation of compounded medication from bulk drugs may be permissible in medically necessary situations when there is no approved product available or the needed compounded preparation cannot be made from an FDA-approved drug. Therefore, legal compounding can only begin with FDA-approved drugs in compliance with federal extra-label drug-use regulations."
The AAEP said legal compounding requires a valid relationship between veterinarians, clients, and patients. Vets should limit use of compounded medications to situations when the patients can be monitored, or for instances in which no other method is practical, the AAEP said.
Complete guidelines are available at www.aaep.org.
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