July 15, 2011

 

 New brochure explains regulations on compounding

posted June 29, 2011
 

mortar and pestle 

A new brochure summarizes the Food and Drug Administration's requirements for compounding preparations for veterinary use.

The Animal Health Institute, the American Veterinary Distributors Association, and the AVMA developed the brochure.

The brochure begins with the following summary of compounding:

"Compounding that is consistent with the FDA Extra-Label Drug Use regulations is the customized manipulation of an approved drug(s) by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient. For example, mixing two injectable drugs is compounding. Preparing a paste or suspension from crushed tablets is another example of compounding. Likewise, adding flavoring to a drug is compounding. Be aware, however, that products are being promoted to veterinarians under the guise of compounding that do not fit this definition. According to the FDA, legal compounding is not the formulation of preparations from bulk or raw active ingredients. Compounding should not be used as a way of circumventing the drug approval process or producing a product so it can be sold for less cost than an FDA-approved drug."

Sections of the brochure cover federal regulations for veterinary compounding, questions to ask compounding pharmacies, characteristics of FDA-approved products versus compounded preparations, and other useful information. One section discusses the need for compounding from raw active ingredients in certain situations to treat conditions for which no FDA-approved product is available, such as compounding poison antidotes available only as bulk chemicals.

The compounding brochure is available in PDF form as a free download at www.avma.org/products by looking under "Scientific Reference & Government Materials."