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AABP Executive Director Dr. Fred Gingrich is joined by AABP Past President Dr. Mike Apley, a clinical pharmacologist from Kansas State University. Apley discusses the FDA Guidance for Industry (GFI) #256 which can be found at this link. We discuss that bulk compounding using active pharmaceutical ingredients (API’s) for use in food animals is prohibited by AMDUCA by FDA. AMDUCA is codified in 21 CFR 530.15 found on this page. GFI #256 provides guidance on products that may be used in food animals which is limited to poison antidotes. FDA will create a list, based on nominations, for bulk compounded products for use in food animals as poison antidotes where they will exercise regulatory discretion. 

 Bulk compounded products have no guarantee of safety, efficacy, purity, potency, bioavailability or stability. Compounding from approved FDA products, such as mixing two products together such as dexamethasone and vitamins into a bottle of IV fluids, is not bulk compounding. Products that are no longer available or on back-order cannot be compounded from bulk products. Veterinarians should always ask their pharmacies if they are using bulk compounding to create products since this would be illegal use in food animals. Apley also reminds us that the veterinarian is responsible for providing all meat and milk withdrawal intervals for all products prescribed for us in cattle and FARAD is an excellent resource to provide assistance in calculating a justification for withdrawal intervals. Submit your cases to FARAD at this link. 

 Apley discusses a document that was produced in collaboration with the American Association of Swine Veterinarians that can be found on the AABP Committee on Pharmaceutical and Biologics Issues resources page at this link. This document discusses the legalities of using compounded products, specifically ponazuril, diclazuril and toltrazuril for the treatment of coccidiosis. Veterinarians can prescribe ponazuril for ELDU as long as all parts of AMDUCA are met and they are using the FDA approved equine product. Diclazuril is a feed pellet and extra-label use of this product in feed is prohibited. Toltrazuril has no approved product in the US and would be prohibited to use. Apley reminds us that veterinarians are the responsible party for ensuring legal and judicious drug use when considering extra-label use and be aware of the prohibition of using bulk compounded products in food animals that are not on the FDA list of poison antidotes. 

Contact Dr. Apley at [email protected]