The Truth About Compounding for Animals from Bulk Substances

The Animal Health Institute (AHI) is a trade group representing pharmaceutical manufacturers with an interest in veterinary medicine. Despite its claim to support what it calls “legitimate animal drug compounding,” it has long opposed many uses of compounding for major species, such as dogs, cats and horses, in modern veterinary practice. The organization espouses the viewpoint that using bulk ingredients to compound medications for use in animals is “illegal.” On June 4, 2013, in an Open Letter to Veterinarians, the AHI asserted:

“In recent days and weeks veterinarians have received communications from compounding pharmacies regarding Congressional consideration of legislation on drug compounding. We, the Animal Health Institute (AHI), have been prominently mentioned and mischaracterized in those communications.”

At the time of its Open Letter to Veterinarians, the AHI also issued a tortured legal analysis to support its claim that compounding from bulk substances for animal use is not legal. It is on this false premise that the AHI is able to claim that the original version of Senate Bill 959 (“The Pharmaceutical Compounding Quality and Accountability Act”) ...

“... is more permissive than current law. It would legalize a certain amount of needed compounding from bulk active ingredients. It would do nothing to restrict current legal compounding–the pharmacy manipulation of approved drugs under a veterinary prescription to meet the needs of a particular patient. It would also provide a mechanism for medically necessary compounding from bulk substances where there are no approved products that will meet a medical need. We have asked Congress to legitimize necessary compounding from bulk substances by directing FDA to create and maintain a list of products or substances that can be compounded from bulk while making it clear that all other, non-listed compounding from bulk remains illegal.”

AHI supports policies that would dramatically re-shape modern veterinary practice, by reducing the number of active ingredients available for compounded medications to a “positive list” of drugs that may be compounded, which would be extraordinarily restrictive compared with current practices.

The AHI also continues to hold the self-serving, scientifically untenable and ultimately dangerous point of view that all compounded medications must be made from the “approved drugs” they manufacture. In this, the AHI demonstrates that its motives are for its members’ profits, not animal health. (For a detailed and accurate discussion about the need to use of active pharmaceutical ingredients in compounding for animals, see What are Bulk Ingredients and Why are they Necessary in Compounding.”) 

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