Safe and effective medicines are important tools for veterinarians, and the FDA is tasked with ensuring those tools that are allowed in the marketplace will improve and protect animal health.
If used correctly and legally, the process of compounding, which is the manipulation of an approved drug to meet the medical needs of a specific animal patient, can help veterinarians treat more animals. Legal compounding includes things like mixing two injectable drugs, preparing a paste or suspension from crushed tablets, or adding flavoring to a drug.
Unfortunately, some large compounding pharmacies have exploited loopholes in current regulations to become de facto drug manufacturers. They import bulk drug substances from overseas and compound large quantities of products that are copies or near copies of FDA-approved products, then market those products to veterinarians as cheap alternatives to approved drugs.
This illegal behavior endangers animals and undermines the FDA drug approval process. Documented cases of animal deaths due to illegal compounding should concern all animal lovers. And allowing companies to circumvent the rigorous research and safety trials that ensure products are safe and effective not only puts animals at risk, it can chill investment in needed therapies.
Currently, the FDA is developing guidance to enhance the safety of compounded drugs, which will benefit animals now and ensure continued investment in innovative solutions to protect animal health.
While we await further guidance from the FDA, pet owners’ first stop for advice on medicines should always be their veterinarian.