AHI Statement Regarding FDA-CVM Clarification
July 16, 2024
The Animal Health Institute (AHI) commends the Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) for its decisive action in clarifying the prioritization of approved pioneer and generic products by veterinarians and pharmacists before considering compounded or illegally imported products.
The use of FDA-approved animal drug products should always be preferred. These products have undergone rigorous FDA review processes, providing assurance of their safety and efficacy. This critical step aligns with our longstanding advocacy for maintaining high standards in animal health care and preventing the risks associated with unapproved animal drugs.
For too long, the practice of compounding large quantities of animal drugs from bulk substances, without the stringent review that FDA-approved products undergo, has jeopardized animal health. These compounded preparations, often produced without proper oversight, have led to severe health consequences, including the death of animals due to incorrect dosages and product contamination. Such avoidable tragedies underscore the need for strict enforcement of existing guidelines.
Large-scale compounding from bulk substances also severely undermines the ability of animal health companies to bring new and innovative products to market, meaning fewer approved drugs are available to meet the many unmet medical needs in animal health.
The FDA’s recent clarification reinforces the importance of using scientifically reviewed, approved products. We urge the FDA-CVM to continue its vigilant enforcement of CVM Guidance 256 – Compounding Animal Drugs from Bulk Drug Substances (August 2022). Ensuring that veterinarians and pharmacists prioritize approved products will enhance the quality of care provided to animals, mitigate the risks associated with unregulated compounded animal drugs from bulk drug substances, and provide a greater incentive for innovation.