The Animal Health Institute welcomes Final Guidance for Industry #256 – Compounding Animal Drugs from Bulk Drug Substances – and we urge the Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) to exercise enforcement of this new guidance.
We support animal drug compounding from approved products by the prescription of a veterinarian for an individual patient. This type of animal drug compounding is permitted by law and is unaffected by this guidance. Guidance for Industry #256 addresses compounding of animal drugs from bulk substances without a prescription. The Guidance is intended to draw a line between bulk compounding that is necessary for animal health and will be permitted by enforcement discretion and that which is illegal and will not be allowed.
For too long a few pharmacies have threatened animal health by making large quantities of products that are copies of approved animal drug products. Yet these compounded preparations are not submitted to the rigorous FDA review process that provides confidence in safety and efficacy. The practice of illegally making large quantities of compounded drugs from bulk substances has led to the death of animals due to incorrect amounts of active ingredients or product contamination. Such tragedies are avoidable. Publication of Guidance for Industry #256 provides rules for compounding animal drugs from bulk active substances and should contribute to protecting animal health.