FDA issued final guidance on animal drug compounding
by Katie Pfaff
The US Food and Drug Administration shared final guidance April 13, 2022 on compounding animal drugs from bulk drugs. In medication compounding, FDA approved medications are combined, mixed, or altered to meet the need of a specific patient, or a few patients.
The guidance pertains to the practice of combing, altering, or mixing FDA-approved veterinary medicine. The above processes with FDA-approved drugs is allowed while compounding of medications from bulk drugs is not allowed as they are not evaluated for safety, efficacy, and adequate manufacturing processes.
"We are taking this step because we recognize the need for veterinarians to have access to compounded animal drugs that aren't available as approved products and that would make a clinical difference in patient care," said Steven M. Solomon, DVM, MPH, director of the Center for Veterinary Medicine of the FDA. "We believe this policy strikes the right balance between maintaining access to drugs veterinarians need to treat diverse animal populations, while ensuring human and animal health is protected from poorly-compounded products, or ones that attempt to copy existing FDA-approved drugs."
The guidance is an update from 2019 and incorporates information gathered from comments from veterinarians, compounders, and others since the initial release of the guidance. The updated and final guidance includes prioritization for enforcement, compounded drugs thought to pose highest level of risk, flexibility that exists for compounding for individual pets, emergency use, and ensuring access to needed medications.
Educational and engagement opportunities are available regarding the guidance. In fiscal year 2023, inspections will begin regarding the guidance.
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