I am reaching out in response to a recent VIN News Service story related to the U.S. Food and Drug Administration's oversight of compounded products.
Edie Lau's March 12 article How FDA effort to limit veterinary compounding is unfolding highlighted just a few of what are significant differences between FDA-approved products and products compounded from bulk drug substances.
The FDA's review process in no way impedes good clinical practice as some in the article suggested. Rather, the FDA's oversight provides reassurance to veterinarians and their clients that the products their pets are receiving are safe, efficacious and manufactured in accordance with Current Good Manufacturing Practice standards approved by the FDA.
Compounded products are not equivalent to FDA-approved generic or branded commercial products and should only be used when clinically necessary for a particular patient or in specific situations involving a shortage of a critical drug.
FDA-approved commercial products undergo significant testing and oversight, both prior to approval and on a regular basis following approval. The manual and variable processes and environmental conditions under which compounded medications are made may affect the consistency of dosage, safety and stability of the compounded medication. Compounded formulations may use excipients or other additives that affect the absorption, bioequivalence and efficacy of the medication, and active pharmaceutical ingredients may not be evenly dispersed.
Further, the shelf life, supply chain conditions (e.g., temperature range for shipping and storage), label details, containers and suppliers must be tested and proven in advance of FDA approval of generic and branded commercial products, while none of these variables are required to be tested or controlled for compounded medications.
FDA and its Center for Veterinary Medicine ensure veterinarians have access to drugs to treat patients and protect animals from unsafe drugs by applying rigorous scientific review before approval and monitoring for continued quality, safety and effectiveness once the drug is marketed. Any suggestion that these standards are too high or unnecessary is irresponsible.
Dr. Jessica Murdock is a senior pharmacovigilance veterinarian for Boehringer Ingelheim Animal Health USA Inc.