FDA Continues Proposed Extra-Statutory Authority Over Compounded Animal Drugs

By Nancy E. Halpern, D.V.M., Fox Rothschild LLP Attorneys at Law
Without clear statutory authority, FDA has proposed to expand its legal authority over veterinarians and veterinary compounding pharmacies in its newly released “Revised Draft Guidance on Compounding Animal Drugs from Bulk Drug Substances,” (#256) as announced on November 19, 2019.
FDA continues to describe the use of certain compounded medications for animals as violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which it will not enforce under certain prescribed circumstances.
As stated in Guidance #256: "The policies described in this document aim to protect human and animal health by limiting the use of animal drugs compounded from bulk drug substances primarily to situations in which a veterinarian is acting within a valid veterinarian client-patient relationship (VCPR) 3 and there is no medically appropriate drug that is FDA approved, conditionally approved, or on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (indexed) to treat the animal."
While FDA states that the “FD&C Act does not generally distinguish between compounding animal drugs from bulk drug substances and other methods of animal drug manufacturing . . . [t]he law permits compounding of animal drugs [only] when the source of the active ingredient is a finished FDA-approved drug, and not a bulk drug substance.”  (Emphasis added).
FDA proposed certain labeling and adverse reporting requirements for drugs compounded pursuant to patient-specific prescriptions for nonfood-producing animals, drugs compounded for office stock for nonfood producing animals, and drugs compounded for use as antidotes for food-producing animals.  Veterinarians administering or dispensing antidotes used for food-producing animals must also provide scientifically-based withdrawal times.
Also, without statutory authority, FDA requests input from the purportedly regulated community about a “List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals.”