Compounding issues

Animal Compounding and GFI #256

It’s not only beyond the agency’s authority, it doesn’t make sense … and it puts animals in jeopardy.

The issue

Action requested

Simply that FDA withdraw GFI #256 in its entirely. Representative Ted Yoho, himself a veterinarian, is already taking the lead with a "Dear Colleague" letter circulating, asking other members of Congress to join him — and representatives Donald Norcross and Mark Pocan — in demanding that FDA Commissioner Stephen Hahn withdraw the guidance.

The FDA, it seems, wants to get into regulating veterinary medicine. And it’s doing it in a clunky, dangerous way.

On November 19, 2019, FDA issued a draft guidance for industry (GFI #256) on animal drug compounding — a GFI that is remarkably similar to one it issued in 2015, and that was subsequently withdrawn in large part because it exceeded FDA's statutory authority, interfered with the state regulated practice of veterinary medicine and pharmacy, and endangered the health of companion and exotic animals.

The GFI number has changed. Nothing else has.

Like its predecessor, GFI #256 is not based on any federal statute, it greatly exceeds the agency’s regulatory authority, and — most importantly — it needlessly interferes with veterinarians’ ability to provide the best care for their animal patients.

The details:

FDA bases its authority for GFI #256 on a misreading of language in a section on use of compounded drugs in the Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994 — a section that states clearly that it has nothing to do with compounding from bulk drugs. On that mistaken authority, FDA would needlessly interfere with veterinarians' ability to provide the best care for their animal patients.

Today, veterinarians who want to prescribe a compounded medication for a specific patient, based on their knowledge and experience, can simply do so — just as other prescribers of human drugs may. Under GFI #256, however, veterinarians will be forced to spend time documenting why the compounded drug is necessary — how it produces a clinical difference and what the medical rationale for the prescription is. That's a requirement without precedent, and it's required of no other prescribers. Moreover, without the vet's documentation that a drug may be compounded from bulk substances, compounders will be restricted to compounding only with FDA-approved drugs — which will most certainly increase costs to animal owners.

Today, vets keeps a variety of compounded medications on hand in their offices for immediate administration when needed — again, based on their knowledge and experience. But under GFI #256, the FDA would provide a list of the only bulk ingredients compounders would be permitted to use when making veterinary medications. That list will restrict the veterinarians' ability to treat animals — because FDA, not the vet or the pharmacist — decides which medications are best, even if state law allows other medications or preparations. The FDA has no statutory authority to practice medicine or to develop such a list.

This provision is particularly dangerous, as veterinary clinics serve as hospitals and emergency rooms, and veterinarians must have commonly used compounded medications available to meet the immediate needs of animals in their care. The FDA has no business interfering in animal health. Congress specifically chose not to include animal health provisions in the Drug Quality and Security Act of 2013, and FDA should not be allowed to act as if it has statutory authority that clearly does not exist.