FDA's New Guidance for Compounding Animal Drugs from Bulk Substances

Background for Veterinarians

FDA’s Center for Veterinary Medicine (CVM) recently issued draft guidance (GFI #256) that, if finalized, threatens to have serious and damaging ramifications for your veterinary practices and their patients. You may recall in 2015, FDA introduced guidance (GFI #230) that was substantially similar on the compounding of animal drugs from bulk drug substances. Following significant pushback from the veterinary and pharmacy community and intervention from members of Congress, FDA formally withdrew that guidance in 2017.

What is the new GFI #256? 

GFI #256 is a draft guidance that would establish FDA’s policies about how and when they would seek enforcement action against veterinarians, state-licensed pharmacies, and federal facilities that compound animal drugs from bulk drug substances. FDA is creating both a positive and negative list for compounding from bulk ingredients. The positive list proposed contains a mere seven active pharmaceutical ingredients.

 If finalized, what repercussions might the GFI #256 have for my practice and patients?

FDA is taking this action, in the form of a supposed “non-binding” guidance document, that places veterinarians and veterinary compounding pharmacies under extremely burdensome restrictions that prohibit veterinarians and pharmacies from properly treating patients, when 99% of veterinarians report that access to compounded medication is important or very important to their practice. Especially important to note is that Congress has not passed legislation giving FDA authority to make such a substantial change in animal health.

If finalized,

  •  Your access to compounded medications would be severely restricted;
  • The quality and safety of compounded medications would suffer;
  • The cost of your compounded medications would drastically increase; and
  • You and your practice would be burdened by additional FDA regulatory oversight.
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