In a guidance posted today, the Center for Veterinary Medicine (CVM) discusses its enforcement discretion policy for the use of bulk substances in the compounding of drugs used for non-food-producing animals and, to a more limited extent, for food-producing animals.
Unlike the statute and regulations for human drugs, there are no provisions for compounding animal drugs using bulk drug substances. As the FDA notes in the guidance:
“The law permits compounding of animal drugs when the source of the active ingredient is a finished FDA-approved drug, and not a bulk drug substance. Specifically, the extralabel use provisions of the FD&C Act (section 512(a) (4) and (5)) permit the compounding of animal drugs made from FDA-approved animal or human drugs, provided the conditions for legal extralabel use described in the FD&C Act and the implementing regulations at 21 CFR part 530 are met. These regulations state that, ‘[n]othing in this part shall be construed as permitting compounding from bulk drugs.’ 21 CFR 530.13(a).”
The FDA does propose a nomination program for bulk drugs to use in compounding for animals akin to that for human drugs, but, in the meantime, has issued this guidance to outline how it will exercise enforcement discretion until the program is in full swing. The guidance outlines different requirements (as noted above) for non-food-producing and food-producing animals so it is important for those involved in compounding to understand the differences, understand the Agency’s concerns, and ensure that you are meeting the spirit of the Agency’s enforcement guidance. The full guidance can be found here.