The Guidance published in the Federal Register last April for “veterinarians, State-licensed pharmacies, and Federal facilities” regarding compounding animal pharmaceuticals will take effect April 2023. The guidance focuses on compounded drugs “for use in non-food-producing animals, as antidotes in food-producing animals, or as sedatives or anesthetics in free-ranging wildlife under limited circumstances when no other medically appropriate treatment options exist.”
Drug compounding is the creation of a unique drug tailored to the needs of the patient by mixing or altering separate drug substances. Pursuant to the Federal Food, Drug, and Cosmetic Act (the “Act”), even if the constituent drugs are FDA-approved, the compounded drug made therefrom is a “new animal drug” subject to approval, conditional approval, or indexing, as detailed in the Act. FDA recognizes that when there is no medically-appropriate alternative drug available that has been approved, conditionally approved or indexed, then compounding may be medically necessary. Broadly speaking, the guidance is aimed at emphasizing limited use of compounded drugs and clarifying enforcement efforts.
With regard to the enforcement of the Act against those creating and utilizing compounded drugs, the guidance wants to clarify when a compounding drug is to be used and emphasize the discretion that FDA may exercise in enforcing the Act. The enforcement discretion policy set forth in the guidance provides that, “FDA generally does not intend to take enforcement action against the compounding of drugs from bulk drug substances intended for use as antidotes for treating toxicoses in food-producing animals or for use as sedatives or anesthetics in free-ranging wildlife species for violations of the requirements for animal drug approval, adequate directions for use, and [Current Good Manufacturing Practice]” when each of six specific circumstances exist. A more detailed description of the circumstances is in the guidance, but below is a summary:
- Compounding is done or supervised by a veterinarian or licensed pharmacist;
- The constituent drugs are all on the list described below;
- The prescribing veterinarian, having established a valid doctor-client-patient relationship, ensures and properly documents that residues of the compounded drug are no longer present at the time of slaughter or harvest;
- The prescribing veterinarian ensures that the animal does not enter the food supply too soon or at all (e.g., tagging free-range animals with a “do not harvest until” date);
- The pharmacist or veterinarian properly reports any adverse events or product defects associated with the compounded drug; and
- The compounded drug is properly labeled with all required information.
As noted in number 2 above, the FDA describes in the guidance how it will be implementing “dynamic lists,” namely the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals and the List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species. The FDA also implemented a nomination process for additional bulk drugs to be added to the lists and intends to update the foregoing lists on a rolling basis.
You can browse comments submitted in response to the FDA guidance between its publication and the comment deadline of May 16, 2022.