The wait is finally over. On April 14, 2022, the Food and Drug Administration (FDA) published its guidance for industry #256 (GFI 256), describing FDA’s position on the legality of compounding animal drugs from bulk ingredients and the limited circumstances under which FDA will exercise enforcement discretion. While FDA reiterates its long-standing position that all compounding of animal drugs from bulk drug ingredients is subject to the animal drug provisions of the Food, Drug, and Cosmetic Act (FD&C Act), and therefore unlawful, FDA will not take enforcement action against certain compounding activities in the following three areas:

This article provides a brief overview of the circumstances in which FDA generally does not intend to take enforcement action against compounding in the areas listed above. We will also take a look at some of the differences when compared to compounding human drugs from bulk under Section 503A of the FD&C Act.

Currently, FDA generally does not intend to take enforcement action against the compounding of animal drugs from bulk drug ingredients for any nonfood-producing animal when all of the circumstances below are present:

Several of these requirements go beyond current practice for many compounders and may represent some compliance difficulties. Specifically, the requirement that the pharmacist document why the product is not a copy and why a legally marketed drug cannot serve as a source of active ingredient. Note, these two requirements are under review by the Office of Management and Budget, under the Paperwork Reduction Act of 1995, and are not for current implementation.

Similarly, FDA will permit compounding of drug products without a patient-specific prescription in limited conditions:

GFI 256 permits limited compounding from bulk for food-producing animals, including antidotes for toxicoses in food-producing animals, and for sedatives and anesthetics for free-range animals. Other uses of compounded drugs in food-producing animals are prohibited.

GFI #256 confirms that animal drug compounding is not subject to the same requirements of Section 503A compounding human drugs from bulk substances.

Here are some of the similarities and differences between compounding from bulk for humans and animals.

Quarles & Brady will be closely watching the implementation of the policies outlined in GFI #256.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Quarles & Brady LLP | Attorney Advertising

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.

Copyright © JD Supra, LLC