Since we first published “FDA Continues Proposed Extra-Statutory Authority Over Compounded Animal Drugs,” a number of impacted stakeholders have been expressing concern about the intended and unintentional consequences of FDA’s current approach.

First, as a result of widespread concern about the proposed guidelines, FDA will be extending the time to comment, previously scheduled to close on February 18, 2020.

According to the American Veterinary Medical Association (AVMA),

[t]he FDA agreed Friday to allow an additional 120 days for public review and commenting on its latest proposal to regulate compounding. Granting a request made by the AVMA on February 3, FDA officials announced they would receive comments on draft Guidance for Industry (GFI) #256, Compounding Animal Drugs from Bulk Drug Substances, until June 17.

As reported by Wedgewood Pharmacy, one of the largest compounding pharmacies in the United States, serving more than 40,000 prescribers of compounded medications, “Veterinarians Report That FDA’s Proposed Guidance Will Have a Significant Negative Impact on Animal Patients.

According to Wedgewood, “a coalition of the largest pharmacies serving veterinarians and animal patients in the U.S. commissioned the study. The survey results, including thousands of comments by veterinary professionals, are available at”

The survey reports on the responses of 1,849 veterinary professionals in the U.S., 78% of whom practice in small businesses with four or fewer veterinarians; 70% of respondents treat primarily companion animals. For 99.4% of those responding, having access to compounded medications when they are necessary in their medical judgement is important.

By grossly limiting, if not eliminating entirely, veterinarians’ use of bulk substances in compounded medications, many are concerned about their ability to provide adequate medical care for species for which FDA-approved drugs are not available, e.g., exotic, wild and zoo animals, animals involved in biomedical research.

In a letter to FDA from the AVMA, dated Feb 3, 2020, AVMA requested clarification about several sections in the Guidance, including: articles used for euthanasia and depopulation of food-producing animals; the use of compounded medications for the immobilization of “animals in zoos, wildlife rehabilitation clinics, and other similar settings [which are] . . . required not only to address animal safety and suffering, but also for human safety when caring for animals,” and use of large-volume parenterals, amongst other concerns.

On the other hand, the Animal Health Institute, a trade association representing the companies that develop and produce animal medicines, published an article on January 30, 2020 in support of FDA’s proposed guidance titled, “Animal Drug Compounding Guidance Will Protect Veterinarians and their Patients,” stating,

The animal health industry supports the use of compounding to address the medical needs of animal patients.  We do not support the ability of compounders to act like manufacturers and put patient health at risk.  This guidance document from FDA defines the difference between the two and we believe it should be finalized.

Undoubtedly, there will more news we will share about FDA’s Guidance #256.