New FDA draft guidance on compounding may not meet your needs. You could help change that


The US Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM) recently released its draft guidance for industry (GFI) #256 for animal drug compounding.

Compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual animal or a small group of animals. Animal drugs compounded from bulk drug substances (BDS) aren’t reviewed by the FDA, which means the agency hasn’t approved them as safe and effective for their intended use.

Draft guidance documents represent the FDA’s current thinking on a particular subject. Sort of like a rough draft or a work in progress, they aren’t binding and don’t have the force of law. In fact, the FDA CVM would like your feedback.

And giving it to them is in your interest. Because they do listen.

For example, in May 2015, FDA CVM introduced GFI #230 for animal drug compounding. It didn’t meet the needs of veterinarians. Following significant feedback from the American Veterinary Medical Association (AVMA) and the veterinary community, the agency formally withdrew that guidance in November 2017. In fact, the new draft guidance draws from that extensive veterinary feedback.

GFI #256 acknowledges that in the limited circumstances where there is no FDA-approved, conditionally approved, or indexed drug that can be used to treat an animal with a particular condition, an animal drug compounded from bulk drug substances may be a medically appropriate treatment.

Perhaps most importantly, GFI #256 identifies circumstances under which the FDA doesn’t intend to take regulatory action against the compounding of drugs from BDS when no other medically appropriate treatment options exist.

“Compounding of animal drugs may help veterinarians meet the legitimate medical needs of their patients when FDA-approved products are not available to address the diverse range of animal species they treat,” said Steven M. Solomon, DVM, MPH, director of the FDA CVM in a statement.

In other words, the FDA is willing to let you off the hook for doing what may be best for your patient, in specific circumstances, even if it conflicts with FDA guidelines.

However, this is not a free pass: As Solomon goes on to note, “[B]ecause compounded drugs are not FDA approved, there can be serious consequences if they are not formulated correctly or contain contaminants. In some situations, compounded drugs have even caused animal suffering and death.”

The subject can be confusing and contradictory, so NEWStat reached out to Gail Golab, PhD, DVM, MANZCVS, DACAW, chief veterinary officer of the AVMA to find out their view.

“Because compounding is a critical tool for veterinarians, the AVMA is committed to preserving veterinary access to necessary compounded preparations while ensuring that—as for all medications—compounded products meet recognized quality standards for safety and efficacy,” Golab said, and noted that the AVMA’s position on GFI #256 is currently under review. “The AVMA has in the past and continues to work hard to keep veterinarians informed about best practices in veterinary compounding and to listen to and share veterinarians’ needs and concerns so that they are considered when state and federal regulatory decisions are made.”

To that end, when the FDA first issued its GFI #256 on Compounding Animal Drugs from Bulk Substances, the AVMA shared a blog with its members seeking comments on the draft guidance.

“Based on feedback received from our members, the AVMA will be sharing its thoughts on the draft guidance with the FDA in accord with FDA’s established deadline for those comments,” Golab said.

That deadline is February 18, 2020.

So, to ensure the FDA considers your comment on GFI #256 before the agency begins work on the final version, submit your comments by February 18, 2020. Read more about the FDA's position on compounding here.

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