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What you need to know about GFI #256 and the changing landscape of compounding medicine
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GFI #256 and compounding medication is the topic of this episode of The Vet Blast Podcast. Marcy Bliss, CEO of Wedgewood Pharmacy, joins Adam Christman, DVM, MBA, to explain the ins and outs of this new FDA guidance.
Below is a partial transcript. Listen to the full podcast for more.
Marcy Bliss: Over many years, FDA has been asserting that it should regulate compounding from bulk drug substances in animal health. So to facilitate that, they've recently released a final guidance to kind of frame up their current thinking, and this guidance is called the GFI #256....Now, this is not a law or regulation. It's not a statute, but the agency has announced its intention to enforce primarily to pharmacy enforcement...For me, I think the broad intent is to ensure that if a veterinarian can use commercial products that they do so, and that compounding is used for its intended purpose purpose, which is really to provide customized medication when the veterinarian determines that an FDA-approved product is not the best treatment for patients. So, either it's a compliance issue, like you said, or the drug isn't available in the marketplace, like potassium bromide, or the drug needs to be changed...Maybe it's available as a tablet and it needs to be an injectable or damaged drug.
So the FDA, I think, really just wants to ensure the appropriate use of compounded medication. Of course, we believe veterinarians are already using it appropriately, but the FDA wants to put this guidance in place, I think, to put some guardrails and a framework around that.