Background
In November 2019, FDA released draft guidance #256 to assert authority over the practice of compounding for animals from bulk ingredients. If finalized, this guidance threatens to have serious and damaging consequences, including lowering quality, increasing cost and preventing access to compounded medication.
For more than a century, veterinary medicine and pharmacy practices have been state-regulated, with licensed professionals taking care of patients under rigorous state laws and quality standards. This allows veterinarians to prescribe specialized medication when they feel a pet’s unique needs cannot be met by a commercial (FDA-approved) drug. This can include altering medication strength, compounding what isn’t available commercially, or flavoring medication to make it easier to administer. GFI #256 would limit access to most of the top medications now prescribed by veterinarians, make it much more difficult to individualize treatments for pets and prevent compounders from responding to medication shortages and recalls from pharmaceutical companies.
Frequently Asked Questions:
If finalized, what repercussions might GFI #256 have for my pet?
It’s estimated that costs for compounded medication could increase, on average, by 300%. Increasing costs will have a negative impact on pets, causing unnecessary suffering and death. Some owners may choose to put a pet down if it is too difficult to medicate or if they can’t afford to medicate their pets. This is heartbreaking and completely unnecessary.
Why would the cost go up so much?
The guidance would require veterinarians and pharmacies to start with FDA-approved finished goods for 98.5% of compounding ingredients, lowering quality and palatability, and significantly increasing compounding effort and time. Current state laws and rigorous quality standards permit the use of bulk active pharmaceutical ingredients from FDA-registered and inspected manufacturers rather than requiring veterinarians and pharmacists to prepare medication from finished goods.
What action are compounding pharmacies taking?
Our goal is to prevent FDA from severely restricting access to compounded medication for animals. We intend to ensure that all animals benefits from the skills, experience, and proven track record of compounding pharmacists to meet your pet’s unique needs.
We will:
▪ Keep you informed and engaged to ensure your access to compounded medication is secure;
▪ Collaborate with a coalition of animal health pharmacies and multiple industry associations to inform FDA on the impact of this guidance on people and their pets, and
▪ Work with Congress to get FDA to rescind GFI #256.