November 19, 2019
“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. However, because 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,” said Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine. “In developing this guidance, we have sought to balance our concerns about the safety, effectiveness and quality of animal drugs compounded from bulk drug substances with the need for options when no FDA-approved, conditionally approved, or indexed drug can be used to treat an animal. It’s important to note that animal drug compounding is not meant to circumvent the animal drug approval process, but instead provides veterinarians with additional tools to help provide comprehensive medical care for their patients.”
Today, the U.S. Food and Drug Administration issued a new draft guidance for industry (GFI) #256, “Compounding Animal Drugs from Bulk Drug Substances,” which addresses situations in which, if the guidance is finalized, the FDA does not intend to take action for certain violations of the Food, Drug, & Cosmetic Act when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances:
- to fill patient-specific prescriptions for nonfood-producing animals;
- to compound “office stock” (certain drugs kept in the veterinarians’ supply) for nonfood-producing animals and
- to compound antidotes for food-producing animals.
The draft guidance acknowledges that in the limited circumstances where there is no FDA-approved, conditionally approved, or indexed drug that can be used to treat an animal with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.
Drug 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, and these drugs can play a critical role in veterinary medicine. Animal drugs compounded from bulk drug substances do not undergo review by the FDA, meaning that the FDA has not determined that these unapproved products are safe and effective for their intended use. Because of the safety benefits and protections of the pre-market review process and post-market monitoring of FDA-approved, conditionally approved and indexed drugs, veterinarians should only use drugs compounded from bulk drug substances if FDA-approved, conditionally approved or indexed drugs are not available to treat the animal.
The FDA previously published draft guidance GFI #230, “Compounding Animal Drugs from Bulk Drug Substances” for public comment in May 2015. After receiving feedback from stakeholders, including more than 150 comments on the guidance, the agency withdrew the guidance. FDA is publishing this new draft guidance for public comment and will actively engage stakeholders to gather feedback and comment on the agency’s position as described in draft guidance GFI #256.
Starting today, the agency is also accepting nominations to the “List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals.”
The FDA will continue to engage with the veterinary, pharmacy, compounding and animal health industries to ensure the unique viewpoints of all stakeholders are heard.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.